Design and rationale of the HD PCI trial: A cluster randomized crossover trial of higher vs. lower dose heparin for elective percutaneous coronary intervention.

BACKGROUND

Balancing ischemic versus bleeding complications following percutaneous coronary intervention (PCI) remains challenging. However, the optimal dose of unfractionated heparin (UFH) for elective PCI is currently unclear.

METHODS

A Randomized Trial of Higher versus Lower Dose Heparin for PCI (HD-PCI) is a multicenter, randomized, controlled, registry-based, open-label, cluster crossover trial of a lower-dose (70 units/kg) versus higher-dose (100 units/kg) UFH dosing hospital-level policy for elective PCI conducted in 11 centres in Ontario, Canada. The primary efficacy outcome was defined as a composite of all-cause death, myocardial infarction or target vessel revascularization; the key safety outcome was defined as major bleeding; and the key net benefit outcome was defined as the composite of all-cause death, myocardial infarction, target vessel revascularization or major bleeding. All outcomes were evaluated within 30 days of the index PCI.

CONCLUSIONS

HD-PCI is a large cluster randomized crossover trial that will inform the ischemic and bleeding effects of lower-dose (70 units/kg) versus higher-dose (100 units/kg) in patients undergoing elective PCI.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04049591.