Bioresorbable Scaffold Combined with Drug-Coated Balloons for Hybrid Percutaneous Coronary Intervention Compared to a Conventional Strategy Based on Drug-Eluting Stents in Patients with Long and Diffuse Coronary Artery Disease: Randomized BIOHYBRID Pilot Study
Zusammenfassung der Studie
Current treatments for long and diffuse coronary lesions primarily rely on the implantation of drug-eluting stents. However, the use of long metal stents increases the risk of complications such as restenosis or stent thrombosis. The BIOHYBRID study compares a new hybrid approach with a conventional strategy. The hybrid approach combines a bioresorbable magnesium scaffold (DREAMS 3G RMS) with a Paclitaxel-coated balloon catheter (Pantera Lux DCB), while the conventional strategy is based on the implantation of a standard stent (Orsiro Mission DES). Eligible patients are randomly assigned to one of the two strategies and followed for one year to assess both treatment strategies – particularly by measuring blood flow in the treated artery using a non-invasive functional test (FFRangio).
(BASEC)
Untersuchte Intervention
The BIOHYBRID study investigates an innovative strategy for coronary revascularization using percutaneous coronary intervention (PCI) in patients with de novo, long and/or diffuse coronary artery lesions (estimated total lesion length >40 mm). After optimal lesion preparation, participants are randomized in a 1:1 ratio, provided that no serious angiographic complications have occurred.
Intervention group: Hybrid PCI (Hybrid-PCI arm)
Patients receive a combination of two medical devices in the consecutive coronary segments of the target lesion:
A bioresorbable magnesium scaffold (BRS) – Freesolve™ (Biotronik AG, Switzerland) – is implanted in the proximal, usually larger segment of the lesion. The implantation must be performed according to the so-called “4P strategy” (Patient selection, Predilatation, precise size adjustment, Postdilatation). The use of multiple overlapping BRS for the treatment of the same lesion is not allowed.
One or more Paclitaxel-coated balloons (DCB) – Pantera Lux (Biotronik AG, Switzerland) – are used in the distal, usually smaller segment of the lesion, according to the recommendations of the international DCB consensus report.
In the case of bifurcated lesions with a side branch diameter <2.0 mm and suboptimal angiographic results after provisional scaffold use, an emergency procedure is planned:
• Kissing balloon technique.
- With acceptable results: Use of a DCB in the side branch possible (at the operator's discretion),
- With insufficient results (e.g., strong recoil or flow-limiting dissection): Implantation of a drug-eluting stent (Orsiro Mission, Biotronik AG, Switzerland) in the side branch is permitted.
Control group: Conventional PCI with Drug-Eluting Stent (DES) (DES arm)
Patients receive one or more latest-generation drug-eluting stents – Orsiro Mission (Biotronik AG, Switzerland) – for the treatment of the entire target lesion. The use of BRS or DCB in this group is not allowed. In the case of bifurcated lesions, the same emergency procedure as in the hybrid arm is applied.
Medication and Imaging
After the intervention, all patients receive dual antiplatelet therapy (Aspirin + P2Y12 inhibitor) for at least 6 months (according to the prescription of the treating physician). A control coronary angiography is performed 12 months after the intervention. The angiographies (at study initiation, after PCI, and after 12 months) are evaluated by an independent central laboratory.
A non-invasive coronary fractional flow reserve (FFR value) (FFRangio, CathWorks, USA) is calculated based on the angiographic image data at the three time points (at study initiation, after PCI, and after 12 months).
(BASEC)
Untersuchte Krankheit(en)
Long and diffuse de novo coronary lesions
(BASEC)
• Age ≥18 years and written informed consent prior to any study-related procedures. • Presence of a long de novo coronary artery lesion with a length >40 mm, suitable for PCI). • Eligibility for dual antiplatelet therapy (Aspirin + Clopidogrel, Prasugrel, or Ticagrelor) for ≥6 months. (BASEC)
Ausschlusskriterien
• Known allergy or intolerance to study-related medications (Aspirin, P2Y12 inhibitors, Heparin, Bivalirudin, Paclitaxel) or components of the medical devices (Magnesium, Aluminum, Tantalum, Poly-L-Lactide, Sirolimus). • Target lesion is a chronic total occlusion or located in the main stem or ostial coronary segments. • Inability to adhere to dual antiplatelet therapy (DAPT) for at least 6 months. (BASEC)
Studienstandort
Basel, Bern, Genf, Zürich
(BASEC)
Sponsor
Hôpitaux Universitaires de Genève (HUG), Genève, Suisse
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Juan Iglesias
+41 79 553 34 67
juanfernando.iglesias@clutterhug.chHôpitaux Universitaires de Genève (HUG)
(BASEC)
Allgemeine Auskünfte
+41795533467+41795533467
juanfernando.iglesias@clutterhug.chjuanfernando.iglesias@clutterhug.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
08.05.2026
(BASEC)
ICTRP Studien-ID
NCT06710210 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
BIOresorbable scaffold combined with drug-coated balloons for HYBRID percutaneous coronary intervention versus a conventional drug-eluting stent-based strategy in patients with long and diffuse coronary artery disease: BIOHYBRID randomized pilot trial (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
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 (ICTRP)
Untersuchte Krankheit(en)
Coronary Artery DiseaseDiffuse Coronary Artery DiseasePercutaneous Coronary Intervention (PCI) (ICTRP)
Untersuchte Intervention
Device: PCI with a bioresorbable scaffold and drug-coated balloon(s)Device: PCI with drug-eluting stent(s) (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion criteria:
