Everolimus-eluting stents in patients undergoing percutaneous coronary intervention: final 3-year results of the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions trial.

OBJECTIVES: We compared the outcomes of patients treated with everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) at 3 years from the large-scale randomized SPIRIT IV trial. BACKGROUND: SPIRIT IV is the largest randomized trial comparing the outcomes of EES and PES. The present report represents the final long-term follow-up analysis from this study. METHODS: A total of 3,687 patients were randomized 2:1 to EES or PES, stratified by presence of diabetes mellitus and lesion characteristics. Prespecified subgroups were compared for interaction with stent allocation. The primary end point was target lesion failure (TLF) (the composite of cardiac death, target vessel-related myocardial infarction [MI], or ischemia-driven target lesion revascularization). RESULTS: At 3 years, TLF occurred in 9.2% versus 11.7% of EES- and PES-treated patients (hazard ratio [HR] 0.78 [0.63-0.97], P = .02). The incidence of death or MI was 5.9% versus 9.1%, respectively (HR 0.67 [0.52-0.85], P = .001), and there was a 64% reduction in stent thrombosis (Academic Research Consortium definite or probable definition) with EES (0.59% vs 1.60%, HR 0.36 [0.18-0.72], P = .003). The difference in target lesion revascularization at 3 years did not reach statistical significance (6.2% vs 7.8%, respectively, HR 0.78 [0.60-1.01], P = .06). There was no significant interaction between treatment allocation and any of the subgroups, including diabetes. CONCLUSIONS: When compared with PES, EES provides durable and significant reduction in TLF, especially due to its enhanced safety profile, with lower rates of death or MI and stent thrombosis up to 3 years.

Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease.

BACKGROUND: Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points. METHODS: We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization). RESULTS: Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80). CONCLUSIONS: Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.)

Left ventricular outflow tract obstruction provoked during dobutamine stress echocardiography predicts future chest pain, syncope, and near syncope.

BACKGROUND: Although dobutamine stress echocardiography (DSE) is associated with dynamic left ventricular (LV) obstruction, it is unknown whether such obstructive event, in general, and the specific site of obstruction, in particular, have unique clinical prognostic significance. We sought to determine whether dynamic LV outflow tract (LVOT) versus LV midcavitary obstruction provoked during DSE would predict future chest pain, syncope, and/or near syncope. METHODS: Two hundred thirty-seven patients (145 men and 92 women, mean age 58 +/- 13 [+/-SD] years) without DSE-provoked ischemia underwent continuous wave Doppler interrogation to detect any inducible dynamic flow obstruction. Patients were prospectively followed for a mean duration of 31 +/- 13 months. RESULTS: One hundred fifty-four of 237 patients had no provoked LV obstruction (group 1). Fifty-four (22.8%) had provoked LV midcavitary (group 2) obstruction, and 29 (12.2%) had outflow tract (group 3) obstruction. During follow-up, chest pain occurred more frequently in groups 2 (46%, P < .05) and 3 (52%, P = .05) as compared with group 1 (31%). A higher incidence of syncope and/or near syncope was noted in group 3 (21% vs 9% in group 1). LVOT obstruction but not midcavitary obstruction was a significant predictor of future chest pain (relative risk 2.63, P = .0021) and syncope and/or near syncope (relative risk 3.11, P = .036). Kaplan-Meier analysis showed a significantly less event-free survival (P = .025) for the combined end point of chest pain, syncope, and/or near syncope in patients with LVOT obstruction. CONCLUSIONS: This is the first prospective study to identify the differential prognostic implications of the site of dynamic obstruction noted during DSE. Our results demonstrate that DSE-provoked LVOT obstruction is an independent positive predictor of future episodes of chest pain and syncope and/or near syncope. These findings warrant larger studies addressing treatment options to ameliorate symptoms in this subgroup of patients.