CAROTID ANGIOPLASTY & STENT PLACEMENT VS. CAROTID ENDARTERECTOMY

Transcription

1 CAROTID ANGIOPLASTY & STENT PLACEMENT VS. CAROTID ENDARTERECTOMY Gustavo J. Rodriguez, MD Associate Professor. Neurology Department Texas Tech Health Sciences Center. Paul L. Foster School of Medicine

2 Disclosures - Consultant for Covidien.

3 Patient category Prevalence General population 2%-18% Patients with ischemic stroke or TIA Anticipating open heart surgery Peripheral vascular disease Post-radiation therapy for head or neck cancer 10%-20% 8%-21% 15%-37% 12%-35% J Neuroimaging Jan;17(1):19-47.

4 CAROTID ENDARTERECTOMY (CEA) - First case was in First randomized trials were negative - Operators continued to perform this procedure with lower complication rates - In 1971 there were 15,000 procedures performed in the USA, 107,000 in A negative trial about extracranial-intracranial bypass led to the NASCET (1991)

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6 NASCET N Engl J Med 1991;325:445-53

7 659 pts. IS or TIA 70%-99% Carotid Endarterectomy (n=328) Medical management (n=331) Ipsilateral Stroke /2-yrs 9% Ipsilateral Stroke /2-yrs 26% N Engl J Med 1991;325:445-53

8 N Engl J Med 1991;325:445-53

9 N Engl J Med 1998;339:

10 858 pts. IS or TIA 50%-69% Carotid Endarterectomy (n=428) Medical management (n=430) Ipsilateral Stroke /5-yrs 16% Ipsilateral Stroke /5-yrs 22% N Engl J Med 1998;339:

11 N Engl J Med 1998;339:

12 N Engl J Med 1998;339:

13 1662pts. 60%-99% Carotid Endarterectomy (n=825) Medical management (n=834) Ipsilateral Stroke /5-yrs 5.1% Ipsilateral Stroke /5-yrs 11% JAMA 1995, 273:

14 CAROTID ENDARTERECTOMY MORTALITY IN THE MEDICARE PATIENTS Venue 30 day mortality NASCET 0.6% ACAS 0.1% Trial hospital in non-trial patients 1.4% Non-trial hospital (high volume >21 CEA/yr) Non-trial hospital (average volume 7-21/yr) Non-trial hospital (low volume <7/yr) 1.7% 1.9% 2.5% JAMA 1998;279:

15 CAROTID ANGIOPLASTY AND STENT (CAS) - First case in First randomized trials comparing with CEA negative - Operators continued to perform this procedure with lower complication rates - Between 2005 and 2009 around 80,000 cases were performed in the USA - The debate led to the development of the CREST (2010)

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17 N Engl J Med 2004;351:

18 N Engl J Med 2004;351:

19 N Engl J Med 2004;351:

20 Randomized (n=307) CAS (n=156) CEA (n=151) 30 Day Stroke, MI Death 5.8% 30 Day Stroke, MI Death 12.6% N Engl J Med 2004;351:

21 Randomized (n=307) CAS (n=156) CEA (n=151) 1-12 months Stroke, MI Death 11.9% 1-12 months Stroke, MI Death 19.9% N Engl J Med 2004;351:

22 SAPPHIRE CAS: a good alternative for CEA in patients with symptomatic moderate-severe stenosis and severe asymptomatic extracranial carotid artery stenosis that are deemed high surgical risk (non STEMI under GA) What about non high surgical risk patient?

23 COMPARATIVE ANALYSIS OF LARGE RANDOMIZED TRIALS: CAS VS. CEA Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) 30 centers in France Any stroke or death within 30 days after treatment Stent-Protected Angioplasty versus Endarterectomy (SPACE) 35 centers in Germany, Austria, and Switzerland Ipsilateral ischemic stroke or death from randomization to 30 days after procedure International Carotid Stenosis Study (ICSS) 50 centers in Europe, New Zealand, Australia and Canada Any disabling or fatal stroke at long term (3 years)

24 RANDOMIZED TRIALS COMPARING CEA AND CAS EVA-3S SPACE ICSS CAS CEA CAS CEA CAS CEA PTS Sx 100% 100% 100% 100% 100% 100% MEN 78% 72% 72% 72% 70% 71% CN 1.1% 7.7% NA NA 0.1% 5% END 9.6% 3.9% 6.8% 6.3% NA NA 30-day 9.6% 3.9% 7.7% 6.5% 7.6%* 4.0%* 30-day=Composed of any stroke death at 30 days post-procedure AP=antiplatelets. *= includes MI

25 RANDOMIZED TRIALS COMPARING CEA AND CAS EVA-3S SPACE ICSS DPD Optional Man datory Optional Optional Dual AP Recommended Mandatory Recommended DPD, distal protection device Dual AP, dual antiplatelet

26 N ENGL J MED 2010;36:11-23

27 N Engl J Med 2010;36:11-23

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37 Lancet Neurol 2012; 11:

38 Lancet Neurol 2012; 11:

39 CREST: Similarity in the Primary Endpoint driven by differences in perioperative stroke and MI - CEA and CAS have similar net outcomes however, lower stroke with CEA and lower MI with CAS - Younger patients may benefit from CAS and older patients may benefit from CEA - At experienced centers both CEA and CAS appear to have low perioperative complications and similar excellent long term results

