Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03045848
Study type Observational [Patient Registry]
Source Wonju Severance Christian Hospital
Contact
Status Terminated
Phase
Start date July 5, 2018
Completion date November 10, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Completed NCT04507529 - Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients N/A
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT03620266 - Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI N/A
Completed NCT04097912 - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed NCT03668587 - Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Recruiting NCT05371470 - Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation N/A
Recruiting NCT04562272 - Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT06007950 - Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health N/A
Withdrawn NCT05327855 - Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI) Phase 2
Recruiting NCT02876952 - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02711631 - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation N/A
Completed NCT02552407 - Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis N/A
Completed NCT02305602 - A Study of VentriGel in Post-MI Patients Phase 1