Impact of baseline hemorrhagic risk on the benefit of bivalirudin versus unfractionated heparin in patients treated with coronary angioplasty: A meta-regression analysis of randomized trials

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• 作者：Giuseppe Tarantini ; MD ; PhD^a ; ^{giuseppe.tarantini.1@gmail.com" class="auth_mail} ; Sorin Jakob Brener ; MD^b ; Alberto Barioli ; MD^a ; Andrea Gratta ; MD^a ; Guido Parodi ; MD^c ; Roberta Rossini ; MD ; PhD^d ; Eliano Pio Navarese ; MD ; PhD^e ; Giampaolo Niccoli ; MD ; PhD^f ; Anna Chiara Frigo ; MSc^a ; Giuseppe Musumeci ; MD^d ; Sabino Iliceto ; MD^a ; Gregg Whitney Stone ; MD^g
• 刊名：American Heart Journal
• 出版年：March, 2014
• 年：2014
• 卷：167
• 期：3
• 页码：401-412.e6
• 全文大小：868 K

文摘

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Background

Bivalirudin significantly reduces 30-day major and minor bleeding compared with unfractionated heparin (UFH), while resulting in similar or lower rates of ischemic events in both patients with stable and unstable coronary disease undergoing percutaneous coronary intervention. We performed a meta-analysis of randomized trials to evaluate the impact of bivalirudin compared with UFH, with or without glycoprotein IIb/IIIa receptor inhibitors (GPI), on the rates of mortality, myocardial infarction (MI), and major bleeding.

Methods

We searched electronic databases for randomized controlled trials with >100 patients comparing bivalirudin (卤provisional GPI) with UFH with either routine or provisional GPI in patients undergoing percutaneous coronary intervention. The principal efficacy end points were mortality and MI within 30 day, whereas major bleeding was the principal safety end point. We assessed the benefit of bivalirudin for each efficacy end point relative to the baseline bleeding risk, using the control (UFH) major bleeding rate as proxy for that risk.

Results

A total of 12 randomized trials that enrolled 33,261 patients were included. Overall, there was no significant difference in mortality and MI between bivalirudin monotherapy and UFH (卤GPI), whereas major bleeding was significantly lower with bivalirudin. Bivalirudin reduced major and minor bleeding across the entire bleeding risk spectrum.

Conclusions

Bivalirudin significantly reduces major and minor bleeding regardless of the estimated baseline hemorrhagic risk.