FRANK J. VEITH MAC TH MUNICH VASCULAR CONF

Transcription

1 UPDATE ON THE NORTH AMERICAN RCTs CREST 2 & ACST 1: WILL CAS SURVIVE AS AN ALTERNATIVE TO BMT OR CEA? FRANK J. VEITH 6 TH MUNICH VASCULAR CONF MAC MUNICH DECEMBER 1, 2016

2 I HAVE NO FINANCIAL CONFLICTS ALTHOUGH LIKE ALL OF YOU - I HAVE LOTS OF BIASES

3 I AM NOT GOING TO TELL YOU ANYTHING ABOUT ACST 1 BECAUSE IT IS MOSTLY NOT NA & ALISON HALLIDAY WILL TELL YOU ALL ABOUT ACST 1

4 CREST 2 NOT GOING TO SAY MUCH NO RESULTS FUNDED BY NIH & RECRUITING RCT OF Rxs FOR ACS PTS IN 2 PARTS: 1. CAS & BMT vs BMT 2. CEA & BMT vs BMT

5 CREST 2 MAY OR MAY NOT BE HELPFUL TO CAS SINCE ACS PTS IN CREST 2 MAY NOT BE AT HIGH ENOUGH RISK OF STROKE TO SHOW BENEFIT FOR CAS & MAY BE OUT OF DATE WILL HAVE VALUE - SEE WHY LATER IN TALK

6 SO I AM GOING TO SPEND THE REST REST OF MY TIME TELLING WHY DESPITE LEVEL 1 & OTHER NEW EVIDENCE TO THE CONTRARY THE OUTLOOK FOR AN UPSURGE IN CAROTID STENTING (CAS) IS BRIGHT

7 DESPITE SOME OPINIONS TO THE CONTRARY CAROTID STENTING OR CAS IS CURRENTLY IN DECLINE GENERALLY FOR TREATMENT OF SYMP & ASYMPTOMATIC CAR STENOSIS THIS IS BECAUSE

8 WITH SYMPTOMATIC CAROTID STENOSIS PTS RECENT RCTs*, POPULTION BASED STUDIES & A SYSTEMATIC REGISTRY REVIEW^ (2015) SHOWED MUCH HIGHER STROKE/DEATH RATES WITH CAS THAN CEA *CREST, ICSS, ETC ^Paraskevas, Naylor: EJVES 2015

9 & WITH MOST ASYMPTOMATIC CAROTID STENOSIS PATIENTS BEST MEDICAL TREATMENT HAS SUCH LOW STROKE RATES THAT IT MAY MAKE CAS (& CEA) UNNECESSARY

10 3-6% PER YR IN 1985 < 1% PER YR IN 2016 ANNUAL STROKE RATE WITH ASX CS DECREASED DUE TO BETTER BMRx & STATINS FROM 3-6% TO <1% / YR FROM A ABBOTT & R NAYLOR

11 IMPORTANT NEW EVIDENCE!

12 ONE ARTICLE BY SPENCE* CONFIRMS THE LOW RISK OF OCCLUSION (<0.1%) & STROKE (.9%) IN PATIENTS WITH ASx CAR STEN ON GOOD MEDICAL Rx *BY YANG, SPENCE ET AL JAMA NEUROL, SEPT 21, 2015

13 A SECOND RECENT ARTICLE BY PARASKEVAS, NAYLOR (EJVES 2015) WAS A SYSTEMATIC REVIEW OF STROKE & DEATH RATES AFTER CAS & CEA IN 21 CONTEMPORARY ADMINISTRATIVE REGISTRIES IT SHOWED THAT CAS HAD SIGNIFICANTLY HIGHER STROKE/DEATH RATES THAN CEA IN MOST OF THESE REGISTRIES FOR SX & ASX CS IN MANY CASES EXCEEDING AHA GLs

14 AHA GUIDELINES FOR STROKE/DEATH RATES FOR INVASIVE Rx OF ACS <3% FOR INVASIVE Rx OF SX CS <6%

15 HERE ARE SOME SPECIFICS* CAS STROKE/DEATH RATE FOR AVERAGE RISK Sx CS EXCEEDED AHA GUIDELINE OF 6% IN 72% OF 18 REGISTRIES & IN 28% IT EXCEEDED 10%!!! *PARASKEVAS, NAYLOR: EJVES 2015

16 SO CAROTID STENTING OR CAS IS CURRENTLY IN DECLINE GENERALLY FOR TREATMENT OF SYMP & ASYMPTOMATIC CAR STENOSIS

17 HOWEVER

18 HOWEVER, I BELIEVE OUTLOOK FOR CAS IS BRIGHT BECAUSE 3 ADVANCES MAY DECR STROKES BETTER EMBOL PROTECT DEVICES WITH CESS/REVERSAL OF FLOW (MOMA) CERVICAL ACCESS (SILK ROAD SYSTEM) TO AVOID THE AORTIC ARCH & REV FL MEMBRANE OR MESH COVERED STENTS TO STOP DELAYED STROKES

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22 OUR 1995 EX VIVO MODEL OF CAS

23 LET US LOOK AT THESE 3 ADVANCES THAT MAY DECR STROKES WITH CAS 2. BETTER EMBOL PROTECT DEVICES WITH CESS/REVERSAL OF FLOW 3. CERVICAL ACCESS (SILK ROAD SYSTEM) TO AVOID THE AORTIC ARCH & REV FL 1. MEMBRANE OR MESH COVERED STENTS TO STOP DELAYED STROKES

