Background The long-term effects of treatment with sirolimus-elutingstents, as compared with bare-metal stents, have not been established.
Methods We performed an analysis of individual data on 4958patients enrolled in 14 randomized trials comparing sirolimus-elutingstents with bare-metal stents (mean follow-up interval, 12.1to 58.9 months). The primary end point was death from any cause.Other outcomes were stent thrombosis, the composite end pointof death or myocardial infarction, and the composite of death,myocardial infarction, or reintervention.
Results The overall risk of death (hazard ratio, 1.03; 95% confidenceinterval [CI], 0.80 to 1.30) and the combined risk of deathor myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to1.16) were not significantly different for patients receivingsirolimus-eluting stents versus bare-metal stents. There wasa significant reduction in the combined risk of death, myocardialinfarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34to 0.54) associated with the use of sirolimus-eluting stents.There was no significant difference in the overall risk of stentthrombosis with sirolimus-eluting stents versus bare-metal stents(hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there wasevidence of a slight increase in the risk of stent thrombosisassociated with sirolimus-eluting stents after the first year.
Conclusions The use of sirolimus-eluting stents does not havea significant effect on overall long-term survival and survivalfree of myocardial infarction, as compared with bare-metal stents.There is a sustained reduction in the need for reinterventionafter the use of sirolimus-eluting stents. The risk of stentthrombosis is at least as great as that seen with bare-metalstents.
Restenosis after percutaneous coronary intervention (PCI) reducesthe quality of life and increases the morbidity of patientswith this complication1; it may even increase the risk of death.2Drug-eluting stents are highly effective in preventing restenosisafter PCI.3 It has been anticipated that by reducing the rateof restenosis, drug-eluting stents may have the potential toimprove the long-term prognosis of patients treated with thesedevices. However, initial randomized studies focused on restenosisitself and had insufficient power and duration to assess theincidence of less frequent adverse events, such as death.
Recent reports have identified pathologic responses of the vesselwall to drug-eluting stents that may serve as precursors toadverse clinical events.4 Such studies have raised concern thatdrug-eluting stents might actually worsen, rather than improve,long-term prognosis. However, efforts to examine this issueby combining data from previous randomized trials have beenlimited to published trial-level data and have not includedall the relevant studies.5,6,7 The aim of this study was toassess the long-term outcome after implantation of sirolimus-elutingstents on the basis of data from individual patients from randomizedclinical trials comparing this device with bare-metal stents.
Methods
Inclusion Criteria
We included in our analysis the results of randomized clinicaltrials that compared sirolimus-eluting stents (Cypher or CypherSelect, Cordis) with bare-metal stents for management of coronaryartery disease if results for a mean follow-up period of atleast 1 year were reported or made available by the trials'investigators or sponsors.
Data Sources
We searched the National Library of Medicine (PubMed, at www.pubmed.gov),the National Institutes of Health clinical trials registry (www.clinicaltrials.gov),and the Cochrane Central Register of Controlled Trials (www.mrw.interscience.wiley.com/cochrane/cochrane_clcentral_articles_fs.html)for randomized trials comparing sirolimus-eluting stents withbare-metal stents in patients with coronary artery disease.We also searched Internet-based sources of information on theresults of clinical trials in cardiology (www.cardiosource.com/clinicaltrials,www.theheart.org, www.clinicaltrialresults.com. and www.tctmd.com),as well as conference proceedings from meetings of the AmericanCollege of Cardiology, the American Heart Association, and theEuropean Society of Cardiology. Relevant reviews and editorialspublished within the past year in major medical journals wereidentified and assessed for possible information on trials ofinterest. Searches were restricted to the period from January2002 through September 2006.
We found and screened 16 randomized trials,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23the main characteristics of which are shown in Table 1. Tworandomized trials, Reduction of Restenosis in Saphenous VeinGrafts with Cypher Sirolimus-Eluting Stent (RRISC)16 and Sirolimus-ElutingStent in the Prevention of Restenosis in Small Coronary Arteries(SES-SMART),19 were not included in this analysis because eachhad a mean follow-up of less than 1 year; the findings of thesetrials are displayed in Table 1 of the Supplementary Appendix(available with the full text of this article at www.nejm.org).
An electronic form containing the data fields to be completedfor individual patients was sent to all principal investigatorsor sponsors of the trials. Data from nine randomized trials8,11,13,14,17,18,20,22,23were provided by the principal investigators; data from theremaining five trials9,10,12,15,21 were provided by the sponsor,who had no role in the study design or analysis or in the writingof or decision to publish the manuscript.
The data requested for each patient included the date of randomization,treatment allocation, diabetes status, event status (includingdeath, myocardial infarction, coronary reintervention [percutaneousor surgical], and stent thrombosis and the respective datesof occurrence), and the date of the last follow-up visit. Alldata were thoroughly checked for consistency (logical checkingand checking against the original publications). Any querieswere resolved and the final database entries verified by theresponsible trial investigator.
We also evaluated each trial for the adequacy of allocationconcealment, performance of the analysis according to the intention-to-treatprinciple, and blind assessment of the outcomes of interest.We used the criteria recommended by Altman and Schulz24 andby Jüni et al.25 to decide whether the treatment allocationwas adequately concealed. Some trials used a modified intention-to-treatprinciple (i.e., excluding patients who did not receive thestudy stent) (see Table 2 of the Supplementary Appendix).
Study Outcomes
The primary end point of this analysis was death from any cause.Secondary end points were the composite of death or myocardialinfarction and the composite of death, myocardial infarction,or reintervention (major adverse cardiac events). We also assessedthe occurrence of stent thrombosis (see Table 2 of the Supplementary Appendixfor the end-point definitions used in individual trials). Itis important to note that in eight trials, data for patientswho underwent target-lesion revascularization were censoredwith respect to the subsequent assessment of stent thrombosis.The adjudication of events in each trial was performed by thesame event committee over the entire follow-up period.
Statistical Analysis
We performed survival analyses with the use of the Mantel–Coxtest stratified according to trial. Survival was defined asthe interval from randomization until the event of interest.Data for patients who did not have the event of interest werecensored at the date of the last follow-up visit. The log-ranktest was used to calculate hazard ratios and their 95% confidenceintervals (CIs).
Trials in which the event of interest was not observed in eitherstudy group were omitted from the analysis of that event. Fortrials in which only one of the groups had no event of interest,the estimate of treatment effect and its standard error werecalculated after adding 0.5 to each cell of the 2x2 table forthe trial.26
We assessed the heterogeneity across trials by the Cochran testand by calculating the I2 statistic (describing the percentageof total variation across trials that was due to heterogeneityrather than chance), as proposed by Higgins et al.27 We pooledhazard ratios from individual trials according to the methodof DerSimonian and Laird for random effects.28
Sensitivity analyses were performed by comparing the treatmenteffects obtained with each trial removed consecutively fromthe analysis with the overall treatment effects. In addition,we used a random-effects meta-regression analysis to estimatethe extent to which including four covariates — the natureof the study with respect to blinding (double blinding or nodouble blinding), the length of follow-up, the protocol-mandatedduration of dual antiplatelet therapy, and the presence of acutemyocardial infarction — as inclusion criteria for thetrial might have influenced the treatment effect. Using theMantel–Cox model, we checked for statistically significantinteraction between the treatment effect (sirolimus-elutingstent vs. bare-metal stent) and the presence of diabetes mellitus(the only prespecified subgroup that was analyzed).
All P values are two-sided. Results were considered to be statisticallysignificant at a P value of less than 0.05. Statistical analysiswas performed with the use of Stata software, version 9.2 (Stata).Survival curves are presented as simple, nonstratified Kaplan–Meiercurves across all trials and constructed with the use of S-Plussoftware, version 4.5 (Insightful).
