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Vascular and Endovascular Surgery Unit - University of Siena Palermo 27 October, 2009 Vascular and Endovascular Surgery Unit University of Siena Siena.

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Presentation on theme: "Vascular and Endovascular Surgery Unit - University of Siena Palermo 27 October, 2009 Vascular and Endovascular Surgery Unit University of Siena Siena."— Presentation transcript:

1 Vascular and Endovascular Surgery Unit - University of Siena Palermo 27 October, 2009 Vascular and Endovascular Surgery Unit University of Siena Siena - Italy Carlo Setacci, Gianmarco de Donato CAS: present and future Milan – September 29

2 Vascular and Endovascular Surgery Unit - University of Siena EVIDENCE BASED MEDICINE SELF EVIDENCE MEDICINE Is there a future for Carotid Stenting? Points of view

3 Vascular and Endovascular Surgery Unit - University of Siena General feeling of CAS → at least equivalent to CEA Points of view: Self evidence medicine In recent years CAS has rapidly gained recognition worldwide in high volume centers

4 Vascular and Endovascular Surgery Unit - University of Siena Level I scientific evidence Based on well conducted randomized controlled Trials Level 4. Expert opinion, GPP

5 Vascular and Endovascular Surgery Unit - University of Siena Cochrane Database Syst Rev Oct 17;(4):CD Cochrane systematic review. Stroke. 2009; 40(4):

6 Vascular and Endovascular Surgery Unit - University of Siena 7 completed RCTs (CAS vs CEA or BMT) involving 941 patients, - CAVATAS-CEA 2001; - CAVATAS-MED 2007; - Kentucky 2001; - Kentucky 2004; - Beijing 2003; - BACASS TESCAS-C further RCTs were stopped early (2286 patients) - Leicester 1998; - Wallstent SAPPHIRE 2004; - EVA-3S 2006; - SPACE 2006; Cochrane Database Syst Rev Oct 17;(4):CD Single center < 100 pz

7 Vascular and Endovascular Surgery Unit - University of Siena Death or any stroke within 30 days Cochrane systematic review. Stroke. 2009; 40(4): For the primary outcome comparison of any stroke or death within 30 days of treatment, CAS was inferior to surgery (OR 1.3), though the difference was not statistically significant.

8 Vascular and Endovascular Surgery Unit - University of Siena Secondary Outcomes Cochrane systematic review. Stroke. 2009; 40(4): In addition, no significant difference between CAS and CEA was found for 30-day stroke, myocardial infarction, or death (OR 1.12); 30-day disabling stroke or death (OR 1.19); 30-day death (OR 0.99); and 24-month death or stroke (OR 1.26). Death or disabling stroke within 30 days Death within 30 days Stroke within 30 days Death or stroke or MI within 30 days

9 Vascular and Endovascular Surgery Unit - University of Siena CONCLUSION The data are difficult to interpret because the trials are heterogeneous. Five trials were stopped early, perhaps leading to an overestimate of the risks of endovascular treatment. The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials. Stroke Apr;40(4): Epub 2009 Feb 19 Cochrane Systematic Review: Update 2009

10 Vascular and Endovascular Surgery Unit - University of Siena Lancet Neurol Published online August 29, 2009 DOI: /S (09) “…all the available data on long-term outcome in randomised trials of endovascular treatment versus endarterectomy for symptomatic carotid stenosis now shows a significantly worse outcome after endovascular treatment”

