Background Definitions of stent thrombosis that have been usedin clinical trials of drug-eluting stents have been restrictiveand have not been used in a uniform manner.
Methods We applied a hierarchical classification of stent thrombosisset by the Academic Research Consortium (ARC) across randomizedtrials involving 878 patients treated with sirolimus-elutingstents, 1400 treated with paclitaxel-eluting stents, and 2267treated with bare-metal stents. We then pooled 4 years of follow-updata. All events were adjudicated by an independent clinical-eventscommittee.
Results The cumulative incidence of stent thrombosis accordingto the original protocol definitions was 1.2% in the sirolimus-stentgroup versus 0.6% in the bare-metal–stent group (P=0.20;95% confidence interval [CI], –0.4 to 1.5) and 1.3% inthe paclitaxel-stent group versus 0.8% in the bare-metal–stentgroup (P=0.24; 95% CI, –0.3 to 1.4). The incidence ofdefinite or probable stent thrombosis as defined by the ARCwas 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal–stentgroup (P=0.70; 95% CI, –1.5 to 1.0) and 1.8% in the paclitaxel-stentgroup versus 1.4% in the bare-metal–stent group (P=0.52;95% CI, –0.7 to 1.4). The incidence of definite or probableevents occurring 1 to 4 years after implantation was 0.9% inthe sirolimus-stent group versus 0.4% in the bare-metal–stentgroup and 0.9% in the paclitaxel-stent group versus 0.6% inthe bare-metal–stent group.
Conclusions The incidence of stent thrombosis did not differsignificantly between patients with drug-eluting stents andthose with bare-metal stents in randomized clinical trials,although the power to detect small differences in rates waslimited.
The treatment of obstructive coronary artery disease with percutaneousplacement of coronary stents is associated with significantlyimproved procedural safety and a lower rate of restenosis, ascompared with balloon angioplasty alone.1,2 However, repeatedpercutaneous and surgical revascularization procedures are neededto treat restenosis in 14% of patients.3 The use of drug-elutingstents has reduced the occurrence of such procedures by 50 to70%.4,5
Clinical studies involving two drug-eluting stents that havebeen approved by the Food and Drug Administration (FDA) weredesigned primarily to test the effectiveness of this strategy.The studies also examined whether there was a safety penaltyto this mechanism of action, including whether thrombotic occlusionwithin the stent occurred more frequently or at a later timethan the expected rate of about 1% occurring within 30 daysafter the procedure in patients with bare-metal stents.6 Individualreports and meta-analysis of randomized trials showed no significantincrease in risk associated with drug-eluting stents, as comparedwith bare-metal stents, at 1 year.7,8,9 However, these studiesused relatively restrictive and nonuniform definitions of stentthrombosis and had limited power to detect low-frequency events.Furthermore, observational studies have reported an increasedrisk of thrombotic events in patients with drug-eluting stentsafter 1 year,10,11,12 and there has been concern that late stentthrombosis may contribute to increased late mortality.13,14
We sought to increase the power to detect differences in stentthrombosis in data available from extended follow-up of randomizedtrials of drug-eluting stents and to evaluate the effect ofstent thrombosis on late mortality. We implemented a new standardized,hierarchical definition of stent thrombosis for uniform evaluationof events in a pooled analysis of eight randomized trials ofthe two FDA-approved drug-eluting stents, as compared with theirrespective bare-metal stents.
Methods
Study Design
We readjudicated the latest available data from eight trialsof two approved drug-eluting stents according to standardizeddefinitions of stent thrombosis requested by the FDA for presentationat an advisory panel on drug-eluting stents in December 2006.15All the studies remained blinded at the patient level to investigators,patients, and adjudication committees.
