Interventional Treatment of Stroke

Transcription

1 Interventional Treatment of Stroke Andrew F. Ducruet, MD Barrow Neurological Institute 2018 BNI Stroke Rehab Symposium October 13, 2018

2 Disclosures Consultant: Medtronic, Penumbra, Cerenovus

3 Lecture Overview Introduction Current State of Interventional Stroke treatment Recent Clinical Studies Case Studies Future Directions

4 BNI Endovascular Stroke Volume

5 Mechanical Thrombectomy: MERCI Approved 2004

6 Aspiration: Penumbra Approved 2007

7 First generation IA trials (2013)

8 No difference in outcomes

9 Limits of 1 st generation IA trials Improper patient selection Only 47% of patient had baseline CTA or MRA documenting an occlusion Outdated devices incomplete recanalization Only 27% TICI 2B/3 Significant delays to reperfusion Mean 325 minutes in the endovascular cohort with a strong time-treatment interaction Every 30 minutes delay 10% worse outcomes

10 Stentrievers: 2012

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14 2015 Endovascular Stroke Trials IV tpa Primary endpoint Time frame Site of LVO # patients Selection criteria MR CLEAN 90% mrs at 90 days < 6 hrs ICA/M1/M2 500 NIHSS > 2 Grey area principle EXTEND-IA 100% Reperfusion at 24 hours without sich <72 hours < 6 hrs ICA/M1/M2 70 Core < 70 cc Penumbra > 10 cc REVASCAT 100% mrs 0-2 at 90 days < 8 hrs ICA/M1 206 NIHSS > 5 ASPECT > 6 ESCAPE >70% NIHSS score 0-2 or mrs 0-2 at 90 days < 12 hrs ICA/M1 314 NIHSS > 5; ASPECT > 5 P2P < 60 min; P2R < 90 min SWIFT PRIME 100% mrs at 90 days < 6 hrs ICA/M1 196 ASPECT > 6 NIHSS > 7

15 MR CLEAN trial (Netherlands) mrs 0-2 at 90d: % vs. 19.1% - absolute diff: 13.5% - NNT = 7 ASPECTS 8-10: 75% (Berkhemer et al NEJM 2015)

16 EXTEND IA trial (Australia/NZ) mrs 0-2 at 90d: - 71% vs. 40% - absolute difference: 31% - NNT= 3 (Campbell et al NEJM 2015)

17 REVASCAT (Spain) mrs 0-2 at 90d: - 44% vs. 28% - NNT = 4 - IV tpa failure patients only. (30min delay in treatment for tpa evaluation) (Jovin et al NEJM 2015)

18 ESCAPE trial (international) mrs 0-2 at 90d: %, vs. 29.3% - absolute diff: 24% - NNT = 4 (Goyal et al NEJM 2015)

19 SWIFT PRIME trial (international) mrs 0-2 at 90d: - 60% vs. 35% - NNT = 4 (Saver et al NEJM 2015)

20 (Goyal et al Lancet 2016)

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23 BNI Vascular Neurology

24 BESTU: October 2017

25 Wall Street Journal. 2/6/18

26 Stroke at the BNI Positive Endovascular trials BESTU Negative Endovascular trials Dr. Waters DAWN/ DEFUSE-3

27 Endovascular Stroke Treatment in 2018: Techniques

28 Stentrievers Trevo Solitaire 3D Embotrap

29 Contact Aspiration (ADAPT) Vargas J, et al. J NeuroIntervent Surg 2017;9: doi: /neurintsurg

30 SMAT (Solumbra) SMAT: Stent retriever mediated manual aspiration thrombectomy Tri-axial system: microwire: microcatheter: aspiration catheter

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32 Recent Endovascular Stroke Clinical Trials

33 N Engl J Med Jan 4;378(1): DAWN Trial

34 DAWN Trial 500 patients (pivotal); 50 sites 6-24 hours NIHSS > 9 ICA or M1 occlusion Medical therapy vs. thrombectomy (Trevo) N Engl J Med Jan 4;378(1):11-21.

35 DAWN Trial Clinical Imaging Mismatch (CIM) Core defined on DWI or rcbf maps (RAPID) 0-20 cc core & NIHSS >= 10 ( 80yr) 0-30 cc core & NIHSS >= 10 (< 80yr) cc core & NIHSS 20 (< 80yr) N Engl J Med Jan 4;378(1):11-21.

36 DAWN Trial- RAPID 3rd European Stroke Organisation Conference (ESOC) Session PL01. Presented May 16, 2017.

37 Primary Outcomes * Similar to p< NNT for functional outcome independence at 90 days= 2.8 N Engl J Med Jan 4;378(1):11-21.

