Bivalirudin versus Heparin in Transradial Coronary Interventions: A Pairwise and Network Meta-Analysis of Randomized Controlled Trials

Kheiri, Babikir

Bivalirudin versus Heparin in Transradial Coronary Interventions: A Pairwise and Network Meta-Analysis of Randomized Controlled Trials

Tuesday, May 21, 2019

Belmont Ballroom 2-3 (The Cosmopolitan of Las Vegas)

Babikir Kheiri, MD, MRCP, PGDip , Hurley Medical Center, Flint, MI

Sunil V. Rao, M.D., FSCAI , Duke University Hospital, Durham, NC

Mohammed Osman, MD , West Virginia University Medical Center, morgantown, WV

Mahmoud Barbarawi, MD , Hurley Medical Center, Flint, MI

Yazan Zayed, M.D. , Hurley Medical Center, Flnit, MI

Harsukh N Dhillon, MD , Hurley Medical Center, Flint, MI

Ghassan Bachuwa, MD, MS, MHSA , Hurley Medical Center, Flint, MI

Mustafa Hassan, MD, MRCP, MMSc , Hurley Medical Center, Flint, MI

Mohamad Alkhouli, M.D. , WVU Heart and Vascular Institute, Morgantown, WV

Deepak L. Bhatt, M.D., FSCAI , Brigham And Women's Hospital, Newton, MA

Gregg W. Stone, M.D., FSCAI , Cardiovascular Research Foundation, New York, NY

Joaquin E. Cigarroa, M.D., FSCAI , OHSU, Portland, OR

Background:
Bivalirudin and radial artery access are associated with better cardiovascular outcomes. However, data supporting the combination strategy are conflicting. Therefore, we sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients undergoing transradial artery coronary intervention (TRI) across the spectrum of coronary artery disease.

Methods:
An electronic database search was performed to identify randomized controlled trials (RCTs) of bivalirudin in which outcomes according to access site were reported. We performed direct and network meta-analysis to calculate study-level summary estimates. The primary outcome was 30-day net adverse clinical events (NACE). Secondary outcomes were long-term NACE, short- and long-term major adverse cardiovascular events (MACE), myocardial infarction (MI), unplanned revascularization, stent thrombosis, all-cause mortality, and major bleeding.

Results:
We identified 10 RCTs in which 16,328 patients underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male, glycoprotein IIb/IIIa receptor inhibitors [GPIs] were used in 29.2% of heparin assigned patients). Bivalirudin use was associated with reduced 30-day NACE compared with heparin (RR=0.87; 95% CI=0.76-0.99; P=0.04), without heterogeneity (I²=0). In addition, no significant interaction was observed based on the presentation (acute coronary syndrome vs stable) or the administration of P2Y₁₂ inhibitors (prasugrel and ticagrelor vs clopidogrel) and GPIs (bailout vs routine). There were no significant differences between groups in long-term NACE and short- or long-term MACE, MI, unplanned revascularization, stent thrombosis, all-cause mortality, or major bleeding. In trial sequential analysis, the sample size was adequate to estimate precision for NACE and MACE, however, it was underpowered for lower frequency endpoints.

Conclusions:
Among patients undergoing TRI, bivalirudin was associated with reduced 30-day NACE without significant differences in other ischemic and bleeding events. Large adequately powered trials are still warranted to determine the relative efficacy and safety of bivalirudin in patients undergoing TRI.