Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease

Phase 2

Completed

• Conditions: Heart Disease; Myocardial Ischaemia; Coronary Disease; Coronary Artery Disease
• Interventions: Procedure: Hybrid revascularization; Procedure: Coronary Artery Bypass Grafting

• Registration Number: NCT01035567
• Lead Sponsor: Silesian Centre for Heart Diseases

Brief Summary

The purpose of the study is to assess the safety and efficacy of hybrid revascularization in comparison with coronary artery bypass grafting among patients with multivessel coronary artery disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Primary Completion: 2013-05
• Study Completion: 2013-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-01
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 18 or more
• Angiographically confirmed multivessel CAD with involved LAD and critical (>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG
• Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia
• Patient is willing to comply with all follow-up visits
• Patient signed an Informed Consent

Exclusion Criteria

• Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment
• Prior surgery with the opening of pericardium or pleura
• Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects
• Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation
• One or more chronic total occlusions in major coronary territories
• Left main stenosis (at least 50% diameter stenosis)
• Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization
• Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
• Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition
• Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
• Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
• Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease
• Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age
• Concurrent enrollment in another clinical trial
• Patient inaccessible for follow-up visits required by protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid revascularization	Hybrid revascularization	-
Coronary Artery Bypass Grafting	Coronary Artery Bypass Grafting	-

Primary Outcome Measures

Name	Time	Method
Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding.	1 year

Secondary Outcome Measures

Name	Time	Method
Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2	1 year
Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments	1 year
Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.	1 year

Trial Locations

Locations (2)

Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease; 🇵🇱 Zabrze, Poland

Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease; 🇵🇱 Zabrze, Poland