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Endovascular challenges for the next decade

6. 5. 4. 3. Endovascular challenges for the next decade. The ART of endovascular therapy. The way to your heart!. Brachial approach. Radial approach. Femoral approach. PCI in the treatment of AMI. Occluded RCA Aspiration of thrombus Direct stenting Nice result. Rotablator.

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Endovascular challenges for the next decade

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  1. 6

  2. 5

  3. 4

  4. 3

  5. Endovascular challenges forthe next decade

  6. The ART of endovascular therapy

  7. The way to your heart! Brachial approach Radial approach Femoral approach

  8. PCI in the treatment of AMI Occluded RCA Aspiration of thrombus Direct stenting Nice result

  9. Rotablator ELCA Laser IABP Current affairs >45 Clinical trials High-technological diagnostic tools Virtual Histology Palpography High-technological therapeutical tools

  10. Act from the heart…

  11. …work on the brain

  12. Treatment of carotid stenosis • Goal • Prevention of stroke • Means • Carotid endarterectomy (CEA) • Carotid artery stenting (CAS)

  13. Carotid Endarterectomy (1) • Carotid Endarterectomy • >50 years • Peri-operative combined mortality and major stroke risk is 2 – 5% (6.5% in NASCET) • Indicatons • Symptomatic patients + 70-99% stenosis (NNT 6 to prevent 1 major stroke at 2 years) • Symptomatic patients + >60% stenosis still benefit, but less • NASCET (North American Symptomatic Carotid Endarterectomy Trial) • Asymptomatic patients + >75% stenosis • ACST (European asymptomatic carotid surgery trial)

  14. Carotid Endarterectomy (2) • Contra-indications • Complete internal carotid artery obstruction (because the intraluminal thrombus then extends too far downstream, well into the intracranial portion of the artery, for endarterectomy to be successful) • Previous stroke on the ipsilateral side with heavy sequelae because there is no point in preventing what has already happened • Patient deemed unfit for the operation by the anaesthesiologist

  15. Carotid Endarterectomy (3) The long term benefits of carotid endarterectomy for both symptomatic and asymptomatic patients need to be weighed against the immediate risk of complications of the procedure, thus benefit is tangible only in the presence of a low perioperative complication rate. The surgical procedure should be performed by an experienced surgeon with good patient selection and as such continues to be the gold standard

  16. A good stent is as good as a good endarterectomy Horst Sievert, MD

  17. Stent trials CAVATAS SAPPHIRE EVA-3S SPACE

  18. CAVATAS Carotid and Vertebral Artery Transluminal Angioplasty Study The Lancet 2001; 357: 1729-1737

  19. Study design 504 patients with carotid stenosis Endovascular treatment (n=251) Carotid endarterectomy (n=253) Exploratory Trial 26% stents (n=55) 74% balloon angioplasty (n=158)

  20. Outcome

  21. Conclusion Endovascular treatment had similar major risks and effectiveness at prevention of stroke during 3 years compared with carotid surgery, but with wide CIs. Endovascular treatment had the advantage of avoiding minor complications. PS: Distal emboli-protection devices were not routinely used

  22. SAPPHIRE Protected Carotid-Artery Stenting versus Endarterectomy in High-Risk Patients N Engl J Med Volume 351;15:1493-1501 October 7, 2004

  23. Study design 334 high risk patients with carotid stenosisSymptomatic + 50% or Asymptomatic + 80% stenosis Endovascular treatment (n=167) Carotid endarterectomy (n=167) Noninferiority trial 100% Distal emboli-protection devices

  24. Major eligibility criteria

  25. At 30 days At 1 Year Cumulative Incidence of Adverse Eventsat 30 days and within 1 Year ?

  26. Conclusions Among patients with severe carotid-artery stenosis and co-existing conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy. Therefore, the less invasive approach may be an acceptable alternative among patients with high-risk carotid-artery stenosis.