- Clinical inclusion criteria
1. Participant is >=18 years.
2. 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.
3. Participant is eligible for PCI according to the ESC guidelines (4, 5) .
4. Participant is hemodynamically stable.
5. 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.
Exclusion criteria:
Clinical exclusion criteria
1. 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).
2. Participant with STEMI <72 hours prior to study index procedure. 12a: Participants
with hemodynamically stable NSTEMI are eligible for study enrolment.
3. Participant with prior PCI within the target vessel during the last 12 months prior
to the study index procedure.
4. Participant is on dialysis or has chronically impaired renal function defined as
serum creatinine >2.5 mg/dL or 221 mol/L.
5. Participant is unable to adhere to DAPT for at least 6 months (e.g. planned surgery,
dental surgical procedure, active bleeding disorders, active coagulopathy).
6. Participant is on oral anticoagulation therapy (OAC) prior to index procedure unless
DAPT plus OAC (i.e. triple therapy) can be maintained for a minimum of 1 month.
7. Participant with life expectancy <1 year.
8. Participant is pregnant and/or breastfeeding or intends to become pregnant during
the duration of the study.
9. Participant is currently participating or planning to participate in another
interventional clinical trial, except for observational registries or previous
enrolment into the current investigation.
10. Participant unwilling or unable (e.g. physical or cognitive) to comply with study
procedures, medication adherence and schedule.
11. Contraindications and limitations of the medical devices as described in the
instructions for use.
12. Known or suspected non-compliance, drug or alcohol abuse.
13. Inability to follow the procedures of the investigation, e.g. due to language
problems, psychological disorders, dementia, etc. of the participant.
14. Participation in another investigation with an investigational drug or another MD
within the 30 days preceding and during the present investigation.
Angiographic exclusion criteria
15. Target vessel previously treated with a bare-metal stent or a drug-eluting stent and
the target lesion is within 5 mm proximal or distal to the previously treated
lesion.
16. Target lesion is a chronic total occlusion.
17. Target lesion is located in left main coronary artery, ostial left anterior
descending artery, ostial left circumflex artery, or ostial right coronary artery
(within 5.0 mm of the vessel origin).
18. Target lesion is located in, or supplied by, an arterial or venous bypass graft.
19. Target lesion with excessive tortuosity proximal to or within the lesion based on
operator visual estimation, or heavily calcified target lesion which may be
adequately prepared using a non-compliant and/or cutting/scoring balloon.
20. Target lesion requires treatment with a device other than a non-compliant balloon
and/or a modified (cutting/scoring) balloon prior to scaffold/stent placement
(including but not limited to atherectomy devices, intravascular lithotripsy).
21. Target lesion involves a coronary bifurcation with a side branch with reference
vessel diameter >=2.0 mm that requires a two-device strategy after pre-dilatation.
22. Presence of thrombus in the target vessel.
23. Future planned staged PCI or coronary artery bypass graft surgery after the study
PCI procedure.
24. Target with unsuccessful lesion preparation, defined as the absence of residual
stenosis >=30%, TIMI flow grade <3 following complete lesion preparation (6), type C
to F coronary artery dissection according to the National Heart, Lung and Blood
Institute (NHLBI) classification (7) (Appendix 2) and angiographic complications
(e.g. distal embolization, or side branch closure). (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Vessel-level delta FFRangio values between post-PCI and 12-month follow-up (ICTRP)
Vessel-level FFRangio value after index PCI;Vessel-level FFRangio value at 12-month follow-up;Rate of target vessel failure (ICTRP)
Registrierungsdatum
25.11.2024 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Clinical Trials Unit Bern (CTU) (ICTRP)
Weitere Kontakte
Juan F Iglesias, Principal Investigator;Juan F Iglesias, Principal Investigator, juanfernando.iglesias@hug.ch, +41795533467;+41795533467 (ICTRP)
Sekundäre IDs
2024-0000 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06710210 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar