Why is this study important?
- Previous trials varied with respect to use of 2b3a inhibitors with heparin, absence of post-PCI bivalirudin infusion and radial access.
- A direct comparison of bivalirudin with a 2-4 hr post-PCI infusion v heparin monotherapy to compare ischemic and hemorrhagic complications in STEMI pts undergoing PPCI with radial access has not been performed in an adequately powered RCT.
What question was this study supposed to answer?
Will heparin monotherapy or bivalirudin with post-PCI infusion provide best outcomes in STEMI PPCI with radial access in a large RCT with 6016 patients enrolled exclusively in China?
What did the study show?
- All-cause death or BARC types 3-5 bleeding was reduced with bivalirudin with post-PCI infusion; 4.4% v 3.1 %, p=0.0070.
- All-cause death reduced with bivalirudin 3.9% v 3.0%, p=.0420
- BARC 3-5 bleeding reduced with bivalirudin 0.8% v 0.2%, p=0.0014
- Stent thrombosis reduced with bivalirudin 1.1% v 0.4%, p=0.0015
In STEMI PPCI patients with radial artery access, bivalirudin with a median 3-hr post PCI high-dose infusion reduced 30-day all-cause mortality and BARC 3-5 types major bleeding compared with heparin monotherapy.