Comparative Effectiveness and Safety of New-Generation Versus Early-Generation Drug-Eluting Stents According to Complexity of Coronary Artery Disease: A Patient-Level Pooled Analysis of 6,081 Patients

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• 作者：Raffaele Piccolo ; MD^&lowast ; ; Thomas Pilgrim ; MD^&lowast ; ; Dik Heg ; PhD^&dagger ; ; Anna Franzone ; MD^&lowast ; ; Julie Rat-Wirtzler ; MSc^&dagger ; ; Lorenz Rä ; ber ; MD^&lowast ; ; Sigmund Silber ; MD^&Dagger ; ; Patrick W. Serruys ; MD^§ ; ; Peter Jü ; ni ; MD^‖ ; Stephan Windecker ; MD^&lowast ; ; ^{stephan.windecker@insel.ch" class="auth_mail" title="E-mail the corresponding author}
• 关键词：coronary artery disease complexity ; drug-eluting stent(s) ; percutaneous coronary intervention ; SYNTAX score
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：8
• 期：13
• 页码：1657-1666
• 全文大小：1159 K

文摘

The purpose of this study was to compare the 2-year safety and effectiveness of new- versus early-generation drug-eluting stents (DES) according to the severity of coronary artery disease (CAD) as assessed by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score.

Background

New-generation DES are considered the standard-of-care in patients with CAD undergoing percutaneous coronary intervention. However, there are few data investigating the effects of new- over early-generation DES according to the anatomic complexity of CAD.

Methods

Patient-level data from 4 contemporary, all-comers trials were pooled. The primary device-oriented clinical endpoint was the composite of cardiac death, myocardial infarction, or ischemia-driven target-lesion revascularization (TLR). The principal effectiveness and safety endpoints were TLR and definite stent thrombosis (ST), respectively. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated at 2 years for overall comparisons, as well as stratified for patients with lower (SYNTAX score ≤11) and higher complexity (SYNTAX score >11).

Results

A total of 6,081 patients were included in the study. New-generation DES (n = 4,554) compared with early-generation DES (n = 1,527) reduced the primary endpoint (HR: 0.75 [95% CI: 0.63 to 0.89]; p = 0.001) without interaction (p = 0.219) between patients with lower (HR: 0.86 [95% CI: 0.64 to 1.16]; p = 0.322) versus higher CAD complexity (HR: 0.68 [95% CI: 0.54 to 0.85]; p = 0.001). In patients with SYNTAX score >11, new-generation DES significantly reduced TLR (HR: 0.36 [95% CI: 0.26 to 0.51]; p < 0.001) and definite ST (HR: 0.28 [95% CI: 0.15 to 0.55]; p < 0.001) to a greater extent than in the low-complexity group (TLR p_int = 0.059; ST p_int = 0.013). New-generation DES decreased the risk of cardiac mortality in patients with SYNTAX score >11 (HR: 0.45 [95% CI: 0.27 to 0.76]; p = 0.003) but not in patients with SYNTAX score ≤11 (p_int = 0.042).

Conclusions

New-generation DES improve clinical outcomes compared with early-generation DES, with a greater safety and effectiveness in patients with SYNTAX score >11.