Background New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. Methods In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated targetlesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. Results At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P = 0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (±SD) of in-stent stenosis (21.65±14.42% for zotarolimus vs. 19.76±14.64% for everolimus, P = 0.04 for noninferiority). In-stent late lumen loss was 0.27±0.43 mm in the zotarolimus-stent group versus 0.19±0.40 mm in the everolimusstent group (P = 0.08). There were no significant between-group differences in the rate of adverse events. Conclusions At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria.

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BES=biodegradable polymer biolimus-eluting stent, SES=durable polymer sirolimus-eluting stent, PCI=percutaneous coronary intervention. Note that we have no reliable data on the number of patients assessed for eligibility Baseline characteristics Biodegradable polymer BES (N=857) Durable polymer SES (N=850) Age (years) 64•6 (10•8) 64•5 (10•7) Male 643 (75•0%) 634 (74•6%) Diabetes mellitus 223 (26•0%) 191 (22•5%) Insulin requiring 81 (9•5%) 77 (9•1%) Hypertension 630 (73•5%) 618 (72•7%) Hypercholesterolemia 560 (65•3%) 580 (68•2%) Current smoker 206 (24•0%) 214 (25•2%) Family history of coronary artery disease 339 (39•6%) 374 (44•0%)

The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

In selected patients with multivessel coronary disease, PTCA and CABG as initial treatments resulted in equivalent improvement in angina after one year. However, in order to achieve similar clinical outcomes, the patients treated with PTCA were more likely to require further interventions and antianginal drugs, whereas the patients treated with CABG were more likely to sustain an acute myocardial infarction at the time of the procedure.

The SXscore, when applied to an all-comers patient population treated with drug-eluting stents, may allow prospective risk stratification of patients undergoing percutaneous coronary intervention. (LEADERS Trial Limus Eluted From A Durable Versus ERodable Stent Coating; NCT00389220).

Background-The age, creatinine, and ejection fraction (ACEF) score (age/left ventricular ejection fractionϩ1 if creatinine Ͼ2.0 mg/dL) has been established as an effective predictor of clinical outcomes in patients undergoing elective coronary artery bypass surgery; however, its utility in "all-comer" patients undergoing percutaneous coronary intervention is yet unexplored. Methods and Results-The ACEF score was calculated for 1208 of the 1707 patients enrolled in the LEADERS trial. Post hoc analysis was performed by stratifying clinical outcomes at the 1-year follow-up according to ACEF score tertiles: ACEF low Յ1.0225, 1.0225Ͻ ACEF mid Յ1.277, and ACEF high Ͼ1.277. At 1-year follow-up, there was a significantly lower number of patients with major adverse cardiac event-free survival in the highest tertile of the ACEF score (ACEF low ϭ92.1%, ACEF mid ϭ89.5%, and ACEF high ϭ86.1%; Pϭ0.0218). Cardiac death was less frequent in ACEF low than in ACEF mid and ACEF high (0.7% vs 2.2% vs 4.5%; hazard ratioϭ2.22, Pϭ0.002) patients. Rates of myocardial infarction were significantly higher in patients with a high ACEF score (6.7% for ACEF high vs 5.2% for ACEF mid and 2.5% for ACEF low ; hazard ratioϭ1.6, Pϭ0.006). Clinically driven target-vessel revascularization also tended to be higher in the ACEF high group, but the difference among the 3 groups did not reach statistical significance. The rate of composite definite, possible, and probable stent thrombosis was also higher in the ACEF high group (ACEF low ϭ1.2%, ACEF mid ϭ3.5%, and ACEF high ϭ6.2%; hazard ratioϭ2.04, PϽ0.001). Conclusions-ACEF score may be a simple way to stratify risk of events in patients treated with percutaneous coronary intervention with respect to mortality and risk of myocardial infarction. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00389220. (Circ Cardiovasc Interv. 2011;4:47-56.)

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