Bioflow-DAPT Study

Phase 4

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT04137510
• Lead Sponsor: Biotronik AG

Brief Summary

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.

A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.

Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2020-02-24
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20
• Status Verified: 2023-04
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1948

Inclusion Criteria

1. Subject is acceptable candidate for treatment with a DES

2. Subject is considered at high bleeding risk (HBR), defined as meeting one or more of the following criteria at the time of enrollment:

   1. ≥ 75 years of age
   2. Moderate (estimated GFR 30-59 ml/min) or severe (estimated GFR < 30 ml/min) chronic kidney disease or failure (dialysis dependent)
   3. Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices.
   4. Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated
   5. Anemia with hemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization
   6. Baseline thrombocytopenia defined as a platelet count <100,000/mm3
   7. History of stroke (ischemic or hemorrhagic), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a brain arteriovenous malformation
   8. History of hospitalization for bleeding within the previous 12 months
   9. Chronic clinically significant bleeding diathesis
   10. Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC)
   11. Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin
   12. Nondeferrable major surgery on DAPT
   13. Recent major surgery or major trauma within 30 days before PCI
   14. Precise DAPT score ≥ 25

3. Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrollment

4. Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure

5. Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month

6. Subject is eligible for dual antiplatelet therapy treatment with aspirin plus a P2Y12 inhibitor agent for 1-month post index procedure

Exclusion Criteria

1. Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel
2. Subject has a known allergy to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), molybdenum, platinum and irridium, silicon carbide, PLLA,polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media
3. Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 72 hours prior to or during the index procedure
4. 4. Subject with documented left ventricular ejection fraction (LVEF) <30% as evaluated by the most recent imaging exam (i.e. echocardiogram, ventriculogram, MUGA, etc.), but within 90 days pre/procedure or during the index procedure
5. Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT
6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor and/or aspirin within the first month post-index procedure Note - planned staged procedure at the time of index procedure is not allowed
7. Active bleeding at the time of inclusion
8. Subject with a current medical condition with a life expectancy of less than 12 months
9. Subject is currently participating or intends to participate in another investigational drug or device trial within 12 months following the index procedure or any other clinical trial that may interfere with the treatment or protocol of this study
10. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
11. In the investigator's opinion, subject will not be able to comply with the follow-up requirements
12. Subjects who need an impartial witness to give an informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months	12 months post-procedure

Secondary Outcome Measures

Name	Time	Method
Rate of MACE	until 12 months post-procedure	composite of cardiac death, MI, and Target Vessel Revascularization (TVR)
Rate of cardiac death or MI	until 12 months post-procedure	all, target vessel related MI, Q-wave and non Q-wave, ST-related and non ST-related
Rate of all-cause death, cardiac, non-cardiac	until 12 months post-procedure
Rate of clinically-indicated TVR	until 12 months post-procedure
Rate of Target Vessel Failure (TVF)	until 12 months post-procedure	Composite of clinically-driven TVR, cardiac death or target-vessel related MI
Rate of bleeding according to BARC definition	until 12 months post-procedure
Rate of definite/probable stent thrombosis according to the ARC definition	until 12 months post-procedure
Rate of stroke, ischemic and hemorrhagic	until 12 months post-procedure
Rate of clinically-indicated Target Lesion Revascularization (TLR)	until 12 months post-procedure
Rate of target lesion failure (TLF)	until 12 months post-procedure	Composite of clinically driven TLR, cardiac death or target vessel related MI
Rate of bleeding according to TIMI definition	until 12 months post-procedure
Rate of Device success	until 12 months post-procedure	Attainment of less than 30% residual stenosis of the target lesion using assigned stent only
Rate of bleeding according to GUSTO definition	until 12 months post-procedure
Rate of MACCE	until 12 months post-procedure	composite of all-cause death, MI, and stroke
Rate of Procedure success	until 12 months post-procedure	Attainment of less than 30% residual stenosis of the target lesion using assigned stent only without occurrence of in-hospital major adverse cardiac events

Trial Locations

Locations (53)

The Northern Hospital; 🇦🇺 Epping, Australia

John Hunter Hospital; 🇦🇺 New Lambton, Australia

Royal Perth Hospital; 🇦🇺 Perth, Australia

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Uniklinikum Salzburg; 🇦🇹 Salzburg, Austria

AZ St Jan Brugge; 🇧🇪 Brugge, Belgium

Ziekenhuis Oost Limburg Genk; 🇧🇪 Genk, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

UCL St Luc; 🇧🇪 Woluwe-Saint-Lambert, Belgium

Herlev og Gentofte Hospital; 🇩🇰 Hellerup, Denmark

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