Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts

National Institute of Cardiology, Warsaw, Poland50 enrolled

Overview

Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stenosis in Saphenous Vein Graft, Drug Eluting Stent

Interventions

Taxus stent implantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70% 2. Stable coronary artery disease or non ST segment elevation acute coronary syndrome 3. Reference segment diameter in range of 2.5-4.5mm Exclusion Criteria: 1. Cardiogenic shock 2. Contraindications to prolonged dual antiplatelet therapy 3. Female of child birth potential unless on effective contraception 4. Other medical condition that may limit survival

Outcomes

Primary Outcomes

Neointima hyperplasia volume by Intravascular Ultrasound

Time frame: 9 months

Secondary Outcomes

All cause mortality

Time frame: 5 years

Cardiovascular mortality

Time frame: 5 years

Stent thrombosis

Time frame: 5 years

Target lesion revascularization

Time frame: 5 years

Angiographic late loss

Time frame: 9 months

Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes