Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
ST-elevation myocardial infarction, Multivessel coronary artery disease, Pharmaco-invasive strategy, Complete revascularization, Staged percutaneous coronary intervention, Fibrinolysis, Non-culprit lesion intervention, Primary percutaneous coronary intervention delay
Brief summary
This study compares two treatment strategies in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing a pharmaco-invasive approach after successful fibrinolysis. The study evaluates whether one-time complete revascularization, in which the culprit and significant non-culprit lesions are treated during the same percutaneous coronary intervention (PCI) session, is better than a staged strategy, in which non-culprit lesions are treated in a separate percutaneous coronary intervention (PCI) procedure within 1 month. The hypothesis is that one-time complete revascularization may reduce hospitalization time, cost, and recurrent ischemic symptoms without increasing short-term complications. Participants are adults with acute ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) who had successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention (PCI). Outcomes include total hospitalization time, total expenses, contrast-induced nephropathy (CIN) within 72 hours, and major adverse cardiovascular events (MACE) during 3 months of follow-up.
Interventions
PROCEDUREOne-Time Complete Revascularization
Revascularization strategy in which the culprit coronary artery and all significant non-culprit lesions are treated during the index percutaneous coronary intervention session after successful fibrinolysis.
PROCEDUREStaged Percutaneous Coronary Intervention
Revascularization strategy in which only the culprit coronary artery is treated during the index percutaneous coronary intervention session after successful fibrinolysis, with treatment of significant non-culprit lesions deferred to a separate staged percutaneous coronary intervention within 1 month after discharge.
Sponsors
Tanta University
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study. Participants, care providers, and investigators were aware of treatment assignment because the timing and extent of revascularization differed by protocol. No formal masking of outcome assessment was specified.
Intervention model description
Participants were randomized in a parallel two-arm design to undergo either one-time complete revascularization during the index percutaneous coronary intervention or culprit-only percutaneous coronary intervention followed by staged non-culprit percutaneous coronary intervention within 1 month after discharge.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults older than 18 years. * Acute ST-elevation myocardial infarction treated with a pharmaco-invasive strategy. * Successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention. * Multivessel coronary artery disease. * Ability to provide written informed consent.
Exclusion criteria
* Primary percutaneous coronary intervention. * Unsuccessful fibrinolysis requiring rescue percutaneous coronary intervention. * Candidacy for coronary artery bypass grafting after angiography. * Failed complete revascularization. * Cardiogenic shock. * Single-vessel coronary artery disease treated with a pharmaco-invasive strategy. * Stent thrombosis. * Chronic total occlusion. * Planned percutaneous transluminal coronary angioplasty to a non-culprit lesion in a vessel smaller than 2.5 millimeters with more than 70 percent stenosis. * Severe valvular heart disease. * Pregnancy. * Prior cardiac surgery. * Congenital heart disease. * Severe hepatic impairment. * Severe renal impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total hospitalization time | up to 1 month post operatively | Total duration of hospitalization in days. For participants assigned to staged revascularization, the duration of the staged admission was added to the index admission to calculate the total hospitalization time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total expenses | up to 1 month post operatively | Total treatment-related expenses in Egyptian pounds for the index admission and, when applicable, the staged admission. |
| Contrast-induced nephropathy | Within 72 hours after percutaneous coronary intervention | Increase in serum creatinine by at least 0.5 milligrams per deciliter or at least 25 percent from baseline within 72 hours after percutaneous coronary intervention. |
| Angina-related hospitalization | Within 3 months after index percutaneous coronary intervention | Hospital admission due to recurrent anginal symptoms during follow-up. |
| Left ventricular ejection fraction | Baseline and 3 months after index percutaneous coronary intervention | Left ventricular systolic function assessed by transthoracic echocardiography using the modified Simpson method. |
| Wall motion score index | Baseline and 3 months after index percutaneous coronary intervention | Regional left ventricular wall motion score index assessed by transthoracic echocardiography. |
| Serum creatinine | Baseline, 72 hours after percutaneous coronary intervention, and 3 months | Serum creatinine concentration measured to assess renal function. |
Countries
Egypt
Outcome results
None listed