11 Vascular and Endovascular Surgery Unit - University of Siena CMS proposes to retain its existing coverage for the following patients with a slight revision to the language regarding EPDs: Patients at high risk for CEA and symptomatic stenosis ≥70%. Coverage is limited to CAS with FDA-approved stents and and FDA-approved or cleared EPDs Patients at high risk for CEA and symptomatic stenosis 50% to 69%and who are enrolled in Category IDE clinical trials (regulation 42 CFR )or CAS post-approval studies (Medicare NCD Manual 20.7)as routine cost under the clinical trials policy or in accordance with the NCD on CAS postapproval studies Patients at high risk for CEA and asymptomatic stenosis ≥ 80% who are enrolled in Category IDE clinical trials (regulation 42 CFR )or CAS post-approval studies (Medicare NCD Manual 20.7)as routine cost under the clinical trials policy (Medicare NCD Manual 310.1) or in accordance with the NCD on CAS postapproval studies

12 Vascular and Endovascular Surgery Unit - University of Siena The recent EVA-3S, SPACE and ICSS RCTs failed to clarify whether stenting can be considered ‘‘equivalent’’ to CEA in normal risk patients. Indications for and early outcomes of CAS therefore remain a controversial topic. CAS CEA Debate

13 Vascular and Endovascular Surgery Unit - University of Siena minimal endovascular experience required to enroll patients in RCTs Since randomized clinical trials are considered the gold standard of clinical investigation, it appears foolish at first sight to challenge them.

14 Vascular and Endovascular Surgery Unit - University of Siena RCTs CEA vs CAS Why did RCTs fail to clarify whether stenting can be considered ‘‘equivalent’’ to CEA Questionable minimal endovascular expertise required in the trials. - increased complication rate due to the limited skills - increased complication rate due to wrong patient selection

15 Vascular and Endovascular Surgery Unit - University of Siena SAPPHIRE 2002 the most stringent with respect to required endovascular experience, investigators had to submit their track record to an executive review committee: Procedure-related death or stroke rates had to be <6% and no tutoring was allowed in the trial. Milestones –FDA approval –CMS reimbursement

16 Vascular and Endovascular Surgery Unit - University of Siena n =156 n = 151 CAS 5.8% CEA 12.6% Difference of 3.4% PRO-CAS Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy The Sapphire Trial Minimal requirement in terms endovascular experience: - Documented CAS periprocedural death or stroke rate <6%. - No tutor-assisted procedures allowed.

17 Vascular and Endovascular Surgery Unit - University of Siena CAVATAS any stroke lasting more than 7 days, or death Lancet 2001; 357: PTA alone in 74% No cerebral protection 10.0% CAS9.9% CEA Randomisation finished in 1997 Training in neuroradiology and angioplasty (but not necessarily in the carotid artery) required. Tutor-assisted procedures allowed.

18 Vascular and Endovascular Surgery Unit - University of Siena Lancet Neurol 2009 Aug; 8: CAVATAS (10 y Follow-Up) Pts enrolled from March 1992 to July Follow-up to 2007 (Median length of follow-up in both groups was 5 years - IQR 2–6)

19 Vascular and Endovascular Surgery Unit - University of Siena Should the long term data after CAS turn out to be unsatisfactory, the whole debate about indications, optimal techniques, equipment, and early outcomes would be no longer worthy of discussion. Long term results Is there a future? de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M. Long-term results of carotid artery stenting. J Vasc Surg Dec;48(6):

20 Vascular and Endovascular Surgery Unit - University of Siena Lancet Neurol 2009 Aug; 8: CAVATAS (10 y Follow-Up) - Only 26% stenting - How was restenosis calculated?

21 Vascular and Endovascular Surgery Unit - University of Siena Restenosis? Which velocity parameters can we use for Intra- Stent-Restenosis (ISR) diagnosis?

