Bivalirudin Versus Heparin During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

Abstract

BackgroundThe aim of the study was to compare the efficacy and safety of bivalirudin versus unfractionated heparin (UFH) in patients with acute myocardial infarction who undergo percutaneous coronary intervention (PCI). Earlier trials comparing bivalirudin and UFH during PCI demonstrated that bivalirudin caused less bleeding with more stent thrombosis. Since then, adjunct antiplatelet strategies have evolved. Improved upstream platelet inhibition with potent P2Y12 inhibitors decreased the need for routine glycoprotein IIb/IIIa inhibitor (GPI), resulting in similar outcomes among UFH and bivalirudin. Therefore, the role of bivalirudin in modern PCI practices is questionable.MethodsWe utilized Cochrane Review Manager (RevMan) 5.3 to perform a meta-analysis of seven randomized controlled trials (RCTs) with 22,844 patients to compare bivalirudin to UFH in patients with acute myocardial infarction requiring revascularization.ResultsThere was no difference between bivalirudin and UFH regarding major adverse cardiac events (MACE), risk ratio (RR) 0.99, 95% confidence interval (CI) 0.87 - 1.12; P = 0.83) or cardiovascular mortality (RR 0.87, 95% CI 0.71 - 1.07; P = 0.18). Bivalirudin increased acute stent thrombosis (RR 2.77, 95% CI 1.49 - 5.13; P = 0.001), which was only significant among ST-elevation myocardial infarction (STEMI) only trials. Bivalirudin caused less major bleeding (RR 0.66, 95% CI 0.49 - 0.90; P = 0.007), which was negated when GPI was used provisionally (RR 0.93, 95% CI 0.64 - 1.33; P = 0.67).ConclusionsAmong patients with acute myocardial infarction who underwent PCI, bivalirudin and UFH demonstrated similar MACE and cardiovascular mortality. Bivalirudin increased acute stent thrombosis, which was more remarkable among STEMI. Bivalirudin decreased major bleeding, but this benefit was negated when GPI was used provisionally.

Safety of Bivalirudin Combined with Ticagrelor in the Emergency PCI in Patients with Acute ST-Segment Elevation Myocardial Infarction

“…A meta-analysis suggested 29 that in patients with acute myocardial infarction undergoing PCI, therapy of bivalirudin and heparin showed a similar incidence of MACE and cardiovascular mortality, but the use of bivalirudin would increase the risk of in-stent acute thrombosis. It was suggested in that study that stent thrombosis in the bivalirudin group was correlated with the thrombus load, and there was no stent thrombosis in patients with NSTEMI.…”

Bivalirudin versus Heparin on Net Adverse Clinical Events, Major Adverse Cardiac and Cerebral Events, and Bleeding in Elderly Chinese Patients Treated with Percutaneous Coronary Intervention

“…Moreover, bivalirudin (vs. heparin) (OR: 0.342, P=0.003) was an independent factor for fewer major bleeding incidence, whereas age≥75 year (OR: 2.392, P=0.003), CRUSADE high risk (OR: 2.142, P=0.008), and emergency operation (vs. elective operation) (OR: 2.605, P=0.001) were independent factors for higher incidence of major bleeding (Figure 6B). Bivalirudin is an effective anticoagulant inhibiting thrombin either free or bound to fibrin, while lowering bleeding rates compared to heparin (Gargiulo et al 2018, Li et al 2022, Meng et al 2020, Montinari and Minelli 2022, Ng et al 2016, Patel et al 2019. For example, one study demonstrates that bivalirudin significantly reduces bleeding complications than UFH in ACS patients receiving PCI (10.8% vs. 12.2%) (Gargiulo et al 2018).…”

“…For example, one study demonstrates that bivalirudin significantly reduces bleeding complications than UFH in ACS patients receiving PCI (10.8% vs. 12.2%) (Gargiulo et al 2018). Another meta-analysis for AMI patients with PCI shows that bivalirudin decreases major bleeding compared to heparin (2.3% vs. 3.5%) (Patel et al 2019). Concerning heightened surgical complexities during PCI attributed to agerelated anatomical and physiological changes, it is imperative to pay more attention to the utilization of drugs for reducing risks of adverse events in elderly patients .…”

Myocardial damage after ST-segment elevation myocardial infarction by use of bivalirudin or heparin: a DANAMI-3 substudy

“…Several trials comparing bivalirudin and UFH±GPI have since questioned this survival advantage and created controversy related to bivalirudin-associated improved bleeding outcome and the risk of acute stent thrombosis. Recently, the VALIDATE-SWEDEHEART bivalirudin versus heparin monotherapy in myocardial infarction during PCI trial reported no differences in myocardial infarction, major bleeding, definite stent thrombosis and death 1 . Clinically meaningful reduced efficacy of either regimen in antithrombotic protection during primary PCI is likely to lead to increased myocardial damage.…”