CAS as first line of treatment in the future

Azienda Ospedaliera Universitaria Senese CHIRURGIA VASCOLARE Chief:Prof. Carlo Setacci CAS as first line of treatment in the future Prof. Carlo Setacci Chief of Vascular Surgery University of Siena - Italy

Disclosure Speaker name: Carlo Setacci, MD I have the following potential conflicts of interest to report: Consulting Boston Scientific EndoLogix evascular Terumo 2/24

Carotid artery stenting renaissance

CEA vs CAS Current Evidence based on trials vs Trial Status End point CAS CEA P value SAPPHIRE CEA high risk Symptomatic > 50% Asymptomatic > 80% 30 days: MI; 1 year: ipsilateral stroke or death 12,2% 20,1% 0.05 SPACE Symptomatic > 50% 30 days: ipsilateral stroke or death 6,8% 6,3% NS EVA-3S Symptomatic > 70% 30 days: death; 4 years: ipsilateral stroke 9,6% 3,9% NS CREST Symptomatic > 50% Asymptomatic > 80% 4 years: ipsilateral stroke or surgical death 7,2% 6,8% NS ICSS Symptomatic > 50% 120 days: stroke, death, or periprocedural ; MI 8,5% 5,2% 0,006

META-ANALYSIS OF RCTS UPDATED 2011 CONCLUSIONS: For every 1000 patients opting for stenting rather than endarterectomy: 19 more patients would have strokes, 3 more patients would be dead 10 fewer would have MIs J Vasc Surg. 2011 Mar;53(3):792-7.

CAROTID ARTERY STENTING AS AN ENDOVASCULAR ORIENTED VASCULAR SURGEON I BELIEVE IN THE RENAISSANCE OF CAS

LONG TERM CREST RESULTS : RESULTS AT 4 YEAR THE ONLY DIFFERENCE IS HERE!!

WE NEED BETTER PROTECTION AGAINST SMALL EMBOLUS Brott TG et al. N Engl J Med 2010;363:11-23.

WHICH STENT? closed cell Wallstent (BSCI) Adapt (BSCI) open cell Precise (Cordis) Acculink (Guidant)

IDEAL STENT - Low profile - High trackability & flexibility - Complete plaque coverage - Perfect vessel apposition Answer by OCT

OCT FOR STENT SELECTION Optical Coherence Tomography is an intravascular high-resolution (10 micron) imaging technology that employs near-infrared light 0.2 mm

OCT FOR STENT SELECTION J Endovasc Ther 2012 Jun;19(3):303-11

OCT & CAROTID STENT DESIGN Design Prospective single center study Objectives To evaluate the rate of: - stent malapposition - plaque prolapse - fibrous cap rupture G. de Donato, F. Setacci, P. Sirignano, G. Galzerano, A.Cappelli, C. Setacci. OPTICAL COHERENCE TOMOGRAPHY AFTER CAROTID STENTING: RATE OF STENT MALAPPOSITION, PLAQUE PROLAPSE AND FIBROUS CAP RUPTURE ACCORDING TO STENT DESIGN. Eur J Vasc Endovasc Surg 2013;45:579-87 Embedded

Design Prospective single center study Objectives To evaluate the rate of: OCT & CAROTID STENT - stent malapposition - plaque prolapse - fibrous cap rupture DESIGN G. de Donato, F. Setacci, P. Sirignano, G. Galzerano, A.Cappelli, C. Setacci. OPTICAL COHERENCE TOMOGRAPHY AFTER CAROTID STENTING: RATE OF STENT MALAPPOSITION, PLAQUE PROLAPSE AND FIBROUS CAP RUPTURE ACCORDING TO STENT DESIGN. Eur J Vasc Endovasc Surg 2013;45:579-87

Objectives To evaluate the rate of: OCT & CAROTID STENT Design Prospective single center study - stent malapposition - plaque prolapse - fibrous cap rupture DESIGN G. de Donato, F. Setacci, P. Sirignano, G. Galzerano, A.Cappelli, C. Setacci. OPTICAL COHERENCE TOMOGRAPHY AFTER CAROTID STENTING: RATE OF STENT MALAPPOSITION, PLAQUE PROLAPSE AND FIBROUS CAP RUPTURE ACCORDING TO STENT DESIGN. Eur J Vasc Endovasc Surg 2013;45:579-87

OCT & CAROTID STENT DESIGN Design Prospective single center study Objectives To evaluate the rate of: - stent malapposition - plaque prolapse - fibrous cap rupture according to carotid stent design Closed cell (CC) Open cell (OC) Hyb G. de Donato, F. Setacci, P. Sirignano, G. Galzerano, A.Cappelli, C. Setacci. OPTICAL COHERENCE TOMOGRAPHY AFTER CAROTID STENTING: RATE OF STENT MALAPPOSITION, PLAQUE PROLAPSE AND FIBROUS CAP RUPTURE ACCORDING TO STENT DESIGN.. Eur J Vasc Endovasc Surg 2013;45:579-87 open closed open

IDEAL STENT - OCT ANSWER - Stent malapposition is more frequent with closed cell stent - Plaque prolapse is more common with open cell stents We need new stent design We need MESH-STENT

IDEAL STENT - OCT ANSWER

NEW CAROTID STENT DESIGN Terumo - Roadsaver Gore Mesh carotid stent Inspire C-Guard

IMPACT OF NEW STENT DESIGN Expert Rev Cardiovasc Ther. 2017 Aug 16:1-10. doi: 10.1080/14779072.2017.1364627. Device selection for carotid stenting: reviewing the evidence. Setacci C 1, Mele M 1, de Donato G 1, Mazzitelli G 1, Benevento D 1, Palasciano G 1, Setacci F 1.

IMPACT OF NEW STENT DESIGN Sustained embolic protection Double layer micromesh nitinol design Smallest cell stent size preventing embolic release Double layer micromesh design -- Chronic embolic protection Lesion specific scaffolding: Extremely high plaque coverage Superior in vessel flexibility Excellent wall apposition: the two mash layers enable a flexible scaffold

IMPACT OF NEW STENT DESIGN

IMPACT OF NEW STENT DESIGN

IMPACT OF NEW STENT DESIGN EuroIntervention. 2017 May 9. pii: EIJ-D-17-00008. doi: 10.4244/EIJ-D-17-00008. [Epub ahead of print] 30-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard micronet-covered embolic prevention stent system in real world multicenter clinical practice: the IRON-GUARD study. Speziale F 1, Capoccia L, Sirignano P, Mansour W, Pranteda C, Casana R, Setacci C, Accrocca F, Alberti D, de Donato G, Ferri M, Gaggiano A, Galzerano G, Ippoliti A, Mangialardi N, Pratesi G, Ronchey S, Ruffino MA, Siani A, Spinazzola A, Sponza M.

ITALIAN REGISTRY - ROADSAVER Torino: Dr. C.Rabbia Radiologist Cotignola: Dr. A.Cremonesi Cardiologist Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach. Nerla R, Castriota F, Micari A, Sbarzaglia P, Secco GG, Ruffino MA, de Donato G, Setacci C, Cremonesi A. EuroIntervention. 2016 Aug 5;12(5):e677-83 Siena: Prof. C. Setacci Vascular Surgeon

3 ITALIAN CENTRES ITALIAN REGISTRY - ROADSAVER Cotignola n= 82 Siena n= 52 Torino n= 16 150 (OCTOBER 2014- OCTOBER 2015) Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach. Nerla R, Castriota F, Micari A, Sbarzaglia P, Secco GG, Ruffino MA, de Donato G, Setacci C, Cremonesi A. EuroIntervention. 2016 Aug 5;12(5):e677-83

