Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial
| Autor: | Gregg W, Stone, Mark, Midei, William, Newman, Mark, Sanz, James B, Hermiller, Jerome, Williams, Naim, Farhat, Kenneth W, Mahaffey, Donald E, Cutlip, Peter J, Fitzgerald, Poornima, Sood, Xiaolu, Su, Alexandra J, Lansky, S, Oxborough |
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| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Paclitaxel medicine.medical_treatment Myocardial Infarction Coronary Artery Disease Coronary Angiography Coronary artery disease Coronary Restenosis Angioplasty medicine Clinical endpoint Humans Single-Blind Method Myocardial infarction Everolimus Prospective Studies Angioplasty Balloon Coronary Ultrasonography Interventional Antibacterial agent Aged Sirolimus business.industry Percutaneous coronary intervention Stent Drug-Eluting Stents General Medicine Middle Aged medicine.disease Surgery Logistic Models Drug-eluting stent Female business Immunosuppressive Agents |
| Zdroj: | JAMA. 299(16) |
| ISSN: | 1538-3598 |
| Popis: | A thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease.To evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.The SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based US institutions between June 22, 2005, and March 15, 2006. Patients were 1002 men and women undergoing percutaneous coronary intervention in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm. Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.Patients were randomized 2:1 to receive the everolimus-eluting stent (n = 669) or the paclitaxel-eluting stent (n = 333).The primary end point was noninferiority or superiority of angiographic in-segment late loss. The major secondary end point was noninferiority assessment of target vessel failure events (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months. An additional secondary end point was evaluation of major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization) at 9 and 12 months.Angiographic in-segment late loss was significantly less in the everolimus-eluting stent group compared with the paclitaxel group (mean, 0.14 [SD, 0.41] mm vs 0.28 [SD, 0.48] mm; difference, -0.14 [95% CI, -0.23 to -0.05]; Por = .004). The everolimus stent was noninferior to the paclitaxel stent for target vessel failure at 9 months (7.2% vs 9.0%, respectively; difference, -1.9% [95% CI, -5.6% to 1.8%]; relative risk, 0.79 [95% CI, 0.51 to 1.23]; P.001). The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at 9 months (4.6% vs 8.1%; relative risk, 0.56 [95% CI, 0.34 to 0.94]; P = .03) and at 1 year (6.0% vs 10.3%; relative risk, 0.58 [95% CI, 0.37 to 0.90]; P = .02), due to fewer myocardial infarctions and target lesion revascularization procedures.In this large-scale, prospective randomized trial, an everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during 1 year of follow-up.clinicaltrials.gov Identifier: NCT00180479. |
| Databáze: | OpenAIRE |
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