Elsevier

Journal of the Neurological Sciences

Volume 371, 15 December 2016, Pages 96-99
Journal of the Neurological Sciences

Clinical Short Communication
Eligibility for mechanical thrombectomy in acute ischemic stroke: A phase IV multi-center screening log registry

https://doi.org/10.1016/j.jns.2016.10.018Get rights and content

Highlights

  • No eligibility screening logs were kept in recent mechanical thrombectomy (MT) randomized clinical trials (RCTs).

  • We evaluated the potential eligibility for MT in consecutive acute ischemic stroke (AIS) patients from a multicenter registry.

  • Approximately 1 out of 13 to 17 consecutive AIS were found eligible for MT, according to MR CLEAN and REVASCAT criteria.

  • Absence of proximal intracranial occlusion and delayed hospital arrival were the two most common reasons for ineligibility.

  • Efforts should focus in reducing onset-to-treatment time, which seems to be the only modifiable exclusion factor for MT.

Abstract

No eligibility screening logs were kept in recent mechanical thrombectomy (MT) RCTs establishing safety and efficacy of endovascular reperfusion therapies for acute ischemic stroke (AIS). We sought to evaluate the potential eligibility for MT among consecutive AIS patients in a prospective international multicenter study. We prospectively evaluated consecutive AIS patients admitted in four tertiary-care stroke centers during a twelve-month period. Potential eligibility for MT was evaluated using inclusion criteria from MR CLEAN & REVASCAT. Our study population consisted of 1464 AIS patients (mean age 67 ± 14 years, 56% men, median admission NIHSS-score: 5, IQR: 3–10). A total of 123 (8%, 95% CI: 7%–10%) and 82 (6%, 95% CI: 5%–7%) patients fulfilled the inclusion criteria for MR CLEAN&REVASCAT respectively. No evidence of heterogeneity (p > 0.100) was found in the eligibility for MT across the participating centers. Absence of proximal intracranial occlusion (69%) and hospital arrival outside the eligible time window (38% for MR CLEAN & 35% for REVASCAT) were the two most common reasons for ineligibility for MT. Our everyday clinical practice experience suggests that approximately one out of thirteen to seventeen consecutive AIS may be eligible for MT if inclusion criteria for MR CLEAN and REVASCAT are strictly adhered to.

Introduction

A series of randomized-controlled clinical trials (RCTs) have recently established mechanical thrombectomy (MT) as both safe and highly effective treatment for acute ischemic stroke (AIS) patients with emergent large vessel occlusion (ELVO) [1]. Despite the thorough attention that was given to both the design and implementation of these studies, no eligibility screening logs were kept [2], [3], [4], [5], [6].

In the present study we sought to evaluate the potential eligibility for MT among consecutive AIS patients using data from a prospective, international, multicenter screening log registry.

Section snippets

Methods

We prospectively evaluated consecutive AIS patients admitted in four comprehensive stroke centers (CSC; “Attikon” University Hospital, Athens, Greece; St. Anne's University Hospital, Brno, Czech Republic; University of Tennessee Health Science Center, Memphis, TN, USA; National University Hospital, Singapore, Singapore) during a twelve-month period (July 2014–June 2015). We recorded baseline characteristics on admission, as previously described [7]. Admission stroke severity was documented

Statistical analyses

Continuous variables are presented as mean ± SD (normal distribution) and as median with interquartile range (skewed distribution). The adjusted Wald method, which provides the best coverage for binomial CI when samples are < 150, was used for computation of the corresponding 95% CI. The presence of heterogeneity regarding the eligibility of AIS for MT across the participating centers was tested with the Pearson's chi-square test. Statistical analyses were conducted using the Stata Statistical

Results

Our study population consisted of 1464 AIS patients (mean age 67 ± 14 years, 56% men, median admission NIHSS-score: 5, IQR: 3–10, median ASPECT: 9, IQR: 8–10). Baseline characteristics of our study population are available in Table 1. A total of 123 (8%, 95% CI: 7%–10%; Supplemental Fig. I) and 82 (6%, 95% CI: 5%–7%; Supplemental Fig. I) patients fulfilled the inclusion criteria for MR CLEAN & REVASCAT respectively, while 68 cases were eligible for inclusion in both trials (5%, 95% CI: 4%–6%;

Discussion

Our everyday clinical practice experience suggests that approximately one out of thirteen to seventeen consecutive AIS may be eligible for MT if inclusion criteria for MR CLEAN and REVASCAT are strictly adhered to. Nevertheless, despite the small number of consecutive AIS that fulfill the criteria for treatment with MT, the clinical effectiveness and cost-effectiveness of endovascular reperfusion therapies has been validated in cost-utility analytic models [13]. Thus, a new robust and

Conclusions/summary

Available literature data, coupled with the findings from the present report, suggest that transferring the experience from RCTs on MT for AIS into clinical practice is particularly challenging. As shortening the onset-to-treatment time seems to be the only modifiable exclusion factor for MT, and given the cost-effectiveness of MT for AIS patients with ELVO, there is a significant need to intensify national and institutional efforts, along with quality monitoring aimed at increasing public

Conflict of interest disclosure statement

The authors report no disclosures.

Author contributions

Dr. Tsivgoulis: Study concept and design, acqusition of data, analysis and interpretation, critical revision of the manuscript for important intellectual content.

Dr. Goyal: acqusition of data, critical revision of the manuscript for important intellectual content.

Dr. Mikulik: acqusition of data, critical revision of the manuscript for important intellectual content.

Dr. Sharma: acqusition of data, critical revision of the manuscript for important intellectual content.

Dr. Katsanos: analysis and

Sources of funding

Drs Tsivgoulis, Mikulik and Volny are supported by project no. LQ1605, National Program of Sustainability II. Dr. Volny has received a scholarship of city Ostrava in 2015–2016.

Acknowledgements

This study has been partially presented as Moderated Poster in the International Stroke Conference 2016 (Los Angeles, CA).

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