Why the study?
The study was designed to validate the efficacy and safety of a pharmacoinvasive strategy compared with percutaneous coronary intervention in patients with STEMI in a metropolitan region of Mexico.
Does a pharmacoinvasive strategy reduce the composite of cardiovascular death, re-infarction, stroke, and cardiogenic shock compared to primary PCI in patients with STEMI?
Does a pharmacoinvasive strategy reduce the composite of cardiovascular death, re-infarction, stroke, and cardiogenic shock compared to primary PCI in patients with STEMI?
The PHASE-MX registry protocol outlines a prospective cohort study to compare the real-world efficacy and safety of a pharmacoinvasive strategy versus primary PCI in Mexican patients with STEMI.
PHASE-MX will generate prospective real-world data on pharmacoinvasive versus primary PCI in Mexican STEMI patients; leaves open comparative efficacy and safety.
Objective: The objective of PHASE-MX registry is to validate the efficacy and safety of the pharmacoinvasive strategy in comparison with percutaneous coronary intervention (PCI) in patients with acute myocardial infarction with ST segment elevation (STEMI) in a metropolitan region of Mexico. The primary outcome will consist of the composite of cardiovascular death, re-infarction, stroke and cardiogenic shock. Methods: The PHASE-MX registry will include a prospective cohort of patients with STEMI who received reperfusion treatment (mechanical of pharmacological) in the first 12 h after the onset of symptoms. The registry is designed to compare the efficacy and safety of primary PCI and pharmacoinvasive strategy. The simple size was calculated in 344 patients divided into two groups, with an estimated loss rate of 10%. Patients included in the PHASE-MX cohort will be followed for up to one year. Conclusion: In Mexico, only 5 out of 10 patients with STEMI have access to reperfusion therapy. Pharmacoinvasive strategy is takes advantage of the accessibility of fibrinolysis and the effectiveness of PCI. The present research protocol aims to provide information that serves as a link between information derived from controlled clinical trials and records derived from real world experience.
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Baeza-Herrera et al. (2020) studied this question.
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