NCT01699048

The Comparative Effectiveness of Hybrid Revascularization (MIDCAB Then PCI) With DES Versus Multivessel DES PCI or CABG

Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Minimally invasive revascularization of the left anterior descending artery followed by stent implantation versus percutaneous coronary intervention or coronary artery bypass in patients with multi-vessel coronary disease

Detailed description

Prospective, single-center, randomized trial, intended to compare three revascularization strategies in patients with multi-vessel coronary artery disease: 1. Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50) 2. Multi-vessel PCI with DES (MV-PCI group, n=50) 3. Coronary artery bypass graft (CABG) treatment (CABG group, n=50) PCI in Hybrid and MV-PCI group will be performed with the same 2nd generation clinically proven DES (Xience V, Xience Prime). Study objective Compare three different revascularization strategies in patients with multi-vessel coronary disease The endpoints: The primary endpoints: I. % ischemic myocardium on a 12-month follow-up scan with single photon emission computed tomography (SPECT); The secondary endpoints: I. Major adverse cardiac and cerebral events (MACCE), including (1) death, (2) non-fatal myocardial infarction (non-fatal MI), transitory ischemic attack (TIA) or stroke within 30 days, 12 months and 5-year follow-up; II. Target vessel/graft failure (for any of the target vessels in a given patient - stented or grafted) = a composite of cardiac death, MI attributable to the target vessel, or clinically-driven \[ie, not angio-driven\] Target Vessel Revascularization (TVR); III. Restenosis = angiographically-detected target lesion stenosis \>50% \[diameter stenosis\] or graft stenosis \>50%; IV. Procedural success: The treatment will be considered successful when a revascularisation in the absence of complications during the index hospitalization has been achieved; V. Procedural and post-procedural hemorrhagic complications \[ Time Frame: up to discharge from the hospital \]; VI. Recovery time \[ Time Frame: up to discharge from the hospital \];

Conditions

• Coronary Artery Disease
• Myocardial Ischemia
• Coronary Disease
• Heart Diseases

Interventions

Type	Name	Description
PROCEDURE	Hybrid (MIDCAB+PCI)	Hybrid approach (Minimally invasive of-pump revascularization of the left anterior descending artery (LAD) via left internal mammary artery (LIMA) bypass with consecutive percutaneous coronary intervention (PCI) in the rest arteries with drug eluting stents (DES). The revascularization will be performed in two stages within a 3-days interval
PROCEDURE	PCI	Multi-vessel PCI with DES
PROCEDURE	CABG	Coronary artery bypass graft (CABG) treatment

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-03-01
• Completion: 2017-09-16
• First posted: 2012-10-03
• Last updated: 2017-09-29

Locations

1 site across 1 country: Russia