Abstract W P4: Time to Angiographic Reperfusion: A Decision Analysis
Introduction: The Interventional Management of Stroke (IMS) III trial found no significant difference in outcomes between the combined intravenous (IV) t-PA/endovascular and IV t-PA groups. A suggested reason for lack of IV/IA effect is that good clinical outcome following angiographic reperfusion is strongly time dependent; this was shown in IMS I/II and validated in IMS III. Using decision modeling we addressed the following question: How quickly should reperfusion with IA therapy be achieved to demonstrate superiority of IV/IA therapy versus IV t-PA alone?
Methods: We developed a decision analytic model using IMS III trial data and comprehensive literature review. Base case: large vessel occlusion, IV t-PA within 3 hours, time from stroke onset to reperfusion 325 min, reperfusion rate with IA therapy 0.76, probability of good outcome after IA reperfusion 0.40, probability of good outcome after no IA reperfusion 0.10. IV t-PA rates of good outcome were based on subset of IMS III subjects with large vessel occlusion on baseline CTA. Utilities were assigned to mRS outcome levels based on previously published data.
Results: The IV t-PA alone approach yielded expected utility of 1.26 quality-adjusted life years (QALYs) compared to 1.08 QALYs for the IV/IA approach. One-way sensitivity analyses for time to reperfusion demonstrated superiority of IV t-PA alone above a reperfusion time of 273 minutes. IV/IA approach could be superior if reperfusion times were shorter.
Conclusion: If mean reperfusion time can be reduced to ≤ 273 minutes our analysis suggests that IV/IA therapy could be superior to IV t-PA alone using the IMS III revascularization approaches given the original sample size of IMS III. Further analyses will be included in the abstract presentation, by which time the IMS III database will be closed and additional relevant data available to investigators. We then will be able to more accurately estimate the various time components modeled, including: time from onset to IV start, IV start to groin puncture, groin puncture to IA start and time from IA start to IA end, as well as the impact of reperfusion delay and reperfusion rates on clinical outcomes along with probabilistic sensitivity analyses.
Author Disclosures: A. Vagal: Research Grant; Significant; American Roentgen Ray Society Scholarship Grant. M. Eckman: Research Grant; Significant; NIH Informatics Core Co-Leader , University of Cincinnati CTSA grant, Foundation for Informed Medical Decision Making,and The Pfizer Medical Education fund. J. Broderick: Research Grant; Significant; NIH. Other Research Support; Significant; Genentech-study medication for NINDS-funded IMS III and CLEARER trials, Genentech -PRISMS Trial consultant on steering committee, Penumbra-THERAPY Trial. T. Tomsick: Research Grant; Significant; NIH. S. Yeatts: Research Grant; Significant; NIH. Consultant/Advisory Board; Modest; Genentech: PRISMS Steering Committee Member. P. Khatri: Honoraria; Modest; Academic Grand Rounds (paid to Dept). Other; Modest; Taylor and Francis-Stroke Ctr Handbook book royalties (paid to Dept). Research Grant; Significant; NIH/NINDS (IMS III, NSTN NCC/RCC). Other Research Support; Significant; Significant; Genentech-PRISMS Trial PI (paid to Dept), Penumbra-THERAPY Trial PI (paid to Dept).
- © 2014 by American Heart Association, Inc.