Bivalirudin versus heparin in patients planned for percutaneous coronary intervention: a meta-analysis of randomised controlled trials

Salient features of the study

  • The authors searched Medline, the Cochrane Library, and relevant meeting abstracts (search done on April 9, 2014) for randomised trials that assessed bivalirudin versus heparin in patients planned for PCI
  • Primary efficacy endpoint –  incidence of major adverse cardiac events (MACE) up to 30 days
  • Secondary efficacy endpoints – death, myocardial infarction, ischaemia-driven revascularisation, and stent thrombosis
  • Primary safety endpoint – major bleeding up to 30 days
  • The authors also calculated pooled risk ratios and 95% CIs using random-effects models
  • Data obtained from 16 trials involving 33958 patients –  2422 experienced MACE and 1406 had a major bleed
  • There was an increase in the risk of MACE with bivalirudin-based regimens compared with heparin-based regimens (risk ratio 1·09, 95% CI 1·01–1·17; p=0·0204), which was largely driven by increases in myocardial infarction (1·12, 1·03–1·23) and seemingly also by ischaemia-driven revascularisation (1·16, 0·997–1·34) with bivalirudin compared with heparin, with no effect on mortality (0·99, 0·82–1·18) – please see Figure 1 below
  • Bivalirudin increased the risk of stent thrombosis (risk ratio 1·38, 95% CI 1·09–1·74; p=0·0074), which was primarily due to an increase in acute cases in ST-segment elevation myocardial infarction (4·27, 2·28–8·00; p<0·0001) – please see Figure 2 below
  • Overall, bivalirudin-based regimens lowered the risk of major bleeding (risk ratio 0·62, 95% CI 0·49–0·78; p<0·0001), but the magnitude of this effect varied greatly (p<0·0001) depending on whether glycoprotein IIb/IIIa inhibitors were used predominantly in the heparin arm only (0·53, 0·47–0·61; p<0·0001), provisionally in both arms (0·78, 0·51–1·19; p=0·25), or planned in both arms (1·07, 0·87–1·31; p=0·53)

The authors concluded that

  • Compared with a heparin-based regimen, a bivalirudin-based regimen increases the risk of myocardial infarction and stent thrombosis, but decreases the risk of bleeding, with the magnitude of the reduction depending on concomitant glycoprotein IIb/IIIa inhibitor use
  • Physicians should weigh the trade-off between ischaemic and bleeding events when choosing between different anticoagulant regimens

More articles by Dr Vivek Baliga here.

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