Results
Our analysis included 14 trials and 4958 patients, 1411 of whomhad diabetes mellitus.8,9,10,11,12,13,14,15,17,18,20,21,22,23Table 1 displays the main characteristics of these trials. Theage of the patients in the trials ranged from 59.3 to 66.6 years,and the length of follow-up ranged from 12.1 to 58.9 months.
Figure 1A shows the absolute numbers of deaths in each trialaccording to treatment group, with the hazard ratio for eachtrial. There was no statistical evidence of heterogeneity acrossthe 14 trials. In total, there were 146 deaths (83 from cardiaccauses) in patients with sirolimus-eluting stents and 147 deaths(79 from cardiac causes) in patients with bare-metal stents.Overall, the use of sirolimus-eluting stents was associatedwith a hazard ratio for death of 1.03 (95% CI, 0.80 to 1.30;P=0.80), as compared with that of bare-metal stents.
Figure 1. Hazard Ratios for Individual Trials and for the Pooled Population and Kaplan–Meier Estimates for 5-Year Survival.
In Panel A, hazard ratios are shown on a logarithmic scale. The size of each square is proportional to the weight of the individual study, measured as the inverse of the estimated variance of the log hazard ratio. In Panel B, Kaplan–Meier curves are shown for survival for the pooled population during a 5-year period in each of the stent groups.
Sequential exclusion of each individual trial from the analysisof death yielded hazard ratios that ranged from 0.96 (95% CI,0.74 to 1.25) to 1.06 (95% CI, 0.84 to 1.34) and were not significantlydifferent from the overall hazard ratio (P0.71). No significantinfluence of prespecified covariates on the treatment effectwas observed, including the length of follow-up (P=0.44), theprotocol-mandated duration of dual antiplatelet therapy (P=0.69),the presence of patients with acute myocardial infarction inthe trial (P=0.56), or the presence of double blinding in thetrial design (P=0.70). Figure 1B shows the overall 5-year survivalcurves for the two treatment groups.
Figure 2A shows the absolute numbers of patients who died orhad a myocardial infarction in each trial according to treatmentgroup, with the hazard ratio for each trial. There was no statisticalevidence of heterogeneity across the 14 trials. In total, 241patients with sirolimus-eluting stents either died or had amyocardial infarction, as compared with 252 patients with bare-metalstents. Overall, use of sirolimus-eluting stents was associatedwith a hazard ratio for death or myocardial infarction of 0.97(95% CI, 0.81 to 1.16; P=0.76), as compared with use of bare-metalstents. Figure 2B shows the overall 5-year curves for survivalfree of myocardial infarction in the two study groups.
Figure 2. Hazard Ratios for Death or Myocardial Infarction and Kaplan–Meier Estimates for Survival Free of Myocardial Infarction.
In Panel A, hazard ratios are shown on a logarithmic scale. The size of each square is proportional to the weight of the individual study, measured as the inverse of the estimated variance of the log hazard ratio. In Panel B, Kaplan–Meier curves are shown for survival free of myocardial infarction for the pooled population during a 5-year period in each of the stent groups.
Figure 3A shows the absolute numbers of patients who died, hada myocardial infarction, or required reintervention in eachtrial according to treatment group, with the hazard ratio foreach trial. In total, 331 patients with sirolimus-eluting stentsdied, had a myocardial infarction, or required reintervention,as compared with 649 patients with bare-metal stents. Overall,the use of sirolimus-eluting stents was associated with a hazardratio for death, myocardial infarction, or reintervention of0.43 (95% CI, 0.34 to 0.54; P<0.001), as compared with theuse of bare-metal stents. Although the point estimates for individualtrials all favored sirolimus-eluting stents, there was a significantheterogeneity across trials with a high I2 value. Figure 3Bshows the overall 5-year curves for survival free of myocardialinfarction and reintervention in the two study groups.
Figure 3. Hazard Ratios for Death, Myocardial Infarction, or Reintervention and Kaplan–Meier Curves for Survival Free of Myocardial Infarction and Reintervention.
Panel A shows significant heterogeneity in the effect of treatment resulting from the differing magnitude of risk reduction observed in patients with sirolimus-eluting stents among the 14 trials. Hazard ratios are shown on a logarithmic scale. The size of each square is proportional to the weight of the individual study, measured as the inverse of the estimated variance of the log hazard ratio. In Panel B, Kaplan–Meier curves are shown for survival free of myocardial infarction and reintervention for the pooled population during a 5-year period in each of the stent groups.
No significant interaction between treatment groups and thediagnosis of diabetes was observed for any of the three endpoints of the study, including death (P=0.19), death or myocardialinfarction (P=0.39), and death, myocardial infarction, or reintervention(P=0.49). We nonetheless performed a separate analysis of therate of death in the subgroup of patients with diabetes. Figure 4Ashows the absolute numbers of deaths in each trial by treatmentgroup, with the hazard ratio for the subgroup of patients withdiabetes in each trial. There was no significant heterogeneityacross trials. In total, 59 patients with diabetes and sirolimus-elutingstents died, as compared with 56 patients with diabetes andbare-metal stents. The overall hazard ratio associated withsirolimus-eluting stents was 1.27 (95% CI, 0.83 to 1.95; P=0.26).Figure 4B shows the overall 5-year survival curves in the subgroupof patients with diabetes.
Figure 4. Hazard Ratios for Death in a Subgroup of Patients with Diabetes and Kaplan–Meier Curves for Overall Survival.
In Panel A, hazard ratios are shown on a logarithmic scale. The size of each square is proportional to the weight of the individual study, measured as the inverse of the estimated variance of the log hazard ratio. In Panel B, Kaplan–Meier curves are shown for survival for the pooled subgroup of patients with diabetes during a 5-year period in each of the stent groups.
Stent thrombosis (as defined by the individual trials) was observedin 65 patients (34 with sirolimus-eluting stents and 31 withbare-metal stents). The hazard ratio for stent thrombosis was1.09 (95% CI, 0.64 to 1.86; P=0.75). After the first year, stentthrombosis occurred in nine patients, eight of whom had sirolimus-elutingstents (Figure 5A). Over the 4-year period after the first yearfollowing the procedure, the overall risk of stent thrombosiswas 0.6% (95% CI, 0.3 to 1.2) in the sirolimus-stent group and0.05% (95% CI, 0.01 to 0.4) in the bare-metal–stent group(P=0.02). Figure 5B shows the curves of probability of stentthrombosis in the two study groups after the trial-defined minimumduration of recommended use of dual antiplatelet therapy (Table 1).The overall risk of stent thrombosis during 4 years after thistime was 0.8% (95% CI, 0.5 to 1.5) in the sirolimus-stent groupand 0.3% (95% CI, 0.1 to 0.6) in the bare-metal–stentgroup (P=0.16).
Figure 5. Kaplan–Meier Curves for Stent Thrombosis in the Pooled Population According to Stent Type and the Duration of Dual Antiplatelet Therapy.
Panel A shows that after the first year following the index procedure, stent thrombosis occurred in eight patients in the sirolimus-stent group and in only one patient in the bare-metal–stent group. Panel B shows the probability of stent thrombosis after the use of a trial-defined minimum duration of recommended dual antiplatelet therapy, according to stent type.
In 8 of the 14 trials, data for patients undergoing target-lesionrevascularization were censored with respect to the subsequentassessment of stent thrombosis. This censoring resulted in theexclusion of five additional cases of stent thrombosis, allin the bare-metal–stent group. In contrast, in the othersix trials, such censoring did not occur, which resulted inthe inclusion of one case of stent thrombosis that occurredafter target-lesion revascularization in the sirolimus-stentgroup.
