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Long-Term (Three-Year) Safety and Efficacy of Everolimus-Eluting Stents Compared to Paclitaxel-Eluting Stents (from the SPIRIT III Trial)

2011; Elsevier BV; Volume: 107; Issue: 6 Linguagem: Inglês

10.1016/j.amjcard.2010.10.069

1879-1913

Robert J. Applegate, Manejeh Yaqub, James Hermiller, Poornima Sood, Shui Yu, Julie Doostzadeh, Jerome Williams, Naim Farhat, Ronald Caputo, Alexandra J. Lansky, Donald E. Cutlip, Krishnankutty Sudhir, Gregg W. Stone,

Coronary Interventions and Diagnostics

The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express 2 Stone G.W. Midei M. Newman W. Sanz M. Hermiller J.B. Williams J. Farhat N. Mahaffey K.W. Cutlip D.E. Fitzgerald P.J. Sood P. Su X. Lansky A.J. SPIRIT III InvestigatorsComparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: A randomized trial. JAMA. 2008; 299: 1903-1913 Crossref PubMed Scopus (521) Google Scholar paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup. The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express 2 Stone G.W. Midei M. Newman W. Sanz M. Hermiller J.B. Williams J. Farhat N. Mahaffey K.W. Cutlip D.E. Fitzgerald P.J. Sood P. Su X. Lansky A.J. SPIRIT III InvestigatorsComparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: A randomized trial. JAMA. 2008; 299: 1903-1913 Crossref PubMed Scopus (521) Google Scholar paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.