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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
Prospective, single-center, randomized trial, intended to compare three revascularization strategies in patients with multi-vessel coronary artery disease:
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 ];
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid group | Other | 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 | Other | Multi-vessel PCI with DES (MV-PCI group, n=50) |
|
| CABG | Other | Coronary artery bypass graft (CABG) treatment (CABG group, n=50) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid (MIDCAB+PCI) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Residual ischemia | ≥5% residual ischemia by single photon emission computed tomography (SPECT) | 6 - to 18-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Angiographic exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Complex Issues of Cardiovascular Diseases | Kemerovo | Kemerovo Oblast | 650002 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34016423 | Derived | 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. | |
| 31969796 |
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|
|
| PCI | Procedure | Multi-vessel PCI with DES |
|
| CABG | Procedure | Coronary artery bypass graft (CABG) treatment |
|
| up to 5 years |
| 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 |
| 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 |
| 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 |
| 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 |
| Restenosis | angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%; | 6- to 18-month follow-up |
| Ganyukov 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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