22 Vascular and Endovascular Surgery Unit - University of Siena …Velocity parameters used for native carotid arteries… CLASS % STENOSISPEAK SISTOLIC END DIASTOLIC A 0% <4 KHz <125 cm/s - B 1-15% <4 KHz <125 cm/s - C 16-49% <4 KHz <125 cm/s - D 50-79% >4 KHz >125 cm/s - D %- >4.5 KHz >140 cm/s E 100%N/A Strandness Criteria

23 Vascular and Endovascular Surgery Unit - University of Siena Stroke. 2008;39: % Stenosis PSV (cm/s) EDV (cm/s) ICA/CCA [<30]>104-- [30-50]105 – [50-70] [>70]>300> 140> 3.8

24 Vascular and Endovascular Surgery Unit - University of Siena Cutting Balloon Angioplasty Setacci C, et al IN-STENT RESTENOSIS AFTER CAROTID ANGIOPLASTY AND STENTING: A CHALLENGE FOR THE VASCULAR SURGEON. Eur J Vasc Endovasc Surg 2005; 28: The most effective cerebral protection for symptomatic in-stent restenosis is a further endovascular treatment ISR = <2%

25 Vascular and Endovascular Surgery Unit - University of Siena SAPPHIRE Milestones ICSS (Still pending the full report of the results) EVA 3S SPACE IP 44,16 IP 23,40

26 Vascular and Endovascular Surgery Unit - University of Siena Invited Commentary SPACE and EVA 3S trials: the need of standards for Carotid Stenting Carlo Setacci, MD; Alberto Cremonesi, MD. EJVES 2007; 33: 47-8

27 Vascular and Endovascular Surgery Unit - University of Siena EVA-3S: 12 CAS or 35 stenting supra-aortic trunks (5 CAS) or Ø CAS + proctoring SPACE: 25 successful percutaneous transluminal angioplasties or stent procedures Track record Recent Trials Nervenarzt. 2007;78(10): a later publication appeared in a second-tier journal reveals that during the trial an amendment of the protocol allowed for tutoring of interventionalists who had a total experience of at least 10 CAS procedures.

28 Vascular and Endovascular Surgery Unit - University of Siena Invited Commentary “As difficult as it is to say, we must admit that both EVA 3S and SPACE didn’t match an acceptable level of physician training and credentialing. The consequences of this technical bias on the reported CAS results are left to the scientific community’s evaluation.” Setacci C, Cremonesi A. SPACE and EVA 3S trials : the need of standards for Carotid Stenting. EJVES 2007; 33: 47-8

29 Vascular and Endovascular Surgery Unit - University of Siena CAVATAS ICSS Brown MM. Safety Results of the ICSS Study. Presented at the European Stroke Conference, Stockholm, Sweden, May 2009.

30 Vascular and Endovascular Surgery Unit - University of Siena ICSS Brown MM. Safety Results of the ICSS Study. Presented at the European Stroke Conference, Stockholm, Sweden, May centers, from 15 countries in Europe, Canada, Australia and New Zealand 1710 pts included in the intention-to-treat analysis Primary aim = long term survival free of disabling stroke (expected in 2011) Now = only primary safety data Still pending the full report of the results Symptomatic (within 6 months) stenosis >50%

31 Vascular and Endovascular Surgery Unit - University of Siena ICSS In the ICSS trial, a minimum of 50 total stenting procedures was required as long as at least 10 of them involved the carotid artery. Tutor-assisted procedures were allowed for interventionalists with insufficient experience. Featherstone RL, Brown MM, Coward LJ. International carotid stenting study: protocol for a randomised clinical trial comparing carotid stenting with endarterectomy in symptomatic carotid artery stenosis. Cerebrovasc Dis. 2004;18(1): soft requirements in terms of endovascular experience !

32 Vascular and Endovascular Surgery Unit - University of Siena ICSS n = 853 n = 857 Brown MM. Safety Results of the ICSS Study. Presented at the European Stroke Conference, Stockholm, Sweden, May CAS 7.6% CEA 3.9% PRO-CEA Difference of 3.7% Still pending the full report of the results

