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