Bivalirudin Compared With Unfractionated Heparin for PCI in STEMI Patients

November 11, 2016—Findings from a study conducted to describe temporal trends and determine the comparative effectiveness of bivalirudin versus unfractionated heparin (UFH) during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) was published online ahead of print by Eric A. Secemsky, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

According to the investigators, the background of the study is that results have been conflicting in several clinical trials that have compared the safety and effectiveness of bivalirudin versus UFH during PCI for STEMI.

As summarized in JACC: Cardiovascular Interventions, the investigators examined trends in anticoagulant use among 513,775 PCIs for STEMI from July 2009 through December 2014 within the National Cardiovascular Data Registry CathPCI Registry. They conducted an instrumental variable analysis comparing bivalirudin with UFH using operator preference for bivalirudin as the instrument. A test of mediation determined the extent to which differences in outcomes between anticoagulants were caused by differences in the use of glycoprotein IIb/IIIa inhibitors (GPIs). Primary outcomes were in-hospital bleeding and mortality.

The investigators reported that bivalirudin use increased between 2009 and 2013, followed by a new decline. GPIs were used in 74.7% of UFH PCIs versus 26.5% of bivalirudin PCIs. In unadjusted analyses, bivalirudin was associated with decreased bleeding (risk difference [RD], -4.2%; P < .001) and mortality (RD, -0.84%; P < .001). 

After instrumental variable analyses, bivalirudin remained associated with less bleeding (RD, -3.75%; P < .001), but not mortality (RD: -0.1%; P = .28). 

The higher rate of GPI use with UFH was responsible for more than one-half of bivalrudin’s bleeding reduction (GPI-adjusted RD, -1.57%; P < .001). Bleeding reductions were negligible for transradial PCI (RD, -0.11%; P = .842).

The study showed that the use of bivalirudin during STEMI has decreased but was associated with reduced bleeding and no mortality difference. The bleeding reduction with bivalirudin was largely explained by the greater use of GPIs with UFH, concluded the investigators in JACC: Cardiovascular Interventions.