ITALIAN REGISTRY - ROADSAVER Subgroup analysis_oct 36 patients Plaque prolapse 2/36 cases studied with OCT (5.5%)

ITALIAN REGISTRY ROADSAVER 30-DAYS RESULTS 0% STROKE AND DEATH 0% TIA 0% MI PROCEDURAL SUCCESS: 100%

CLEAR ROAD - PROSPECTIVE INTERNATIONAL TRIAL -97.9% freedom from MAE (94,4% symptomatic patients vs 100% asymptomatic patients) -MAE rate: 2.1%: no notable difference between symptomatic and asymptomatic patients or between EPD use

CLEAR ROAD - PROSPECTIVE INTERNATIONAL TRIAL Siena - Italy Europe Belgium and Germany 0 % of MAE 2.5% of MAE (all in symptomatic patients)

CLEAR ROAD - PROSPECTIVE INTERNATIONAL TRIAL Critical Issue Coming Out from the Data Little Cohort of patients (bias in statistics?) Selective use of EPD

Scaffold Clinical Study

10 top rules for CAS 1.Correct patient selection and adequate learnig curve

10 top rules for CAS 1.Correct patient selection and adequate learnig curve 2. Overview of Anatomy (Arch and intracranial vessels)

10 top rules for CAS 1. Correct patient selection and adequate learnig curve 2. Overview of Anatomy 3. Plaque evaluation

10 top rules for CAS 1. Correct patient selection and adequate learning curve 2. Overview of Anatomy 3. Plaque evaluation 4. Pre-, Intra- & post-procedural medical therapy

10 top rules for CAS 1. Correct patient selection and adequate learnig curve 2. Overview of Anatomy 3. Plaque evaluation 4. Pre-, Intra- & post-procedural medical therapy 5. Vascular access (brachial/radial/cervical)

10 top rules for CAS 1. Correct patient selection and adequate learnig curve 2. Overview of Anatomy 3. Plaque evaluation 4. Pre-, Intra- & post-procedural medical therapy 5. Vascular access (brachial/radial/cervical) 6. Correct Embolic Protection Device

10 top rules for CAS 1. Correct patient selection and adequate learnig curve 2. Overview of Anatomy 3. Plaque evaluation 4. Pre-, Intra- & post-procedural medical therapy 5. Vascular access (brachial/radial/cervical) 6. Correct Embolic Protection Device 7. Correct Stent

10 top rules for CAS 1. Correct patient selection and adequate learnig curve 2. Overview of Anatomy 3. Plaque evaluation 4. Pre-, Intra- & post-procedural medical therapy 5. Vascular access (brachial/radial/cervical) 6. Correct Embolic protection Device 7. Correct Stent 8. Intravascular imaging during CAS

10 top rules for CAS 1. Correct patient selection and adequate learnig curve 2. Overview of Anatomy 3. Plaque evaluation 4. Pre-, Intra- & post-procedural medical therapy 5. Vascular access (brachial/radial/cervical) 6. Correct Embolic protection Device 7. Correct Stent 8. Intravascular imaging during CAS 9. Intracranial evaluation post-cas

10 top rules for CAS 1. Correct patient selection and adequate learnig curve 2. Overview of Anatomy 3. Plaque evaluation 4. Pre-, Intra- & post-procedural medical therapy 5. Vascular access (brachial/radial/cervical) 6. Correct Embolic protection Device 7. Correct Stent 8. Intravascular imaging during CAS 9. Intracranial evaluation post-cas 10. Vascular access evaluation after CAS

PERSONAL CONSIDERATIONS The ideal stent still does not exists at the moment! Patient s tailored approach remains by now the logical answer for treating standard as well as complex carotid lesions and anatomies (different stents for different anatomies and plaque morphology) New generation of stents offering high scaffolding and conformability properties will give new rush to CAS...Long term results of CAS are perfect, however there is still room for peri-procedural improvement!!