Paclitaxel-Eluting or Sirolimus-Eluting Stents to Prevent Restenosis in Diabetic Patients
Alban Dibra, M.D., Adnan Kastrati, M.D., Julinda Mehilli, M.D., Jürgen Pache, M.D., Helmut Schühlen, M.D., Nicolas von Beckerath, M.D., Kurt Ulm, Ph.D., Rainer Wessely, M.D., Josef Dirschinger, M.D., Albert Schömig, M.D., for the ISAR-DIABETES Study Investigators
Background Drug-eluting stents are highly effective in reducingthe rate of in-stent restenosis. It is not known whether thereare differences in the effectiveness of currently approved drug-elutingstents in the high-risk subgroup of patients with diabetes mellitus.
Methods We enrolled 250 patients with diabetes and coronaryartery disease: 125 were randomly assigned to receive paclitaxel-elutingstents, and 125 to receive sirolimus-eluting stents. The primaryend point was in-segment late luminal loss. Secondary end pointswere angiographic restenosis (defined as in-segment stenosisof at least 50 percent at follow-up angiography) and the needfor revascularization of the target lesion during a nine-monthfollow-up period. The study was designed to show noninferiorityof the paclitaxel stent as compared with the sirolimus stent,defined as a difference in the extent of in-segment late luminalloss of no more than 0.16 mm.
Results The extent of in-segment late luminal loss was 0.24mm (95 percent confidence interval, 0.09 to 0.39) greater inthe paclitaxel-stent group than in the sirolimus-stent group(P=0.002). In-segment restenosis was identified on follow-upangiography in 16.5 percent of the patients in the paclitaxel-stentgroup and 6.9 percent of the patients in the sirolimus-stentgroup (P=0.03). Target-lesion revascularization was performedin 12.0 percent of the patients in the paclitaxel-stent groupand 6.4 percent of the patients in the sirolimus-stent group(P=0.13).
Conclusions In patients with diabetes mellitus and coronaryartery disease, use of the sirolimus-eluting stent is associatedwith a decrease in the extent of late luminal loss, as comparedwith use of the paclitaxel-eluting stent, suggesting a reducedrisk of restenosis.
Coronary artery disease is a major cause of complications anddeath among patients with diabetes mellitus.1 In particular,patients with diabetes are prone to a diffuse and rapidly progressiveform of atherosclerosis, which increases their likelihood ofrequiring revascularization.2,3,4 Percutaneous coronary interventionand aortocoronary bypass surgery are recommended revascularizationstrategies for such patients. However, because of the increasedrisk of restenosis after percutaneous coronary interventionsin these patients,5,6,7 aortocoronary bypass surgery has beenconsidered to be the preferred revascularization strategy formany.8,9
Drug-eluting stents markedly reduce the incidence of restenosisas compared with bare-metal stents, both in patients withoutdiabetes and in those with diabetes.10,11,12,13,14,15,16,17However, no data are available on the relative efficacy of particulardrug-eluting stents in patients with diabetes. This issue hasimportant implications for the selection of the most effectivetherapy in this high-risk group of patients. We therefore designeda prospective, randomized trial to compare paclitaxel- and sirolimus-elutingstents in patients with diabetes and coronary artery disease.
Methods
Patients
Enrollment of participants began on June 11, 2003, and was completedon March 15, 2004. Two German centers participated in the trial:Deutsches Herzzentrum and First Medizinische Klinik rechts derIsar, both in Munich. Patients were considered eligible if theyhad diabetes mellitus, presented with angina pectoris or hada positive stress test or met both criteria, and had clinicallysignificant angiographic stenosis in a native coronary vessel.Exclusion criteria included acute ST-segment–elevationmyocardial infarction; a target lesion in the left main trunk;in-stent restenosis; any contraindication to the use of aspirin,heparin, or clopidogrel; and lack of consent to participatein the study. The study protocol was approved by the institutionalethics committees at both participating centers. All patientsgave written informed consent.
Randomization, Interventions, and Adjunct Drug Therapy
All patients received a loading dose of 600 mg of clopidogrelat least two hours before undergoing coronary angiography.18,19After the guide wire had crossed the lesion, patients were randomlyassigned to receive a paclitaxel-eluting stent (Taxus, BostonScientific) or a sirolimus-eluting stent (Cypher; Cordis, Johnson& Johnson) with the use of sealed envelopes containing acomputer-generated randomization sequence. The same randomlyassigned stent had to be implanted in all lesions in patientswho required stenting in multiple lesions; the use of more thanone stent per lesion was also allowed.
