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

Yonsei University

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Device: BioFreedom with 1 month DAPT

Device: BioMatrix or Ultimaster with 6 to 12 months DAPT

Study type

Interventional

Funder types

Other

Identifiers

NCT02513810

1-2015-0040

Details and patient eligibility

About

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.

Enrollment

3,020 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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