Biofreedom Prospective Multicenter Observational Registry
- Conditions
- Myocardial IschemiaCoronary Artery Disease AggravatedMyocardial Infarction
- Interventions
- Device: Biofreedom drug-coated stent
- Registration Number
- NCT03045848
- Lead Sponsor
- Wonju Severance Christian Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 194
- Subject with ≥ 19 years
- Subject implanted with Biofreedom DCS within 1 month
- Subject who decided to participation and signed informed consent
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Biofreedom drug-coated stent Biofreedom drug-coated stent Subject implanted Biofreedom DCS for coronary artery disease
- Primary Outcome Measures
Name Time Method Device-oriented composite end point (TLF) 12 months Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization
- Secondary Outcome Measures
Name Time Method Cardiac death 12 months Any myocardial infarction not clearly attributable to a non-target vessel 12 months Any revascularization 12 months Non-cardiac death 12 months Clinically indicated target-vessel revascularization 12 months Patient-oriented composite end point 12 months Composite of any death, any myocardial infarction, and any revascularization
Any myocardial infarction 12 months Clinically indicated target-lesion revascularization 12 months ARC defined stent thrombosis 12 months
Trial Locations
- Locations (16)
Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon-do, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Chungcheongnam-do, Korea, Republic of
Kangwon National University School of Medicine
🇰🇷Chuncheon, Gangwon-do, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Gyeonggi-do, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Gyeongsangbuk-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Gyeongsangbuk-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Busan, Gyeongsangnam-do, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University at Gangdong
🇰🇷Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Veterans Health Service Medical Center
🇰🇷Seoul, Korea, Republic of
Eulji General Hospital
🇰🇷Seoul, Korea, Republic of