Periprocedural antithrombotic therapy consisted of intravenouslyadministered aspirin and heparin; abciximab (ReoPro, Lilly)was given only to patients with acute coronary syndromes. Afterthe intervention, the protocol mandated the use of antiplatelettherapy consisting of 100 mg of aspirin twice a day indefinitelyas well as 75 mg of clopidogrel twice a day until discharge,followed by a dose of 75 mg a day for at least six months.
Follow-up Protocol
After undergoing stenting, all patients remained in the hospitalfor at least 48 hours. Electrocardiography was performed andblood was collected for the measurement of creatine kinase andits MB isoenzyme before stenting, every 8 hours for the first24 hours after the procedure, and daily thereafter during hospitalization.A telephone interview was conducted after 30 days to assesseach patient's clinical status. All patients were asked to returnfor coronary angiography between six and eight months afterthe procedure, or earlier if anginal symptoms occurred. Telephoneinterviews were repeated nine months after the intervention.Relevant data were collected and entered into a computerizeddatabase by specialized personnel at the clinical data-managementcenter. All data were verified with the use of hospital recordsor the records of family physicians, and all adverse clinicalevents were adjudicated by an events committee whose memberswere unaware of patients' treatment assignments.
Quantitative Coronary Angiography
Baseline, postprocedural, and follow-up coronary angiogramswere digitally recorded and assessed off-line in the quantitativeangiographic core laboratory (Deutsches Herzzentrum) with anautomated edge-detection system (CMS version 5.1.4.1
[EC]
, MedisMedical Imaging Systems) by experienced personnel unaware ofthe type of stent implanted. The complexity of the lesions wasdefined according to the modified grading system of the AmericanCollege of Cardiology–American Heart Association.20 Themorphologic appearance of in-stent restenosis at follow-up angiographywas classified according to the system proposed by Mehran etal.21 All measurements were performed on cineangiograms recordedafter the intracoronary administration of nitroglycerin. Thesame single, worst-view projection was used at all times. Thecontrast-filled nontapered catheter tip was used for calibration.The reference diameter was determined by interpolation.
The variables that were measured included the reference diameterof the vessel, the minimal diameter of the lumen, the extentof stenosis (the difference between the reference diameter andthe minimal luminal diameter, divided by the reference diameterand multiplied by 100), late luminal loss (the difference betweenthe minimal luminal diameter at the end of the procedure andthe minimal luminal diameter at follow-up), and net luminalgain (the difference between the minimal luminal diameter atfollow-up and the minimal luminal diameter before the procedure).Quantitative analysis was used to evaluate the stented area("in stent") and the area that included the stented segmentas well as the 5-mm margins proximal and distal to the stent("in segment").
Study End Points, Definitions, and Design
The primary end point of the study was in-segment late luminalloss on follow-up angiography. Secondary end points were angiographicrestenosis (defined as in-segment stenosis of at least 50 percenton follow-up angiography) and the need for revascularizationof the target lesion owing to narrowing of the lumen in thepresence of symptoms or objective signs of ischemia during thenine-month follow-up interval.
The diagnosis of diabetes mellitus was considered confirmedin all patients receiving active treatment with an oral hypoglycemicagent or insulin; for patients with a diagnosis of diabeteswho were receiving dietary therapy alone, enrollment in thetrial required the documentation of an abnormal blood glucoselevel after an overnight fast or an abnormal glucose-tolerancetest.22 The diagnosis of myocardial infarction during follow-uprequired the presence of new Q waves on the electrocardiogramor an elevation of creatine kinase or its MB isoenzyme to atleast three times the upper limit of the normal range in atleast two blood samples (some patients met both criteria).23
Statistical Analysis
The objective of the study was to assess whether the outcomeof treatment with the paclitaxel-eluting stent was not inferiorto the outcome of treatment with the sirolimus-eluting stent.Calculation of the sample size was based on a margin of noninferiorityfor in-segment late luminal loss of 0.16 mm. This value is equalto 35 percent of an assumed mean (±SD) late luminal lossof 0.46±0.45 mm in diabetic patients after the implantationof a sirolimus stent, as found in an analysis of a series ofdiabetic patients treated with sirolimus stents at participatingcenters in the 10 months that preceded the initiation of thestudy.
