Abstract 35: MR CLEAN Registry: A Post-trial Multicenter Registry of Intra-arterial Treatment for Acute Ischemic Stroke in the Netherlands
Background & Purpose: Intra-arterial therapy (IAT) is being implemented worldwide as the main treatment option for acute ischemic stroke (AIS). We wondered whether effectiveness and safety results that have been reported in randomized clinical trials can be reproduced in everyday clinical practice. We will report results of the Dutch National post MR CLEAN IAT registry including work flow parameters, primary and secondary outcomes, as well as serious adverse events.
Methods: The MR CLEAN Registry is a prospective registry of all patients undergoing IAT for AIS in the Netherlands, started after completion of the MR CLEAN trial in March 2014. Registration was required for reimbursement. A core set was defined, with inclusion criteria similar to those of the MR CLEAN trial, including a proven anterior circulation occlusion and treatment possible withing 6 hours from onset. The primary study outcome is the score on the modified Rankin Scale (mRS) at 90 days. The secondary clinical outcome is NIHSS after 24 to 48 hours. Secondary radiological outcomes include the mTICI score on DSA and final infarct volume and major bleeding on follow up NCCT. We used a propensity weighted and an unadjusted ordinal logistic regression model to compare outcomes in the MR CLEAN Registry core and total dataset with the treatment arm of MR CLEAN.
Results: Between March 2014 and August 2016 the inclusion rate of the MR CLEAN Registry has been increasing steadily to an average of 79 (SD 22) per month for a cumulative inclusion of 1548 patients in July 2016 (Figure 1).
Conclusions: The MR CLEAN registry data is now being analyzed. Results will be reported at the conference.
Author Disclosures: I. Jansen: None. M. Mulder: None. R. Goldhoorn: None. A. van der Lugt: None. H. Marquering: None. W. van Zwam: Consultant/Advisory Board; Modest; Stryker, paid to institution. Y. Roos: Consultant/Advisory Board; Modest; Stryker®, paid to institution. J. Vos: None. C. Slump: None. W. Schonewille: None. J. Boiten: None. G. Lyclama a Nijeholt: None. J. Martens: None. J. Hofmeijer: None. R. van Oostenbrugge: None. D. Dippel: Research Grant; Significant; AngioCare BV (to institution), Medtronic/Covidien/EV3 (to institution), MEDAC Gmbh/LAMEPRO (to institution), Penumbra Inc. (to institution), Stryker (to institution), Top Medical/Concentric (to institution). Consultant/Advisory Board; Modest; Stryker and Bracco Imaging, paid to institution. C. Majoie: Consultant/Advisory Board; Modest; Stryker®, paid to institution.
- © 2017 by American Heart Association, Inc.