Author + information
- Mahesh Anantha Narayanan1,
- Yogesh NV. Reddy2,
- Dixitha Anugula3,
- Nagarjuna Gujjula3,
- Apurva Badheka4,
- Abhishek Deshmukh2,
- Manu Kaushik5 and
- Ganesh Raveendran6
- 1University of Minnesota, Roseville, Minnesota, United States
- 2Mayo Clinic, Rochester, Minnesota, United States
- 3CHI Health Creighton University Medical Center, Omaha, Nebraska, United States
- 4The Everett Clinic, Everett, Washington, United States
- 5NWI VA Medical Center, Omaha, Nebraska, United States
- 6University of Minnesota, Saint Paul, Minnesota, United States
The safety and efficacy of bivalirudin in patients with primary percutaneous coronary intervention (PCI) remains controversial, with conflicting data from randomized trials. We performed a comprehensive meta analysis to compare bivalirudin to heparin, with and without routine GPIIb/IIIa inhibitors (GPI) in patients who underwent PCI.
We searched PubMed, Cochrane, EMBASE, CINAHL and WOS from inception to June 2016 for clinical trials comparing bivalirudin to heparin, with and without routine GPI in PCI. Cochrane’s Q statistics were used to determine heterogeneity. Random effects model was used.
A total of 18 studies (14 original studies and 4 subgroups) with 57,928 patients were included in the final analysis. Mean follow up was 2.96 months with maximum follow-up of 1 year. There was no difference between the two groups in all cause mortality (Mantel Haenszel (MH) risk ratio (RR): 0.99, 95% CI: 0.86-1.14, P=0.904), risk of myocardial infarction (MH RR:1.07,95% CI:1-1.15, P=0.057), target vessel revascularization (MH RR: 1.13 ,95% CI: 0.94-1.36, P=0.185) or stroke (MH RR: 0.9, 95% CI: 0.68-1.19, P=0.451). Rates of major bleeding were lower in the bivalirudin group (MH RR: 0.56, 95% CI: 0.45-0.69, P<0.001). Though bivalirudin appeared to have a higher risk of stent thrombosis (MH RR: 1.57, 95% CI: 1.11-2.22, P=0.01), exclusion of studies with routine GPIs in both arms showed no difference (MH RR: 1.66, 95% CI: 0.53-5.16, P=0.384). Major bleeding was still low in the bivalirudin arm after excluding studies with routine GPI use (MH RR: 0.56, 95% CI: 0.34-0.94, P=0.027).
Bivalirudin is safe and effective in PCI when compared to heparin. It is associated with a lower risk of major bleeding and no difference in all cause mortality or major adverse cardiac events at follow up.
CORONARY: Acute Coronary Syndromes