Using a one-sided level of 0.05, we estimated that 99 patientsper group were needed to demonstrate noninferiority of the paclitaxelstent with a statistical power of 80 percent. Expecting thatup to 20 percent of the patients would not return for follow-upcoronary angiography, we included 250 patients in the study.Sample size was calculated with the use of nQuery Advisor (version4.0, Statistical Solutions) according to the method of O'Brienand Muller.24
Analyses related to angiographic measures were conducted accordingto the number of patients available for each analyses. All otheranalyses were conducted according to the intention-to-treatprinciple. For patients with multilesion interventions, onlythe data pertaining to the first treated lesion were includedin the analysis. The noninferiority hypothesis was assessedstatistically with EquivTest (Statistical Solutions) accordingto the method of Chow and Liu.25 The differences between thegroups were assessed with a two-sided chi-square test or Fisher'sexact test for categorical data and Student's t-test for continuousdata. The relative risk and its 95 percent confidence intervalwere computed for outcome measures. The differences in quantitativeangiographic results at follow-up between the two study groupswere also assessed after adjustment for baseline characteristicsby means of multiple linear regression analysis (continuousdependent variables) or multiple logistic-regression analysis(dichotomous dependent variables). All P values were two-sided,and a P value of less than 0.05 was considered to indicate statisticalsignificance.
Results
A total of 250 patients were enrolled in the study and randomlyassigned to receive either a paclitaxel stent or a sirolimusstent. Table 1 shows the baseline demographic, clinical, andangiographic characteristics of the study population. The proceduralcharacteristics are shown in Table 2. Implantation of the randomlyassigned stent was successful in all patients. In 12.0 percentof patients, more than one lesion was treated. There was onlyone case of early stent thrombosis: in one patient in the paclitaxel-stentgroup, the stent became occluded five hours after the indexprocedure.
Follow-up angiography was performed in 103 patients (82.4 percent)in the paclitaxel-stent group and 102 patients (81.6 percent)in the sirolimus-stent group. Patients who did not undergo follow-upangiography did not differ significantly from those who didwith respect to the baseline characteristics shown in Table 1.Five of the 22 patients who did not undergo follow-up angiographyin the paclitaxel-stent group died during the nine-month follow-upperiod, as did 4 of the 23 such patients in the sirolimus-stentgroup. No other adverse events were observed among these patients,and none required rehospitalization during follow-up.
The median duration of angiographic follow-up was 196 days (10thand 90th percentiles, 92 and 236) in the paclitaxel-stent groupand 196 days (10th and 90th percentiles, 91 and 238) in thesirolimus-stent group (P=0.94). Table 3 shows the results ofthe quantitative analysis of follow-up angiograms. The meandifference in in-segment late luminal loss between the paclitaxel-stentgroup and the sirolimus-stent group was 0.24 mm (95 percentconfidence interval, 0.09 to 0.39), a result failing to showthe noninferiority of the paclitaxel stent and instead demonstratingthe statistical superiority of the sirolimus stent (P=0.002)(Figure 1). This difference remained significant after adjustmentfor the baseline characteristics of the patients (P=0.001) (Table 3).Figure 2 shows the cumulative rates of in-segment stenosisat follow-up angiography.
Figure 1. Cumulative Rates of In-Segment Late Luminal Loss at Follow-up Angiography.
Late luminal loss was defined as the difference between the minimal luminal diameter at the end of the procedure and the minimal luminal diameter at follow-up.
Figure 2. Cumulative Rates of In-Segment Stenosis at Follow-up Angiography.
The extent of stenosis was defined as the difference between the reference diameter and the minimal luminal diameter, divided by the reference diameter and multiplied by 100.
Among patients who were receiving insulin, in-segment late luminalloss averaged 0.72±0.66 mm in the paclitaxel-stent groupand 0.41±0.42 mm in the sirolimus-stent group (P=0.02).Among patients who were not receiving insulin, in-segment lateluminal loss averaged 0.65±0.60 mm in the paclitaxel-stentgroup and 0.44±0.46 mm in the sirolimus-stent group (P=0.03).