The Academic Research Consortium (ARC) was formed before thisrequest to implement consensus definitions for implementationin clinical trials of drug-eluting stents. Invited to attenddiscussions were representatives of international academic researchorganizations who were involved in designing these trials, representativesof the FDA, and representatives of manufacturers of drug-elutingstents that were involved in managing or planning clinical trials.The stent manufacturers included Abbott Vascular Devices, BiosensorsInternational, Boston Scientific, Conor Medsystems, Cordis,Guidant, and Medtronic. Funding to cover the costs of the meetingswas requested and received from each manufacturer but was nota requirement for participation. Meetings and final consensusdefinitions were controlled by the academic researchers.
Harvard Clinical Research Institute was contracted by Cordisand Boston Scientific to adjudicate clinical events and by Cordisto manage and analyze the data. The academic authors designedand performed the analyses and prepared the manuscript; theauthors assume responsibility for the integrity and completenessof the data and analyses.
Study Population
Patient-level data were pooled for four randomized, controlled,double-blind trials evaluating the sirolimus-eluting stent,as compared with the same stent without a drug or polymer coating(bare-metal stent) and separately for four randomized trialsevaluating the paclitaxel-eluting stent, as compared with thecorresponding bare-metal stent.4,5,16,17,18,19,20,21 Eligiblepatients received treatment of single, previously untreatedcoronary lesions, as previously described. The trial cohortof patients with sirolimus-eluting stents included those enrolledin the Randomized Study with the Sirolimus-Eluting Bx VelocityBalloon-Expandable Stent (RAVEL; ClinicalTrials.gov number,NCT00233805
[ClinicalTrials.gov]
)16 and the Sirolimus-Coated Bx Velocity Balloon-ExpandableStent in the Treatment of De Novo Native Coronary Artery Lesions(SIRIUS in the United States [NCT00232765
[ClinicalTrials.gov]
],4 C-SIRIUS in Canada[NCT00381420
[ClinicalTrials.gov]
],17 and E-SIRIUS in Europe [NCT00235144
[ClinicalTrials.gov]
]18). Thesedatabases were managed by the Harvard Clinical Research Institute,except for the RAVEL trial, which was managed by Cardialysisand transferred to the Harvard Clinical Research Institute.The trial cohort of patients with paclitaxel-eluting stentsincluded those enrolled in the TAXUS-I,19 TAXUS-II (NCT00299026
[ClinicalTrials.gov]
),20TAXUS-IV (NCT00292474
[ClinicalTrials.gov]
),5 and TAXUS-V (NCT00301522
[ClinicalTrials.gov]
)21 trials.The individual databases were managed by Boston Scientific,and data for our study were transferred to the authors. Patientswere prescribed aspirin indefinitely and clopidogrel for a minimumof 2 to 3 months in the trials involving sirolimus-eluting stentsand for 6 months in the trials involving paclitaxel-elutingstents, regardless of study-group assignments.
End Point Definitions
In the study protocol, stent thrombosis was defined accordingto the protocols used in the original clinical trials, as adjudicatedby the independent clinical-event committees for each trial.These definitions uniformly regarded evidence of any myocardialinfarction with angiographic confirmation of in-stent thrombusor unexplained death within 30 days after the procedure as stentthrombosis but varied when myocardial infarction was presentwithout angiographic confirmation of target-vessel involvement.Thrombotic occlusion of the study stent subsequent to repeatedpercutaneous treatment of the target lesion did not qualifyas stent thrombosis in these definitions, and none of the protocolsreported late unexplained deaths as stent thrombosis. Stentthrombosis was then classified by the ARC definition as definite,probable, or possible and as early (0 to 30 days), late (31to 360 days), or very late (>360 days). The definition ofdefinite stent thrombosis required the presence of an acutecoronary syndrome with angiographic or autopsy evidence of thrombusor occlusion. Probable stent thrombosis included unexplaineddeaths within 30 days after the procedure or acute myocardialinfarction involving the target-vessel territory without angiographicconfirmation. Possible stent thrombosis included all unexplaineddeaths occurring at least 30 days after the procedure. Interveningtarget-lesion revascularization was defined as any repeatedpercutaneous revascularization of the stented segment, includingthe 5-mm proximal and distal margins, that preceded stent thrombosis.
Statistical Analysis
We compared the time to stent thrombosis during 4 years of follow-upfor patients with drug-eluting stents, as compared with thosewith bare-metal stents, using the unstratified log-rank testfor each definition of stent thrombosis that was used: protocol,definite, definite or probable, and any ARC criterion. Datafor patients who did not have stent thrombosis were censoredeither at 4 years or at the last known time of follow-up, whicheverwas earlier. Data for patients who died before the 4-year follow-upand without thrombosis were censored at the time of death. Thetreatment of death as a competing risk yielded results thatwere very similar to those of the approach reported here. Theproportional-hazards assumption for each stent group was assessedwith the use of the Kolmogorov-type supremum test.22 Kaplan–Meierestimates of the cumulative incidence of stent thrombosis arepresented for each group during a 4-year period and during thespecified ARC time intervals and are based on a risk set ofthe number of patients who were alive at the beginning of theinterval. The time from target-lesion revascularization to stentthrombosis was calculated as days from the last target-lesionrevascularization to stent thrombosis. Statistical analyseswere performed with the use of SAS software, version 9.1. Allreported P values are two-sided. Exact results of the log-ranktest (as calculated by StatXact software, version 7.0.0) wereconfirmed to be similar to the log-rank results calculated byasymptotic methods, as reported here.
Results
Patients and Lesions
The cohorts included 878 patients treated with sirolimus-elutingstents, 870 patients treated with corresponding bare-metal stents,1400 patients treated with paclitaxel-eluting stents, and 1397treated with corresponding bare-metal stents. Follow-up differedbetween the sirolimus-stent group and the paclitaxel-stent groupbecause of the later initiation of the trials in the paclitaxel-stentgroup but remained balanced across randomized study groups.The median duration of follow-up was 1804 days in both the sirolimus-stentgroup and the corresponding bare-metal–stent group, 1423days in the paclitaxel-stent group, and 1430 days in the correspondingbare-metal–stent group.
Within each cohort, the patients were well matched with respectto clinical and lesion characteristics across the treatmentgroups (Table 1). Furthermore, the characteristics of the patientsin the pooled trials of sirolimus-eluting stents and paclitaxel-elutingstents were similar: the frequency of diabetes mellitus was26%, the mean reference-vessel diameter was 2.7 mm, and themean lesion length was 14 mm.
Table 1. Baseline Characteristics of the Study Patients.
Definitions of Stent Thrombosis
According to the protocol definitions, the cumulative incidenceof stent thrombosis during 4 years of follow-up was not significantlydifferent for either of the groups receiving drug-eluting stents,as compared with those receiving bare-metal stents, althoughthere were numerically more events after 1 year for both sirolimus-elutingstents and paclitaxel-eluting stents (Table 2 and Figure 1A and 1B).As assessed by each of the ARC categories, differences in thecumulative incidence of stent thrombosis during 4 years betweenpatients with sirolimus-eluting stents and those with paclitaxel-elutingstents, as compared with patients with bare-metal stents, wereless than those observed for the protocol definitions, owingto more late or very late events adjudicated for both bare-metal–stentgroups. The most inclusive ARC category, including possiblestent thrombosis, yielded an increase by a factor of 2 in thenumber of events in all four groups, mostly owing to very lateunexplained deaths (Figure 1C and 1D, and Figure 2 of the Supplementary Appendix,available with the full text of this article at www.nejm.org).
Figure 1. Cumulative Incidence of Stent Thrombosis at 4 Years after Implantation of FDA-Approved Drug-Eluting Stents, According to Definitions Used in Trial Protocol versus ARC Definite or Probable Categories.
Panels A and B show comparisons of the incidence of stent thrombosis in patients with sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, according to the definition of stent thrombosis used in the original cohort trials. Panels C and D show data from the same trials with the definition of definite or probable stent thrombosis recommended by the Academic Research Consortium (ARC). P values were calculated by the log-rank test. I bars indicate 95% confidence intervals.
