Hybrid Percutaneous Coronary Intervention Combining a Bioresorbable Scaffold With Drug-coated Balloons Versus a Conventional Drug-eluting Stent-based Strategy in Patients With Long and Diffuse Coronary Artery Disease: the BIOHYBRID Randomized Pilot Trial
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 is hemodynamically stable.
⁃ Participant with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS): unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or stabilized ST-segment elevation myocardial infarction (STEMI).
• 5a. Participants with STEMI are eligible for the treatment of non-culprit coronary lesions, if participant consent occurs ≥72 hours after successful primary PCI of the culprit STEMI lesion.
• 5b. Target lesion(s) to be treated are not located in the STEMI culprit vessel(s) and are not STEMI culprit lesion(s).
• 6\. Participant is eligible for dual antiplatelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, or ticagrelor for ≥6 months.
• 7\. Participant is willing to participate and able to comply with the protocol requirements for the duration of the study, including completion of study visits and control coronary angiogram at 12 months.
∙ Angiographic inclusion criteria 8. Target lesion length is \>40 mm according to operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA), Intravascular Ultrasound (IVUS), or Optical Coherence Tomography (OCT).
∙ 9\. Target vessel has a maximum reference diameter between 3.0-4.6 mm according to operator visual estimation, which may be assisted by QCA, IVUS, or OCT.
∙ Notes: The proximal segment, which has a larger vessel diameter, will be treated with one Freesolve scaffold, in accordance with the vessel diameter range specified in the IFU. The distal segment, which naturally tapers to a smaller diameter, can be treated with one or more Pantera Lux DCB, in accordance with the vessel diameter range specified in the IFU.
∙ 10\. Target lesion with a baseline (pre-PCI) Thrombolysis In Myocardial Infarction (TIMI) flow ≥1.