Bioflow-DAPT Study

NCT04137510 | Completed Phase 4 DMC

• 1 other identifier: C1703
• Study Type: interventional
• Target: 1,948
• Locations: 17 countries
• Sites: 50

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.

Conditions

Coronary Artery Disease

Keywords

DAPT; Dual antiplatelet therapy; high bleeding risk; HBR; Coronary artery disease; Percutaneous coronary intervention; PCI

Outcome Measures

Primary Outcomes (1)

• Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months

  12 months post-procedure

Secondary Outcomes (15)

• Rate of definite/probable stent thrombosis according to the ARC definition

  until 12 months post-procedure

• Rate of MACCE

  until 12 months post-procedure

• Rate of MACE

  until 12 months post-procedure

• Rate of cardiac death or MI

  until 12 months post-procedure

• Rate of all-cause death, cardiac, non-cardiac

  until 12 months post-procedure

Study Arms (2)

Orsiro

EXPERIMENTAL

Device: Percutaneous coronary intervention

Resolute Onyx

ACTIVE COMPARATOR

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel.

Orsiro; Resolute Onyx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥ 75 years of age
• Moderate (estimated GFR 30-59 ml/min) or severe (estimated GFR \< 30 ml/min) chronic kidney disease or failure (dialysis dependent)
• Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices.
• Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated
• Anemia with hemoglobin \< 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization
• Baseline thrombocytopenia defined as a platelet count \<100,000/mm3
• 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
• History of hospitalization for bleeding within the previous 12 months
• Chronic clinically significant bleeding diathesis
• Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC)
• Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin
• Nondeferrable major surgery on DAPT
• Recent major surgery or major trauma within 30 days before PCI

You may not qualify if:

• 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 irridium, silicon carbide, PLLA,polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media
• 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
• \. 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
• 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
• 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 the 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's opinion, subject will not be able to comply with the follow-up requirements
• Subjects who need an impartial witness to give an informed consent

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (53)

The Northern Hospital

Epping, 3076, Australia

Location

John Hunter Hospital

New Lambton, 2305, Australia

Location

Royal Perth Hospital

Perth, 6000, Australia

Location

Medizinische Universität Graz

Graz, 8036, Austria

Location

Uniklinikum Salzburg

Salzburg, 5020, Austria

Location

AZ St Jan Brugge

Bruges, 8000, Belgium

Location

Ziekenhuis Oost Limburg Genk

Genk, 3600, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

UCL St Luc

Woluwe-Saint-Lambert, 1200, Belgium

Location

Herlev og Gentofte Hospital

Hellerup, 2900, Denmark

Location

Roskilde University Hospital

Roskilde, 4000, Denmark

Location

CHU Brest

Brest, 29601, France

Location

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

Location

Hopital Privé Jacques Cartier

Massy, 91300, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Assistance Publique Hopitaux de Paris (APHP)

Paris, 75004, France

Location

Assistance Publique Hopitaux de Paris

Paris, 75004, France

Location

Clinique Saint Hilaire

Rouen, 76000, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CHU de Toulouse

Toulouse, 31400, France

Location

CHRU de Tours

Tours, 37044, France

Location

Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Charite Virchow-Klinikum

Berlin, 13353, Germany

Location

Contilla Herz- und Gefäßzentrum, Elisabeth-Krankenhaus

Essen, 45138, Germany

Location

Klinikum Friedrichshafen GmbH

Friedrichshafen, 88048, Germany

Location

Städtische Kliniken Neuss, Lukaskrankenhaus GmbH

Neuss, 41464, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

Semmelweis University

Budapest, 1124, Hungary

Location

Somogy County Kaposi Mór Teaching Hospital

Kaposvár, 7400, Hungary

Location

University of Pécs

Pécs, 7624, Hungary

Location

Azienda Ospedaliero - Universitaria Policlinico - Vittorio

Catania, 95125, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

IRCCS Fondazione Policlinico "San Matteo"

Pavia, 27100, Italy

Location

Azienda Ospedaliero-Universitaria

Torrette, 60126, Italy

Location

Sia AK Medical Solutions

Engure, LV-3113, Latvia

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Haga Ziekenhuis

The Hague, 2545 AA, Netherlands

Location

Auckland City Hospital

Auckland, 1142, New Zealand

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla

Krakow, 31-202, Poland

Location

Miedziowe Centrum Zdrowia

Lubin, 59-301, Poland

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de la Valencia

Valencia, 46010, Spain

Location

Hospital Universitario Araba

Vitoria-Gasteiz, 01009, Spain

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Centre Hospitalier Universitaires Vaudoise

Lausanne, 1011, Switzerland

Location

CardioCentro Ticino

Lugano, 6900, Switzerland

Location

Hôpital de Morges

Morges, 1110, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Central Chest Institute of Thailand

Bangkok, 11000, Thailand

Location

Related Publications (3)

• Valgimigli M, Wlodarczak A, Tolg R, Merkely B, Kelbaek H, Legutko J, Galli S, Godin M, Toth GG, Lhermusier T, Honton B, Dietrich PL, Stammen F, Ferdinande B, Silvain J, Capodanno D, Cayla G; Bioflow-DAPT Investigators. Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial. Circulation. 2023 Sep 26;148(13):989-999. doi: 10.1161/CIRCULATIONAHA.123.065448. Epub 2023 Aug 25.

  PMID: 37624364 DERIVED

• Landi A, Wlodarczak A, Tolg R, Kelbaek H, Legutko J, Galli S, Godin M, Toth GG, Lhermusier T, Honton B, Dietrich PL, Stammen F, Ferdinande B, Silvain J, Capodanno D, Cayla G, Valgimigli M; BIOFLOW-DAPT investigators. Design and Rationale of the BIOFLOW-DAPT Trial: a Prospective, Randomized, Multicenter 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. J Cardiovasc Transl Res. 2023 Oct;16(5):1135-1143. doi: 10.1007/s12265-023-10400-x. Epub 2023 Jun 1.

  PMID: 37264295 DERIVED

• 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.

  PMID: 34503738 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Marco Valgimigli, Prof. Dr.

  Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, international, two-arm randomized controlled clinical study.

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: February 24, 2020
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: June 7, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); CH (5); AU (2); IT (4); NZ (1); BE (4); HU (3); HK (2); PL (2); ES (3); TH (2); DE (5); FR (10); DK (2); LA (2); NL (1); SG (1)