HD-PCI: Higher-Dose Heparin Does Not Provide Appreciable Benefit Over Lower-Dose Strategy During PCI
SAN DIEGO – New results from the HD-PCI study show that a higher-dose unfractionated heparin (UFH) regimen did not improve clinical outcomes compared with a lower-dose strategy during percutaneous coronary intervention (PCI).
Findings were reported today at TCT® 2026, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.
Current guidelines recommend a broad range of heparin doses, yet high-quality evidence from randomized trials is limited, and thus, the optimal dose of UFH remains uncertain. Too much intraprocedural heparin can increase the risk of major bleeding, while too little increases the risk of thrombotic events. The HD-PCI study was designed to determine whether a lower or higher-dose UFH strategy offers the best balance between ischemic protection and bleeding risk in contemporary elective PCI.
HD-PCI was a multicenter, randomized, controlled, registry-based, open-label, cluster crossover trial conducted at 11 PCI centers in Canada. A total of 11,619 patients were enrolled from March 2022 to November 2024, representing 72% of the target sample size. Patient and procedural characteristics were similar between both groups. Hospitals were randomized to implement institutional UFH dosing strategies of either 70 U/kg (n=5,778) or 100 U/kg (n=5,841) for elective PCI, with crossover between treatment periods. Adult patients undergoing elective PCI with stable coronary artery disease were eligible for inclusion. Chronic total occlusion cases were excluded.
The primary efficacy outcome was defined as the composite of all-cause death, myocardial infarction, or target vessel revascularization within 30 days of the initial PCI procedure. The results showed no statistical difference between events in the higher-dose UFH group (n=70) and the lower-dose UFH (n=55) group [95% CI: 1.29 (0.89-1.87), p=0.17]. For the primary safety outcome of major bleeding, the incidence among the higher-dose (n=58) and lower-dose groups (n=59) were also similar [95% CI: 1.03 (0.70-1.52), p=0.87]. The key net benefit outcome defined as the composite of all-cause death, myocardial infarction, target vessel revascularization or major bleeding was also not statistically significant between the higher-dose (n=126) and lower-dose (n=113) groups [95% CI: 1.16 (0.87-1.54), p=0.30].
“Despite the need to balance ischemic protection against bleeding risk, randomized evidence to guide the optimal dose of UFH for elective PCI has been limited,” said Sanjit S. Jolly, MD, MSc, FRCPC, interventional cardiologist with Hamilton Health Sciences and Stuart Connolly Chair in Cardiology, professor of medicine, at McMaster University. “In HD-PCI, a higher-dose strategy offered no added benefit in contemporary practice. These findings suggest that a lower dose of 70 U/kg of heparin is sufficient, with ACT measured at 30 minutes for prolonged procedures.”
The study was funded by a PHRI internal funding competition.
Dr. Jolly reported the following disclosures: grant/research support from Boston Scientific and consultant fees/honoraria from Johnson & Johnson MedTech, Teleflex and SIS.
The results of the study were presented on Sunday, November 1 at 11:29 AM PT in the Main Arena at the San Diego Convention Center during TCT 2026.
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