enVast Thrombectomy Reduces Infarct Size in Large-Thrombus STEMI Trial

Findings from the NATURE randomized trial (NCT04969471) reported that use of enVast-assisted mechanical thrombectomy led to reduced enzymatically assessed infarct size compared with conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) and large thrombus burden.¹

“Large thrombus burden remains a significant challenge in primary PCI, and there is an ongoing need for effective strategies to improve myocardial reperfusion and limit infarct size,” principal investigator Marco Valgimigli, MD, PhD, chief of cardiology at the Cardiocentro Ticino Institute in Lugano, Switzerland, said in a statement.¹ “The reduction in infarct size demonstrated in NATURE, together with the favorable safety profile observed, represents important new evidence for mechanical thrombectomy in patients with [large thrombus burden].”

NATURE was a prospective, multicenter, 2-arm trial that randomly assigned 154 patients at 11 centers in a 1:1 ratio to enVast-assisted thrombectomy followed by conventional PCI or standard care. The study specifically enrolled patients with STEMI and large thrombus burden, a subgroup in whom distal embolization and incomplete tissue-level reperfusion remain concerns despite restoration of epicardial coronary flow.^1,2

The primary end point was infarct size measured by the area under the curve for creatine kinase–MB activity. Presented as late-breaking science at the 2026 European Society of Cardiology (ESC) Congress, held August 28–31, in Munich, Germany, results showed that enVast-assisted treatment produced a nearly 26% relative reduction compared with standard care (P = .001).

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Infarct size, a secondary end point assessed by cardiac magnetic resonance imaging at day 3, showed a directionally consistent 25% relative reduction as a percentage of left ventricular mass. At 30 days, no strokes or deaths occurred in the enVast group, compared with stroke in 1.3% and death in 2.6% of control participants. Major adverse cardiovascular events occurred in 1.3% and 3.8%, respectively.

Primary PCI remains the central reperfusion strategy for STEMI. Contemporary European guidance does not recommend routine thrombus aspiration, reflecting prior evidence that broadly applied aspiration strategies did not improve clinical outcomes and raised safety concerns.⁴ NATURE differs by testing a stent-based retrieval system in a selected population with large thrombus burden rather than applying routine aspiration to an unselected STEMI population.

For context, the enVast device is designed to engage coronary thrombus from distal to proximal while aspiration is performed. It is FDA cleared and CE marked for nonsurgical removal of thrombus from coronary vessels.¹ Earlier prospective first-in-human research with Vesalio’s NeVa mechanical thrombectomy technology reported feasibility and a favorable initial safety experience in acute coronary syndromes, but randomized evidence was needed.³

“We are grateful to the patients who participated in the NATURE trial and to the investigators and study teams whose dedication made this important study possible. The positive results from NATURE add meaningful evidence to the body of research in coronary thrombectomy,” Steve Rybka, chief executive officer at Vesalio, said in a statement.¹ “We are committed to advancing our understanding of the role of mechanical thrombectomy, and, ultimately, to improving treatment strategies and outcomes for STEMI patients with large thrombus burden.”

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REFERENCES
1. NATURE randomized controlled trial meets primary endpoint evaluating enVast-assisted mechanical thrombectomy in large-thrombus STEMI. Vesalio. August 28, 2026. Accessed September 1, 2026. https://www.vesalio.com/nature-randomized-controlled-trial-meets-primary-endpoint-evaluating-envast-assisted-mechanical-thrombectomy-in-large-thrombus-stemi/
2. Landi A, Biscaglia S, Cuculi F, et al. The use of mechanical thrombectomy in patients with STEMI and large thrombus burden: design and rationale of the NATURE trial. Cardiovasc Revasc Med. Published online March 4, 2026. doi:10.1016/j.carrev.2026.03.002
3. Spirito A, Quagliana A, Coiro M, et al. A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes. EuroIntervention. 2022;18(3):242-252. doi:10.4244/EIJ-D-21-00741
4. Byrne RA, Rossello X, Coughlan JJ, et al. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023;44(38):3720-3826. doi:10.1093/eurheartj/ehad191