Use of Bivalirudin During Percutaneous Coronary Intervention in Patients With Diabetes Mellitus: An Analysis From the Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Re

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• 作者：Hitinder S. Gurm ; Ian J. Sarembock ; Dean J. Kereiakes ; John J. Young ; Robert A. Harrington ; Neal Kleiman ; Frederick Feit ; Kathy Wolski ; John A. Bittl ; Robert Wilcox ; Eric J. Topol ; A. Michael Lincoff
• 刊名：Journal of the American College of Cardiology
• 出版年：2005
• 出版时间：21 June 2005
• 年：2005
• 卷：45
• 期：12
• 页码：1932-1938
• 全文大小：128 K

文摘

Objectives

The objective of this study was to confirm that the efficacy and safety of percutaneous coronary intervention (PCI) in diabetic patients are not compromised by a bivalirudin-based antithrombotic strategy.

Background

Previous studies have shown a survival benefit with use of platelet glycoprotein (GP) IIb/IIIa inhibitors in diabetic patients undergoing PCI. The Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial showed the non-inferiority of a strategy of bivalirudin with provisional GP IIb/IIIa inhibition compared with routine GP IIb/IIIa inhibition. The relative efficacy of these two strategies in diabetic patients has not been studied.

Methods

We evaluated the diabetic patients enrolled in the REPLACE-2 trial to assess the impact of these antithrombotic strategies on the short- and long-term outcome after PCI.

Results

The REPLACE-2 trial enrolled 1,624 diabetic patients and 4,368 non-diabetic patients. Compared with non-diabetic patients, diabetic patients had similar short-term outcome but higher mortality at 1 year (3.06 % vs. 1.85 % , p = 0.004). There was no difference in short-term or long-term ischemic events among the diabetic patients randomized to the two arms. Specifically, the 1-year mortality rate was non-significantly lower in the bivalirudin arm, suggesting no differential survival impact of the two strategies (2.3 % vs. 3.9 % ). There was less minor bleeding in the bivalirudin arm in diabetic patients (12.6 % vs. 24.4 % , p < 0.001), whereas no difference was seen in the incidence of major bleeding (3.0 % vs. 3.3 % , p = 0.69).

Conclusions

Compared with routine GP IIb/IIIa inhibition, the use of bivalirudin with provisional GP IIb/IIIa inhibitors in diabetic patients is associated with no differences in clinical outcomes at 30 days, a trend toward lesser mortality at 1 year, and a reduction in minor bleeding.