Prognostic role of restenosis in 10 004 patients undergoing routine control angiography after coronary stenting.

AIM: Routine control angiography is a valuable tool with high-sensitivity in detecting restenosis after coronary stenting. However, the prognostic role of restenosis is still controversial. We investigated the impact of restenosis on 4-year mortality in patients undergoing routine control angiography after coronary stenting. METHODS AND RESULTS: All the patients undergoing successful implantation of coronary stents for de novo lesions from 1998 to 2009 and routine control angiography after 6-8 months at two centres in Munich, Germany were studied. Restenosis was defined as diameter stenosis ≥50% in the in-segment area at follow-up angiography. The primary outcome was 4-year mortality. The study included 10 004 patients with 15 004 treated lesions. Restenosis was detected in 2643 (26.4%) patients. Overall, there were 702 deaths during the follow-up. Of these, 218 deaths occurred among patients with restenosis and 484 deaths occurred among patients without restenosis [unadjusted hazard ratio: HR: 1.19; (95% confidence interval CI: 1.02-1.40); P = 0.03]. The Cox proportional hazards model adjusting for other variables identified restenosis as an independent correlate of 4-year mortality [HR: 1.23; (95% CI: 1.03-1.46); P = 0.02]. Other independent correlates of 4-year mortality were age [for each 10-year increase, HR: 2.34; (95% CI: 2.12-2.60); P < 0.001], diabetes mellitus [HR: 1.68; (95% CI: 1.41-1.99); P < 0.001], current smoking habit [HR: 1.39; (95% CI: 1.09-1.76); P = 0.01], and left ventricular ejection fraction [for each 5% decrease, HR: 1.39; (95% CI: 1.31-1.48); P < 0.001]. CONCLUSIONS: In this large cohort of patients, the presence of restenosis at follow-up angiography after coronary stenting was predictive of 4-year mortality. Whether routine control angiography after coronary stenting is beneficial and influences outcomes should be evaluated by properly designed randomized trials.

ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting.

BACKGROUND: In patients receiving aspirin, the optimal duration of clopidogrel therapy after drug-eluting stent (DES) implantation remains unclear. METHODS: This multicentre, randomized, double-blind, placebo-controlled trial tested the hypothesis that in patients undergoing DES implantation, 6 months of clopidogrel is non-inferior to 12 months in terms of clinical outcomes. At 6 months after DES implantation, patients on clopidogrel were randomly assigned to either a 6-month period of placebo or an additional 6-month period of clopidogrel. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, and thrombolysis in myocardial infarction major bleeding at 9 months after randomization. RESULTS: Owing to slow recruitment and low event rates, the trial was stopped prematurely after enrolment of 4005 of 6000 planned patients. Of 4000 patients included in the final analysis, 1997 received 6 months of clopidogrel and 2003 received 12 months. The primary endpoint occurred in 29 patients (1.5%) assigned to 6 months of clopidogrel and 32 patients (1.6%) assigned to 12 months, observed difference -0.1%, upper limit of one-sided 95% confidence interval (CI) 0.5%, limit of non-inferiority 2%, Pfor noninferiority <0.001. Stent thrombosis was observed in five patients (0.3%) assigned to 6 months of clopidogrel and three patients (0.2%) assigned to 12 months; hazard ratio (HR) 1.66, 95% CI: 0.40-6.96, P = 0.49. Thrombolysis in myocardial infarction major bleeding was observed in 4 patients (0.2%) assigned to 6 months clopidogrel and 5 patients (0.3%) assigned to 12 months; HR 0.80, 95% CI: 0.21-2.98, P = 0.74. CONCLUSIONS: In the present trial, characterized by low event rates, we did not observe a significant difference in net clinical outcome between 6 and 12 months of clopidogrel therapy after DES implantation. However, the results of the trial must be considered in view of its premature termination and lower than expected event rates. The trial is registered with ClinicalTrials.gov, Identifier: NCT00661206.