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.

Mechanical thrombectomy in ischemic stroke after cardiovascular procedures: a propensity-matched cohort analysis

“…Regarding transferability of our findings to the typical patients who were included in the ground-breaking MT trials, a recent analysis published from the German Stroke Registry (GSR), where our cohort represents a large portion of the total study cohort, investigated the eligibility for inclusion in these large randomized clinical trials (namely, SWIFT‐PRIME, MR CLEAN, ESCAPE, DAWN, and DEFUSE‐3). Briefly, within the GSR population only a relatively small proportion of patients met all inclusion criteria, ranging from 3% (DEFUSE‐3 criteria) to 35% (MR CLEAN criteria) 33. Similar findings were also reported from our single-center cohort 34.…”

Comparing stroke rehabilitation inpatients and clinical trials eligibility criteria: A secondary chart review analysis revealing that most patients could have been excluded from rehabilitation trials based on comorbidity status

“…In addition, more than 80% of patient charts in the stroke rehabilitation inpatient sample contained queries regarding cognition, therefore it is reasonable to extrapolate that many of these people would have been ineligible to participate in the RCTs). These results align with a substantial pool of published work examining common exclusion criteria within RCTs, [23][24][25][26][27][28][29] and provide stroke rehabilitation-specific data, a population that has not been extensively examined. Prior research regarding the generalizability of RCT results has compared baseline characteristics between study participants and the stroke rehabilitation inpatients using a single study exclusion criterion (age, comorbidity, etc.)…”

Multivariable Prediction Model for Futile Recanalization Therapies in Patients With Acute Ischemic Stroke

“…Despite the success of IVT and MT in improving stroke outcome, rates of FRT remain considerable for both treatments. 26 Given more liberal indications in the real-world as compared with the patients included in the original randomized controlled studies, 35 , 36 for both treatments, there is a gradual shift from selecting patients to deselecting patients. However, this development is likely to cause an increase in FRT.…”