The incidence of definite or probable events occurring 31 to360 days after the procedure was 0.1% in the sirolimus-stentgroup versus 1.0% in the corresponding bare-metal–stentgroup and 0.4% in the paclitaxel-stent group versus 0.3% inthe corresponding bare-metal–stent group. At year 4, theincidence of such events was 0.9% in the sirolimus-stent groupversus 0.4% in the corresponding bare-metal–stent groupand 0.9% in the paclitaxel-stent group versus 0.6% in the correspondingbare-metal–stent group (Figure 1C and 1D). For both pooledcohorts, the proportional-hazards assumption for treatment groupwas not rejected over the 4 years (P=0.23 for the sirolimus-stentgroup and P=0.93 for the paclitaxel-stent group for definiteor probable events, as compared with the corresponding bare-metal–stentgroups).
Clinical Outcomes
In the 68 patients with definite or probable stent thrombosis,21 patients died (30.9%) and 57 had myocardial infarction (83.8%)(Table 3). Outcome rates after stent thrombosis were similaramong treatment groups. At 4 years, on the basis of the overallrates of death from any cause reported in the study by Stoneet al.23 in this issue of the Journal, the proportions of deathsfrom stent thrombosis in our study were 7.0% in the sirolimus-stentgroup versus 11.1% in the corresponding bare-metal–stentgroup and 8.2% in the paclitaxel-stent group versus 6.1% inthe corresponding bare-metal–stent group.
Table 3. Clinical Outcomes in Patients after Definite or Probable Stent Thrombosis.
Effect of Repeated Revascularization
Percutaneous target-lesion revascularization during the 4-yearfollow-up period occurred in 8.4% of patients with sirolimus-elutingstents versus 29.0% of patients with bare-metal stents (P<0.001)and in 7.7% of paclitaxel-eluting stents versus 15.6% of patientswith bare-metal stents (P<0.001). Either definite or probablestent thrombosis was not observed after target-lesion revascularizationin the sirolimus-stent group and was observed in one patientin the paclitaxel-stent group. In the bare-metal–stentgroups of both cohorts, stent thrombosis occurred somewhat morefrequently among patients who underwent intervening target-lesionrevascularization than in patients without such intervention(binary rates, 2.4% of patients with target-lesion revascularizationvs. 1.5% of those without such intervention in the sirolimus-stenttrial cohort and 2.3% of patients with target-lesion revascularizationvs. 1.1% of those without such intervention in the paclitaxel-stenttrial cohort) (see Figure 3 of the Supplementary Appendix).Events occurred 15 to 669 days after the target-lesion revascularizationand were fatal in two patients.
Effect of Intracoronary Brachytherapy
Brachytherapy was frequently used to treat restenosis amongpatients with definite or probable stent thrombosis at any timeafter target-lesion revascularization. The treatment was performedin 9 of 11 patients in the bare-metal–stent groups andin the 1 patient who underwent target-lesion revascularizationin the paclitaxel-stent group. (Table 4).
Table 4. Intervening Target-Lesion Revascularization in Patients with Definite or Probable Stent Thrombosis.
Effect of Discontinuation of Antiplatelet Therapy
Information regarding compliance with dual antiplatelet therapywas limited, since it was not ascertained in the trials of sirolimus-elutingstents beyond the protocol-recommended durations of 2 to 3 months;in the trials of paclitaxel-eluting stents, compliance was determinedwithin follow-up intervals but not with actual dates of discontinuance.The retrospective collection of data in the trials of sirolimus-elutingstents indicated that 2 of 9 patients (22.2%) with sirolimus-elutingstents and 6 of 12 patients (50.0%) with bare-metal stents whohad definite or probable stent thrombosis (according to ARCcriteria) after 30 days were receiving dual antiplatelet therapy.
