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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Risk Factors for Stent Thrombosis After Implantation of Sirolimus-Eluting Stents in Diabetic and Nondiabetic Patients

The EVASTENT Matched-Cohort Registry

Jacques Machecourt, MD, FESC^_*, Nicolas Danchin, MD, FESC^,_*, Jean Marc Lablanche, MD, FESC, Jean Marie Fauvel, MD, FESC, Jean Louis Bonnet, MD, FESC^||, Stephanie Marliere, MD^_*, Alison Foote, PhD^¶, Jean Louis Quesada^¶, Hélène Eltchaninoff, MD, FESC^#, Gérald Vanzetto, MD, PhD^_* for the EVASTENT Investigators

^_* CHU Michallon, Grenoble, France
Hôpital Européen Georges Pompidou, Paris, France
Hôpital Cardiologique, CHU Lille, Lille, France
Hôpital Cardiologique, CHU Toulouse, Toulouse, France
^|| CHU La Timone, Marseille, France
^¶ INSERM Clinical Research Center, Grenoble, France
^# CHU Charles Nicolle, Rouen, France

Manuscript received December 1, 2006; revised manuscript received March 28, 2007, accepted April 10, 2007.

^_* Reprint requests and correspondence: Dr. Jacques Machecourt, Service Cardiologie et Urgences Cardiologiques, CHU Grenoble, BP 217 X, 38043 Grenoble Cedex 09, France (Email: jmachecourt{at}chu-grenoble.fr).

Objectives: We sought to assess the frequency and causes of stent thrombosis in diabetic and nondiabetic patients after implantation of sirolimus-eluting stents.

Background: Safety concerns about late stent thrombosis have been raised, particularly when drug-eluting stents are used in less highly selected patients than in randomized trials.

Methods: The EVASTENT study is a matched multicenter cohort registry of 1,731 patients undergoing revascularization exclusively with sirolimus stents; for each diabetic patient included (stratified as single- or multiple-vessel disease), a nondiabetic patient was subsequently included. Patients were treated with aspirin + clopidogrel for at least 3 months and were followed for 465 (range 0 to 1,062) days (1-year follow-up in 98.5%). The primary end point was a composite of stent thrombosis (according to Academic Research Consortium definitions), cardiovascular death, and nonfatal myocardial infarction (major adverse cardiac events [MACE]).

Results: During follow-up, MACE occurred in 78 patients (4.5%), cardiac death in 35 (2.1%), and stent thrombosis in 45 (2.6%): 30 definite, 23 subacute, and 22 late, including 9 at >6 months. In univariate analysis, the 1-year stent thrombosis rate was 1.8 times higher in diabetic than in nondiabetic patients (3.2% vs. 1.7%; log rank p = 0.03), with diabetic patients with multiple-vessel disease experiencing the highest rate and nondiabetic single-vessel disease patients the lowest (4.3% vs. 0.8%; p < 0.001). In multivariate analysis, in addition to the interruption of antithrombotic treatment, independent stent thrombosis predictors were previous stroke, renal failure, lower ejection fraction, calcified lesion, length stented, and insulin-requiring diabetes.

Conclusions: The risk of sirolimus stent thrombosis is higher for multiple-vessel disease diabetic patients.

Abbreviations and Acronyms   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   LAST = late acute stent thrombosis   MACE = major adverse cardiac events   MI = myocardial infarction   MVD = multivessel disease   SAE = serious adverse event   SAT = subacute stent thrombosis   SES = sirolimus-eluting stent(s)   SVD = single-vessel disease   TLR = target lesion revascularization   TVF = target vessel failure   TVR = target vessel revascularization

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