In-segment restenosis was found on follow-up angiography in17 of 103 patients in the paclitaxel-stent group, as comparedwith 7 of 102 patients in the sirolimus-stent group (16.5 percentvs. 6.9 percent; relative risk, 2.40; 95 percent confidenceinterval, 1.04 to 5.55; P=0.03). With respect to the patternof restenosis on follow-up angiography, all seven of the patientsin the sirolimus-stent group presented with pattern I. In thepaclitaxel-stent group, 13 patients presented with pattern I,1 patient with pattern II, 1 patient with pattern III, and 2patients with pattern IV.
Clinical Outcomes
All patients completed the nine-month follow-up. Six patients(4.8 percent) in the paclitaxel-stent group and four patients(3.2 percent) in the sirolimus-stent group died during thisperiod (P=0.52). Myocardial infarction occurred in three patients(2.4 percent) in the paclitaxel-stent group and five patients(4.0 percent) in the sirolimus-stent group (P=0.72). Target-lesionrevascularization was performed in 15 patients in the paclitaxel-stentgroup, as compared with 8 patients in the sirolimus-stent group(12.0 percent vs. 6.4 percent; relative risk, 1.89; 95 percentconfidence interval, 0.82 to 4.27; P=0.13). Among the patientswho underwent target-lesion revascularization, the mean extentof in-segment stenosis at follow-up angiography was 65.0±17.0percent.
Discussion
In this randomized trial, we compared the efficacy of the sirolimus-elutingstent and the paclitaxel-eluting stent in the prevention ofrestenosis in patients with diabetes mellitus and coronary arterydisease. The paclitaxel stent was associated with a higher rateof in-segment late luminal loss as well as an increased riskof angiographic restenosis. Our study was not sufficiently poweredto assess the incidence of clinical restenosis, and we foundno significant differences in the rates of clinical end pointsbetween the two groups. Nonetheless, our results imply thatthe sirolimus stent may be preferable to the paclitaxel stentin patients with diabetes who require coronary revascularization.
We chose late luminal loss at follow-up angiography as the primaryend point of our trial because it reflects the degree of neointimalproliferation,26 which is the chief cause of restenosis afterstent implantation.27 Late loss is the most sensitive measureof the antiproliferative effectiveness of drug-eluting stents,28,29although in-stent late loss may be a more reliable predictorof restenosis than in-segment late loss.29 In a recent trial,a 70 percent reduction in the rate of in-segment late luminalloss with the sirolimus-eluting stent was associated with a75 percent reduction in the rate of target-lesion revascularizationas compared with the rates with the control bare-metal stent.12However, it should be stressed that late luminal loss constitutesonly a surrogate for clinical end points. The limitations ofsurrogate end points have been well described.30,31 Our resultsshould be interpreted in this context.
Our calculation of sample size was based on a margin of noninferiorityof 0.16 mm for in-segment late luminal loss. This value wasselected after an analysis of a series of diabetic patientstreated with sirolimus stents at our own institutions. It isalso a reasonable margin of difference on the basis of findingsin other studies. In the SIRIUS trial, an absolute reductionof 0.57 mm in in-segment late luminal loss was achieved withthe use of the sirolimus-eluting stent as compared with thebare-metal stent.12 Our margin of difference of 0.16 mm representsthe preservation of 72 percent of the effect demonstrated bythe sirolimus-eluting stent in that trial. A new treatment isconsidered noninferior to a standard treatment when it retains50 to 80 percent of the superiority that the standard treatmenthas shown over placebo.32
Another issue that requires comment is our observation thatthe extent of in-segment late luminal loss exceeded the extentof in-stent late luminal loss. This finding differs from theresults of most other stenting trials, although a similar resultwas reported among patients receiving a sirolimus stent in theSIRIUS trial.12,16 The phenomenon of greater in-segment lateloss may be a consequence of two factors. First, after the procedure,the in-stent minimal luminal diameter (2.65 mm) was nearly identicalto the in-segment minimal luminal diameter (2.62 mm) —a result that is somewhat unexpected, especially in diabeticpatients with diffuse coronary disease. Second, patients withdiabetes have a distinctive, swiftly progressive form of atherosclerosis,which increases the reactivity of the vascular wall to the injuryproduced by the procedure at the stent margins as well as therate of natural progression of disease outside the stent, aneffect presumably mitigated within the stent by the antiproliferativeproperties of sirolimus and paclitaxel.
