Change in enrollment patterns, patient selection, and clinical outcomes with the availability of drug-eluting stents in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial

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• 作者：Binita Shah ; Vankeepuram S. Srinivas ; Jiang Lu ; Maria M. Brooks ; Eric R. Bates ; Zoran S. Nedeljkovic ; Jorge Escobedo ; Gladwin S. Das ; John J. Lopez ; Frederick Feit
• 刊名：American Heart Journal
• 出版年：2013
• 出版时间：September, 2013
• 年：2013
• 卷：166
• 期：3
• 页码：519-526.e2
• 全文大小：590 K

文摘

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Background

In the BARI 2D trial, patients with type 2 diabetes and stable coronary artery disease were randomized to prompt revascularization versus intensive medical therapy (IMT). This analysis sought to evaluate how the availability of drug-eluting stents (DESs) has changed practice and outcomes.

Methods

In BARI 2D, 1,605 patients were in the percutaneous coronary intervention (PCI)-intended stratum. As DES became available midway through recruitment, we report clinical outcomes among patients who underwent IMT versus prompt PCI with bare-metal stents (BMSs) or DES up to 4 years.

Results

In North America, after DES became available, selection for the PCI-intended stratum increased from 73 % to 79 % (P = .003). Fewer BMS than DES patients had total occlusions treated or underwent rotational atherectomy (5.6 % vs 9.7 % , P = .02, and 1.2 % vs 3.7 % , P < .01, respectively). Subsequent revascularization (IMT 39 % , BMS 29 % , DES 21 % , P < .01) and target vessel revascularization (BMS 16.1 % vs DES 9.6 % , P = .03) were lower with DES. Angina at 2 years tended to be less common with DES (IMT 39 % , BMS 37 % , DES 29 % , P = .04, for 3 groups, P = .07 for DES vs BMS). The composite of death, myocardial infarction, or stroke was IMT 16.0 % , BMS 20.5 % , DES 17.5 % ; P = .80.

Conclusions

When DES became available in North America, patients were more likely to be selected into the PCI-intended stratum. Compared with patients receiving BMS, those receiving DES tended to have less target vessel revascularization and angina.