Pharmacoinvasive Strategy vs. Primary PCI in STEMI: A Prospective Registry in a Large Geographical Area
Condition: Myocardial Infarction, Acute
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational [Patient Registry]

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.
    

Intervention name(s): Primary percutaneous coronary intervention; Pharmacoinvasive strategy
Intervention type(s): Other; Other
Intervention description(s): Patient receives primary percutaneous coronary intervention as part of his treatment; decision to allocate by treating physician.; Patient receives primary fibrinolysis and subsequent coronary angiography (pharmacoinvasive strategy) as part of his treatment; cases with failed fibrinolysis are scheduled for immediate rescue PCI. Decision to allocate by treating physician.
Other intervention name(s): Primary PCI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with STEMI presenting to a primary reperfusion center in the metropolitan area of
        Mexico City.
      
Keywords: pharmacoinvasive strategy; Mexico; registry