Interim Analysis Presented From STRIKE-PE Study of Penumbra’s Indigo Aspiration System

November 1, 2023—The STRIKE-PE study is evaluating real-world safety, performance, and long-term quality-of-life outcomes of computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra, Inc.) for the treatment of pulmonary embolism (PE).

The prospective, international, multicenter study will enroll 600 patients with acute PE symptoms of ≤ 14 days and a right ventricular/left ventricular (RV/LV) ratio ≥ 0.9. Primary endpoints are the change in RV/LV ratio from baseline to 48 hours postprocedure and the incidence of major adverse events (MAEs) at 48 hours. Secondary endpoints include functional outcome measures.

Ido Weinberg, MD, presented acute clinical and 90-day functional outcomes from an interim analysis of STRIKE-PE during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

As summarized in the VIVA press release, this interim analysis included 150 patients (mean age, 61.3 years; 54.7% male; 5.3% with high-risk PE; 94.7% with intermediate-risk PE). Patients presented with high thrombus burden (modified Miller score ≥ 12) in 80.7% of cases.

Mean RV/LV ratio significantly decreased from 1.39 at baseline to 1.01 at 48 hours postthrombectomy (∆ 25.7%; P < .0001). Four (2.7%) patients experienced an MAE(s) within 48 hours. From baseline to 48 hours, the median clinical measures of heart rate and respiratory rate significantly decreased (P < .0001).

Borg dyspnea scale significantly improved from presentation to discharge and from presentation to 90-day follow-up (P < .0001). The 6-minute walk test distance significantly improved from discharge to 90-day follow-up (P < .0001). At 90-day follow-up, the New York Heart Association class proportion distribution was similar to that reported before the acute PE episode (P = .39).

STRIKE-PE interim results demonstrated a rapid, statistically significant improvement in RV/LV ratio and clinical measures while maintaining safety. At 90-day follow-up, treatment with CAVT with the Indigo aspiration system improved patients’ functional capacity by reducing dyspnea, increasing aerobic endurance, and improving cardiac symptoms.