MAY 6, 2010 | Gregg W. Stone, M.D., Ali Rizvi, M.D., William Newman, M.D., Kourosh Mastali, M.D., John C. Wang, M.D., Ronald Caputo, M.D., Julie Doostzadeh, Ph.D., Sherry Cao, M.S., Charles A. Simonton, M.D., Krishnankutty Sudhir, M.D., Ph.D., Alexandra J. Lansky, M.D., Donald E. Cutlip, M.D., and Dean J. Kereiakes, M.D., for the SPIRIT IV Investigators*
The SPIRIT IV trial compared the safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The primary endpoint was the 1-year composite rate of target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization). The study included 3687 patients randomized to receive either EES or PES without routine follow-up angiography. The results showed that EES were superior to PES in reducing the primary endpoint (4.2% vs. 6.8%; relative risk, 0.62; P=0.001) and the major secondary endpoint of ischemia-driven target-lesion revascularization (2.5% vs. 4.6%; relative risk, 0.55; P=0.001). EES were noninferior to PES in the major secondary endpoint of cardiac death or target-vessel myocardial infarction (2.2% vs. 3.2%; P=0.09 for superiority). Additionally, EES reduced the rates of stent thrombosis and myocardial infarction. The benefits of EES were consistent across most subgroups, except for patients with diabetes, where no significant differences were observed between the two stent types. The study concluded that EES are superior to PES in reducing target-lesion failure and ischemia-driven target-lesion revascularization, with noninferior rates of cardiac death or target-vessel myocardial infarction.The SPIRIT IV trial compared the safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The primary endpoint was the 1-year composite rate of target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization). The study included 3687 patients randomized to receive either EES or PES without routine follow-up angiography. The results showed that EES were superior to PES in reducing the primary endpoint (4.2% vs. 6.8%; relative risk, 0.62; P=0.001) and the major secondary endpoint of ischemia-driven target-lesion revascularization (2.5% vs. 4.6%; relative risk, 0.55; P=0.001). EES were noninferior to PES in the major secondary endpoint of cardiac death or target-vessel myocardial infarction (2.2% vs. 3.2%; P=0.09 for superiority). Additionally, EES reduced the rates of stent thrombosis and myocardial infarction. The benefits of EES were consistent across most subgroups, except for patients with diabetes, where no significant differences were observed between the two stent types. The study concluded that EES are superior to PES in reducing target-lesion failure and ischemia-driven target-lesion revascularization, with noninferior rates of cardiac death or target-vessel myocardial infarction.