33 Vascular and Endovascular Surgery Unit - University of Siena Stroke.2006; 37: Carotid Artery Stenting: First Consensus Document of the ICCS-SPREAD Joint Committee Alberto Cremonesi, MD; Carlo Setacci, MD; Angelo Bignamini, MD; Leonardo Bolognese, MD; Francesco Briganti, MD; Germano Di Sciascio, MD; Domenico Inzitari, MD; Gaetano Lanza, MD; Luciano Lupattelli, MD; Salvatore Mangiafico, MD; Carlo Pratesi, MD; Bernard Reimers, MD; Stefano Ricci, MD; Gianmarco de Donato, MD; Ugo Ugolotti, MD; Augusto Zaninelli, MD Gian Franco Gensini, MD

34 Vascular and Endovascular Surgery Unit - University of Siena CAS: Training and Expertise Recommendation 10: Grade GPP [C] Once the basic skill for catheter-based intervention has been achieved by the already-active interventionist, the minimum reccomended training to achieve competence is as follows: 1.At least 150 procedures of supra-aortic vessel engagement (during diagnostic as well as interventional procedures) within 2 years, of which at least 100 as the primary operator. 2.At least 75 carotid stenting procedures, of which at least 50 as the primary operator, within a 2-year fellowship. Recommendation 11: Grade GPP [C] The minimum requirement to maintain technical skill (competence) is the number of 50 carotid stenting procedures performed and documented by each primary operator per year. Stroke.2006; 37: CAS: First Consensus Document of the ICCS-SPREAD Joint Committee

35 Vascular and Endovascular Surgery Unit - University of Siena THE IMPORTANCE OF A CORRECT LEARNING CURVE We need to be TRAINED !!!

36 Vascular and Endovascular Surgery Unit - University of Siena Vascular surgeon CAS CEA 2000 – Future in doubt Which was the future for a Vascular Surgeon?

37 Vascular and Endovascular Surgery Unit - University of Siena Carotid Artery Stenting in a single center: are six years of experience enough to achieve the standard of care? Setacci C, Chisci E, de Donato G, Setacci F, Sirignano P, Galzerano G. Eur J Vasc Endovasc Surg Sep

38 Vascular and Endovascular Surgery Unit - University of Siena During these eight years we observed a drastic drop in the number of CEA procedures and on the contrary a rapid growth in the number of CAS procedures

39 Vascular and Endovascular Surgery Unit - University of Siena Stroke and death rate at 30 days, from 2000 to 2006 for CAS and CEA As the experience increases (learning curve), the complications decrease…. Siena experience. Setacci C, Chisci E, de Donato G, Setacci F, Sirignano P, Galzerano G. Carotid artery stenting in a single center: are six years of experience enough to achieve the standard of care? Eur J Vasc Endovasc Surg Dec;34(6):655-62

40 Vascular and Endovascular Surgery Unit - University of Siena – Carotidaxis Ourexperience Our experience 2023 CEA (49%) 2190 CAS (51%) elective CAS - 69 urgent CAS elective CEA - 81 urgent CEA

41 Vascular and Endovascular Surgery Unit - University of Siena EARLY OUTCOME Clinical outcomeCAS Events during procedureNo.% Death (any cause)00.00 Major stroke10.05 Minor stroke30.17 TIA90.5 Myocardial Infarction10.05 Cranial neuropathy-- Postoperative Events, at dischargeNo.% Any death procedure related Any death not procedure related Major stroke Minor stroke9 0.5 TIA Myocardial Infarction All neurological complications and death at discharge

42 Vascular and Endovascular Surgery Unit - University of Siena EARLY OUTCOME Events between discharge and 30 daysNo.% Any death procedure related Any death not procedure related Major stroke Minor stroke TIA All TIAs at 30 days Myocardial Infarction at 30 days All neurological complications and death at 30 days38 2.1