  27. EVA-3S Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis N Engl J Med, Volume 355(16):1660-1671, October 19, 2006

  28. Study design 527 patients with carotid stenosis ≥60% + Σ Endovascular treatment (n=247) Carotid endarterectomy (n=257) Noninferiority trial 91.1% Distal emboli-protection devices (change in protocol during study – 1/3 without recommendation)

  29. EVA-3S Primary Endpoint @ 30d Carotid Stenting vs Endarterectomy Endpoint RR (95% CI) unadjusted Stenting (n=261) Relative Risk ± 95% CI CEA (n=259) p-value Death 1.2% 0.8% 0.7 (0.1-3.9) 0.68 Stroke 0.004 2.7% 8.8% 3.3 (1.4-7.5) Death/Stroke 9.6% 3.9% 2.5 (1.2-5.1) 0.01 Mas JL et al. N Engl J Med 2006 Stenting better CEA better

  30. EVA 3S What was different from the other trials?

  31. EVA-3S • Initially embolic protection was optional • 5/20 pts without embolic protection suffered from a stroke! • Experienced Surgeons, unexperienced Interventionalists • Surgeons: >25 endarterectomies /year • Interventionalists: • Only 12 carotid stenting procedures were required • Regardless of the result • Some operators were even in training phase!

  32. EVA-3S • Unexperienced centers • 1.7 pts/year • Aspirin + Plavix was not mandatory • Not prescribed in 15% ! • 2.4 % did not receive heparin! • Patients with high surgical risk were excluded • But patients with high stent risk not!

  33. SPACE Stent-Protected Angioplasty versus Carotid Endarterectomy Lancet 2006;368:1239-47

  34. Study design 1900 patients with carotid stenosis ≥70% + neurological symptoms Stopped premature at 1200 ptn Carotid stenting (n=605) Carotid endarterectomy (n=595) Noninferiority trial 27% Distal emboli-protection devices

  35. SPACE • Trial stopped after the second interim-analysis (n=1200) • Patient recruitment too slow • Funding too low • Statistical power too low (37% chance for false negative conclusion)

  36. SPACEPrimary Endpoint: Ipsilateral Stroke and Death @ 30 Days n.s.

  37. SPACEPrimary Endpoint: Ipsilateral Stroke and Death @ 30 Days

  38. SPACE • "SPACE failed to prove non-inferiority of stenting compared with endarterectomy" • No significant difference regarding the primary end-point • No significant differences between CAS and CEA • Regarding secondary endpoints • Subgroups

  39. SPACE: Important to know • Many centers/investigators had problems to fulfill the entrance criteria • Which were low! • Only 25 carotid stent procedures! • Limited availability of embolic protection devices (only few were allowed) • Some operators had limited experience with those embolic protection devices allowed in the trial • 73% of CAS performed without embolic protection

  40. SPACE: Important to know • Not included as end-points (primary or secondary) • Myocardial infarction • Contralateral stroke • Cranial nerve palsy • Length of hospital stay • Other MAE • Again, patients with high surgical risk were excluded but not patients with high stenting risk

  41. SPACE: Important to know • Complete data monitoring in only 10% of the patients in each centre • Trial stopped early • Large pt numbers but still underpowered

  42. Don’t judge too quickly

  43. SPACE did not show a difference between surgery and stenting, but imagine … • … an excellent clinical trial • with experienced operators • randomized • controlled/monitored • multicenter • including all relevant endpoints • well powered • would show superiority of carotid surgery compared to stenting

  44. Then we would have the same situation as with coronary stenting • We have a number of excellent clinical trials PCI versus CABG • with experienced operators • randomized • controlled/monitored • multicenter • including all relevant endpoints • well powered • Showing superiority of CABG compared to PCI and coronary stenting

  45. Why is that? Number of PCIs goes up, number of CABG goes down! Nobody cares!

  46. Take Home Messages • In high grade carotid stenoses surgery is better than medical therapy • The results of stent implantation are comparable to the results of surgery • Therefore stent implantation is a treatment option in high grade stenosis • EVA 3S and SPACE have shown again that stenting requires training and experience • Nobody wants surgery

  47. Why should we stay behind? We could start with a n adjusted screening program

  48. Patient selection All specifically referred patients + All patients send for coronarography and/or left-right catheterization, who are planned for CABG and/or valve surgery

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