Background and purpose The recent randomized trials demonstrated the benefit of mechanical thrombectomy in stroke therapy. However, treatment using different strategies is an ongoing area of investigation. The PROMISE study analyzed the safety and effectiveness of the Penumbra System with the ACE68 and ACE64 reperfusion catheters in aspiration thrombectomy of stroke, using A Direct Aspiration First Pass Technique (ADAPT).
Methods PROMISE was a prospective study which enrolled 204 patients with intracranial anterior circulation large vessel occlusion (LVO) ischemic stroke in 20 centers from February 2016 to May 2017. Initial treatment was with the ACE68/ACE64 catheters within 6 hours of symptom onset. Imaging and safety review was performed by an independent Core Laboratory and a Clinical Events Committee. The primary angiographic outcome was revascularization to mTICI 2b-3 at immediate post-procedure and the primary clinical outcome was 90-day modified Rankin Scale (mRS) score ≤2. Safety assessment included device- and procedure-related serious adverse events (SAEs), symptomatic intracranial hemorrhage (sICH), mortality, and embolization of new territory (ENT).
Results Enrolled patients had a median age of 74 (IQR 65–80) years and a median admission NIHSS of 16 (IQR 11–20). The post-procedure mTICI 2b-3 revascularization rate was 93.1% and the 90-day mRS 0–2 rate was 61%. Device- and procedure-related SAEs at 24 hours occurred in 1.5% and 3.4%, respectively, 90-day mortality was 7.5%, sICH occurred in 2.9% while ENT occurred in 1.5%.
Conclusions For frontline therapy of LVO stroke, the ACE68/ACE64 catheters for aspiration thrombectomy were found to be safe and showed similar efficacy to randomized trials using other revascularization techniques.
Clinical Trial Registration NCT02678169; Pre-results.
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Contributors All authors made a substantial, direct, and intellectual contribution to the work.
Funding This study was funded by Penumbra, Inc (9508).
Competing interests The following investigators report financial conflicts with this study: PS reports being a consultant for Penumbra and Stryker, and receiving research support from Penumbra, Philips, and Siemens. RP reports proctoring and consulting for Medtronic, Penumbra, and Implemed. WW reports a proctor agreement with Microvention/Terumo, Medtronic, and Phenox, and being a consultant with Penumbra (speaker and chairman fees). JF reports being a consultant for Penumbra, Acandis, Boehringer Ingelheim, Cerenovus, Covidien, Medtronic, Microvention, Route92, and Stryker, and receiving research support from the German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Philips, and Stryker. PM reports speaker and consulting fees from Medtronic, used for stroke education. TK and VMP received funding from the sponsor for imaging core lab oratory activities. VMP reports being a consultant for Penumbra (PROMISE study), Medtronic, Stryker, and Neurovasc. LP received funding from Penumbra for CEC activities and is a consultant for Balt, Cerenovus/Neuravi, and Microvention.
Patient consent Not required.
Ethics approval The local Ethics Committees approved the study, and the patients or their representatives provided written informed consent, according to local regulations.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to Penumbra, Inc. at email@example.com.
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