Multi Vessel Coronary Artery Disease
Conditions
Keywords
ACS, CAD, MACE, OMT
Brief summary
This randomized controlled trial will compare the clinical outcomes of partial revascularization with percutaneous coronary intervention (PCI) versus optimal medical therapy (OMT) alone in patients with diffuse multivessel coronary artery disease who are not suitable for complete surgical or percutaneous revascularization. A total of 140 eligible patients will be randomized into two groups. The partial revascularization group will undergo PCI of the left anterior descending artery, while the control group will receive guideline-directed optimal medical therapy. Patients will be followed for 12 months, with major adverse cardiovascular events (MACE) and Canadian Cardiovascular Society (CCS) angina class assessed at 3, 6, and 12 months.
Detailed description
This randomized controlled trial will compare the clinical outcomes of medical management versus partial revascularization in patients with angiographically confirmed diffuse multivessel coronary artery disease who are considered unsuitable for complete revascularization by coronary artery bypass grafting (CABG) or complete percutaneous coronary intervention (PCI), but in whom PCI of the left anterior descending (LAD) artery is technically feasible. Eligible participants will be assessed by a Heart Team consisting at minimum of a cardiac surgeon and an interventional cardiologist. Participants will be randomly assigned to one of two parallel treatment groups. The partial revascularization group will undergo PCI of the LAD, while the medical management group will receive optimal medical therapy. Participants will be followed for 12 months, with assessments at 3, 6, and 12 months. The primary outcome will be the occurrence of major adverse cardiovascular events (MACE) at 12 months, defined as cardiovascular death, nonfatal myocardial infarction, or urgent unplanned revascularization. Secondary outcomes will include angina severity according to the Canadian Cardiovascular Society (CCS) classification, MACE at earlier follow-up points, and hospitalization for acute coronary syndrome. The study aims to determine whether partial revascularization of the LAD provides better clinical outcomes compared with medical management alone in this selected group of patients with diffuse multivessel coronary artery disease who are not suitable for complete revascularization.
Interventions
PROCEDUREPartial per cutaneous coronary intervention
PCI of the left anterior descending artery in patients with diffuse multi vessel coronary artery disease who are not suitable for complete Revascularization
Patients managed conservatively with guideline directed medical therapy.
Sponsors
CH. Pervaiz Elahi Institute of Cardiology, Multan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Diffuse multivessel coronary artery disease confirmed by coronary angiography. * Not suitable for complete percutaneous or surgical revascularization as determined by the Heart Team. * PCI of the LAD is technically possible. * No planned surgical revascularization. * Willingness to provide informed consent.
Exclusion criteria
* Acute ST-segment elevation myocardial infarction requiring emergent PCI. * Cardiogenic shock. * Previous CABG. * Significant valvular disease requiring surgery. * Unwillingness to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACE) | 12 months after randomization | Frequency of major adverse cardiovascular events, defined as the composite of cardiovascular death, non-fatal myocardial infarction, and urgent unplanned revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Cardiovascular Society (CCS) Angina Class | 3, 6, and 12 months after randomization | Change in angina severity according to the Canadian Cardiovascular Society angina classification. |
| Major Adverse Cardiovascular Events at 3 Months | 3 months | Frequency of MACE, defined as cardiovascular death, non-fatal myocardial infarction, or urgent unplanned revascularization. |
| Major Adverse Cardiovascular Events at 6 Months | 6 months | Frequency of MACE, defined as cardiovascular death, non-fatal myocardial infarction, or urgent unplanned revascularization. |
| Hospitalization Due to Acute Coronary Syndrome | 12 months | Frequency of hospital admission due to acute coronary syndrome during follow-up. |
Countries
Pakistan
Outcome results
None listed