Pharmaco-Invasive Strategy with Half-Dose Recombinant Human Prourokinase Versus Primary Percutaneous Coronary Intervention.

Abstract

Background: Primary percutaneous coronary intervention (PPCI) is preferred as the reperfusion option for patients with ST-segment elevation myocardial infarction (STEMI).

Methods: This study conducted the pharmacoinvasive strategy with half-dose recombinant human prourokinase (PHDP) trial to evaluate whether the PHPD encompassing early fibrinolysis coupled with timely catheterization, provides efficacy and safety similar to that of PPCI in STEMI patients. We randomly assigned patients with STEMI aged 18-80 years who presented within 24 h of their symptoms to receive either PHDP or PPCI.

Results: There was no significant difference in the 2 arms for the primary endpoints, which were defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, TIMI myocardial perfusion grade 3, and ST-segment resolution ≥70% 1 hour after percutaneous coronary intervention. The secondary endpoints, including slow flow/no-reflow (P < .001), malignant arrhythmia (P < .001), and hypotension (P < .001), occurred more frequently in the PPCI arm than in the PHDP arm. The combined 30-day follow-up outcomes occurred more often in the PPCI group than in the PHDP group (P = .032). There were no reported cases of in-hospital intracranial hemorrhage or major bleeding events; the rates of minor bleeding events were similar (P = .157).

Conclusion: Among patients with STEMI presenting ≤24 hours after symptom onset who received the PHDP, the efficacy of complete epicardial and myocardial reperfusion was similar to that among patients who received the PPCI. In addition, PHDP was associated with a decreased risk of procedure-related complications. Conducting clinical efficacy and safety trials with the pharmacoinvasive strategy and the half-dose of fibrinolytic drug is warranted.