Risk factors for stent thrombosis after implantation of sirolimus-eluting stents in diabetic and nondiabetic patients: the EVASTENT Matched-Cohort Registry.
OBJECTIVE
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.
Machecourt
Jacques
J
CHU Michallon, Grenoble, France. jmachecourt@chu-grenoble.fr
Danchin
Nicolas
N
Lablanche
Jean Marc
JM
Fauvel
Jean Marie
JM
Bonnet
Jean Louis
JL
Marliere
Stephanie
S
Foote
Alison
A
Quesada
Jean Louis
JL
Eltchaninoff
Hélène
H
Vanzetto
Gérald
G
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D016022:Case-Control Studies; D003327:Coronary Disease / Q000150:complications / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000150:complications / Q000188:drug therapy / Q000628:therapy*; D018572:Disease-Free Survival; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents / Q000009:adverse effects*; D013927:Thrombosis / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D007328:Insulin; D020123:Sirolimus