Discussion
In our study, we analyzed individual data for patients withcoronary heart disease from 14 randomized trials comparing sirolimus-elutingstents with bare-metal stents. We found that the use of sirolimus-elutingstents was associated with rates of death alone or combinedwith myocardial infarction that were similar to those observedwith the use of bare-metal stents. Sirolimus-eluting stentswere also associated with a sustained reduction in the needfor reintervention but with an overall risk of stent thrombosisthat was at least as high as that seen with bare-metal stents.
Several previous analyses of trials comparing drug-eluting stentsand bare-metal stents in patients with coronary artery diseasehave been reported.5,6,7,29,30,31,32,33,34 In these previousstudies, aggregate data from published reports, rather thandata from individual patients, were examined. The superiorityof analysis of data from individual patients over meta-analysisof lumped study outcomes has been emphasized.35,36,37,38 Inparticular for survival data, the lack of adjustment for censoringleads to an imprecise estimate of the overall treatment effectand interstudy heterogeneity.39 Access to data for individualpatients also makes it possible to analyze the timing of events.We made an extensive effort to identify and incorporate alltrials comparing sirolimus-eluting stents with bare-metal stents.As a result, we believe that we have reduced the likelihoodof study-selection bias, the major risk of any meta-analysis,which may have been present in previous reports.
The effect of the use of sirolimus-eluting stents on long-termmortality has not previously been established. Contrary to theexpectation that prevention of restenosis by sirolimus-elutingstents might lead to improved survival, recent reports suggestedthat sirolimus-eluting stents were associated with an increasedrate of death as early as 2 years after the procedure.5,6 Althoughthis finding was not statistically significant, it generatedmuch concern among the medical community.40 Our study showsno difference in mortality between patients with sirolimus-elutingstents and those with bare-metal stents during a 5-year period.The same finding was true for the combined end point of deathor myocardial infarction.
No significant increase in the overall rate of stent thrombosiswas seen with sirolimus-eluting stents. However, this complicationwas significantly more frequent in patients with sirolimus-elutingstents after the first year following the procedure, a findingthat was consistent with another recent report.41 This differenceis chronologically associated with the end of the protocol-specifiedinterval of dual antiplatelet therapy with thienopyridines andaspirin. Although an accurate assessment of this issue cannotbe made without knowledge of the actual timing of discontinuationof thienopyridine therapy in individual patients, our findings,as well as other recently published observations,42 may suggestthe need for a longer duration of dual antiplatelet therapyin patients receiving sirolimus-eluting stents.
As noted, there were another five cases of stent thrombosisthat were censored from the analysis of the original trialsbecause they occurred after target-lesion revascularization.One case of stent thrombosis that was included in our countwould have been excluded if such censoring had been appliedto all the trials. Whether such cases of stent thrombosis shouldbe included in comparisons of this kind is open to question.Proponents of inclusion would argue that post-revascularizationepisodes of stent thrombosis are an inseparable part of theexperience of receiving a stent and that such episodes are morecommon with bare-metal stents because target-lesion revascularizationis required more often in patients with such stents. The argumentfor excluding such episodes is that they may have occurred notas a result of the original stent choice, but as a result ofthe subsequent revascularization procedure, and thus that theydo not reflect the biologic effects of the specific stent type.
Our observation that there is no late difference in hard endpoints (death or myocardial infarction) despite an increasein late stent thrombosis associated with sirolimus-eluting stentsmay be explained by the small proportion of patients with thiscomplication in the trials. Also, the negative effect of latestent thrombosis on clinical outcome might have been offsetby the reduction in the need for reintervention with the sirolimus-elutingstent and, consequently, by the exposure of a lower number ofpatients to postprocedural complications, as suggested by recentanalyses.43
We paid special attention to patients with diabetes througha prespecified subgroup analysis. Patients with diabetes areat increased risk for adverse events after PCI,44,45 and aortocoronarybypass surgery is often considered to be a better treatmentoption for them. The effect of drug-eluting stents on the long-termoutcome of patients with diabetes is not known. In the Sirolimus-CoatedBx Velocity Balloon-Expandable Stent in the Treatment of DeNovo Native Coronary Artery Lesions (SIRIUS) trial, the largesttrial in our analysis, patients with diabetes continued to havea relatively high rate of restenosis even after receiving drug-elutingstents.21 In our study, there was no statistical interactionbetween the presence of diabetes and the effect of sirolimus-elutingstents on the outcome of patients, including the rate of death.However, when we analyzed mortality in the subgroup of patientswith diabetes, there was a trend toward a higher hazard ratioin patients with sirolimus-eluting stents. This observationsuggests that patients with diabetes should be observed andfollowed especially carefully after treatment with sirolimus-elutingstents. It also justifies further collection of data on thelong-term outcome of patients with diabetes who are treatedwith such stents. In addition, it will be important to evaluatewhether other available or new drug-eluting stents may offerbetter results to patients with diabetes.
In conclusion, the use of sirolimus-eluting stents did not havea significant effect on overall long-term survival or on survivalfree of myocardial infarction, as compared with bare-metal stents.There was a sustained reduction in the need for reinterventionafter the placement of sirolimus-eluting stents. The risk ofstent thrombosis was at least as great as that seen with bare-metalstents.
Supported by Deutsches Herzzentrum, Munich, Germany.
Dr. Kastrati reports receiving lecture fees from Bristol-MyersSquibb, Cordis, GlaxoSmithKline, Lilly, Medtronic, Novartis,and Sanofi-Aventis; Dr. Valgimigli, lecture fees from Guilfordand Merck and grant support from Merck; Dr. Kelbæk, unrestrictedgrant support from Cordis to fund part of the salary of a researchnurse; Dr. Pfisterer, lecture fees from Medtronic; and Dr. Schömig,unrestricted grant support for the Department of Cardiologyhe chairs from Amersham/General Electric, Bayerische Forschungsstiftung,Bristol-Myers Squibb, Cordis, Cryocath, Guidant, Medtronic,Nycomed, and Schering. No other potential conflict of interestrelevant to this article was reported.
Source Information
From Deutsches Herzzentrum, Technische Universität, Munich, Germany (A.K., J.M., J.P., M. Seyfarth, A.S.); University of Basel, Basel, Switzerland (C.K., M.E.P.); University of Ferrara, Ferrara, Italy (M.V.); Rigshospitalet, Copenhagen (H.K.); San Camillo Hospital, Rome (M.M.); Cardiovascular Institute, Hospital de la Santa Creu i Sant Pau, Barcelona (M. Sabaté); St. Antonius Hospital, Nieuwegein, the Netherlands (M.J.S.); and Preventicum–Klinik für Diagnostik, Essen, Germany (D.B.). This article (10.1056/NEJMoa067484) was published at www.nejm.org on February 12, 2007.
Address reprint requests to Dr. Kastrati at Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany, or at kastrati{at}dhm.mhn.de.
