4-Year Clinical Outcomes and Predictors of Repeat Revascularization in Patients Treated With New-Generation Drug-Eluting Stents: A Report From the RESOLUTE All-Comers Trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting

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• 作者：Masanori Taniwaki ; MD^&lowast ; ; Giulio G. Stefanini ; MD^&lowast ; ; Sigmund Silber ; MD ; PhD^&dagger ; ; Gert Richardt ; MD^&Dagger ; ; Pascal Vranckx ; MD^§ ; ; Patrick W. Serruys ; MD ; PhD^鈥?/sup> ; Pawel E. Buszman ; MD^¶ ; ; Henning Kelbaek ; MD^# ; Stephan Windecker ; MD^&lowast ; ; ^{stephan.windecker@insel.ch" class="auth_mail} ; on behalf of the RESOLUTE All-Comers Investigators
• 关键词：all-comers population ; drug-eluting stent(s) ; everolimus-eluting stent(s) ; long-term outcomes ; Resolute zotarolimus-eluting stent(s)
• 刊名：Journal of the American College of Cardiology
• 出版年：29 April 2014
• 年：2014
• 卷：63
• 期：16
• 页码：1617-1625
• 全文大小：804 K

文摘

The aim of the study was to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Minneapolis, Minnesota) and XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Abbott Park, Illinois) in the RESOLUTE (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) All-Comers trial.

Background

Data on long-term outcomes of new-generation drug-eluting stents are limited, and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown.

Methods

Patients were randomly assigned to treatment with the R-ZES (n = 1,140) or the EES (n = 1,152). We assessed pre-specified 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.

Results

At 4 years, the rates of target lesion failure (15.2% vs. 14.6%, p = 0.68), cardiac death (5.4% vs. 4.7%, p = 0.44), and target vessel myocardial infarction (5.3% vs. 5.4%, p = 1.00), clinically-indicated target lesion revascularization (TLR) (7.0% vs. 6.5%, p = 0.62), and definite/probable stent thrombosis (2.3% vs. 1.6%, p = 0.23) were similar with the R-ZES and EES. Independent predictors of TLR were age, insulin-treated diabetes, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score, treatment of saphenous vein grafts, ostial lesions, and in-stent restenosis. Independent predictors of any revascularization were age, diabetes, previous percutaneous coronary intervention, absence of ST-segment elevation myocardial infarction, smaller reference vessel diameter, SYNTAX score, and treatment of left anterior descending, right coronary artery, saphenous vein grafts, ostial lesions, or in-stent restenosis.

Conclusions

R-ZES and EES demonstrated similar safety and efficacy throughout 4 years. TLR represented less than one-half of all repeat revascularization procedures. Patient- and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap. (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention [RESOLUTE-AC]; NCT00617084)