The incidence ratio of target-lesion revascularization to angiographicrestenosis in our study was 78.6 percent. In previous randomizedtrials comparing drug-eluting stents with bare-metal stents,this ratio ranged from 38 and 46 percent12,13 to 85 percent33among patients assigned to receive the drug-eluting stent. Itis difficult to be certain of the reason for the higher ratioin our study than in several previous trials. The rate of lateloss in our trial was also higher than that in other, similartrials, possibly because we limited our study population topatients with diabetes. The higher rate may reflect not onlyan increased incidence but also increased severity of angiographicallyevident restenosis, increasing the likelihood of the need forreintervention. In addition, diabetes mellitus is often perceivedas a disease that attenuates anginal symptoms even in the presenceof clinically significant coronary artery stenosis. This perceptionmay have induced the clinicians to overestimate symptoms andlower their threshold for reintervention in some patients withangiographically evident restenosis in the present trial.
Although the exact mechanism underlying our findings remainsunclear, pharmacologic differences between the two drugs, differencesin the dose response of patients with diabetes, or differencesin the properties of the two drug-delivery stents (such as releasekinetics and polymeric coating) may account for the results.A study of another high-risk subgroup of patients (those within-stent restenosis) also found sirolimus stents to reduce therisk of target-vessel revascularization more effectively thandid paclitaxel stents.34 These findings, however, cannot beextrapolated to a patient population with a more favorable riskprofile. This issue has recently been investigated in othertrials, and preliminary results have been presented.35
In conclusion, we did not establish the noninferiority of paclitaxel-elutingstents to sirolimus-eluting stents in patients with diabetesand coronary artery disease. Instead, we found that the useof the sirolimus-eluting stent in this setting was associatedwith a decrease in the extent of late luminal loss, suggestinga reduced risk of restenosis.
Supported by a grant (KKF 04-03) from Deutsches Herzzentrum,Munich, Germany.
Dr. Kastrati reports having received research grants from DeutschesHerzzentrum and Medtronic as well as lecture fees from Guidant.Dr. Schühlen reports having received lecture fees fromBoston Scientific, Guidant, and Lilly. Dr. Schömig reportshaving received research grants on behalf of the Departmentof Cardiology from Bristol-Myers Squibb, Guidant, and Lilly.
* The Intracoronary Stenting and Angiographic Results: Do DiabeticPatients Derive Similar Benefit from Paclitaxel-Eluting andSirolimus-Eluting Stents (ISAR-DIABETES) study investigatorsare listed in the Appendix.
Source Information
From Deutsches Herzzentrum (A.D., A.K., J.M., J.P., N.B., R.W., A.S.), First Medizinische Klinik rechts der Isar (H.S., J.D., A.S.), and Institut für Medizinische Statistik und Epidemiologie (K.U.), Technische Universität — all in Munich, Germany.
Address reprint requests to Dr. Kastrati at Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany, or at kastrati{at}dhm.mhn.de.
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The following centers and investigators participated in theISAR-DIABETES Study: Steering Committee: A. Schömig (chair),A. Kastrati (principal investigator); Event-Adjudication Committee:J. Dirschinger, H. Schühlen, J. Pache; Data-CoordinatingCenter: J. Mehilli, H. Bollwein, C. Markwardt; AngiographicCore Laboratory: A. Dibra, S. Piniek, S. Meier; Clinical Follow-upCenter: H. Holle, K. Hösl, F. Rodrigues, C. Peterler; ParticipatingCenters and Investigators:Deutsches Herzzentrum, Munich —J. Pache, C. Schmitt, N. von Beckerath, R. Wessely; Klinikumrechts der Isar, Munich — J. Dirschinger, H. Schühlen,M. Seyfarth, M. Karch.
Drug-Eluting Coronary Stents
Alarcón J. A., Arribas J. M., Ruiz V., Czupryniak L., Pawlowski M., Loba J., Bonvini R. F., Verin V., Waksman R., Wolfram R. M., Jneid H., Jang I.-K., Palacios I., Kastrati A., Dibra A., Schömig A., Windecker S., Jüni P., Meier B., Moliterno D. J.
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level of 0.05, we estimated that 99 patients per group were needed to demonstrate noninferiority of the paclitaxel stent with a statistical power of 80 percent. Expecting that up to 20 percent of the patients would not return for follow-up coronary angiography, we included 250 patients in the study. Sample size was calculated with the use of nQuery Advisor (version 4.0, Statistical Solutions) according to the method of O'Brien and Muller.24 
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