Use of the Envast (Vesalio) coronary clot retriever prior to percutaneous coronary intervention (PCI) has been shown to reduce infarct size in patients with ST-segment elevation myocardial infarction (STEMI) and large thrombus burden.
Findings of the NATURE trial, a multicentre prospective randomised controlled trial assessing the safety and effectiveness of the stent-based thrombectomy technology as an adjunctive reperfusion strategy, were presented during a late-breaking trial session at the European Society of Cardiology’s 2026 congress (28–31 August, Munich, Germany) and published in the Journal of the American College of Cardiology (JACC).
The study’s principal investigator, Marco Valgimigli (Cardiocentro Ticino Institute, Lugano, Switzerland) reported at ESC 2026 that use of Envast reduced infact size by nearly 26% compared to conventional PCI alone.
“Several studies have investigated the use of manual thrombectomy in patients with and without large thrombus burden there is no hint that they would affect infarct size or mortality,” Valgimigli said, noting that STEMI patients with large thrombus burden—determined in the trial as a Thrombolysis In Myocardial Infarction (TIMI) thrombus grade ≥3 in the infarct-related artery—are typically at higher risk for either outcome.
The Envast stent-retriever—which has CE-marking and US Food and Drug Administration (FDA) clearance—comprises a self-expanding nitinol stent designed to entrap thrombus and facilitate its removal. Vesalio, the maker of the device, says it is designed to conform to the vessel wall, enabling distal-to-proximal clot engagement with circumferential clot capture and controlled clot retrieval under concomitant aspiration.
More commonly used in stroke intervention, where they have a class Ia recommendation, data for the use of stent retrievers in coronary interventions are limited.
In the NATURE study, investigators screened STEMI patients within eight hours of symptom onset for eligibility based upon TIMI grade, with 160 patients ultimately enrolled across 11 centres, and 156 randomised 1:1 to Envast-assisted mechanical thrombectomy followed by conventional PCI versus the standard of care—PCI alone. The primary endpoint was infarct size assessed by the creatine kinase-MB (CK-MB) area under the curve (AUC) activity.
Speaking to Cardiovascular News, Valgimigli described the reduction in infarct size of 26% with Envast compared to standard PCI as a “meaningful” and “tangible” difference between the two treatment strategies.
Study investigators also saw that infarct size on cardiac magnetic resonance imaging (CMR), a secondary endpoint, showed a positive trend favouring Envast, with a 25% relative reduction in infarct size (% of left ventricular mass) compared with standard of care at day three.
“Both [endpoints] are very supportive to the concept that Envast usage would be associated with lower infarct size. The 25% reduction of global infarct size is a meaningful difference; not only statistically significant, but it’s a tangible difference between the two groups,” Valgimigli commented.
Additionally, investigators found that safety outcomes were favourable with Envast, with no strokes or death at 30 days in the device arm compared with 1.3% and 2.6% in the control group, respectively. Major adverse cardiovascular events (MACE) were also lower in the device arm (1.3%) than the control group (3.8%).
In his presentation, Valgimigli noted some limitations of the trial, including its open label design, the fact that it was powered for mechanistic rather than clinical endpoints, and that it was a strategy trial, with differences in the two study groups in terms of rates of predilatation, the usage of manual thrombectomy and postdilation.
The NATURE trial was sponsored by Vesalio.