Discussion
On the basis of a uniform hierarchical classification for stentthrombosis, we did not find statistically significant differencesin the overall incidence between either of the currently approveddrug-eluting stents, as compared with their bare-metal–stentcontrols, during the 4 years after implantation. Stent thrombosis,a low-frequency event with serious, life-threatening consequencesand variable rates of confirmation, poses many difficultiesfor analysis. Restrictive and nonuniform definitions from protocolsof previous clinical trials and confounding in observationalstudies provide further challenges. We used the ARC definitionto allow uniform ascertainment of end points across a largecohort derived from randomized trials. Our clinical review suggestedthat the most restrictive category, definite stent thrombosis,although unbiased, may have missed true events of stent thrombosisby requiring angiographic or autopsy confirmation even whenthe clinical presentation was consistent with stent thrombosis.The most inclusive definition, possible stent thrombosis, introduceda large number of events, owing to insufficient informationto specify the cause of death, particularly after 1 year. Theseevents were equally distributed across groups and weakened anypotential signal of harm. Thus, we believe the "definite orprobable" category provided the best approximation of the trueincidence of stent thrombosis.
Although clinical end points have primary importance for thepatient, they may fail to discriminate between small differencesin the risk of stent thrombosis, since the condition accountsfor a small fraction of the total number of these events. Infact, death from stent thrombosis accounted for about 10% ofthe total number of deaths reported in these studies.23 Ouranalysis demonstrates that recent reports of higher mortalityin meta-analyses of trials involving sirolimus-eluting stents,as compared with bare-metal stents,13,14 are not attributableto differences in the risk of stent thrombosis across treatments.However, the fact that stent thrombosis is an infrequent causeof death in these studies does not diminish its relevance orthe relevance of accurate assessment, given the strong associationwith mortality and morbidity, regardless of stent type.
We found that definite or probable stent thrombosis was relativelymore frequent after treatment for restenosis. A dilemma existsin these cases as to whether to attribute stent thrombosis tothe initial treatment strategy or the intervening treatmentfor restenosis. The original protocol definitions did not allowany event occurring after revascularization to be classifiedas stent thrombosis. This approach departed from an intention-to-treatprinciple and introduced a bias against devices that reducerestenosis. The restenosis treatments applied according to thestandard of care represent a part of the strategy of the useof bare-metal stents. Therefore, we included such events. Outcomesof death and myocardial infarction after stent thrombosis weresimilar for patients with bare-metal stents and those with drug-elutingstents, suggesting that stent thrombosis after a previous target-lesionrevascularization carries equally dire consequences.
During these trials, investigators remained unaware of treatmentassignments, but brachytherapy, the standard of care at thetime, was more commonly used in the groups with bare-metal stents,in which restenosis occurred more frequently and more diffuselythan in the groups with drug-eluting stents.4,5 Although intracoronarybrachytherapy for restenosis treatment has been previously identifiedas a risk for late thrombosis, this risk has been mainly attributedto concurrent implantation of a new stent,24,25 which was notthe case in any patients with definite or probable stent thrombosisin our study. Furthermore, the association of brachytherapywith thrombosis is probably confounded by the occurrence andseverity of restenosis. Our data do not allow us to speculatewhether the risk of subsequent thrombosis after target-lesionrevascularization would be different with other methods of restenosistreatment. Although brachytherapy is the only approved treatmentfor restenosis associated with bare-metal stents, it has beenlargely supplanted by other treatments (in particular, by treatmentwith drug-eluting stents).26,27 Therefore, further analysisis needed to determine the frequency of late thrombosis whena strategy of bare-metal stenting is followed by drug-elutingstenting to treat restenosis.
Analyses in which events before a given time point (such as6 months or 1 year) are excluded have indicated an increasedlate risk associated with drug-eluting stents.11,28 We aimedto avoid bias introduced by omitting or censoring early eventsfrom statistical comparisons but observed that the incidencefrom year 1 through year 4 ranged from 0.4 to 0.9%, with verylate events occurring in all stent groups. A larger number ofvery late events occurred in patients with drug-eluting stentsthan in those with bare-metal stents, but nearly 40% of patientswith very late stent thrombosis had bare-metal stents.
