Study Criteria Applied to Real Life-A Multicenter Analysis of Stroke Patients Undergoing Endovascular Treatment in Clinical Practice

Abstract

Background Randomized controlled clinical trials (RCT) have demonstrated the efficacy of endovascular treatment in anterior circulation large vessel occlusions. However, outcome of patients treated in daily practice differs from the results of the clinical trials. We hypothesize that this is attributable to the study criteria and that application of the criteria on patients undergoing endovascular therapy in daily routine would improve their outcome. Methods and Results Data from a multicenter prospective registry of GSR-ET (German Stroke Registry - Endovascular Treatment) was used. Inclusion criteria and selectivity of SWIFT-PRIME (Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment trial), MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial), ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times trial), DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo trial) and DEFUSE-3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke trial) trials were analyzed. Baseline characteristics, procedural and outcome data of patients from GSR-ET before and after selection were compared with the results of the RCTs. Furthermore, outcome of patients who underwent endovascular treatment despite not fulfilling the RCT criteria was analyzed. A total of 2611 patients were included (median age, 75 years; 49.6% women; median National Institute of Health Stroke Scale, 16). A minority of patients met all inclusion criteria, ranging from 3% (DEFUSE-3 criteria) to 35% (MR CLEAN criteria). Of the patients fulfilling the MR CLEAN criteria, 41% of patients had a good clinical outcome, compared with 34% of patients that did not fulfill MR CLEAN criteria. Conclusions The RCTs represent a selected population with higher rates of good clinical outcome compared with daily practice. The good outcomes of RCTs can be reproduced in clinical routine in patients who fulfill the RCT inclusion criteria. Furthermore, patients who did not meet the criteria of the RCT still had substantial rates of good clinical outcome.

Keywords: endovascular stroke treatment; randomized controlled clinical trials; real life stroke outcome; stroke.

Conflict of interest statement

Fiehler is a consultant for Acandis, Boehringer Ingelheim, Codman, Microvention, Sequent, and Stryker and a speaker for Bayer Healthcare, Bracco, Covidien/ev3, Penumbra, Philips, and Siemens. He has received grants from Bundesministeriums für Wirtschaft und Energie, Bundesministerium für Bildung und Forschung, Deutsche Forschungsgemeinschaft, European Union, Covidien, Stryker (Thrombectomy in patients ineligible for iv tPA study), and Microvention (ERic Acute StrokE Recanalization study). Thomalla received personal fees as a consultant or lecturer from Acandis, Bayer, Boehringer Ingelheim, Bristol‐Myers Squibb/Pfizer, Daichi Sankyo, and Stryker and research grants from Bayer, Federal Ministry for Economic Affairs and Energy (Bundesministeriums für Wirtschaft und Energie), Corona‐ Foundation, German Research Foundation (Deutsche Forschungsgemeinschaft), Else Kröner‐ Fresenius Foundation, European Union (Horizon 2020), and German Innovation Fund. Gerloff reports honoraria as speaker and/or scientific advisory board member from Actitor Biotech, Amgen, Bayer Healthcare, Boehringer Ingelheim, Prediction Biosciences, Sanofi Aventis. The remaining authors have no disclosures to report.

Figures

Figure 1

Workflow of the study (A). Percentage of patients of the GSR‐ET (German Stroke Registry – Endovascular Treatment) fulfilling the inclusion criteria of SWIFT‐PRIME (Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment trial), MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial), ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times trial), DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake‐Up and Late Presenting Strokes Undergoing Neurointervention with Trevo trial), and DEFUSE‐3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke trial) (B).

Figure 2. Most selective inclusion criteria of the MR CLEAN, ESCAPE, and SWIFT‐PRIME trials.

ESCAPE indicates Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times trial; Intravenous t‐PA, intravenous thrombolysis; MR CLEAN, Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial; and SWIFT‐PRIME, Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment trial.

Figure 3. Outcome (modified Rankin Scale at 90 days) of patients who fulfill the inclusion criteria of the randomized controlled clinical trial compared with the endovascular treatment study arm of each trial (A).

Outcome (mRS 90 days) of patients from GSR‐ET who do not fulfill all inclusion criteria of the MR CLEAN trial (B). EVT indicates endovascular treatment; ESCAPE, Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times; GSR‐ET, German Stroke Registry – Endovascular Treatment; MR CLEAN, Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; mRS, modified Rankin Scale; and SWIFT‐PRIME, Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment.