Cardiovasc Revasc Med. 2026 Mar 4:S1553-8389(26)00082-5. doi: 10.1016/j.carrev.2026.03.002. Online ahead of print.
ABSTRACT
The optimal management of patients with ST-segment elevation myocardial infarction (STEMI) with large thrombus burden (LTB) undergoing primary percutaneous coronary intervention (PCI) remains unsettled. The NATURE (clinicaltrials.gov, NCT04969471) study is a prospective, multicenter, two-arm randomized clinical trial designed to assess the safety and effectiveness of the enVast stent retriever as an adjunctive reperfusion strategy in STEMI patients with LTB undergoing primary PCI. Eligible patients consenting for trial participation are randomly allocated (1:1) to enVast-assisted mechanical thrombectomy followed by conventional PCI (experimental arm) versus standard of care (control arm). Randomization is stratified by site, time from symptom onset (≤ 3 versus >3 h) and intended use of parenteral antiplatelet agents (i.e. glycoprotein IIb/IIIa inhibitors or cangrelor). Scheduled follow-up visits take place at 30 (±7) days, 150 (±60) days, and 365 (±30) days post-randomization. The primary endpoint is the infarct size assessed by the area under the curve for creatin kinase myocardial band (CK-MB) activity. Clinical events will be adjudicated by an independent Clinical Events Committee. A central core-lab will analyse 12‑lead ECG, coronary angiography examinations, cardiac magnetic resonance imaging and echocardiography examinations. A sample size of 148 (74 per arm) STEMI patients with complete primary endpoint assessment will provide a 90% power with a two-sided 5% significance level to detect a decrease in the AUC for CK-MB by 30%. The NATURE trial is the first randomized clinical trial aimed at investigating if enVast-assisted mechanical thrombectomy as adjunctive reperfusion strategy is safe and may reduce infarct size in STEMI patients with LTB undergoing primary PCI. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT04969471.
PMID:41820070 | DOI:10.1016/j.carrev.2026.03.002