Pharmacoinvasive Strategy vs. Primary PCI in STEMI: A Prospective Registry in a Large Geographical Area

Completed

• Conditions: Myocardial Infarction, Acute
• Interventions: Other: Primary percutaneous coronary intervention; Other: Pharmacoinvasive strategy

• Registration Number: NCT03974581
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

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.

Study Timeline

• Study Start: 2018-04-30
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-05
• Status Verified: 2020-07
• Primary Completion: 2020-07-14
• Study Completion: 2020-07-14
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pharmacoinvasive strategy	Primary percutaneous coronary intervention	Patients whom received pharmacoinvasive strategy (fibrinolysis and subsequently PCI) as reperfusion treatment.
Primary PCI	Pharmacoinvasive strategy	Patients whom primary PCI as reperfusion treatment.

Primary Outcome Measures

Name	Time	Method
Composite of cardiovascular mortality + cardiogenic shock + reinfarction + stroke.	30-days follow-up.	Main efficacy combined outcome including cardiovascular mortality, cardiogenic shock, reinfarction and stroke.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	1-year follow up.	All cause mortality at 1-year follow up.
Major bleeding	Major bleeding during a 30-days follow-up.	Major bleeding during a 30-days follow-up.

Trial Locations

Locations (1)

Instituto Nacional de Cardiología "Ignacio Chavez"; 🇲🇽 Mexico City, Mexico