Thrombectomy With the pRESET vs Solitaire Stent Retrievers as First-Line Large Vessel Occlusion Stroke Treatment
Authors: Nogueira Raul G. , Lobsien Donald , Klisch Joachim , Pielenz Daniel , Lobsien Elmar , Sauvageau Eric , Aghaebrahim Nima , Möhlenbruch Markus , Vollherbst Dominik , Ulfert Christian , Bozorgchami Hormozd , Clark Wayne , Priest Ryan , Samaniego Edgar A. , Ortega-Gutierrez Santiago , Ghannam Malik , Lopes Demetrius , Billingsley Joshua , Keigher Kiffon , Haussen Diogo C. , Al-Bayati Alhamza R. , Siddiqui Adnan , Levy Elad , Chen Michael , Munich Stephan , Schramm Peter , Boppel Tobias , Narayanan Sandra , Gross Bradley A. , Roth Christian , Boeckh-Behrens Tobias , Hassan Ameer , Fifi Johanna , Budzik Ron F. , Tarpley Jason , Starke Robert M. , Raz Eytan , Brogan Gary , Liebeskind David S. , Hanel Ricardo A. 
Published: January 2024

Importance

Stent retriever–based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking.

Objective

To determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever.

Design, Setting, and Participants

This study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset.

Interventions

Patients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever.

Main Outcomes and Measures

The primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a −12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers.

Results

Of 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, −2.57%; 95% CI, −11.42 to 6.28). As the lower bound of the 95% CI was greater than −12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, −4.83%; 95% CI, −10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, −0.63%; 95% CI, −9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis.

Conclusions and Relevance

In this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke.