Biofreedom Prospective Multicenter Observational Registry

Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients With Coronary Artery Disease (Biofreedom Registry)

LEADERS-FREE trial demonstrated the safety and efficacy of polymer-free drug-coated stent (Biofreedom, Biosensors International Technologies, Singapore) in patients with high bleeding risk. But, there are limited clinical evidences for extending these findings to generalized patients who are eligible to PCI. Therefore, the purpose of this registry is to evaluate the safety and efficacy of Biofreedom stent in patients with coronary artery disease.

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease Aggravated
• Intervention / Treatment: Device: Biofreedom drug-coated stent

Detailed Description

Percutaneous coronary intervention (PCI) and related interventional cardiology field are rapidly growing in current era. First generation drug eluting stent (DES) needed long-term dual antiplatelet therapy (DAPT) for preventing future stent thrombosis. But, second generation DES showed better clinical outcomes in terms of target lesion revascularization and stent thrombosis. Later, polymer technology that was used to release drugs gradually improved. BASKET-PROVE II trial compared biodegradable polymer (BP) DES (Nobori, Terumo) with durable polymer DES (Xience Prime, Abbott Vascular) and bare metal stent (ProKinetik, Biotronik) for the safety and efficacy in 2-year follow-up. BP-DES showed 7.6% of event rates in composite endpoint including cardiac death, myocardial infarction (MI), clinically indicated target-vessel revascularization (TVR) which was non-inferior to DP-DES(6.8%) and superior to bare metal stent (12.7%). There were no statistical differences for the event rates of stent thrombosis, MI and cardiac death among three groups in 1-year follow-up. Biodegradable polymer has begun to emerge and suggested the possibility of shortening the duration of DAPT. LEEDERS-FREE trial was designed to confirm the safety and efficacy of polymer-free drug-coated stent (Biofreedom, Biosensors International Technologies, Singapore) compared to bare metal stent (Gazelle stent, Biosensors International Technologies, Singapore) in patients with high bleeding risk. During 390 days, drug coated stent showed significant superiority to bare metal stent for the safety composite endpoint (cardiac death, MI or stent thrombosis) (9.4% vs. 12.9%, P=0.0005). Clinically-driven target-lesion revascularization also showed significant differences between drug-coated stent (5.1%) and bare metal stent (9.8%) (P<0.001). This results provided new therapeutic options that DAPT duration could be shortened to 1 month in patients with high bleeding risk. The rate of cardiovascular events was relatively higher than second generation DES. However, this result should be carefully interpreted because the main purpose of LEADERS-FREE trial is to enroll high bleeding risk patients who are generally excluded in second generation DES studies. Additional studies are needed because there are limited clinical evidences for extending these findings of LEADERS-FREE trial to generalized patients who are eligible to PCI.

• Study Type: Observational
• Enrollment (Actual): 194

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06973
    • Chung-ang University Hospital
  • Seoul, Korea, Republic of, 07061
    • Seoul National University Boramae Medical Center
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 01830
    • Eulji General Hospital
  • Seoul, Korea, Republic of, 05278
    • KyungHee University at Gangdong
  • Seoul, Korea, Republic of, 134-791
    • Veterans Health Service Medical Center
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, Korea, Republic of, 31116
      • Dankook University Hospital
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 200-722
      • Kangwon National University School of Medicine
    • Wonju, Gangwon-do, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
      • SoonChunHyang University Bucheon Hospital
    • Incheon, Gyeonggi-do, Korea, Republic of, 21565
      • Gachon University Gil Medical Center
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13495
      • CHA Bundang Medical Center
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of, 42415
      • Yeungnam University Medical Center
    • Daegu, Gyeongsangbuk-do, Korea, Republic of, 42472
      • Daegu Catholic University Medical Center
  • Gyeongsangnam-do
    • Busan, Gyeongsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All-comers patient population with all subjects requiring coronary revascularization with a drug-coated stent (DCS)

Description

Inclusion Criteria:

• Subject with ≥ 19 years
• Subject implanted with Biofreedom DCS within 1 month
• Subject who decided to participation and signed informed consent

Exclusion Criteria:

• Known intolerance to heparin, aspirin, clopidogrel, biolimus, cobalt chromium or contrast media (Subject with hypersensitivity to contrast media controlled by steroid and pheniramine can be included this study, but subject with anaphylaxis to contrast media will be excluded).
• Pregnancy
• Woman who have a plan of pregnancy during study period
• Subject with life expectancy less than 12 months
• Subject with cardiogenic shock
• Subject treated with other drug-eluting stent (DES), bioresorbable vascular scaffold (BVS) or bare metal stent (BMS)
• Subject participating in other randomized controlled study with DES, BVS or BMS

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Biofreedom drug-coated stent; Subject implanted Biofreedom DCS for coronary artery disease	Device: Biofreedom drug-coated stent; BioFreedom (Biosensors International Technologies, Singapore) is the only polymer- and carrier-free drug coated stent with Biolimus A9 in a selectively micro-structured abluminal surface. It is a stainless steel bare metal surface with 120 micron thick corrugated ring strut.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-oriented composite end point (TLF)	Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARC defined stent thrombosis		12 months
Cardiac death		12 months
Patient-oriented composite end point	Composite of any death, any myocardial infarction, and any revascularization	12 months
Non-cardiac death		12 months
Any myocardial infarction		12 months
Any myocardial infarction not clearly attributable to a non-target vessel		12 months
Any revascularization		12 months
Clinically indicated target-lesion revascularization		12 months
Clinically indicated target-vessel revascularization		12 months

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Collaborators: Cordis Corporation
• Investigators: Study Director: Junghan Yoon, MD, PhD, Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Multicenter; Observational registry; Stenting; Coronary revascularization; All-comers open label registry; Drug coated stent
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID Numbers: Biofreedom V2.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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