Early cessation of clopidogrel is commonly reported in patientswith thrombosis associated with drug-eluting stents.29 However,we observed events in patients with both bare-metal stents anddrug-eluting stents in the presence of both aspirin and clopidogrel.These findings are consistent with a recent observational studyshowing ongoing risk despite continued dual antiplatelet therapy12and suggest that although a protective effect may exist,28 extendeddual antiplatelet therapy alone may not be sufficient to eliminatethe occurrence of late thrombosis in patients with either bare-metalstents or drug-eluting stents.
Our analysis includes all trials used to support the FDA approvalof the two drug-eluting stents. Nonetheless, on the basis ofthe rates observed in these trials (i.e., assuming a thrombosisrate of 1% with the use of bare-metal stents and an absoluteincrease of 1% in the rate of thrombosis with drug-eluting stents),a randomized trial with a power of 90% to detect a doublingof the risk of stent thrombosis would require approximately8000 subjects. The duration of such a study would depend onthe expected duration of thrombosis risk beyond 1 year. Observationsregarding variations of hazard rates over time are difficultto make with certainty, since such variations are also limitedby the small number of events. Whether the incidence curvesfor the events associated with drug-eluting stents and thoseassociated with bare-metal stents will remain convergent orseparate beyond 4 years is unknown, and follow-up for longerthan 4 years will be necessary to answer this question. Finally,this study reflects rates of stent thrombosis in a populationof patients who were at moderate risk for the condition. Theapplication of drug-eluting stents has been extended in practicebeyond the population of patients who are reflected in thesetrials. Since the individual characteristics of patients, lesions,and procedural factors are known to contribute to the risk ofstent thrombosis,30 higher rates would be expected in higher-riskgroups or in situations in which maintenance of recommendedantiplatelet therapy is not possible. Our findings may not beapplicable to these subgroups of patients.
In summary, we used a standardized, hierarchical definitionof stent thrombosis to compare risk across studies. We foundthat during 4 years of follow-up, overall rates of stent thrombosiswere not significantly different for patients who had receivedone of two approved types of drug-eluting stents and those whohad received bare-metal stents. However, both longer-term andlarger studies are needed to better understand how these infrequentbut deadly events can be prevented.
Cordis and Boston Scientific contracted with Harvard ClinicalResearch Institute to perform independent adjudication of clinicalevents and data management, the results of which were used inthis analysis. No external funds were received for this analysisor in the preparation of the manuscript, and industry sponsorswere not involved in the preparation of the manuscript or consultedbefore the submission of results for publication.
Drs. Mauri, Massaro, and D'Agostino report receiving reimbursementfor travel expenses and lodging for preparation and presentationof part of these results during a recent FDA advisory panelmeeting; Dr. Mauri, administering an educational grant fromCordis without payment; and Dr. Cutlip, receiving a consultingfee from Bristol-Myers Squibb for participating in an advisorymeeting on stent thrombosis. No other potential conflict ofinterest relevant to this article was reported.
Source Information
From Brigham and Women's Hospital (L.M.), Harvard Clinical Research Institute (L.M., W.H., J.M.M., K.K.L.H., R.D., D.E.C.), Beth Israel Deaconess Medical Center (K.K.L.H., D.E.C.), Harvard Medical School (L.M., K.K.L.H., D.E.C.), and Boston University (J.M.M., R.D.) — all in Boston. This article (10.1056/NEJMoa067731) was published at www.nejm.org on February 12, 2007.
Address reprint requests to Dr. Cutlip at Beth Israel Deaconess Medical Center, Baker 4, 185 Pilgrim Rd., Boston, MA 02215, or at don.cutlip{at}hcri.harvard.edu.
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