Clinical trial NCT03045848: Biofreedom Prospective Multicenter Observational Registry
Official title: Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients With Coronary Artery Disease (Biofreedom Registry)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease Aggravated
Myocardial Ischemia
Myocardial Infarction
Keywords: Observational registry
All-comers open label registry
Drug coated stent
Multicenter
Stenting
Coronary Artery Disease
Coronary revascularization
Percutaneous Coronary Intervention
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: Cordis Corporation
First posted: 2017-02-08
Enrollment: 194
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers patient population with all subjects requiring coronary revascularization with a drug-coated stent (DCS)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Device-oriented composite end point (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Patient-oriented composite end point
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Non-cardiac death
timeFrame: 12 months
measure: Any myocardial infarction
timeFrame: 12 months
measure: Any myocardial infarction not clearly attributable to a non-target vessel
timeFrame: 12 months
measure: Any revascularization
timeFrame: 12 months
measure: Clinically indicated target-lesion revascularization
timeFrame: 12 months
measure: Clinically indicated target-vessel revascularization
timeFrame: 12 months
measure: ARC defined stent thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
state: Chungcheongnam-do
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University School of Medicine
state: Gangwon-do
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
state: Gyeongsangbuk-do
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
state: Gyeongsangbuk-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University at Gangdong
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service Medical Center
Study officials:
affiliation: Yonsei University
name: Junghan Yoon, MD, PhD
role: STUDY_DIRECTOR
References: