Abstract | BACKGROUND: In the prospective randomized Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, an everolimus-eluting stent (EES) compared with a widely used paclitaxel-eluting stent (PES) resulted in a statistically significant reduction in angiographic in-segment late loss at 8 months and noninferior rates of target vessel failure ( cardiac death, myocardial infarction, or target vessel revascularization) at 1 year. The safety and efficacy of EES after 1 year have not been reported. METHODS AND RESULTS: A total of 1002 patients with up to 2 de novo native coronary artery lesions (reference vessel diameter, 2.5 to 3.75 mm; lesion length < or =28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for > or =6 months. Between 1 and 2 years, patients treated with EES compared with PES tended to have fewer episodes of protocol-defined stent thrombosis (0.2% versus 1.0%; P=0.10) and myocardial infarctions (0.5% versus 1.7%; P=0.12), with similar rates of cardiac death (0.3% versus 0.3%; P=1.0) and target vessel revascularization (2.9% versus 3.0%; P=1.0). As a result, at the completion of the 2-year follow-up, treatment with EES compared with PES resulted in a significant 32% reduction in target vessel failure (10.7% versus 15.4%; hazard ratio, 0.68; 95% confidence interval, 0.48 to 0.98; P=0.04) and a 45% reduction in major adverse cardiac events ( cardiac death, myocardial infarction, or target lesion revascularization; 7.3% versus 12.8%; hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.83; P=0.004). Among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months, stent thrombosis subsequently developed in 0.4% of EES patients versus 2.6% of PES patients (P=0.10). CONCLUSIONS: Patients treated with EES rather than PES experienced significantly improved event-free survival at a 2-year follow-up in the SPIRIT III trial, with continued divergence of the hazard curves for target vessel failure and major adverse cardiac events between 1 and 2 years evident. The encouraging trends toward fewer stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and after 1 year in all patients treated with EES rather than PES deserve further study.
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Authors | Gregg W Stone, Mark Midei, William Newman, Mark Sanz, James B Hermiller, Jerome Williams, Naim Farhat, Ronald Caputo, Nicholas Xenopoulos, Robert Applegate, Paul Gordon, Roseann M White, Krishnankutty Sudhir, Donald E Cutlip, John L Petersen, SPIRIT III Investigators |
Journal | Circulation
(Circulation)
Vol. 119
Issue 5
Pg. 680-6
(Feb 10 2009)
ISSN: 1524-4539 [Electronic] United States |
PMID | 19171853
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Phytogenic
- Immunosuppressive Agents
- Platelet Aggregation Inhibitors
- Everolimus
- Paclitaxel
- Sirolimus
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Topics |
- Aged
- Angioplasty
- Antineoplastic Agents, Phytogenic
(administration & dosage, adverse effects)
- Coronary Artery Disease
(epidemiology, therapy)
- Coronary Restenosis
(epidemiology, prevention & control)
- Coronary Thrombosis
(epidemiology, prevention & control)
- Disease-Free Survival
- Drug-Eluting Stents
(adverse effects, statistics & numerical data)
- Everolimus
- Female
- Follow-Up Studies
- Humans
- Immunosuppressive Agents
(administration & dosage, adverse effects)
- Incidence
- Male
- Middle Aged
- Paclitaxel
(administration & dosage, adverse effects)
- Platelet Aggregation Inhibitors
(administration & dosage)
- Prospective Studies
- Sirolimus
(administration & dosage, adverse effects, analogs & derivatives)
- Treatment Outcome
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