Author + information
- Rasha Al-Bawardy1,
- Maday Gonzalez2,
- Jerson Munoz Mendoza3,
- Miguel Alvarez4,
- Daniel Pu5,
- Aman Shah6,
- Arrash Fard7,
- Divyanshu Mohananey8,
- Harish Ramakrishna9 and
- Pedro Villablanca10
- 1Massachusetts General Hospital-Harvard Medical School, Boston, Massachusetts, United States
- 2Montefiore Medical Center, Bronx, New York, United States
- 3Montefiore Medical Center, Bronx, New York, United States
- 4Hospital of the Sisters of Charity (Krankenhaus Barmherzige Schwestern) Linz, Department of Cardiology
- 5Montefiore Medical Center
- 6Montefiore Medical Center, Bronx, New York, United States
- 7Tangshan Worker's Hospital, Tangshan, China
- 8John H Stroger, Jr. Hospital of Cook County, Chicago, Illinois, United States
- 9Mayo Clinic, Phoenix, Arizona, United States
- 10Montefiore Medical Center, New York, New York, United States
Bivalirudin may be an effective anticoagulation alternative to heparin in transcatheter aortic valve interventions. There is no clear superiority of one agent and there is a scarcity of data directly comparing heparin and bivalirudin for these procedures. We aimed to compare the safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing transcatheter aortic valve interventions.
We conducted an electronic database search of all published data. The primary efficacy endpoints were all-cause mortality, cardiovascular mortality, myocardial infarction, and stroke within 30 days. Safety end-points include major and life-threatening bleed according to VARC and BARC bleeding >3 within 48-72 hours, the need for blood transfusion, vascular complications within 30 days and acute kidney injury within 30 days. Odds ratios (OR) and 95% confidence intervals (CI) computed using the Mantel-Haenszel method. Fixed-effect model was used; if heterogeneity (I2)>40, effects were obtained using a random model.
Three studies (n=1,690 patients) were included, which included one randomized trial and two observational studies. There was a significance difference favoring bivalirudin over heparin for myocardial infarction (OR 0.41, 95% CI 0.20-0.87). There was no statistically significant difference in all-cause mortality at 30 days (OR 0.97, 95% CI 0.62-1.52), cardiovascular mortality (OR 1.03, 95% CI 0.52-2.05), stroke (OR 1.23, 95% CI 0.62-2.46), vascular complications (OR 0.96, 95% CI 0.70-1.32), acute kidney injury (OR 1.03, 95% CI 0.53-2.00), the need for blood transfusion (OR 0.67, 95% CI 0.45-1.01), major and life threatening bleed (VARC) (OR 0.74, 95% CI 0.37-1.49) and BARC bleeding >3 (OR 0.52, 95% CI 0.23-1.18).
In patients undergoing aortic valve interventions, no statistically significant difference was seen between bivalirudin and heparin use, except for a significant lower myocardial infarction events with bivalirudin compared to heparin. Furthermore, large randomized controlled trials are needed to assess which anticoagulation agent is safer and efficacious in patients undergoing transcatheter aortic valve interventions.
STRUCTURAL: Valvular Disease: Aortic