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

Coronary Artery Disease Clinical Trial

— HREVS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699048
• Other study ID #: HREVS
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: September 27, 2017
• Start date: December 1, 2012
• Est. completion date: September 16, 2017

Study information

• Verified date: September 2017
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 ];

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 16, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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
• PCI
Multi-vessel PCI with DES
• CABG
Coronary artery bypass graft (CABG) treatment

Locations

Country	Name	City	State
Russian Federation	Research Institute of Complex Issues of Cardiovascular Diseases	Kemerovo	Kemerovo region

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual ischemia	=5% residual ischemia by single photon emission computed tomography (SPECT)	6 - to 18-month follow-up
Secondary	MACCE	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.	up to 5 years
Secondary	Procedural success	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.	up to discharge from the hospital
Secondary	Procedural and post-procedural blood loss and number of transfusions	dynamics of hemoglobin at admission and discharge, the number of blood transfusions (in units), classification of bleeding BARC	up to discharge from the hospital
Secondary	Recovery time	Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission	up to discharge from the hospital
Secondary	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);	6- to 18-month follow-up
Secondary	Restenosis	angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%;	6- to 18-month follow-up