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Comprehensive Analysis of IMS III, MR RESCUE, and SYNTHESIS Trials

This study delves into the data from IMS III, MR RESCUE, and SYNTHESIS trials focusing on subject enrollment, treatment groups, and outcomes. It explores the impact of endovascular therapy on patients with ischemic stroke, highlighting the efficacy and safety aspects. The findings reveal the significance of reperfusion and occlusion confirmation in achieving favorable clinical outcomes.

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Comprehensive Analysis of IMS III, MR RESCUE, and SYNTHESIS Trials

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  1. Figures for Draft Response to IMS III, MR RESCUE, and SYNTHSESIS Trials

  2. Figure 1: Lay Press Judgment May Belie a Deeper Examination of the Data. Truman ultimately defeated Dewey for the Presidency

  3. Subject enrollment by CTA and treatment group All Subjects n=656 Baseline CTA/MRA n=306 No Baseline CTA/MRA n=350 47% 292 Baseline CTAs and 14 baseline MRAs Figure 2: Number of IMS III Patients who had pre-procedural imaging. This group represents the key subset analysis because of confirmed Large Vessel Occlusion (LVO)

  4. IMS III: No Treatable Occlusion by CTA • 80 Subjects: No treatable occlusion by operator • - 41: M3 and/or M4 at Angiography by Core Lab • - 15 CTA • - 1 No Occlusion • - 14 Occlusion • - 1 ICA Terminus • - 8 M1 • - 4 M2 • - 1 M3 Figure 3: Over 80 patients in IAT arm of IMS III had no treatable occlusion on angiography (Nearly 20%)

  5. Endovascular therapy not administered n=89 Figure 4: Over 20% of IAT cohort had no endovascular therapy administered

  6. 90-Day Modified Rankin Scale by Baseline NIHSS Strata and Treatment in IMS III Figure 5: Higher NIHSS corresponded with much greater endovascular treatment likely due to the increased incidence of LVO in subjects with NIHSS > 20 and greater opportunity to realize benefit

  7. Figure 6: Recent High Quality Trials Demonstrate: Endovascular is Efficacious (pre-specified analysis) Endovascular confers a statistically significant benefit across the spectrum of mRS A. Demchuk, IMS III: Comparison of Outcomes between IV and IV/IA Treatment in Baseline CTA Confirmed ICA, M1, M2 and Basilar Occlusions, slide 20, Presented at ISC 2013, Honolulu Hawaii With CTA-confirmed occlusion at baseline, representative of current practice, IMS III has a statistically significant positive outcome for endovascular

  8. Figure 7: Recent High Quality Trials Demonstrate: Endovascular is Safe. In IMS III, despite reduced dose IV tPA and being subjected to angiography (with 20% of pts without occlusion), endovascular therapy had NO increase in death or symptomatic ICH

  9. Figure 8: Recent High Quality Trials Demonstrate: Endovascular is Safe. SYNTHESIS conclusion: Subjecting ALL potential IV tPA patients to IA therapy, including those with minimal deficit (NIHSS of 2 included) and without confirmation of occlusion, demonstrated EQUAL efficacy to IV tPA with NO significant safety concerns

  10. Figure 9: Percentage of Patients who achieved a functional outcome in IMS III based on reperfusion result (p=0.001) In IMS III, independent functional outcome (mRS 0-2) was strongly associated with TICI 2b-3 revascularization. Though TICI 2b-3 is the modern endovascular standard, a low percentage of patients in IMS III achieved this technical result due to older, inferior technologies. TICI 2a was considered a good outcome in IMS III but clearly does not translate into good clinical outcomes

  11. Angiographic Reperfusion in IMS III Figure 10: Few patients in IMS III met the clinically significant reperfusion standard due to use of first generation technologies. These TICI 2b and 3 rates fall well short of modern SWIFT and TREVO series

  12. IMS III TICI Reperfusion Primary Target Occlusion Figure 11: Low TICI 2b-3 rates due to first generation endovascular technologies persisted in IMS III independent of LVO location. Half of reperfusion successes in IMS III were only TICI 2a results.

  13. Figure 12: Due to poor technical performance of first generation devices, IAT patients in MR RESCUE did NOT achieve greater reperfusion than Standard Medical Care Patients

  14. Figure 13: Those MR RESCUE patients that DID achieve reperfusion enjoyed better clinical outcomes

  15. Figure 14: In IMS III, time from IV to IAT initiation was greater than 2 hours and greatly exceeds IMS I and II. Though likely secondary to decentralization of care secondary to development of PMSC’s, this diminishes the clinical benefit with endovascular therapy in the trial.

  16. Figure 15: IMS III patients further suffered a significant lag between groin access and initiation of IAT at the lesion. Fourty-four minutes is far beyond reported standards with modern guide and distal access catheter technology.

  17. IMS III Baseline Characteristics Figure 16: Time from puncture to START of IAT was 50 minutes for non cta centers; Centers that did baseline cta's were 20 min faster to IA intervention in IMS III

  18. FIGURE 17RCT for AIS Revascularization: Control arms of PROACT II and NINDS give some indication of LVO natural history

  19. FIGURE 18Prospective Intervention Trials: Inferior Outcomes with First Generation Devices

  20. FIGURE 19: Outcomes at 3 months better with Reperfusion

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