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Palermo 27 October, 2009

Milan – September 29. Palermo 27 October, 2009. CAS: present and future. Carlo Setacci, Gianmarco de Donato. Vascular and Endovascular Surgery Unit University of Siena Siena - Italy. Is there a future for Carotid Stenting?. Points of view. EVIDENCE BASED MEDICINE.

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Palermo 27 October, 2009

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

  2. Is there a future for Carotid Stenting? Points of view EVIDENCE BASED MEDICINE SELF EVIDENCE MEDICINE

  3. Pointsofview: Selfevidence medicine In recent years CAS has rapidly gained recognition worldwide in high volume centers General feeling of CAS → at least equivalent to CEA

  4. Level I scientific evidence Based on well conducted randomized controlled Trials Level 4. Expert opinion, GPP

  5. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000515 Cochrane systematic review. Stroke. 2009; 40(4):1373-1380

  6. 7 completed RCTs (CAS vs CEA or BMT) involving 941 patients, - CAVATAS-CEA 2001; - CAVATAS-MED 2007; - Kentucky 2001; - Kentucky 2004; - Beijing 2003; - BACASS 2006 - TESCAS-C 2006. 5further RCTs were stopped early (2286 patients) - Leicester 1998; - Wallstent 2001 - SAPPHIRE 2004; - EVA-3S 2006; - SPACE 2006; Single center < 100 pz Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000515

  7. Death or anystrokewithin 30 days Cochrane systematic review. Stroke. 2009; 40(4):1373-1380 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. SecondaryOutcomes Cochrane systematic review. Stroke. 2009; 40(4):1373-1380 Death or disabling stroke within 30 days Death within 30 days Death or stroke or MI within 30 days Stroke within 30 days 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).

  9. CochraneSystematicReview: Update 2009 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. 2009 Apr;40(4):1373-80. Epub 2009 Feb 19

  10. “…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” Lancet Neurol. 2009 Published online August 29, 2009 DOI:10.1016/S1474-4422(09)70230-3

  11. 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 405.201)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 405.201)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. Since randomized clinical trials are considered the gold standard of clinical investigation, it appears foolish at first sight to challenge them. minimal endovascular experience required to enroll patients in RCTs

  13. 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

  14. Milestones • 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. • FDA approval • CMS reimbursement

  15. Stenting and AngioplastywithProtection in Patients at High Riskfor Endarterectomy The Sapphire Trial Minimal requirement in terms endovascular experience: - Documented CAS periprocedural death or stroke rate <6%. - No tutor-assisted procedures allowed. Stroke/MI/death @30 CAS 5.8% CEA 12.6% Differenceof3.4% PRO-CAS n = 151 n =156

  16. CAVATAS Training in neuroradiology and angioplasty (but not necessarily in the carotid artery) required. Tutor-assisted procedures allowed. Randomisation finished in 1997 any stroke lasting more than 7 days, or death 10.0% CAS 9.9% CEA PTA alone in 74% No cerebralprotection Lancet 2001; 357: 1729-37

  17. CAVATAS (10 y Follow-Up) Pts enrolled from March 1992 to July 1997. Follow-up to 2007 (Median length of follow-up in both groups was 5 years - IQR 2–6) Lancet Neurol 2009 Aug; 8: 898-907

  18. Isthere a future? Long termresults 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. de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M. Long-term results of carotid artery stenting. J Vasc Surg. 2008 Dec;48(6):1431-40

  19. CAVATAS (10 y Follow-Up) • Only 26% stenting • How was restenosis calculated? Lancet Neurol 2009 Aug; 8: 898-907

  20. Restenosis? Which velocity parameters can we use for Intra-Stent-Restenosis (ISR) diagnosis?

  21. …Velocity parameters used for native carotid arteries… Strandness Criteria

  22. Stroke. 2008;39:1189-96

  23. The most effective cerebral protection for symptomatic in-stent restenosis is a further endovascular treatment ISR = <2% 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: 601-607 Cutting Balloon Angioplasty

  24. Milestones • ICSS (Still pending the full report of the results) • EVA 3S • SPACE • SAPPHIRE IP 44,16 IP 23,40

  25. 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

  26. Recent Trials Track record 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 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 . Nervenarzt. 2007;78(10):1130-1137

  27. 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

  28. CAVATAS ICSS Brown MM. Safety Results of the ICSS Study. Presented at the European Stroke Conference, Stockholm, Sweden, May 2009.

  29. ICSS Symptomatic (within 6 months) stenosis >50% 50 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 Brown MM. Safety Results of the ICSS Study. Presented at the European Stroke Conference, Stockholm, Sweden, May 2009.

  30. ICSS soft requirements in terms of endovascular experience ! 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):69-74.

  31. ICSS Still pending the full report of the results Stroke/death @30 CAS 7.6% CEA 3.9% PRO-CEA Differenceof3.7% n = 857 n = 853 Brown MM. Safety Results of the ICSS Study. Presented at the European Stroke Conference, Stockholm, Sweden, May 2009.

  32. Stroke.2006; 37: 2400-2409 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

  33. CAS: First Consensus Document of the ICCS-SPREAD Joint Committee 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: • 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. • 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: 2400-2409

  34. We need to be TRAINED !!! THE IMPORTANCE OF A CORRECT LEARNING CURVE

  35. 2000 – Future in doubt CEA Vascular surgeon CAS Which was the future for a Vascular Surgeon?

  36. 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. 2007 Sep

  37. 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

  38. 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. 2007 Dec;34(6):655-62

  39. Our experience Our experience Our experience 15.12.2000 – 30.08.2009 4213 Carotid axis 2023 CEA 2190 CAS (49%) (51%) -1942 elective CEA - 81 urgent CEA -2121 elective CAS - 69 urgent CAS

  40. EARLY OUTCOME

  41. EARLY OUTCOME

  42. . San Diego - June 6th, 2008 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

  43. 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. • 3179 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 365-2863). de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M. Long-term results of carotid artery stenting. J Vasc Surg. 2008 Dec;48(6):1431-40

  44. RESULTS Freedomfromallneurologicalcomplication (anystroke+TIA) • 116 ipsilateral strokes: • 82 disabling • 34 non-disabling • 64 TIA 89 %

  45. RESULTS ISR & Reintervention 96% 94% de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M. Long-term results of carotid artery stenting. J Vasc Surg. 2008 Dec;48(6):1431-40

  46. 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].

  47. 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.

  48. Submitted to 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. 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.

  49. Prospective randomized trials are still running ACT 1800 ptsasymptomatic TACIT 3500 ptsasymptomatic CAS+BMTvsCEA+BMTvs BMT CREST 2500 ptssymptomatic asymptomatic ACST 2 5000 ptsasymptomatic HighestlevelofevidenceforCarotid Stenting willbeestablished in 2-5 years

  50. Save the date ! Vascular and Endovascular Surgery Unit - Siena

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