The primary objective of the study is to assess the safety and the efficacy of a hybrid percutaneous coronary intervention (PCI) strategy combining a magnesium-based sirolimus-eluting bioresorbable scaffold (Freesolve, Biotronik AG, Switzerland) and ≥1 paclitaxel-eluting drug-coated balloon(s) (Pantera Lux, Biotronik AG, Switzerland) compared to a conventional DES-based PCI approach using \>1 newer-generation drug-eluting stents (Orsiro Mission, Biotronik AG, Switzerland) for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI with respect to vessel-level absolute change in non-invasive angiography-derived fractional flow reserve (FFRangio, CathWorks, Newport Beach, USA) between post-index PCI and 12-month follow-up.
BIOHYBRID is a coronary revascularization strategy study comparing two contemporary treatment approaches for patients with long and/or diffuse coronary artery lesions undergoing PCI.
The primary hypothesis of the study is that a hybrid PCI strategy using a 'leave nothing behind' or 'metal-free' approach that combines a bioresorbable magnesium scaffold and drug-coated balloons for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI is feasible.
The secondary hypothesis is that a hybrid PCI strategy combining a bioresorbable magnesium scaffold and drug-coated balloons is non-inferior to a conventional DES-based PCI approach using one or several DES for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI with respect to vessel-level absolute change in FFRangio (CathWorks, Newport Beach, USA) between post-index PCI and at 12 months of follow-up.
Clinical inclusion criteria
Participant is ≥18 years.
Participant has provided written informed consent as approved by the independent Ethical Committee (EC) or Institutional Review Board (IRB) of the respective participating centre prior to any study-related procedure.
Participant is eligible for PCI according to the ESC guidelines (4, 5) .
Participant has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy or intolerance to aspirin, P2Y12 receptor inhibitors (clopidogrel, ticagrelor, or prasugrel), both heparin and bivalirudin, any of the following DES or bioresorbable scaffold component (magnesium, aluminium, tantalum, poly-L-lactide, or sirolimus), or drug-coated balloon component (paclitaxel).
Participant with STEMI <72 hours prior to study index procedure. 12a: Participants with hemodynamically stable NSTEMI are eligible for study enrolment.
Participant with prior PCI within the target vessel during the last 12 months prior to the study index procedure.
Participant is on dialysis or has chronically impaired renal function defined as serum creatinine >2.5 mg/dL or 221 μmol/L.
University Hospital, Geneva
Lead sponsor
Clinical Trials Unit Bern (CTU)
Collaborator