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Bivalirudin is a synthetic reversible inhibitor of thrombin and is popularly used in the United States in patients undergoing percutaneous coronary intervention (PCI). While the evidence shows a bleeding benefit with bivalirudin compared to heparin, there are concerns raised regarding the risk of peri-procedural stent thrombosis. We aimed to quantify and analyze the incidence and predictors of the risk of bleeding and stent thrombosis with bivalirudin.
We searched PubMed, the Cochrane library, and major meeting and journal abstracts for studies that reported events with bivalirudin use during PCI. Pooled event rate (ER) and 95% confidence intervals (CI) were calculated with random-effects for up to 30-day bleeding events and stent thrombosis.
We identified 70 studies (n = 71,299) that used bivalirudin as the anti-coagulant of choice for PCI. Major bleeding events were noted in 1053 of 55636 (1.9%) and minor bleeding were noted in 1104 of 24969 (4.4%) patients. Majority of bleeding events were due to use of transfusion (1.6%) and access site bleeding (1.1%). Intracranial and retroperitoneal bleeding were rare (<0.1%). Definite stent thrombosis occurred in 266 of 29875 (0.9%) patients, of which majority were acute stent thrombosis. Pooled event rates for bleeding and stent thrombosis are reported in the figure. Majority of the studies did not report the acuity of stent thrombosis limiting the analysis. On meta-regression analysis, the use of drug eluting stents (DES) was associated with a lower risk of stent thrombosis (t = -2.44, p = 0.022).
Bivalirudin is associated with a 2% risk of major and a 4.4% risk of minor bleeding, majority of which are transfusion and access-site related. The risk of stent thrombosis is around 0.9% and the use of DES decreases this risk.