The trial is the world’s first and only randomised, global 14-day dual antiplatelet therapy (DAPT) study of high bleeding risk patients (HBR). The results were reported during a late-breaking clinical science session at TCT Connect.
The study randomised 996 HBR patients, enrolling global sites to receive either COBRA PzF NCS with 14-day DAPT or a Food and Drug Administration (FDA)-approved DES with three or six months DAPT.
In the study, 100% of enrolled patients were on oral anticoagulation therapy (OAC), which is a major bleeding criterion with over 90% of patients presenting with atrial fibrillation.
Additionally, nearly half of the subject group shared a second or third major or minor ARC-HBR bleeding criteria such as recent ischemic stroke, cancer, anaemia, and severe or end-stage chronic kidney disease.
The study found that fewer patients in the COBRA PzF NCS arm compared to the DES arm received a reduction in OAC intensity.
Both study arms presented with highly complex lesions while the COBRA PzF NCS arm presented bifurcation rates that are statistically higher.
Furthermore, the trial reported numerically lower bleeding in the co-primary endpoint of Barc class ≥2 bleeding after 14 days and statistically lower bleeding over DES in BARC class 1-5 after randomisation.
It also noted numerically similar rates in the composite co-primary endpoint of ischemic safety compared to the DES arm. Further analysis indicated statistical non-inferiority when the composite endpoint includes only cardiac-related mortality.
In addition, equal low probable and definite stent thrombosis in both groups and low initial ischemic-driven TLR at six months were also reported.
CeloNova CEO president Carl St Bernard said: “We are pleased with COBRA PzF NCS’ preliminary performance with just 14-days DAPT in aspects of bleeding and ischemic events.
“Finding the right DAPT balance is critical to reducing the complexity and complications of long-DAPT regimens, following stent placement. The COBRA REDUCE study has advanced our understanding of how to best strike this balance.”
COBRA REDUCE’s final co-primary endpoint analysis and secondary endpoints, including a composite of all-cause death, cardiac death, MI, ischemia-driven TLR, definite and probable stent thrombosis, and ischemic stroke at 12-months, are expected to be revealed during the second quarter of the next year.