STRIVE Evaluates Intracoronary Low-Dose Alteplase During PCI

November 24, 2025—The STRIVE trial evaluated a novel strategy to prevent and treat microvascular obstruction and reduce major cardiovascular events in patients with large-territory ST-elevated myocardial infarction (STEMI) and high thrombus burden undergoing primary percutaneous coronary intervention (PCI).

The findings from the multicenter, randomized, double-blind, placebo-controlled trial were presented at the TCT 2025 scientific symposium and published by Shamir R. Mehta, MD, et a in Journal of the American College of Cardiology.

According to TCT press release, the STRIVE study showed that a strategy of delivering low doses of alteplase directly into the culprit coronary artery did not improve outcomes in these patients.

As summarized in the TCT press release, patients who were eligible for the study presented with STEMI within 6 hours of symptom onset and were referred for primary PCI. All patients were required to have evidence of large territory STEMI on the qualifying electrocardiogram and evidence of large thrombus burden on coronary angiography.

The investigators randomly assigned 210 patients to receive the study drug or placebo (68 received alteplase 10 mg; 69 received alteplase 20 mg; and 70 were given placebo). After antegrade flow was established, a delivery catheter was inserted into the infarct-related artery distal to the culprit lesion and the study drug was infused for 3 minutes. Primary PCI was then performed per standard practice.

The primary outcome was the composite of MACE at 30 days, thrombolysis in myocardial infarction–TIMI–myocardial blush grade 0/1, distal embolization, or failure to achieve 50% ST-segment resolution at 30 minutes after PCI. MACE included the first occurrence of cardiovascular death, repeat myocardial infarction, cardiogenic shock, and new onset heart failure at 30 days.

TCT reported that the primary safety outcomes—major bleeding or the composite of major bleeding or clinically relevant bleeding at 30 days—occurred in 73 patients (53.3%) in the combined alteplase groups versus 37 (52.9%) in the placebo group (relative risk, 1.00; 95% CI, 0.76-1.31; P  > .99).

The study showed that results were consistent across all components of the primary outcome and for each dose group versus placebo. Major or clinically significant bleeding occurred in one patient in the trial (in the alteplase 20 mg group). During study drug administration, there were more episodes of ventricular fibrillation in the alteplase groups compared to the placebo group (10.2% vs 1.4%; relative risk, 6.86; 95% CI, 0.91-51.4; P = .06), stated the TCT press release.

“Microvascular obstruction after primary PCI remains the single most important unresolved issue limiting the efficacy of primary PCI in STEMI patients,” commented Dr. Mehta in the TCT press release. “STRIVE does not support the routine administration of alteplase and it joins the growing list of previously promising therapies that have not succeeded in improving this important issue.”