Seeking a Population That Derives a Significant Benefit From Prasugrel

Harlan M. Krumholz, MD, SM

Disclosures

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In This Article

Abstract and Introduction

Abstract

In TRILOGY ACS, the drug failed to surpass clopidogrel in patients who do not undergo revascularization for acute coronary syndromes.

Introduction

Prasugrel sales are flagging, despite the robust marketing efforts that followed TRITON-TIMI 38 (JW Cardiol Nov 4 2007). Five years later, we have another industry-sponsored prasugrel trial, now in patients with acute coronary syndromes (ACS) without ST-segment elevation who are not treated with revascularization. In this trial, TRILOGY ACS, investigators randomized 7243 such patients younger than 75 to receive prasugrel (10 mg daily) or clopidogrel (75 mg daily) for up to 30 months.

All patients had one of four risk factors — age ≥60 years, diabetes, prior myocardial infarction (MI), or prior revascularization — and all received aspirin. The primary endpoint was a composite of cardiovascular death, nonfatal MI, and nonfatal stroke. The study was designed to have 90% power to detect a 22% relative reduction in risk with prasugrel.

At a median follow-up of 17 months, the rate of the primary endpoint was 13.9% in the prasugrel group and 16.0% in the clopidogrel group (hazard ratio, 0.91; 95% confidence interval, 0.79–1.05; P=0.21). The rate of severe bleeding was similar in both groups, but the combined rate of major and minor bleeding was significantly higher in the prasugrel group.

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