Efficacy and Safety of a Pharmaco-Invasive Strategy With Half-Dose Alteplase Versus Primary Angioplasty in...

Area of Science:

• Cardiology
• Interventional Cardiology
• Emergency Medicine

Background:

• Primary percutaneous coronary intervention (PPCI) is the preferred treatment for ST-segment-elevation myocardial infarction (STEMI).
• Access to timely PPCI is limited for some STEMI patients.
• A pharmaco-invasive (PhI) strategy using fibrinolysis followed by PCI is a potential alternative.

Purpose of the Study:

• To compare the efficacy and safety of a PhI strategy with half-dose alteplase versus PPCI in STEMI patients.
• To evaluate reperfusion rates, infarct size, and left ventricular function.
• To assess 30-day clinical and safety outcomes.

Main Methods:

• The EARLY-MYO trial was a prospective, multicenter, randomized, noninferiority study.
• 344 STEMI patients (18-75 years) presenting within 6 hours with expected PCI delay were randomized to PhI or PPCI.
• The primary endpoint was complete epicardial and myocardial reperfusion, assessed by TIMI flow grade 3, TIMI myocardial perfusion grade 3, and ST-segment resolution ≥70%.

Main Results:

• PhI was noninferior and superior to PPCI for the primary endpoint (34.2% vs. 22.8%, P<0.05).
• Individual reperfusion components and 30-day clinical outcomes (death, reinfarction, heart failure) were similar between groups.
• Infarct size and ejection fraction were comparable; however, minor bleeding was higher in the PhI group (26.9% vs. 11.0%, P<0.001).

Conclusions:

• For STEMI patients with delayed PPCI, a PhI strategy with half-dose alteplase and timely PCI achieves more complete reperfusion than PPCI.
• Further adequately powered trials are warranted to confirm clinical and safety outcomes.