References
Assali AR, Moustapha A, Sdringola S, et al. Acute coronary syndrome may occur with in-stent restenosis and is associated with adverse outcomes (the PRESTO trial). Am J Cardiol 2006;98:729-733. [CrossRef][Web of Science][Medline]
Schühlen H, Kastrati A, Mehilli J, et al. Restenosis detected by routine angiographic follow-up and late mortality after coronary stent placement. Am Heart J 2004;147:317-322. [CrossRef][Web of Science][Medline]
Iijima R, Mehilli J, Schomig A, Kastrati A. Clinical evidence on polymer-based sirolimus and paclitaxel eluting stents. Minerva Cardioangiol 2006;54:539-555. [Medline]
Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193-202. [Free Full Text]
Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J 2006;27:2784-2814. [Free Full Text]
Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med 2006;119:1056-1061. [CrossRef][Web of Science][Medline]
Kaiser C, Brunner-La Rocca HP, Buser PT, et al. Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitats Trial (BASKET). Lancet 2005;366:921-929. [Erratum, Lancet 2005;366:2086.] [CrossRef][Web of Science][Medline]
Schampaert E, Cohen EA, Schluter M, et al. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol 2004;43:1110-1115. [Free Full Text]
Sabate M, Jimenez-Quevedo P, Angiolillo DJ, et al. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation 2005;112:2175-2183. [Free Full Text]
Schofer J, Schlüter M, Gershlick AH, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362:1093-1099. [CrossRef][Web of Science][Medline]
Pache J, Dibra A, Mehilli J, Dirschinger J, Schömig A, Kastrati A. Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial. Eur Heart J 2005;26:1262-1268. [Free Full Text]
Suttorp MJ, Laarman GJ, Rahel BM, et al. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation 2006;114:921-928. [Free Full Text]
Morice M-C, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-1780. [Free Full Text]
Vermeersch P, Agostoni P, Verheye S, et al. Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol 2006;48:2423-2431. [Free Full Text]
Kelbaek H, Thuesen L, Helqvist S, et al. The Stenting Coronary Arteries in Non-stress/Benestent Disease (SCANDSTENT) trial. J Am Coll Cardiol 2006;47:449-455. [Free Full Text]
Baumgart D. A German multicenter randomized controlled open-label study of the cypher sirolimus eluting stent in the treatment of diabetic patients with de novo native coronary artery lesions. (Accessed February 9, 2007, at http://www.attendeeinteractive.com.)
Ardissino D, Cavallini C, Bramucci E, et al. Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. JAMA 2004;292:2727-2734. [Free Full Text]
Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315-1323. [Free Full Text]
Valgimigli M, Percoco G, Malagutti P, et al. Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA 2005;293:2109-2117. [Free Full Text]
Spaulding C, Henry P, Teiger E, et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med 2006;355:1093-1104. [Free Full Text]
Altman DG, Schulz KF. Concealing treatment allocation in randomised trials. BMJ 2001;323:446-447. [Free Full Text]
Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 2001;323:42-46. [Free Full Text]
Egger M, Smith GD, Altman D, eds. Systematic reviews in health care: meta-analysis in context. London: BMJ Publishing, 2001:357.
Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327:557-560. [Free Full Text]
Babapulle MN, Joseph L, Belisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet 2004;364:583-591. [CrossRef][Web of Science][Medline]
Holmes DR Jr, Moses JW, Schofer J, Morice MC, Schampaert E, Leon MB. Cause of death with bare metal and sirolimus-eluting stents. Eur Heart J 2006;27:2815-2822. [Free Full Text]
Moreno R, Fernandez C, Hernandez R, et al. Drug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies. J Am Coll Cardiol 2005;45:954-959. [Free Full Text]
Indolfi C, Pavia M, Angelillo IF. Drug-eluting stents versus bare metal stents in percutaneous coronary interventions (a meta-analysis). Am J Cardiol 2005;95:1146-1152. [CrossRef][Web of Science][Medline]
Biondi-Zoccai GG, Agostoni P, Abbate A, et al. Adjusted indirect comparison of intracoronary drug-eluting stents: evidence from a metaanalysis of randomized bare-metal-stent-controlled trials. Int J Cardiol 2005;100:119-123. [CrossRef][Web of Science][Medline]
Katritsis DG, Karvouni E, Ioannidis JP. Meta-analysis comparing drug-eluting stents with bare metal stents. Am J Cardiol 2005;95:640-643. [CrossRef][Web of Science][Medline]
Simmonds MC, Higgins JP, Stewart LA, Tierney JF, Clarke MJ, Thompson SG. Meta-analysis of individual patient data from randomized trials: a review of methods used in practice. Clin Trials 2005;2:209-217. [Free Full Text]
Stewart LA, Tierney JF. To IPD or not to IPD? Advantages and disadvantages of systematic reviews using individual patient data. Eval Health Prof 2002;25:76-97. [Free Full Text]
Clarke MJ, Stewart LA. Meta-analyses using individual patient data. J Eval Clin Pract 1997;3:207-212. [CrossRef][Medline]
Stewart LA, Parmar MK. Meta-analysis of the literature or of individual patient data: is there a difference? Lancet 1993;341:418-422. [CrossRef][Web of Science][Medline]
Vale CL, Tierney JF, Stewart LA. Effects of adjusting for censoring on meta-analyses of time-to-event outcomes. Int J Epidemiol 2002;31:107-111. [Free Full Text]
Shuchman M. Trading restenosis for thrombosis? New questions about drug-eluting stents. N Engl J Med 2006;355:1949-1952. [Free Full Text]
Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 2006;48:2584-2591. [Free Full Text]
Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 2007;297:159-168. [Free Full Text]
Stone GW. Perspectives on drug-eluting stent safety and efficacy with regulatory recommendations. Presented at the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee, Washington, DC, December 7–8, 2006. (Accessed February 9, 2007, at http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4253oph1_04_Stone.pdf.)
Carrozza JP Jr, Kuntz RE, Levine MJ, et al. Angiographic and clinical outcome of intracoronary stenting: immediate and long-term results from a large single-center experience. J Am Coll Cardiol 1992;20:328-337. [Abstract]
Elezi S, Kastrati A, Pache J, et al. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol 1998;32:1866-1873. [Free Full Text]
Holmes, D. R. Jr, Kereiakes, D. J., Kleiman, N. S., Moliterno, D. J., Patti, G., Grines, C. L.
(2009). Combining Antiplatelet and Anticoagulant Therapies.. J Am Coll Cardiol
54: 95-109
[Abstract][Full Text]
Menozzi, A., Solinas, E., Ortolani, P., Repetto, A., Saia, F., Piovaccari, G., Manari, A., Magagnini, E., Vignali, L., Bonizzoni, E., Merlini, P. A., Cavallini, C., Ardissino, D., for the SES-SMART Investigators,
(2009). Twenty-four months clinical outcomes of sirolimus-eluting stents for the treatment of small coronary arteries: the long-term SES-SMART clinical study. Eur Heart J
0: ehp224v1-ehp224
[Abstract][Full Text]
Aldea, G. S., Mokadam, N. A., Melford, R. Jr, Stewart, D., Maynard, C., Reisman, M., Goss, R.
(2009). Changing Volumes, Risk Profiles, and Outcomes of Coronary Artery Bypass Grafting and Percutaneous Coronary Interventions.. Ann. Thorac. Surg.
87: 1828-1838
[Abstract][Full Text]
Leon, M. B., Allocco, D. J., Dawkins, K. D., Baim, D. S.
(2009). Late Clinical Events After Drug-Eluting Stents: The Interplay Between Stent-Related and Natural History-Driven Events. J Am Coll Cardiol Intv
2: 504-512
[Abstract][Full Text]
Prasad, A., Holmes, D. R
(2009). Update on dual antiplatelet therapy for percutaneous coronary intervention. Heart
95: 861-865
[Full Text]
Ko, D. T., Chiu, M., Guo, H., Austin, P. C., Goeree, R., Cohen, E., Labinaz, M., Tu, J. V.
(2009). Safety and effectiveness of drug-eluting and bare-metal stents for patients with off- and on-label indications.. J Am Coll Cardiol
53: 1773-1782
[Abstract][Full Text]
James, S. K., Stenestrand, U., Lindback, J., Carlsson, J., Schersten, F., Nilsson, T., Wallentin, L., Lagerqvist, B., the SCAAR Study Group,
(2009). Long-Term Safety and Efficacy of Drug-Eluting versus Bare-Metal Stents in Sweden. NEJM
360: 1933-1945
[Abstract][Full Text]
Douglas, P. S., Brennan, J. M., Anstrom, K. J., Sedrakyan, A., Eisenstein, E. L., Haque, G., Dai, D., Kong, D. F., Hammill, B., Curtis, L., Matchar, D., Brindis, R., Peterson, E. D.
