Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03045848 |
| Other study ID # |
Biofreedom V2.2 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 5, 2018 |
| Est. completion date |
November 10, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
Wonju Severance Christian Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
