Coronary Artery Disease Clinical Trial
Official title:
Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease
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:
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 ];
;
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