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39 DAWN Trial Conclusions Thrombectomy associated with higher functional independence compared to medical therapy Treatment effect size in DAWN is highest of any stroke trial Thrombectomy in patients > 6h showed comparable safety profile to thrombectomy performed < 6h

40 N Engl J Med Feb 22;378(8): DEFUSE-3

41 DEFUSE-3 Design Age years ICA or M1 occlusion Treatment between 6-16 hours last known well NIHSS 6 Perfusion imaging required Initial infarct volume <70cc Ratio of ischemic tissue to infarct of >1.8 Absolute value of penumbra of >15cc Any FDA-approved thrombectomy device N Engl J Med Feb 22;378(8):

42 Outcome Median score on 90 day mrs OR favoring endovascular 2.77; P<0.001 N Engl J Med Feb 22;378(8):

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44 DEFUSE-3 Findings More inclusive than DAWN 40% of DEFUSE patients would not qualify for DAWN Larger Core infarcts than DAWN (70 vs. 50) Milder Symptoms (NIHSS 6)

45 2018 Guidelines Update

46 Aspiration vs. Stentriever

47 ASTER Trial Contact aspiration vs. stentriever Randomized, open-label, blinded endpoint trial at 8 centers in France (10/15-10/16) 192 randomized to aspiration vs. 189 to stentriever Primary outcome: TICI 2B/3 revascularization 85.4% in aspiration arm vs. 83.1% in stentriever (p=0.53) Secondary outcomes: change in NIHSS at 24h, mrs at 90 days No significant differences

48 Data presented at 2018 ISC 134 patients in aspiration arm, 136 patients in stentriever arm, 15 centers Primary endpoint : mrs = 0-2 at 90 Days Secondary endpoints : mrs shift, TICI 2c or 3 within 45 min of groin puncture, time from groin puncture to TICI 2b/3 Aspiration was non-inferior 49% in stentriever vs. 52% in aspiration (P=0.0014) 20% in aspiration required stentriever

49 Aspiration vs. Stentriever Available data suggesting no significant difference between the two techniques Aspiration is a reasonable first-line treatment

50 The Future Larger Core infarcts Low NIHSS

51 What about larger core infarcts? Only 9% of patients treated had large core (ASPECT 0-5) but no clear evidence of harm and trend towards benefit

52 Stroke size and cost: Each additional 1cc of infarct increased hospitalization cost by $ Streib et al (submitted)

53 Case 1: Large Core Infarct 37 year old male last known well hours prior to admission, with history of altercation at a party Awoke with right MCA syndrome NIHSS = 19 CTA shows tandem occlusion right MCA/ICA

54 CT Head admission

55 CTA Neck

56 CTA Head

57 CT Perfusion

58 Microcatheter injection

59 Post-thrombectomy

60 Post-Thrombectomy MRI

61 Case #1 Showed rapid improvement over next several days Discharged on day 5 intact except 4+/5 in left hand Lost to follow-up

62 Stroke Nov;42(11): What about low NIHSS

63 NIHSS 5 LVO mrs 0-2 J Neurointerv Surg Sep 2 Epub

64 Case #2: Low NIHSS 52 yo male with hypertension Onset of facial droop, slurred speech mild left sided drift at work Urgicare ER 9.5 hours post-onset NIHSS = 4

65 Admission MRA

66 Admission MRI

67 CT Perfusion

68 Thrombectomy

69 Thrombectomy

70 Post-Thrombectomy

71 Case #2 Immediate improvement of drift and facial,speech rapidly normalized Discharged home neurologically intact following workup for AFib

72 Case #3:Low NIHSS, Basilar 44 yo otherwise healthy male Onset of dizziness, dysphagia, left facial numbness beginning on 7/25 in the afternoon In the ER, CT head normal, NIHSS 0.

73 Case #3:Low NIHSS, Basilar Admitted to MGMC due to difficulty with balance MRA and CTA suggestive of proximal basilar occlusion

74 Case #3 On admission to SJHMC, he has severe vertigo when sitting up accompanied by nausea /vomiting, lateral gaze nystagmus NIHSS = 0

75 MRA

76 Right Subclavian

77 Right ICA

78 Left Vertebral

79 Stentriever Deployed

80 Left Vertebral post-thrombectomy

81 Case #3 Symptoms immediately resolved following treatment MRI shows only punctate infarcts left occipital lobe Discharged home on post-procedure day #2

82 Future Directions IN EXTREMIS: Montpelier Clinically severe stroke and ASPECTS 0-5 Low NIHSS (<6) and M1 occlusion

83 Thank You!