UPDATE ON THE NORTH AMERICAN RCTs CREST 2 & ACST 1:...
Transcript of UPDATE ON THE NORTH AMERICAN RCTs CREST 2 & ACST 1:...
UPDATE ON THE NORTH AMERICAN RCTs – CREST 2 & ACST 1: WILL CAS SURVIVE AS AN ALTERNATIVE TO BMT OR CEA ?
FRANK J. VEITH
MAC - 2016 MUNICH – DECEMBER 1, 2016
6TH MUNICH VASCULAR CONF
I HAVE NO FINANCIAL CONFLICTS ALTHOUGH – LIKE ALL OF YOU - I HAVE LOTS OF BIASES
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
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
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BE HELPFUL TO CAS SINCE ACS PTS IN CREST 2 MAY NOT BE AT HIGH ENOUGH RISK OF STROKE TO SHOW BENEFIT FOR CAS & MAY BE OUT OF DATE – WILL HAVE VALUE - SEE WHY LATER IN TALK
DESPITE LEVEL 1 & OTHER NEW EVIDENCE TO THE CONTRARY THE OUTLOOK FOR AN UPSURGE IN CAROTID STENTING (CAS) IS BRIGHT
SO I AM GOING TO SPEND THE REST REST OF MY TIME TELLING WHY
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…
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
& WITH MOST
ASYMPTOMATIC
CAROTID STENOSIS
PATIENTS
BEST MEDICAL TREATMENT
HAS SUCH LOW STROKE RATES
THAT IT MAY MAKE
CAS (& CEA) UNNECESSARY
ANNUAL STROKE RATE WITH ASX CS
DECREASED DUE TO BETTER BMRx
& STATINS FROM 3-6% TO <1% / YR
< 1% PER YR IN 2016
3-6% PER YR IN 1985
FROM A ABBOTT & R NAYLOR
IMPORTANT NEW
EVIDENCE !
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
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
AHA GUIDELINES FOR
STROKE/DEATH RATES
FOR INVASIVE Rx OF ACS
<3%
FOR INVASIVE Rx OF SX CS
<6%
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
SO CAROTID STENTING OR CAS IS CURRENTLY IN DECLINE GENERALLY FOR TREATMENT OF SYMP & ASYMPTOMATIC CAR STENOSIS
HOWEVER
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
OUR 1995 EX VIVO MODEL OF CAS
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
DEBRIS THOUGH STENT
CAUSING DELAYED EMBOLI
THE SOLUTION MEMBRANE OR MESH
COVERED STENTS
TERUMO
A MESH COVERED STENT TO PREVENT
DELAYED EMBOLIZATION
ROADSAVER
TRIALS PROMISING
BUT NEED MORE
MORE & LATE
RESULTS TO BE SURE
THEY DON’T INCREASE
LATE STENOSIS
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
A NEW, SURGICALLY-INSPIRED
ENDOVASCULAR SOLUTION
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.
Blood flow is reversed
from the common
carotid artery
Dynamic Flow
Controller
Hi / Low / Off Embolic
filter (200µ)
Blood flow is returned
to femoral vein
Shorter delivery system
and wires for simplified
setup and delivery
ENROUTE™ Transcarotid Stent and Neuroprotection System
EARLY RESULTS IN 3
TRIALS* IN HIGH RISK PTS
ARE PROMISING
BUT WE NEED MORE &
LONGER TERM RESULTS
*PROOF, TESLA, ROADSTER
SO
CAS WOULD BE MORE
COMPETITIVE TO CEA
& WOULD REPLACE CEA
MORE WIDELY
THAN IT DOES NOW
FOR SYMPTOMATIC & ASX PTS
- IF THESE 3 ADVANCES
DECREASE CAS STROKE RATES
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%
FOR ASYMPTOMATIC PATIENTS
THERE ARE PROMISING WAYS
ON THE HORIZON TO SELECT
THOSE AT HIGH RISK OF STROKE
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
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
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
THANKS FOR YOUR ATTENTION
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
75 58 141
Profile All-comers All-comers High Surgical Risk
Status Complete Complete Enrollment Complete
VAST 3 2014
PROOF Study: Micro-Embolic Measurements
Manish Mehta MD, EVS 2015
• DW-MRI Studies – TCAR’s CEA like Outcomes
Study Procedure Embolic
Protection
Patie
nts
% w/ New
DWI Lesions
ICSS2 CEA Clamp,
backbleed 107 17%
PROOF3 Silk Road
Transcarotid Access, Flow
Reversal 56 19%
PROFI1 Transfemoral
CAS
Proximal occlusion (MoMA)
31 45%
ICSS2 Transfemoral
CAS
Distal filter
(various) 51 73%
PROFI1 Transfemoral CAS
Distal filter (Emboshield)
31 87% 1 J Am Coll Cardiol. 2012 Jan 19. [Epub ahead of print]
2 Lancet Neurol. 2010 Apr;9(4):353-62
VAST 3 2014
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%
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%
SILK ROAD CERVICAL
ACCESS SYSTEM WITH
REVERSAL OF FLOW