A Randomized Clinical Evaluation of the BioFreedom™ Stent

Conditions

Bleeding, In-stent Coronary Artery Restenosis, Ischemic Heart Disease Silent, Stable Angina, ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction

Keywords

DES, coronary stent, bare metal stent, high bleeding, MI, angina

Brief summary

The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.

Carlos M. Campos, Roxana Mehran, Davide Capodanno, Ruth Owen, Stephan Windecker et al. (14 authors)

Circulation Cardiovascular Interventions2024-04-0116 citations

10.1161/circinterventions.122.013000

Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial.

Richardt G, Maillard L, Nazzaro MS, Abdel-Wahab M, Carrié D, Iñiguez A, Garot P, Abdellaoui M, Morice MC, Foley D, Copt S, Stoll HP, Urban P.

2018-06-2711 citations

10.1007/s00392-018-1308-1

Safety and Efficacy of Polymer-Free Biolimus A9-Coated Versus Bare-Metal Stents in Orally Anticoagulated Patients: 2-Year Results of the LEADERS FREE Oral Anticoagulation Substudy.

Carrié D, Menown I, Oldroyd K, Copt S, Talwar S, Maillard L, Morice MC, Teik LS, Lang I, Urban P.

2017-08-019 citations

10.1016/j.jcin.2017.05.033

2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents.

Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, Carrié D, Naber C, Iñiguez A, Talwar S, Menown IBA, Christiansen EH, Gregson J, Copt S, Hovasse T, Lurz P, Maillard L, Krackhardt F, Ong P, Byrne J, Redwood S, Windhövel U, Greene S, Stoll HP, Urban P, LEADERS FREE Investigators.

2016-10-3080 citations

10.1016/j.jacc.2016.10.009

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

Philip Urban, Ian T. Meredith, Alexandre Abizaid, Stuart Pocock, Didier Carrié et al. (22 authors)

New England Journal of Medicine2015-10-14792 citations

10.1056/nejmoa1503943

Interventions

DEVICEBiofreedom™ Drug Coated Stent (DCS)

Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT

DEVICEGazelle™ Bare Metal Coronary Stent (BMS)

Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.

Exclusion criteria

1. Pregnancy 2. Patients expected not to comply with 1 month DAPT 3. Patients requiring a planned staged PCI procedure more than one week after the index procedure 4. Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy 5. Active bleeding at the time of inclusion 6. Reference vessel diameter \<2.25 - \>4.0mm 7. Cardiogenic shock 8. Compliance with long-term single anti-platelet therapy unlikely 9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated. 10. Participation in another clinical trial (12 months after index procedure).

Design outcomes

Primary

Measure	Time frame	Description
Composite Safety Endpoint	one year	Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year
Primary Efficacy Endpoint	one year	The incidence of clinically driven target lesion revascularization

Countries

Switzerland

Outcome results

None listed