Clinical trial NCT04137510: Bioflow-DAPT Study
Official title: A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: DAPT
Dual antiplatelet therapy
high bleeding risk
HBR
Coronary artery disease
Percutaneous coronary intervention
PCI
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2019-10-24
Enrollment: 1948
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center, international, two-arm randomized controlled clinical study.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Rate of definite/probable stent thrombosis according to the ARC definition
timeFrame: until 12 months post-procedure
measure: Rate of MACCE
timeFrame: until 12 months post-procedure
measure: Rate of MACE
timeFrame: until 12 months post-procedure
measure: Rate of cardiac death or MI
timeFrame: until 12 months post-procedure
measure: Rate of all-cause death, cardiac, non-cardiac
timeFrame: until 12 months post-procedure
measure: Rate of stroke, ischemic and hemorrhagic
timeFrame: until 12 months post-procedure
measure: Rate of clinically-indicated TVR
timeFrame: until 12 months post-procedure
measure: Rate of clinically-indicated Target Lesion Revascularization (TLR)
timeFrame: until 12 months post-procedure
measure: Rate of Target Vessel Failure (TVF)
timeFrame: until 12 months post-procedure
measure: Rate of target lesion failure (TLF)
timeFrame: until 12 months post-procedure
measure: Rate of bleeding according to BARC definition
timeFrame: until 12 months post-procedure
measure: Rate of bleeding according to GUSTO definition
timeFrame: until 12 months post-procedure
measure: Rate of bleeding according to TIMI definition
timeFrame: until 12 months post-procedure
measure: Rate of Device success
timeFrame: until 12 months post-procedure
measure: Rate of Procedure success
timeFrame: until 12 months post-procedure
Other outcomes:
Locations:
city: Epping
country: Australia
facility: The Northern Hospital
city: New Lambton
country: Australia
facility: John Hunter Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Brugge
country: Belgium
facility: AZ St Jan Brugge
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg Genk
city: Roeselare
country: Belgium
facility: AZ Delta
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL St Luc
city: Hellerup
country: Denmark
facility: Herlev og Gentofte Hospital
city: Roskilde
country: Denmark
facility: Roskilde University Hospital
city: Brest
country: France
facility: CHU Brest
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Massy
country: France
facility: Hopital Privé Jacques Cartier
city: Nîmes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris (APHP)
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHRU de Tours
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Berlin
country: Germany
facility: Charite Virchow-Klinikum
city: Essen
country: Germany
facility: Contilla Herz- und Gefäßzentrum, Elisabeth-Krankenhaus
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen GmbH
city: Neuss
country: Germany
facility: Städtische Kliniken Neuss, Lukaskrankenhaus GmbH
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Budapest
country: Hungary
facility: Semmelweis University
city: Kaposvár
country: Hungary
facility: Somogy County Kaposi Mór Teaching Hospital
city: Pécs
country: Hungary
facility: University of Pécs
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Pavia
country: Italy
facility: IRCCS Fondazione Policlinico "San Matteo"
city: Torrette
country: Italy
facility: Azienda Ospedaliero-Universitaria
city: Engure
country: Latvia
facility: Sia AK Medical Solutions
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de la Valencia
city: Vitoria
country: Spain
facility: Hospital Universitario Araba
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaires Vaudoise
city: Lugano
country: Switzerland
facility: CardioCentro Ticino
city: Morges
country: Switzerland
facility: Hôpital de Morges
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Central Chest Institute of Thailand
Study officials:
affiliation: Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland
name: Marco Valgimigli, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028. No abstract available.