(2009). Clinical Effectiveness of Coronary Stents in Elderly Persons: Results From 262,700 Medicare Patients in the American College of Cardiology-National Cardiovascular Data Registry. J Am Coll Cardiol
53: 1629-1641
[Abstract][Full Text]
Awata, M., Nanto, S., Uematsu, M., Morozumi, T., Watanabe, T., Onishi, T., Iida, O., Sera, F., Minamiguchi, H., Kotani, J.-i., Nagata, S.
(2009). Heterogeneous Arterial Healing in Patients Following Paclitaxel-Eluting Stent Implantation: Comparison With Sirolimus-Eluting Stents. J Am Coll Cardiol Intv
2: 453-458
[Abstract][Full Text]
Carlsson, J., James, S. K., Lindback, J., Schersten, F., Nilsson, T., Stenestrand, U., Lagerqvist, B., for the SCAAR (Swedish Coronary Angiography and An,
(2009). Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria. J Am Coll Cardiol
53: 1389-1398
[Abstract][Full Text]
Li, Y., Zheng, Z., Xu, B., Zhang, S., Li, W., Gao, R., Hu, S.
(2009). Comparison of Drug-Eluting Stents and Coronary Artery Bypass Surgery for the Treatment of Multivessel Coronary Disease: Three-Year Follow-Up Results From a Single Institution. Circulation
119: 2040-2050
[Abstract][Full Text]
Byrne, R. A., Mehilli, J., Iijima, R., Schulz, S., Pache, J., Seyfarth, M., Schomig, A., Kastrati, A., for the Intracoronary Stenting and Angiographic Re,
(2009). A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents. Eur Heart J
30: 923-931
[Abstract][Full Text]
Qiangjun Cai, , Skelding, K., Armstrong, A. Jr, Desai, D., Wood, G. C., Blankenship, J.
(2009). Predictors of Long-Term Major Adverse Cardiac Events and Clinical Restenosis Following Elective Percutaneous Coronary Stenting. ANGIOLOGY
60: 141-147
[Abstract]
Byrne, R. A., Iijima, R., Mehilli, J., Pinieck, S., Bruskina, O., Schomig, A., Kastrati, A.
(2009). Durability of Antirestenotic Efficacy in Drug-Eluting Stents With and Without Permanent Polymer. J Am Coll Cardiol Intv
2: 291-299
[Abstract][Full Text]
Horst, B., Rihal, C. S., Holmes, D. R. Jr, Bresnahan, J. F., Prasad, A., Gau, G., Lennon, R., Lerman, A.
(2009). Comparison of Drug-Eluting and Bare-Metal Stents for Stable Coronary Artery Disease. J Am Coll Cardiol Intv
2: 321-328
[Abstract][Full Text]
Chiu, M., Ko, D. T., Austin, P. C., Cohen, E. A., Velianou, J. L., Goeree, R., Blackhouse, G., Tu, J. V.
(2009). Paclitaxel Versus Sirolimus Stents in Diabetic and Nondiabetic Patients. Circ Cardiovasc Qual Outcomes
2: 96-107
[Abstract][Full Text]
Kaltoft, A., Jensen, L. O., Maeng, M., Tilsted, H. H., Thayssen, P., Bottcher, M., Lassen, J. F., Krusell, L. R., Rasmussen, K., Hansen, K. N., Pedersen, L., Johnsen, S. P., Sorensen, H. T., Thuesen, L.
(2009). 2-Year Clinical Outcomes After Implantation of Sirolimus-Eluting, Paclitaxel-Eluting, and Bare-Metal Coronary Stents Results From the WDHR (Western Denmark Heart Registry).. J Am Coll Cardiol
53: 658-664
[Abstract][Full Text]
Kimura, T., Morimoto, T., Nakagawa, Y., Tamura, T., Kadota, K., Yasumoto, H., Nishikawa, H., Hiasa, Y., Muramatsu, T., Meguro, T., Inoue, N., Honda, H., Hayashi, Y., Miyazaki, S., Oshima, S., Honda, T., Shiode, N., Namura, M., Sone, T., Nobuyoshi, M., Kita, T., Mitsudo, K., for the j-Cypher Registry Investigators,
(2009). Antiplatelet Therapy and Stent Thrombosis After Sirolimus-Eluting Stent Implantation. Circulation
119: 987-995
[Abstract][Full Text]
Ezekowitz, J. A.
(2009). What Price to Pay?: The Cost of Everything and the Value of Nothing. Circulation
119: 368-370
[Full Text]
Genereux, P. MD, Mehran, R. MD
(2009). Are drug-eluting stents safe in the long term?. CMAJ
180: 154-155
[Full Text]
Authors/writing members:, , Daemen, J., Simoons, M. L., Wijns, W., Bagust, A., Bos, G., Bowen, J. M., Braunwald, E., Camenzind, E., Chevalier, B., DiMario, C., Fajadet, J., Gitt, A., Guagliumi, G., Hillege, H. L., James, S., Juni, P., Kastrati, A., Kloth, S., Kristensen, S. D., Krucoff, M., Legrand, V., Pfisterer, M., Rothman, M., Serruys, P. W., Silber, S., Steg, P. G., Tariah, I., Wallentin, L., Windecker, S. W., Participants in the Forum:, , Aimonetti, A., Allocco, D., Baczynska, A., Bagust, A., Berenger, M., Bos, G., Boam, A., Bowen, J.M., Braunwald, E., Calle, J.P., Camenzind, E., Campo, G., Carlier, S., Chevalier, B., Daemen, J., de Schepper, J., Di Bisceglie, G., DiMario, C., Dobbels, H., Fajadet, J., Farb, A., Ghislain, J.C., Gitt, A., Guagliumi, G., Hellbardt, S., Hillege, H.L., ten Hoedt, R., Isaia, C., James, S., de Jong, P., Juni, P., Kastrati, A., Klasen, E., Kloth, S., Kristensen, S.D., Krucoff, M., Legrand, V., Lekehal, M., LeNarz, L., Ni Mhullain, F., Nagai, H., Patteet, A., Paunovic, D., Pfisterer, M., Potgieter, A., Purdy, I., Raveau-Landon, C., Rothman, M., Serruys, P.W., Silber, S., Simoons, M.L., Steg, P.G., Tariah, I., Ternstrom, S., Van Wuytswinkel, J., Waliszewski, M., Wallentin, L., Wijns, W., Windecker, S.W.
(2009). Meeting Report: ESC Forum on Drug Eluting Stents European Heart House, Nice, 27-28 September 2007. Eur Heart J
30: 152-161
[Full Text]
Terpening, C.
(2009). An Appraisal of Dual Antiplatelet Therapy with Clopidogrel and Aspirin for Prevention of Cardiovascular Events. J Am Board Fam Med
22: 51-56
[Abstract][Full Text]
Pfisterer, M., Brunner-La Rocca, H. P., Rickenbacher, P., Hunziker, P., Mueller, C., Nietlispach, F., Leibundgut, G., Bader, F., Kaiser, C., for the BASKET Investigators,
(2009). Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET. Eur Heart J
30: 16-24
[Abstract][Full Text]
Chen, J. P., Crisco, L. V., Jabara, R., King, S. B. III
(2009). Late Angiographic Stent Thrombosis: The LAST Straw for Drug-Eluting Stents?. ANGIOLOGY
59: 667-675
[Abstract]
Burzotta, F., Parma, A., Pristipino, C., Manzoli, A., Belloni, F., Sardella, G., Rigattieri, S., Danesi, A., Mazzarotto, P., Summaria, F., Romagnoli, E., Prati, F., Trani, C., Crea, F.
(2008). Angiographic and clinical outcome of invasively managed patients with thrombosed coronary bare metal or drug-eluting stents: the OPTIMIST study. Eur Heart J
29: 3011-3021
[Abstract][Full Text]
Chhatriwalla, A. K., Bhatt, D. L.
