Bivalirudin versus heparin in women undergoing percutaneous coronary intervention: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND

The anticoagulant of choice during percutaneous coronary intervention (PCI) in women is not well established.

METHODS

An electronic search was conducted for trials that randomized patients undergoing PCI to bivalirudin versus heparin, and reported outcomes of interest in women. Random effects DerSimonian-Laird risk ratios (RR) were calculated. Main outcome was net adverse clinical events (NACE) at 30-days. Other outcomes included major adverse cardiac events (MACE), all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), and major bleeding at 30-days. 1-year all-cause mortality and MACE were also examined.

RESULTS

Nine trials that randomized women undergoing PCI to bivalirudin (n=3960) versus heparin (n=4050) were included. At 30-days, bivalirudin was associated with reduced risk of NACE (RR=0.85; 95% CI 0.73-0.98; p=0.03), mainly driven by reduction in major bleeding (RR=0.59; 95% CI 0.49-0.71; p<0.001) compared with heparin. No difference in MACE (p=0.92), all-cause mortality (p=0.23), MI (p=0.86); or TVR (p=0.53) was demonstrated between both groups. At 1-year, the risk of MACE and all-cause mortality was similar in both groups. On a subgroup analysis, the benefit associated with bivalirudin appeared to be less evident when Glycoprotein IIb/IIIa inhibitors (GPI) was used as bailout therapy with heparin, however without significant interaction. Furthermore, in STEMI population, no difference in NACE, MACE, or major bleeding was observed between both groups.

CONCLUSION

In women undergoing PCI, bivalirudin is associated with reduced risk of major bleeding and NACE compared with heparin especially when GPI is routinely used.