The Comparative Effectiveness of Hybrid Revascularization (MIDCAB Then PCI) With DES Versus Multivessel DES PCI or CABG
HREVS
Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease
1 other identifier
interventional
150
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Dec 2012
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2017
CompletedSeptember 29, 2017
September 1, 2017
4.2 years
October 1, 2012
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Residual ischemia
≥5% residual ischemia by single photon emission computed tomography (SPECT)
6 - to 18-month follow-up
Secondary Outcomes (6)
MACCE
up to 5 years
Procedural success
up to discharge from the hospital
Procedural and post-procedural blood loss and number of transfusions
up to discharge from the hospital
Recovery time
up to discharge from the hospital
Target vessel/graft failure
6- to 18-month follow-up
- +1 more secondary outcomes
Study Arms (3)
Hybrid group
OTHERHybrid 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
OTHERMulti-vessel PCI with DES (MV-PCI group, n=50)
CABG
OTHERCoronary artery bypass graft (CABG) treatment (CABG group, n=50)
Interventions
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
Eligibility Criteria
You may qualify if:
- Multi-vessel coronary artery disease with ≥ 70% and \<96% artery stenosis (according to QCA)
- I-IV CCS functional class of angina
- Asymptomatic patients with stress-test documented ischemia.
- Patients at 1 month after acute myocardial infarction
- Ability to perform either of revascularization methods (Hybrid, MVD-PCI, CABG).
- Consensus on the treatment strategy between the members of the working group, including cardiologist, cardiac surgeon and interventional specialist.
- Patients must have signed an informed consent.
You may not qualify if:
- Pregnancy.
- Acute coronary syndrome.
- Previous CABG.
- Previous stent thrombosis.
- Severe comorbidity with high procedural risk for either of the studied strategies.
- Severe peripheral artery disease.
- Other serious diseases limiting life expectancy (e.g. oncology)
- Inability for long-term follow-up.
- Participation in other clinical trials.
- Inability to take dual antithrombotic therapy.
- Critical stenosis (\>95%) in RCA,LAD, CX or Intermediate artery, feasible for revascularization.
- Stenosis of left main ≥ 50%.
- Coronary artery occlusion of the major vessel.
- Single vessel disease.
- Need for emergency revascularization (ACS).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Complex Issues of Cardiovascular Diseases
Kemerovo, Kemerovo Oblast, 650002, Russia
Related Publications (2)
Ganyukov VI, Kochergin NA, Shilov AA, Tarasov RS, Skupien J, Kozyrin KA, Barbarash OL, Musialek P. Randomized Clinical Trial of Surgical Versus Percutaneous Versus Hybrid Multivessel Coronary Revascularization: 3 Years' Follow-Up. JACC Cardiovasc Interv. 2021 May 24;14(10):1163-1165. doi: 10.1016/j.jcin.2021.02.037. No abstract available.
PMID: 34016423DERIVEDGanyukov V, Kochergin N, Shilov A, Tarasov R, Skupien J, Szot W, Kokov A, Popov V, Kozyrin K, Barbarash O, Barbarash L, Musialek P. Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year-Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS). J Interv Cardiol. 2020 Jan 3;2020:5458064. doi: 10.1155/2020/5458064. eCollection 2020.
PMID: 31969796DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hybrid minimally invasive and Interventional coronary revascularization in patients with Multi-vessel coronary artery disease versus complete Endovascular Revascularisation or coronary Artery bypass graft (treatment strategies).
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 3, 2012
Study Start
December 1, 2012
Primary Completion
March 1, 2017
Study Completion
September 16, 2017
Last Updated
September 29, 2017
Record last verified: 2017-09