(2008). Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year?: Dual Antiplatelet Therapy After Drug-Eluting Stents Should Be Continued for More Than One Year and Preferably Indefinitely. Circ Cardiovasc Intervent
1: 217-225
[Full Text]
Pfisterer, M. E
(2008). Commentary on drug-eluting stents: to use or not to use--that is the question!. Heart
94: 1648-1650
[Full Text]
Go, A. S., Magid, D. J., Wells, B., Sung, S. H., Cassidy-Bushrow, A. E., Greenlee, R. T., Langer, R. D., Lieu, T. A., Margolis, K. L., Masoudi, F. A., McNeal, C. J., Murata, G. H., Newton, K. M., Novotny, R., Reynolds, K., Roblin, D. W., Smith, D. H., Vupputuri, S., White, R. E., Olson, J., Rumsfeld, J. S., Gurwitz, J. H.
(2008). The Cardiovascular Research Network: A New Paradigm for Cardiovascular Quality and Outcomes Research. Circ Cardiovasc Qual Outcomes
1: 138-147
[Abstract][Full Text]
Byrne, R. A., Kastrati, A.
(2008). Duration of antiplatelet therapy following intracoronary stenting: are changes needed?. Eur Heart J Suppl
10: I25-I29
[Abstract][Full Text]
Park, D.-W., Yun, S.-C., Lee, S.-W., Kim, Y.-H., Lee, C. W., Hong, M.-K., Cheong, S.-S., Kim, J.-J., Park, S.-W., Park, S.-J.
(2008). Stent Thrombosis, Clinical Events, and Influence of Prolonged Clopidogrel Use After Placement of Drug-Eluting Stent: Data From an Observational Cohort Study of Drug-Eluting Versus Bare-Metal Stents. J Am Coll Cardiol Intv
1: 494-503
[Abstract][Full Text]
Wenaweser, P., Daemen, J., Zwahlen, M., van Domburg, R., Juni, P., Vaina, S., Hellige, G., Tsuchida, K., Morger, C., Boersma, E., Kukreja, N., Meier, B., Serruys, P. W., Windecker, S.
(2008). Incidence and Correlates of Drug-Eluting Stent Thrombosis in Routine Clinical Practice: 4-Year Results From a Large 2-Institutional Cohort Study. J Am Coll Cardiol
52: 1134-1140
[Abstract][Full Text]
Kimura, T., Morimoto, T., Furukawa, Y., Nakagawa, Y., Shizuta, S., Ehara, N., Taniguchi, R., Doi, T., Nishiyama, K., Ozasa, N., Saito, N., Hoshino, K., Mitsuoka, H., Abe, M., Toma, M., Tamura, T., Haruna, Y., Imai, Y., Teramukai, S., Fukushima, M., Kita, T.
(2008). Long-Term Outcomes of Coronary-Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention for Multivessel Coronary Artery Disease in the Bare-Metal Stent Era. Circulation
118: S199-S209
[Abstract][Full Text]
Schomig, A., Mehilli, J., de Waha, A., Seyfarth, M., Pache, J., Kastrati, A.
(2008). A Meta-Analysis of 17 Randomized Trials of a Percutaneous Coronary Intervention-Based Strategy in Patients With Stable Coronary Artery Disease. J Am Coll Cardiol
52: 894-904
[Abstract][Full Text]
Daemen, J., Boersma, E., Flather, M., Booth, J., Stables, R., Rodriguez, A., Rodriguez-Granillo, G., Hueb, W. A., Lemos, P. A., Serruys, P. W.
(2008). Long-Term Safety and Efficacy of Percutaneous Coronary Intervention With Stenting and Coronary Artery Bypass Surgery for Multivessel Coronary Artery Disease: A Meta-Analysis With 5-Year Patient-Level Data From the ARTS, ERACI-II, MASS-II, and SoS Trials. Circulation
118: 1146-1154
[Abstract][Full Text]
Yau, L., Molnar, P., Moon, M. C., Buhay, S., Werner, J. P., Molnar, K., Saward, L., Del Rizzo, D., Zahradka, P.
(2008). meta-Iodobenzylguanidine, an Inhibitor of Arginine-Dependent Mono(ADP-ribosyl)ation, Prevents Neointimal Hyperplasia. J. Pharmacol. Exp. Ther.
326: 717-724
[Abstract][Full Text]
Chieffo, A., Park, S.-J., Meliga, E., Sheiban, I., Lee, M. S., Latib, A., Kim, Y.-H., Valgimigli, M., Sillano, D., Magni, V., Biondi-Zoccai, G., Montorfano, M., Airoldi, F., Rogacka, R., Carlino, M., Michev, I., Lee, C.-W., Hong, M.-K., Park, S.-W., Moretti, C., Bonizzoni, E., Sangiorgi, G. M., Tobis, J., Serruys, P. W., Colombo, A.
(2008). Late and very late stent thrombosis following drug-eluting stent implantation in unprotected left main coronary artery: a multicentre registry. Eur Heart J
29: 2108-2115
[Abstract][Full Text]
Stettler, C., Allemann, S., Wandel, S., Kastrati, A., Morice, M. C., Schomig, A., Pfisterer, M. E, Stone, G. W, Leon, M. B, Lezo, J. S. d., Goy, J.-J., Park, S.-J., Sabate, M., Suttorp, M. J, Kelbaek, H., Spaulding, C., Menichelli, M., Vermeersch, P., Dirksen, M. T, Cervinka, P., Carlo, M. D., Erglis, A., Chechi, T., Ortolani, P., Schalij, M. J, Diem, P., Meier, B., Windecker, S., Juni, P.
(2008). Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis. BMJ
337: a1331-a1331
[Abstract][Full Text]
Anstrom, K. J., Kong, D. F., Shaw, L. K., Califf, R. M., Kramer, J. M., Peterson, E. D., Rao, S. V., Matchar, D. B., Mark, D. B., Harrington, R. A., Eisenstein, E. L.
(2008). Long-term Clinical Outcomes Following Coronary Stenting. Arch Intern Med
168: 1647-1655
[Abstract][Full Text]
Austin, D., Oldroyd, K. G., McConnachie, A., Slack, R., Eteiba, H., Flapan, A. D., Jennings, K. P., Northcote, R. J., Pell, A. C.H., Starkey, I. R., Pell, J. P.
(2008). Drug-Eluting Stents Versus Bare-Metal Stents for Off-Label Indications: A Propensity Score-Matched Outcome Study. Circ Cardiovasc Intervent
1: 45-52
[Abstract][Full Text]
Holmes, D. R. Jr, Teirstein, P. S., Satler, L., Sketch, M. H. Jr, Popma, J. J., Mauri, L., Wang, H., Schleckser, P. A., Cohen, S. A., SISR Investigators,
(2008). 3-Year Follow-Up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) Trial. J Am Coll Cardiol Intv
1: 439-448
[Abstract][Full Text]
Newsome, L. T., Kutcher, M. A., Royster, R. L.
(2008). Coronary Artery Stents: Part I. Evolution of Percutaneous Coronary Intervention. Anesth. Analg.
107: 552-569
[Abstract][Full Text]
Booth, J., Clayton, T., Pepper, J., Nugara, F., Flather, M., Sigwart, U., Stables, R. H., on Behalf of the SoS Investigators,
(2008). Randomized, Controlled Trial of Coronary Artery Bypass Surgery Versus Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease: Six-Year Follow-Up From the Stent or Surgery Trial (SoS). Circulation
118: 381-388
[Abstract][Full Text]
Coylewright, M., Blumenthal, R. S., Post, W.
(2008). Placing COURAGE in Context: Review of the Recent Literature on Managing Stable Coronary Artery Disease. Mayo Clin Proc.
83: 799-805
[Abstract][Full Text]
Malenka, D. J., Kaplan, A. V., Lucas, F. L., Sharp, S. M., Skinner, J. S.
