Bioflow-DAPT Study

NCT ID: NCT04137510

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1948 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2022-09-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orsiro

Group Type: EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type: 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.

Resolute Onyx

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type: 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.

Interventions

Percutaneous coronary intervention

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Valgimigli, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland

Locations

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

Bruges, , Belgium

Ziekenhuis Oost Limburg Genk

Genk, , Belgium

AZ Delta

Roeselare, , Belgium

UCL St Luc

Woluwe-Saint-Lambert, , Belgium

Herlev og Gentofte Hospital

Hellerup, , Denmark

Roskilde University Hospital

Roskilde, , Denmark

CHU Brest

Brest, , France

Centre Hospitalier Universitaire de Lille

Lille, , France

Hopital Privé Jacques Cartier

Massy, , France

CHU Nimes

Nîmes, , France

Assistance Publique Hopitaux de Paris (APHP)

Paris, , France

Assistance Publique Hopitaux de Paris

Paris, , France

Clinique Saint Hilaire

Rouen, , France

Clinique Pasteur

Toulouse, , France

CHU de Toulouse

Toulouse, , France

CHRU de Tours

Tours, , France

Segeberger Kliniken

Bad Segeberg, , Germany

Charite Virchow-Klinikum

Berlin, , Germany

Contilla Herz- und Gefäßzentrum, Elisabeth-Krankenhaus

Essen, , Germany

Klinikum Friedrichshafen GmbH

Friedrichshafen, , Germany

Städtische Kliniken Neuss, Lukaskrankenhaus GmbH

Neuss, , Germany

Queen Mary Hospital

Hong Kong, , Hong Kong

The Chinese University of Hong Kong

Shatin, , Hong Kong

Semmelweis University

Budapest, , Hungary

Somogy County Kaposi Mór Teaching Hospital

Kaposvár, , Hungary

University of Pécs

Pécs, , Hungary

Azienda Ospedaliero - Universitaria Policlinico - Vittorio

Catania, , Italy

Centro Cardiologico Monzino

Milan, , Italy

IRCCS Fondazione Policlinico "San Matteo"

Pavia, , Italy

Azienda Ospedaliero-Universitaria

Torrette, , Italy

Sia AK Medical Solutions

Engure, , Latvia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Institut Jantung Negara

Kuala Lumpur, , Malaysia

Haga Ziekenhuis

The Hague, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Krakowski Szpital Specjalistyczny im. Jana Pawla

Krakow, , Poland

Miedziowe Centrum Zdrowia

Lubin, , Poland

Tan Tock Seng Hospital

Singapore, , Singapore

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Hospital Clinico Universitario de la Valencia

Valencia, , Spain

Hospital Universitario Araba

Vitoria-Gasteiz, , Spain

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Centre Hospitalier Universitaires Vaudoise

Lausanne, , Switzerland

CardioCentro Ticino

Lugano, , Switzerland

Hôpital de Morges

Morges, , Switzerland

Stadtspital Triemli

Zurich, , Switzerland

Phramongkutklao Hospital

Bangkok, , Thailand

Central Chest Institute of Thailand

Bangkok, , Thailand

Countries

Australia; Austria; Belgium; Denmark; France; Germany; Hong Kong; Hungary; Italy; Latvia; Malaysia; Netherlands; New Zealand; Poland; Singapore; Spain; Switzerland; Thailand

References

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.

Reference Type: DERIVED

PMID: 37624364 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37264295 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34503738 (View on PubMed)

Other Identifiers

C1703

Identifier Type: -

Identifier Source: org_study_id

NCT05549440

Identifier Type: -

Identifier Source: nct_alias