A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: BioFreedom with 1 month DAPT; Device: BioMatrix or Ultimaster with 6 to 12 months DAPT

• Registration Number: NCT02513810
• Lead Sponsor: Yonsei University

Brief Summary

DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that consists of a stainless steel stent platform with a textured abluminal surface without use of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give BioFreedom the advantages of both DES and BMS that may require less duration of DAPT. BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with different duration of DAPT. With proven adequate and safe duration, we will compare between one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents implantation using different properties of BioFreedom and BioMatrix Flex.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-03
• Study Start: 2015-12-02
• Primary Completion: 2019-09-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3020

Inclusion Criteria

• Patients ≥ 19 years old
• Patients with ischemic heart disease who are considered for coronary revascularization with PCI
• Significant coronary de novo lesion

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Exclusion Criteria

• Acute myocardial infarction
• Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion
• Need to use of dual antiplatelet therapy more than 1 month because of other medical conditions
• Cardiogenic shock or experience of cardiopulmonary resuscitation
• Contraindication or hypersensitivity to Biolimus A9, stainless steel, heparin, antiplatelet agents or contrast media
• History of documented prior cerebrovascular attack within 6 months
• Treated with any stent within 3 months
• Reference vessel diameter <2.25 mm or >4.0 mm
• Pregnant women or women with potential childbearing
• Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
• Inability to understand or read the informed content

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short-term DAPT after Biofreedom	BioFreedom with 1 month DAPT	-
Long-term DAPT after BioMatrix or Ultimaster	BioMatrix or Ultimaster with 6 to 12 months DAPT	-

Primary Outcome Measures

Name	Time	Method
Composite of major adverse cardiovascular events	1 year	events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of