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25 DEBRIS THOUGH STENT CAUSING DELAYED EMBOLI

26 THE SOLUTION MEMBRANE OR MESH COVERED STENTS

27 TERUMO

28 A MESH COVERED STENT TO PREVENT DELAYED EMBOLIZATION ROADSAVER

29 TRIALS PROMISING BUT NEED MORE MORE & LATE RESULTS TO BE SURE THEY DON T INCREASE LATE STENOSIS

30 OTHER 2 ADVANCES THAT MAY DECR STROKES WITH CAS 2. BETTER EMBOL PROTECT DEVICES WITH CESS/REVERSAL OF FLOW (MOMA) 3* CERVICAL ACCESS (SILK ROAD SYSTEM) TO AVOID THE AORTIC ARCH & REV FL 1. MEMBRANE OR MESH COVERED STENTS TO STOP DELAYED STROKES

31 A NEW, SURGICALLY-INSPIRED ENDOVASCULAR SOLUTION ENROUTE Transcarotid Stent and Neuroprotection System Shorter delivery system and wires for simplified setup and delivery Blood flow is returned to femoral vein Blood flow is reversed from the common carotid artery Dynamic Flow Controller Hi / Low / Off Embolic filter (200µ) CAUTION: Investigational device. Limited by federal (USA) law to investigational use. The ENROUTE Transcarotid Stent and Neuroprotection Systems bear the CE mark of conformity and are available for sale in EU and EFTA countries.

32 EARLY RESULTS IN 3 TRIALS* IN HIGH RISK PTS ARE PROMISING BUT WE NEED MORE & LONGER TERM RESULTS *PROOF, TESLA, ROADSTER

33 SO

34 FOR SYMPTOMATIC & ASX PTS - IF THESE 3 ADVANCES DECREASE CAS STROKE RATES CAS WOULD BE MORE COMPETITIVE TO CEA & WOULD REPLACE CEA MORE WIDELY THAN IT DOES NOW

35 FOR ASYMPTOMATIC PATIENTS THERE ARE PROMISING WAYS ON THE HORIZON TO SELECT THOSE AT HIGH RISK OF STROKE 1. TCD DETECTED MICROEMBOLI 2. DUPLEX PLAQUE EVALUATION 3. MRI & CT PLAQUE EVALUATION 4. SILENT MRI & CT INFARCTS SOME ASX PT GROUPS HAVE >12% PER YEAR STROKE RISK vs <1%

36 THESE HIGH RISK ASYMPTOMATIC PTS SELECTED BY THESE METHODS CLEARLY WOULD BENEFIT MORE FROM CAS OR CEA - IN ADDITION TO BEST MEDICAL TREATMENT THUS INCREASING THE NUMBER OF PATIENT NEEDING CAS

37 HOWEVER THERE IS 1 RESERVATION: THAT IS THE EFFICACY OF THESE 3 METHODS FOR DECREASING CAS STROKE RATES & IMPROVING ASX PATIENT SELECTION MUST BE PROVEN BY APPROPRIATE TRIALS

38 MY CONCLUSIONS 1. DESPITE THIS RESERVATION I BELIEVE THE OUTLOOK FOR CAROTID STENTING OR CAS IS BRIGHT IN THE FUTURE 2. ALL VASCULAR SPECIALISTS SHOULD PREPARE FOR IMPROVING CAS RESULTS

39 THANKS FOR YOUR ATTENTION

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41 SURGICAL OUTCOMES IN STROKE REDUCTION Silk Road Clinical Studies PROOF TESLA ROADSTER Study type First In Man Multicenter EU Post- Market Registry US Pivotal IDE Number of Patients Profile All-comers All-comers High Surgical Risk Status Complete Complete Enrollment Complete

42 PROOF Study: Micro-Embolic Measurements DW-MRI Studies TCAR s CEA like Outcomes Study ICSS 2 PROOF 3 PROFI 1 ICSS 2 PROFI 1 Procedure CEA Silk Road Transfemoral CAS Transfemoral CAS Transfemoral CAS 1 J Am Coll Cardiol Jan 19. [Epub ahead of print] 2 Lancet Neurol Apr;9(4): Embolic Protection Clamp, backbleed Transcarotid Access, Flow Reversal Proximal occlusion (MoMA) Distal filter (various) Distal filter (Emboshield) Patie nts % w/ New DWI Lesions % 56 19% 31 45% 51 73% Manish Mehta MD, VAST EVS %

43 ROADSTER Study Subgroup Analysis High Surgical Risk Pivotal Intention to Treat Age 75 Symptomatic N N=66 (47%) N=36 (26%) S/D/MI 3 (4.5%) 1 (2.8%) Major Stroke 0% 0% Minor Stroke 0% 0% Death 3.0% 2.8% MI 1.5% 0% Stroke & Death 3.0% 2.8% VAST

44 ONE ARTICLE CONFIRMS THE LOW RISK OF OCCLUSION (<0.1%) & STROKE (.9%) IN PATIENTS WITH ASx CAR STEN ON GOOD MEDICAL Rx THIS IS IN A NEW ARTICLE BY YANG, SPENCE ET AL JAMA NEUROL, SEPT 21, 2015 & RISK OF STROKE WITH OCCL = 0.32%

45 SILK ROAD CERVICAL ACCESS SYSTEM WITH REVERSAL OF FLOW