A randomized comparison of clinical outcomes between everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stent in long coronary lesions

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0002900
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio [HR]=0.49, 95% confidence interval [CI]=0.09-2.67, P=0.398).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

•Age 19-85 years
•Patients with ischemic heart disease requiring PCI
•Significant coronary de novo lesion (stenosis >50% by quantitative angiographic analysis) requiring stent =28 mm in length based on angiographic estimation
•Reference vessel diameter of 2.5 to 3.75 mm by operator assessment

Exclusion Criteria

•Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
•Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
•Contraindication or hypersensitivity to anti-platelet agents or contrast media
•Treated with any metallic stent or BVS within 3 months at other vessel
•Cardiogenic shock
•Left ventricular ejection fraction <40%
•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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)