43 Vascular and Endovascular Surgery Unit - University of Siena. LONG TERM RESULTS AFTER CAS Belgium-Italian Carotid (BIC) Registry LONG TERM RESULTS AFTER CAS Belgium-Italian Carotid (BIC) Registry G de Donato(1), C Setacci(1), K Deloose(2), P Peeters(3), J Verbist (3), F Castriota(4), A Cremonesi(4), M Bosiers(2) 1 Department of Vascular and Endovascular Surgery, University of Siena, Italy 2 Department of Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium 3 Department of Cardiovascular and Thoracic Surgery of the Imelda Hospital in Bonheiden, Belgium 4 Interventional Cardio-Angiology Unit, Villa Maria Cecilia Hospital, Cotignola (RA), Italy San Diego - June 6 th, 2008

44 Vascular and Endovascular Surgery Unit - University of Siena Belgium-Italian Carotid (BIC) registry 3 highly experienced European centers –M Bosiers, P Peeters et al. Dendermonde/Bonheiden, Belgium. –C Setacci, G de Donato. Siena, Italy. –A Cremonesi, F Castriota. Cotignola, Italy consecutive CAS procedures –February 1997 – July 2006 –133 pt lost at different times during FU –The mean follow-up period was 961 ± 488 days (range ). de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M. Long-term results of carotid artery stenting. J Vasc Surg Dec;48(6):

45 Vascular and Endovascular Surgery Unit - University of Siena RESULTS Freedom from all neurological complication (any stroke +TIA) year Freedom from any stroke/TIA % 392 % 589 % 116 ipsilateral strokes: - 82 disabling - 34 non-disabling 64 TIA 89 %

46 Vascular and Endovascular Surgery Unit - University of Siena RESULTS ISR & Reintervention 94% 96% de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M. Long-term results of carotid artery stenting. J Vasc Surg Dec;48(6):

47 Vascular and Endovascular Surgery Unit - University of Siena Invasive treatment recommendation 2. CAS in symptomatic patients The available level I evidence suggests that for symptomatic patients, surgery is currently the best option [A]. Mid-term stroke prevention after successful CAS is similar to CEA [A]. CAS should be offered to symptomatic patients, if they are at high risk for CEA, in high-volume centres with documented low peri-procedural stroke and death rates or inside an RCT [C].

48 Vascular and Endovascular Surgery Unit - University of Siena Invasive treatment recommendation 3. CAS in asymptomatic patients Meanwhile, it is advisable to offer CAS in asymptomatic patients only in high-volume centres with documented low peri-procedural stroke and death rates or within well-conducted clinical trials [C]. Critical issue The benefit from CAS in asymptomatic patients with carotid artery stenosis is still to be demonstrated.

49 Vascular and Endovascular Surgery Unit - University of Siena Randomized comparison between carotid artery stenting and surgery: time for a moratorium of ethically questionable trials. Marco Roffi, Horst Sievert, Carlo Setacci, Alberto Cremonesi et al. Submitted to EVA-3s, SPACE, and ICCS provide an unfair comparison between CAS and CEA conveyed by the unacceptable and ethically questionable minimal endovascular expertise required in the trials. Those results oppose personal experiences and large scale high-quality CAS registries that have includes several thousands of patients.

50 Vascular and Endovascular Surgery Unit - University of Siena Prospective randomized trials are still running ACT 1800 ptsasymptomatic TACIT 3500 pts asymptomatic CAS+BMT vsCEA+BMTvs BMT CREST2500 ptssymptomatic asymptomatic ACST ptsasymptomatic Highest level of evidence for Carotid Stenting will be established in 2-5 years

51 Vascular and Endovascular Surgery Unit - University of Siena Vascular and Endovascular Surgery Unit - Siena Save the date !

52 Vascular and Endovascular Surgery Unit - University of Siena Thank you for listening

53 Vascular and Endovascular Surgery Unit - University of Siena

54 CMS concluded that because there are no new completed, published randomized trials, and there are two nonsupportive registry studies, there is insufficient evidence to conclude that CAS for asymptomatic patients with carotid artery stenosis ≥ 80% improves health outcomes compared to CEA or optimal medical therapy outside the clinical trial or postapproval study setting.


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