Performance of everolimus-eluting stents: Pooled analysis from the SPIRIT trials

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.

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