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.
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 is hemodynamically stable.
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.
Parallel
PCI with a bioresorbable scaffold and drug-coated balloon(s)
DeviceHybrid PCI 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)
PCI with drug-eluting stent(s)
DevicePCI with \>1 newer-generation drug-eluting stent (Orsiro Mission, Biotronik AG, Switzerland)
Vessel-level delta FFRangio values between post-PCI and 12-month follow-up
Vessel-level delta angiography-derived Fractional Flow Reserve values between post-PCI and 12-month follow-up
Vessel-level FFRangio value after index PCI
Vessel-level angiography-derived fractional flow reserve value after index PCI
Vessel-level FFRangio value at 12-month follow-up
Vessel-level angiography-derived Fractional Flow Reserve value at 12-month follow-up
Rate of target vessel failure
Composite of cardiac death, target vessel myocardial infarction, or clinically indicated target vessel revascularization
Rate of vessel-oriented composite endpoint (VOCE)
Composite of vessel-related cardiac death, vessel-related myocardial infarction, or target vessel revascularization
Rate of all-cause death
Cardiac and non-cardiac death
Rate of any myocardial infarction
Periprocedural or spontaneous, Q wave or non-Q wave, myocardial infarction
Rate of any revascularization
PCI or CABG, clinically and not clinically indicated target lesion revascularization, clinically and not clinically indicated target vessel revascularization
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University Hospital, Geneva
Lead sponsor
Clinical Trials Unit Bern (CTU)
Collaborator
