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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Heart Diseases; Myocardial Ischemia; Coronary Disease
• Interventions: Procedure: Hybrid (MIDCAB+PCI); Procedure: PCI; Procedure: CABG

• Registration Number: NCT01699048
• Lead Sponsor: Russian Academy of Medical Sciences

Brief 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 \[ Time Frame: up to discharge from the hospital \];

Study Timeline

• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Study Start: 2012-12-01
• Primary Completion: 2017-03-01
• Status Verified: 2017-09
• Study Completion: 2017-09-16
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Multi-vessel coronary artery disease with ≥ 70% and <96% artery stenosis (according to QCA)
2. I-IV CCS functional class of angina
3. Asymptomatic patients with stress-test documented ischemia.
4. Patients at 1 month after acute myocardial infarction
5. Ability to perform either of revascularization methods (Hybrid, MVD-PCI, CABG).
6. Consensus on the treatment strategy between the members of the working group, including cardiologist, cardiac surgeon and interventional specialist.
7. Patients must have signed an informed consent.

Exclusion Criteria

1. Pregnancy.
2. Acute coronary syndrome.
3. Previous CABG.
4. Previous stent thrombosis.
5. Severe comorbidity with high procedural risk for either of the studied strategies.
6. Severe peripheral artery disease.
7. Other serious diseases limiting life expectancy (e.g. oncology)
8. Inability for long-term follow-up.
9. Participation in other clinical trials.
10. Inability to take dual antithrombotic therapy.

Angiographic exclusion criteria

1. Critical stenosis (>95%) in RCA,LAD, CX or Intermediate artery, feasible for revascularization.
2. Stenosis of left main ≥ 50%.
3. Coronary artery occlusion of the major vessel.
4. Single vessel disease.
5. Need for emergency revascularization (ACS).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid group	Hybrid (MIDCAB+PCI)	Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with the 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)
PCI	PCI	Multi-vessel PCI with DES (MV-PCI group, n=50)
CABG	CABG	Coronary artery bypass graft (CABG) treatment (CABG group, n=50)

Primary Outcome Measures

Name	Time	Method
Residual ischemia	6 - to 18-month follow-up	≥5% residual ischemia by single photon emission computed tomography (SPECT)

Secondary Outcome Measures

Name	Time	Method
Procedural and post-procedural blood loss and number of transfusions	up to discharge from the hospital	dynamics of hemoglobin at admission and discharge, the number of blood transfusions (in units), classification of bleeding BARC
MACCE	up to 5 years	Major adverse cardiac and cerebral events (MACCE), including death,a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: Death from any cause From cardiovascular causes From noncardiovascular causes Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.
Procedural success	up to discharge from the hospital	Procedural success: The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.
Recovery time	up to discharge from the hospital	Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission
Restenosis	6- to 18-month follow-up	angiographically-detected target lesion stenosis \>50% \[diameter stenosis\] or graft stenosis \>50%;
Target vessel/graft failure	6- to 18-month follow-up	(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);

Trial Locations

Locations (1)

Research Institute of Complex Issues of Cardiovascular Diseases; 🇷🇺 Kemerovo, Kemerovo region, Russian Federation