Long-term clinical and angiographic outcomes of diabetic patients after revascularization with early generation drug-eluting stents.

BACKGROUND: Early generation drug-eluting stents (DESs) reduce restenosis and repeat revascularization procedures. However, the long-term safety and efficacy of early generation DES according to diabetic status are poorly established. METHODS: A total of 1,012 patients were randomly assigned to treatment with sirolimus-eluting (n = 503) or paclitaxel-eluting stents (n = 509). Serial angiographic follow-up at baseline, 8 months, and 5 years was available in 293 patients with 382 lesions. The primary end point was a composite of major adverse cardiac events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization). Clinical and angiographic outcomes through 5-year follow-up were compared between diabetic and nondiabetic patients. RESULTS: Major adverse cardiac events were more common among diabetic than nondiabetic patients at 5 years (25.9% vs 19.2%, hazard ratio [HR] 1.45, 95% CI 1.06-1.99, P = .02). The difference in disfavor of diabetic patients was largely determined by a higher rate of cardiac mortality (11.4% vs 4.3%, HR 2.86, 95% CI 1.69-4.84, P < .0001), whereas the risk of myocardial infarction (6.5% vs 6.8%, HR 1.00, 95% CI 0.55-1.84, P = .99) and ischemia-driven target lesion revascularization (14.4% vs 14.1%, HR 1.09, 95% CI 0.73-1.64, P = .67) was comparable. The risk of stent thrombosis was similar among diabetic and nondiabetic patients (definite or probable: 6.0% vs 4.6%, HR 1.36, 95% CI 0.71-2.67, P = .35). Among 293 patients undergoing serial angiography, very-late lumen loss amounted to 0.42 ± 0.63 mm in diabetic patients and 0.44 ± 0.68 mm in nondiabetic patients (P = .79). CONCLUSIONS: Diabetic patients remain at increased risk for mortality after revascularization with early generation DES during long-term follow-up. Conversely, diabetes is no longer associated with an increased risk of clinical and angiographic restenosis after revascularization with early generation DES.

Long-term comparison of everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes.

OBJECTIVES: The goal of this study was to compare the long-term clinical outcome between everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) in patients with acute coronary syndromes (ACS). BACKGROUND: EES have not been directly compared with SES in ACS patients to date. METHODS: Between 2004 and 2009, 1,746 consecutive ACS patients (ST-segment elevation ACS [STE-ACS]: 33.5%; non-ST-segment elevation ACS [NSTE-ACS]: 66.5%) were treated with EES (n=903) or SES (n=843). Using propensity score matching, clinical outcome was compared among 705 matched pairs of ACS patients treated with EES and SES. RESULTS: Through 3 years, the primary endpoint-the composite of death, myocardial infarction (MI), and target vessel revascularization (TVR)-occurred in 13.8% of EES- and 17.7% of SES-treated ACS patients (hazard ratio [HR]: 0.72, 95% confidence interval [CI]: 0.54 to 0.95, p=0.02). The difference in favor of EES was driven by a lower risk of TVR (5.7% vs. 8.8%, HR: 0.65, 95% CI: 0.43 to 0.98, p=0.04) and a trend toward a lower risk of MI (2.1% vs. 3.3%, HR: 0.56, 95% CI: 0.29 to 1.12, p=0.10). The risk of death (7.2% vs. 8.8%, HR: 0.75, 95% CI: 0.50 to 1.10, p=0.14) showed no difference between EES and SES. The treatment effect in favor of EES for the primary endpoint was similar for patients with STE-ACS (16.4% vs. 18.5%, HR: 0.80, 95% CI: 0.50 to 1.27) and NSTE-ACS (12.4% vs. 17.3%; HR: 0.67, 95% CI: 0.47 to 0.96; pfor interaction=0.56) and across major subgroups. Definite (0.4% vs. 1.8%, p=0.03), and definite or probable stent thrombosis (3.4% vs. 6.1%, p=0.02) were less frequent among EES- than SES-treated ACS patients. CONCLUSIONS: Among patients with ACS, the unrestricted use of EES is associated with improved clinical outcome compared with SES during long-term follow-up to 3 years. Notably, the risk of stent thrombosis was lower among EES-treated ACS patients.