Pharmacoinvasive Strategy vs. Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction: A Prospective, Real-World Registry in a Large Geographical Area
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Infarction, Acute
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Composite of cardiovascular mortality + cardiogenic shock + reinfarction + stroke.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking, especially in developing countries.
The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area.
Detailed Description
For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. The optimal choice between primary percutaneous coronary intervention (PPCI) and intravenous thrombolytic agents depends upon the timeliness of effective delivery, as well as the total ischemic time. While PPCI is widespread available in the USA and Europe, limited resources and lack of infrastructure means that patients with STEMI in low- and middle-income countries (LMICs) receive significantly less reperfusion therapy, and when they do, they are more prone to receive thrombolytic agents. Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking. The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area. PHASE-Mx study is a prospective, real-world registry including patients with STEMI finally treated at a large cardiovascular center. In brief, patients aged 18-99 years old with the diagnosis of STEMI whom received either PI or PPCI during the first 12 hours since symptom onset were included. Patients could have a first medical contact directly at the study center or in one of other 60 hospitals along the STEMI network. Patients with a discharge diagnosis other than STEMI were excluded. Four of the investigators recorded the study data at admission and during hospital stay. Main efficacy outcome will be the composite of cardiovascular death, cardiogenic shock, reinfarction or stroke. Main safety outcome will include rates of major bleeding.
Investigators
Diego Araiza-Garaygordobil
Principal Investigator
Instituto Nacional de Cardiologia Ignacio Chavez
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18-99 years old, with the diagnosis of STEMI whom received either PI or PPCI during the first 12 hours since symptom onset. Patients could have a first medical contact directly at the study center or in one of other 60 hospitals along the STEMI network.
Exclusion Criteria
- •Patients with a discharge diagnosis other than STEMI.
Outcomes
Primary Outcomes
Composite of cardiovascular mortality + cardiogenic shock + reinfarction + stroke.
Time Frame: 30-days follow-up.
Main efficacy combined outcome including cardiovascular mortality, cardiogenic shock, reinfarction and stroke.
Secondary Outcomes
- All-cause mortality(1-year follow up.)
- Major bleeding(Major bleeding during a 30-days follow-up.)