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

Figures for Draft Response to IMS III, MR RESCUE, and SYNTHSESIS Trials. Figure 1: Lay Press Judgment May Belie a Deeper Examination of the Data. Truman ultimately defeated Dewey for the Presidency. Subject enrollment by CTA and treatment group. All Subjects n=656. Baseline CTA/MRA n=306.

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