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February 11, 2014

Four-Year Results Published From RESOLUTE All Comers Trial

February 12, 2014—Masanori Taniwaki, MD, et al have published 4-year data from the RESOLUTE All Comers randomized trial. The study is available online ahead of print in the Journal of the American College of Cardiology (JACC).

The investigators sought to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent (ZES; Medtronic, Inc., Minneapolis, MN) and the Xience V everolimus-eluting stent (EES; Abbott Vascular, Santa Clara, CA) in the RESOLUTE All Comers trial.

The investigators concluded that the Resolute ZES and Xience V EES demonstrated similar safety and efficacy through 4 years. Target lesion revascularization (TLR) represented less than half of all repeat revascularization procedures. Patient- and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap.

As summarized in JACC, patients were randomly assigned to treatment with ZES (n = 1,140) or EES (n = 1,152). The investigators assessed prespecified safety and efficacy outcomes at 4 years, including target lesion failure and stent thrombosis. Predictors of revascularization at 4 years were identified by Cox regression analysis.

The investigators found that at 4 years, rates of target lesion failure (15.2% vs 14.6%; P = .68), cardiac death (5.4% vs 4.7%; P = .44), target vessel myocardial infarction (5.3% vs 5.4%; P = 1), clinically indicated TLR (7% vs 6.5%; P = .62), and definite/probable stent thrombosis (2.3% vs 1.6%; P = .23) were similar with ZES and EES.

Independent predictors of TLR were age, insulin-treated diabetes, SYNTAX score, treatment of saphenous vein grafts, ostial lesions, and in-stent restenosis. Independent predictors of any revascularization were age, diabetes, previous percutaneous coronary intervention, ST-elevation myocardial infarction, smaller reference vessel diameter, SYNTAX score, and treatment of left anterior descending or right coronary artery, saphenous vein grafts, ostial lesions, or in-stent restenosis, reported the investigators in JACC.

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February 12, 2014

CDRH Announces 2014–2015 Strategic Priorities

February 12, 2014

CDRH Announces 2014–2015 Strategic Priorities


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