BIOFLOW-Dual Anti-Platelet Therapy (BIOFLOW-DAPT)

BIOTRONIK- A Prospective, Randomised, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to Resolute Onyx Stent in Subjects at High Risk of Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomised controlled clinical study. A total of 1,948 subjects will be randomised 1:1 to receive either Orsiro 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.

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Intervention
• Intervention / Treatment: Device: Orsiro Mission; Device: Resolute Onyx

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong, 999077
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Daniel Xu; Phone Number: 1518 35051518; Email: danielxu@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is acceptable candidate for treatment with a DES

• 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 30-59ml/min) or severe (estimated GFR <= 30ml/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 haemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomisation
  6. baseline thrombocytopenia defined as a platelet count < 100,000/mm3.
  7. History of stroke (ischemic or haemorrhagic), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a brain arteriovenus malformation
  8. history of hospitalisation for bleeding within the past 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. clinically indication for chronic or lifelong steroid or oral non-steroidal anti-inflammation drug(s) (NSAIDs), other than aspirin
  12. Nondeferrable major surgery on DAPT
  13. Recent major surgery or trauma within 30 days before PCI
  14. PRECISE DAPT score >= 25
• Subject is >=18 years or the minimum age required for legal adult consent in the country of enrollment
• Subject is capable ( no legally authorised 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.
• Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month.
• Subject is eligible for dual antiplatelet therapy treatment with aspiring plus a P2Y12 inhibitor agent for 1-month post index procedure

Exclusion Criteria:

• Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel
• 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 iridium, silicon carbide, PLLA, polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media
• Revascularisation of any target vessel within 9 months prior to the index procedure
• Subject with documented left ventricular ejaculation 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.
• Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT
• 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
• Active bleeding at the time of inclusion
• Subject with a current medical condition with a life expectancy of less than 12 months
• Subject is currently participating or intends to participate in another investigational drug or device trial within 12 months following index procedure or any other clinical trial that may interfere with the treatment or protocol of this study
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
• In the investigator' opinion, subject will not be able to comply with the follow-up requirements
• Subjects who needs an impartial witness to give an informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orsiro	Device: Orsiro Mission; Percutaneous intervention using Orsiro Mission stent
Active Comparator: Resolute Onyx	Device: Resolute Onyx; Percutaneous intervention using Resolute Onyx stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Major Adverse Cardiovascular Event (MACE) 12 months post-operation	The composite of cardiac death, myocardiac infraction (MI) and definite or probable stent thrombosis at 12 months post-index procedure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of stent thrombosis (ST)	Rate of definite/ possible ST utilizing the Academic Research Consortium-2 (ARC-2) definition	12 months
Rate of Major Adverse Cerebral &Cardiovascular Event (MACCE)	Rate of the composite of all-cause death, MI, and stroke	12 months
Death rate	Rate of all-cause death, cardiac and non-cardiac death	12 months
Rate of tricuspid valve replacement (TVR)	Rate of clinically-indicated TVR	12 months
Rate of Revascularisation	Rate of clinically-indicated target lesion revascularisation (TLR)	12 months
rate of Target vessel failure	Composite of clinically driven TVR, cardiac death or target vessel related MI	12 months
Rate of Target lesion failure	Composite of clinically driven TLR, cardiac death or target vessel related MI	12 months
Rate of bleeding	Defined by BARC definition; GUSTO definition and TIMI definition	12 months
Device success rate	Attainment of < 30% residual stenosis of the target lesion using the assigned study stent only	12 months
Procedure success rate	Attainment of < 30% residual stenosis of the target lesion using the assigned study stent without occurance of in-hospital MACE	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Anticipated): June 28, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020.154

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No