(2008). Outcomes Following Coronary Stenting in the Era of Bare-Metal vs the Era of Drug-Eluting Stents. JAMA
299: 2868-2876
[Abstract][Full Text]
Austin, D., Oldroyd, K. G., McConnachie, A., Slack, R., Eteiba, H., Flapan, A. D., Jennings, K. P., Northcote, R. J., Pell, A. C. H., Starkey, I. R., Pell, J. P.
(2008). Hospital and operator variations in drug-eluting stent use: a multi-level analysis of 5967 consecutive patients in Scotland. J Public Health (Oxf)
30: 186-193
[Abstract][Full Text]
Li, J., Jabara, R., Pendyala, L., Otsuka, Y., Shinke, T., Hou, D., Robinson, K., Chronos, N.
(2008). Abnormal Vasomotor Function of Porcine Coronary Arteries Distal to Sirolimus-Eluting Stents. J Am Coll Cardiol Intv
1: 279-285
[Abstract][Full Text]
Becker, R. C., Meade, T. W., Berger, P. B., Ezekowitz, M., O'Connor, C. M., Vorchheimer, D. A., Guyatt, G. H., Mark, D. B., Harrington, R. A.
(2008). The Primary and Secondary Prevention of Coronary Artery Disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest
133: 776S-814S
[Abstract][Full Text]
Kelbaek, H., Klovgaard, L., Helqvist, S., Lassen, J. F., Krusell, L. R., Engstrom, T., Botker, H. E., Jorgensen, E., Saunamaki, K., Aljabbari, S., Thayssen, P., Galloe, A., Jensen, G. V.H., Thuesen, L.
(2008). Long-Term Outcome in Patients Treated With Sirolimus-Eluting Stents in Complex Coronary Artery Lesions: 3-Year Results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) Trial. J Am Coll Cardiol
51: 2011-2016
[Abstract][Full Text]
Groeneveld, P. W., Matta, M. A., Greenhut, A. P., Yang, F.
(2008). Drug-Eluting Compared With Bare-Metal Coronary Stents Among Elderly Patients. J Am Coll Cardiol
51: 2017-2024
[Abstract][Full Text]
Mark, D. B.
(2008). Interpreting the Music of Drug-Eluting Stents: Halcyon Song or Albatross Dirge?. J Am Coll Cardiol
51: 1854-1856
[Full Text]
Bhatt, S. H, Hauser, T. H
(2008). Very Late Stent Thrombosis After Dual Antiplatelet Therapy Discontinuation in a Patient with a History of Acute Stent Thrombosis. The Annals of Pharmacotherapy
42: 708-712
[Abstract][Full Text]
Hannan, E. L., Racz, M., Holmes, D. R., Walford, G., Sharma, S., Katz, S., Jones, R. H., King, S. B. III
(2008). Comparison of Coronary Artery Stenting Outcomes in the Eras Before and After the Introduction of Drug-Eluting Stents. Circulation
117: 2071-2078
[Abstract][Full Text]
Zellweger, M. J., Kaiser, C., Brunner-La Rocca, H. P., Buser, P. T., Osswald, S., Weiss, P., Mueller-Brand, J., Pfisterer, M. E., for the BASKET Investigators,
(2008). Value and Limitations of Target-Vessel Ischemia in Predicting Late Clinical Events After Drug-Eluting Stent Implantation. JNM
49: 550-556
[Abstract][Full Text]
Taggart, D. P., Kaul, S., Boden, W. E., Ferguson, T. B. Jr, Guyton, R. A., Mack, M. J., Sergeant, P. T., Shemin, R. J., Smith, P. K., Yusuf, S.
(2008). Revascularization for unprotected left main stem coronary artery stenosis stenting or surgery.. J Am Coll Cardiol
51: 885-892
[Abstract][Full Text]
Kirtane, A. J., Ellis, S. G., Dawkins, K. D., Colombo, A., Grube, E., Popma, J. J., Fahy, M., Leon, M. B., Moses, J. W., Mehran, R., Stone, G. W.
(2008). Paclitaxel-Eluting Coronary Stents in Patients With Diabetes Mellitus Pooled Analysis From 5 Randomized Trials.. J Am Coll Cardiol
51: 708-715
[Abstract][Full Text]
Ortolani, P., Balducelli, M., Marzaroli, P., Piovaccari, G., Menozzi, A., Guiducci, V., Sangiorgio, P., Tarantino, F., Geraci, G., Castriota, F., Tondi, S., Saia, F., Cooke, R. M.T., Guastaroba, P., Grilli, R., Marzocchi, A., Maresta, A.
(2008). Two-Year Clinical Outcomes With Drug-Eluting Stents for Diabetic Patients With De Novo Coronary Lesions: Results From a Real-World Multicenter Registry. Circulation
117: 923-930
[Abstract][Full Text]
Jeremias, A., Kirtane, A.
(2008). Balancing Efficacy and Safety of Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention. ANN INTERN MED
148: 234-238
[Abstract][Full Text]
Saia, F., Marzocchi, A., Branzi, A.
(2008). Review: The safety of drug-eluting stents. Ther Adv Cardiovasc Dis
2: 43-52
[Abstract]
Austin, D., Pell, J. P, Oldroyd, K. G
(2008). Drug-eluting stents: do the risks really outweigh the benefits?. Heart
94: 127-128
[Full Text]
Melikian, N, Wijns, W
(2008). Drug-eluting stents: a critique. Heart
94: 145-152
[Abstract][Full Text]
Romagnoli, E., Sangiorgi, G. M., Cosgrave, J., Guillet, E., Colombo, A.
(2008). Drug-eluting stenting the case for post-dilation.. J Am Coll Cardiol Intv
1: 22-31
[Abstract][Full Text]
Holmes, D. R. Jr, Gersh, B. J., Whitlow, P., King, S. B. III, Dove, J. T.
(2008). Percutaneous coronary intervention for chronic stable angina a reassessment.. J Am Coll Cardiol Intv
1: 34-43
[Abstract][Full Text]
American College of Cardiology/American Heart Asso, , 2007 Writing Group to Review New Evidence and Upda, , King, S. B. III, Smith, S. C. Jr, Hirshfeld, J. W. Jr, Jacobs, A. K., Morrison, D. A., Williams, D. O.
(2008). 2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention. J Am Coll Cardiol
51: 172-209
[Full Text]
King, S. B. III, Smith, S. C. Jr, Hirshfeld, J. W. Jr, Jacobs, A. K., Morrison, D. A., Williams, D. O., 2005 WRITING COMMITTEE MEMBERS, , Smith, S. C. Jr, Feldman, T. E., Hirshfeld, J. W. Jr, Jacobs, A. K., Kern, M. J., King, S. B. III, Morrison, D. A., O'Neill, W. W., Schaff, H. V., Whitlow, P. L., Williams, D. O., Smith, S. C. Jr, Jacobs, A. K., Adams, C. D., Anderson, J. L., Buller, C. E., Creager, M. A., Ettinger, S. M., Halperin, J. L., Hunt, S. A., Krumholz, H. M., Kushner, F. G., Lytle, B. W., Nishimura, R., Page, R. L., Riegel, B., Tarkington, L. G., Yancy, C. W.
(2008). 2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee. Circulation
117: 261-295
[Full Text]
Gitt, A. K., Betriu, A.
(2008). Antiplatelet therapy in acute coronary syndromes. Eur Heart J Suppl
10: A4-A12
[Abstract][Full Text]
Abbott, J. D., Voss, M. R., Nakamura, M., Cohen, H. A., Selzer, F., Kip, K. E., Vlachos, H. A., Wilensky, R. L., Williams, D. O.
(2007). Unrestricted Use of Drug-Eluting Stents Compared With Bare-Metal Stents in Routine Clinical Practice: Findings From the National Heart, Lung, and Blood Institute Dynamic Registry. J Am Coll Cardiol
50: 2029-2036
[Abstract][Full Text]
Buttner, H. J., Neumann, F.-J.
(2007). Peeling-Off Labels: Mounting Evidence for Benefit of Drug-Eluting Stents With Off-Label Use. J Am Coll Cardiol
50: 2037-2038
[Full Text]
Doyle, B., Rihal, C. S., O'Sullivan, C. J., Lennon, R. J., Wiste, H. J., Bell, M., Bresnahan, J., Holmes, D. R. Jr
(2007). Outcomes of Stent Thrombosis and Restenosis During Extended Follow-Up of Patients Treated With Bare-Metal Coronary Stents. Circulation
116: 2391-2398
[Abstract][Full Text]
Kastrati, A., Dibra, A., Spaulding, C., Laarman, G. J., Menichelli, M., Valgimigli, M., Di Lorenzo, E., Kaiser, C., Tierala, I., Mehilli, J., Seyfarth, M., Varenne, O., Dirksen, M. T., Percoco, G., Varricchio, A., Pittl, U., Syvanne, M., Suttorp, M. J., Violini, R., Schomig, A.
(2007). Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J
28: 2706-2713
[Abstract][Full Text]
Lamas, G. A, Hochman, J. S
(2007). Where does the Occluded Artery Trial leave the late open artery hypothesis?. Heart
93: 1319-1321
[Abstract][Full Text]
Fleisher, L. A., Beckman, J. A., Brown, K. A., Calkins, H., Chaikof, E. L., Fleischmann, K. E., Freeman, W. K., Froehlich, J. B., Kasper, E. K., Kersten, J. R., Riegel, B., Robb, J. F., Smith, S. C. Jr, Jacobs, A. K., Adams, C. D., Anderson, J. L., Antman, E. M., Buller, C. E., Creager, M. A., Ettinger, S. M., Faxon, D. P., Fuster, V., Halperin, J. L., Hiratzka, L. F., Hunt, S. A., Lytle, B. W., Nishimura, R., Ornato, J. P., Page, R. L., Riegel, B., Tarkington, L. G., Yancy, C. W.
(2007). ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) Developed in Collaboration With the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. J Am Coll Cardiol
50: e159-e242
[Full Text]
Baumgart, D., Klauss, V., Baer, F., Hartmann, F., Drexler, H., Motz, W., Klues, H., Hofmann, S., Volker, W., Pfannebecker, T., Stoll, H.-P., Nickenig, G., for the SCORPIUS Study Investigators,
(2007). One-Year Results of the SCORPIUS Study: A German Multicenter Investigation on the Effectiveness of Sirolimus-Eluting Stents in Diabetic Patients. J Am Coll Cardiol
50: 1627-1634
[Abstract][Full Text]
Windecker, S., Meier, B.
(2007). Late Coronary Stent Thrombosis. Circulation
116: 1952-1965
[Full Text]
Fleisher, L. A., Beckman, J. A., Brown, K. A., Calkins, H., Chaikof, E. L., Fleischmann, K. E., Freeman, W. K., Froehlich, J. B., Kasper, E. K., Kersten, J. R., Riegel, B., Robb, J. F.
(2007). ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery). Circulation
116: e418-e500
[Full Text]
Tu, J. V., Bowen, J., Chiu, M., Ko, D. T., Austin, P. C., He, Y., Hopkins, R., Tarride, J.-E., Blackhouse, G., Lazzam, C., Cohen, E. A., Goeree, R.
(2007). Effectiveness and Safety of Drug-Eluting Stents in Ontario. NEJM
357: 1393-1402
[Abstract][Full Text]
Schomig, A., Dibra, A., Windecker, S., Mehilli, J., Suarez de Lezo, J., Kaiser, C., Park, S.-J., Goy, J.-J., Lee, J.-H., Di Lorenzo, E., Wu, J., Juni, P., Pfisterer, M. E., Meier, B., Kastrati, A.
(2007). A Meta-Analysis of 16 Randomized Trials of Sirolimus-Eluting Stents Versus Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease. J Am Coll Cardiol
50: 1373-1380
[Abstract][Full Text]
Anderson, J. L., Adams, C. D., Antman, E. M., Bridges, C. R., Califf, R. M., Casey, D. E. Jr, Chavey, W. E. II, Fesmire, F. M., Hochman, J. S., Levin, T. N., Lincoff, A. M., Peterson, E. D., Theroux, P., Wenger, N. K., Wright, R. S., Smith, S. C. Jr, Jacobs, A. K., Adams, C. D., Anderson, J. L., Antman, E. M., Halperin, J. L., Hunt, S. A., Krumholz, H. M., Kushner, F. G., Lytle, B. W., Nishimura, R., Ornato, J. P., Page, R. L., Riegel, B.
(2007). ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol
50: e1-e157
[Full Text]
Bavry, A. A., Bhatt, D. L.
(2007). Drug-Eluting Stents: Dual Antiplatelet Therapy for Every Survivor?. Circulation
116: 696-699
[Full Text]
(2007). Additional articles abstracted in ACP Journal Club. Evid. Based Med.
12: 126-126
[Full Text]
Bode, C., Zehender, M.
(2007). The use of antiplatelet agents following percutaneous coronary intervention: focus on late stent thrombosis. Eur Heart J Suppl
9: D10-D19
[Abstract][Full Text]
Jensen, L. O., Maeng, M., Kaltoft, A., Thayssen, P., Hansen, H. H. T., Bottcher, M., Lassen, J. F., Krussel, L. R., Rasmussen, K., Hansen, K. N., Pedersen, L., Johnsen, S. P., Soerensen, H. T., Thuesen, L.
(2007). Stent Thrombosis, Myocardial Infarction, and Death After Drug-Eluting and Bare-Metal Stent Coronary Interventions. J Am Coll Cardiol
50: 463-470
[Abstract][Full Text]
Vermeersch, P., Agostoni, P., Verheye, S., Van den Heuvel, P., Convens, C., Van den Branden, F., Van Langenhove, G., DELAYED RRISC (Death and Events at Long-term follo,
(2007). Increased Late Mortality After Sirolimus-Eluting Stents Versus Bare-Metal Stents in Diseased Saphenous Vein Grafts: Results From the Randomized DELAYED RRISC Trial. J Am Coll Cardiol
50: 261-267
[Abstract][Full Text]
Kastrati, A., Schomig, A.
(2007). Drug-Eluting Stents: Is Their Future as Bright as Their Past?. J Am Coll Cardiol
50: 146-148
[Full Text]
Kaul, S., Shah, P. K., Diamond, G. A.
(2007). As Time Goes By: Current Status and Future Directions in the Controversy Over Stenting. J Am Coll Cardiol
50: 128-137
[Abstract][Full Text]
Jaffe, R., Strauss, B. H.
(2007). Late and Very Late Thrombosis of Drug-Eluting Stents: Evolving Concepts and Perspectives. J Am Coll Cardiol
50: 119-127
[Abstract][Full Text]
Holmes, D. R. Jr, Kereiakes, D. J., Laskey, W. K., Colombo, A., Ellis, S. G., Henry, T. D., Popma, J. J., Serruys, P. W.J.C., Kimura, T., Williams, D. O., Windecker, S., Krucoff, M. W.
(2007). Thrombosis and Drug-Eluting Stents: An Objective Appraisal. J Am Coll Cardiol
50: 109-118
[Abstract][Full Text]
0.71). No significant influence of prespecified covariates on the treatment effect was observed, including the length of follow-up (P=0.44), the protocol-mandated duration of dual antiplatelet therapy (P=0.69), the presence of patients with acute myocardial infarction in the trial (P=0.56), or the presence of double blinding in the trial design (P=0.70). Figure 1B shows the overall 5-year survival curves for the two treatment groups. 
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