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Performance of Everolimus‐Eluting Stents: Pooled Analysis from the SPIRIT Trials

2009; Wiley; Volume: 22; Issue: s1 Linguagem: Inglês

10.1111/j.1540-8183.2009.00452.x

1540-8183

Raymond Miu, Patrick W. Serruys, Gregg W. Stone,

Coronary Interventions and Diagnostics

Background: First‐generation drug‐eluting stents (DES) still have significant rates of restenosis and stent thrombosis, especially in complex lesions. A second‐ generation stent eluting everolimus from a thin, non‐adhesive, non‐inflammatory durable polymer coated onto a low‐profile, cobalt‐ chromium stent has been developed and evaluated in patients with coronary artery disease. Methods: Following the SPIRIT First proof‐of‐concept trial, the everolimus‐eluting stent (EES) was compared to a widely used paclitaxel‐eluting stent (PES) in patients with non‐complex coronary artery disease in 2 successive randomized trials in Europe and Asia (SPIRIT II) and the United States (SPIRIT III). The databases from these trials were pooled for a patient‐level meta‐analysis. Results: Collectively, the SPIRIT II and SPIRIT III trials randomized 1,302 patients to either EES (n = 892) or PES (n = 410), with a total of 1,501 randomized lesions treated. EES compared to PES resulted in reduced mean in‐segment late loss (0.11 ± 0.37 vs. 0.22 ± 0.44 mm, P = 0.0004) and binary angiographic restenosis (4.1% vs. 7.8%, P = 0.039) at 6–8 months. The 30‐day rates of myocardial infarction (MI) were lower with EES than PES (1.0% vs. 2.9%, P = 0.02). At 1‐year, EES compared to PES resulted in reduced rates of target lesion revascularization (TLR; 3.1% vs. 5.8%, P = 0.02), a trend toward less MI (2.3% vs. 4.0%, P = 0.08), and comparable rates of cardiac death (0.6% vs. 1.0%, P = 0.39) and stent thrombosis (0.7% vs. 0.8%, P = 0.90). As a result, patients treated with EES compared to PES had significantly reduced rates of major adverse cardiac events (cardiac death, MI, or TLR) at 1 year (5.2% vs. 10.0%, P = 0.002). Conclusions: The EES stent is a second‐generation DES which results in improved clinical and angiographic outcomes compared to PES at 1 year. Longer‐term follow‐up from these trials and larger comparative trials are under way to evaluate the durability and utility of this device in more complex patients and lesions.