Key result
rhTNK-tPA was non-inferior to rt-PA for achieving TIMI flow grade 2 or 3 recanalization in acute STEMI (78.3% vs 81.7%; difference -3.4%, 95% CI -11.5% to 4.8%, non-inferiority margin -15%).
Why the study?
Following preliminary phase II efficacy data for rhTNK-tPA in STEMI, this pivotal postmarketing trial was designed to compare its efficacy and safety with rt-PA in Chinese patients with STEMI.
Does tenecteplase improve recanalization in Chinese patients with acute STEMI compared to alteplase?
RCT (n=767)
Open-label
1:1
Yes
Does tenecteplase improve recanalization in Chinese patients with acute STEMI compared to alteplase?
A single intravenous bolus of tenecteplase is non-inferior to alteplase infusion for achieving coronary recanalization in Chinese patients with acute STEMI.
Supports bolus tenecteplase as a convenient alternative to alteplase infusion in Chinese STEMI patients; extends non-inferiority data to this population.
BACKGROUND: A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI. METHODS: In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints. RESULTS: From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a -15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: -3.4%; 95% confidence interval [CI]: -11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: -0.5%; 95% CI: -5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. CONCLUSION: rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI. TRIAL REGISTRATION: www.ClinicalTrials.gov (No. NCT02835534).
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Zhao et al. (2023) conducted an RCT in Acute ST-segment elevation myocardial infarction (STEMI) (n=767). Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) vs. Alteplase (rt-PA) 8 mg intravenous bolus followed by 42 mg infusion over 90 min was evaluated on Recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3 (difference -3.4%, 95% CI -11.5%, 4.8%). rhTNK-tPA was non-inferior to rt-PA for achieving TIMI flow grade 2 or 3 recanalization in acute STEMI (78.3% vs 81.7%; difference -3.4%, 95% CI -11.5% to 4.8%, non-inferiority margin -15%).
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