Key result
Bivalirudin plus prasugrel significantly reduced the 30-day composite of cardiac death, thrombosis, MI, and stroke compared to bivalirudin plus clopidogrel (0% vs 5.7%; P=0.042).
Why the study?
Does bivalirudin plus prasugrel reduce cardiovascular events compared to bivalirudin plus clopidogrel in patients with STEMI undergoing primary angioplasty?
Cohort (n=168)
Does bivalirudin plus prasugrel reduce cardiovascular events compared to bivalirudin plus clopidogrel in patients with STEMI undergoing primary angioplasty?
Absolute Event Rate: 0% vs 5.7%
p-value: p=0.042
In STEMI patients undergoing primary PCI, bivalirudin plus prasugrel significantly reduced 30-day cardiovascular events compared to bivalirudin plus clopidogrel without increasing major bleeding.
Hypothesis-generating for prasugrel with bivalirudin in STEMI PCI; leaves open confirmation in randomized trials.
INTRODUCTION AND OBJECTIVES: In primary angioplasty, bivalirudin is superior to treatment with heparin plus glycoprotein inhibitors for reducing cardiovascular events, although bivalirudin increases the risk of stent thrombosis. Our hypothesis is that the use of prasugrel plus bivalirudin in primary angioplasty would reduce stent thrombosis and cardiovascular events. METHOD: Consecutive patients with acute ST-segment elevation myocardial infarction who were treated by primary angioplasty within 12 hours of the onset of symptoms received bivalirudin plus clopidogrel (Group A) or bivalirudin plus prasugrel (Group B). We compared the groups using propensity score matching. The combined end-point was cardiac death, thrombosis, acute myocardial infarction, and cerebrovascular accident at 30 days. RESULTS: We assessed 168 patients. The approach was preferentially radial (95.7%). No differences in baseline characteristics were observed between Groups A (n = 70) and B (n = 70). The total mortality and rate of major bleeding complications at 30 days were 0% for both of the groups. The rate of acute and subacute thrombosis was 4.3% in Group A and 0% in Group B (P = 0.08). We observed an increased rate of events in Group A (5.7%) versus Group B (0%) (P = 0.042). CONCLUSIONS: The administration of bivalirudin plus prasugrel in primary percutaneous coronary intervention reduces cardiovascular effects compared to bivalirudin plus clopidogrel without increasing major bleeding complications during the first 30 days following primary angioplasty performed with a preferentially radial approach.
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Llera et al. (2013) conducted a cohort in Acute ST-segment elevation myocardial infarction (n=168). Bivalirudin plus prasugrel vs. Bivalirudin plus clopidogrel was evaluated on Cardiac death, thrombosis, acute myocardial infarction, and cerebrovascular accident at 30 days (p=0.042). Bivalirudin plus prasugrel significantly reduced the 30-day composite of cardiac death, thrombosis, MI, and stroke compared to bivalirudin plus clopidogrel (0% vs 5.7%; P=0.042).
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