40 EVIDENCE BASED MEDICINE J Vasc Surg 2012;56:317-23

41 EVIDENCE BASED MEDICINE Classes of Recommendations Class I: Evidence for and/or general agreement that the treatment is useful and effective Class II: Conflicting evidence and/or a divergence of opinion about usefulness/efficacy of a treatment IIa: Weight of evidence or opinion is in favor of the treatment. IIb: Usefulness is less well established by evidence or opinion. Class III: Evidence and/or general agreement that the treatment is not useful and in some cases may be harmful American Heart Association

42 EVIDENCE BASED MEDICINE Levels of evidence Level A : Multiple populations. Data derived from multiple randomized controlled trials (RCT) Level B: Limited populations. Data derived from single RCT or nonrandomized studies Level C: Limited populations. Consensus opinion of experts American Heart Association

43 EVIDENCE BASED MEDICINE Patients at average or low surgical risk who experience nondisabling IS or TIA, including hemispheric events or amaurosis fugax, within 6 months (symptomatic patients) should undergo CEA if the diameter of the lumen of the ipsilateral ICA is reduced >70% as documented by noninvasive imaging (Class I, Level of Evidence: A) or >50% as documented by catheter angiography (Class I, Level of Evidence: B) and the anticipated rate of perioperative stroke or mortality is <6%. Stroke Aug;42(8):e420-63

44 EVIDENCE BASED MEDICINE CAS is indicated as an alternative to CEA for symptomatic patients at average or low risk of complications associated with endovascular intervention when the diameter of the lumen of the internal carotid artery is reduced by >70% as documented by noninvasive imaging or >50% as documented by catheter angiography and the anticipated rate of periprocedural stroke or mortality is <6%. (Class I, Level of Evidence B) Stroke Aug;42(8):e420-63

45 EVIDENCE BASED MEDICINE Selection of asymptomatic patients for carotid revascularization should be guided by an assessment of comorbid conditions, life expectancy, and other individual factors and should include a thorough discussion of the risks and benefits of the procedure with an understanding of patient preferences. (Class I, Level of Evidence C) Stroke Aug;42(8):e420-63

46 EVIDENCE BASED MEDICINE It is reasonable to choose CEA over CAS when revascularization is indicated in older patients, particularly when arterial pathoanatomy is unfavorable for endovascular intervention. (Class IIa, Level of Evidence B) Stroke Aug;42(8):e420-63

47 EVIDENCE BASED MEDICINE It is reasonable to perform CEA in asymptomatic patients who have >70% stenosis of the ICA if the risk of perioperative stroke, MI, and death is low. (Class IIa, Level of Evidence A) Stroke Aug;42(8):e420-63

48 EVIDENCE BASED MEDICINE It is reasonable to choose CAS over CEA when revascularization is indicated in patients with neck anatomy unfavorable for arterial surgery.(class IIa, Level of Evidence B) Stroke Aug;42(8):e420-63

49 EVIDENCE BASED MEDICINE When revascularization is indicated for patients with TIA or stroke and there are no contraindications to early revascularization, intervention within 2 weeks of the index event is reasonable rather than delaying surgery.(class IIa, Level of Evidence B) Stroke Aug;42(8):e420-63

50 EVIDENCE BASED MEDICINE Prophylactic CAS might be considered in highly selected patients with asymptomatic carotid stenosis (minimum 60% by angiography, 70% by validated Doppler ultrasound), but its effectiveness compared with medical therapy alone in this situation is not well established.(class IIb, Level of Evidence B) Stroke Aug;42(8):e420-63

51 EVIDENCE BASED MEDICINE In symptomatic or asymptomatic patients at high risk of complications for carotid revascularization by either CEA or CAS because of comorbidities, the effectiveness of revascularization versus medical therapy alone is not well established.(class IIb, Level of Evidence B) Stroke Aug;42(8):e420-63

52 EVIDENCE BASED MEDICINE Except in extraordinary circumstances, carotid revascularization by either CEA or CAS is not recommended when atherosclerosis narrows the lumen by less than 50%. (Class III, Level of Evidence A) Stroke Aug;42(8):e420-63

53 EVIDENCE BASED MEDICINE Carotid revascularization is not recommended for patients with chronic total occlusion of the targeted carotid artery. (Class III, Level of Evidence C) Stroke Aug;42(8):e420-63

54 EVIDENCE BASED MEDICINE Carotid revascularization is not recommended for patients with severe disability caused by cerebral infarction that precludes preservation of useful function. (Class III, Level of Evidence C) Stroke Aug;42(8):e420-63

55 CAROTID ARTERY STENTING FOR SYMPTOMATIC SEVERE STENOSIS: PROTOCOL FOR CAROTID ARTERY STENT PROCEDURES PAUL L. FOSTER SCHOOL OF MEDICINE Informed consent signed by all patients or patient s relative The degree of stenosis was measured according NASCET criteria on pre-procedural CTA or cerebral angiogram ASA 325 mg plus Clopidogrel 75 mg 5 days before the procedure Conscious sedation with intravenous Fentanyl and Midazolam Transfemoral approach using the modified Seldinger technique ACT (activated clotting time) over 250 seconds Target lesion was crossed with distal embolic protection device and deployed in the distal cervical ICA (Fig.2A) Predilation balloon angioplasty (Fig.2B) Placement of the nitinol self-expanding Xact carotid Stent system (Fig.2C) IV Medication: Glycopyrrolate2 mg IV (optional/as needed) Postdilation balloon angioplasty (Fig.2D) Distal embolic protection device recaptured Deployment of femoral artery closure device ICU admission for hemodynamic and neurological assessments every 1 hours Dual antiplatelet regimen for 4 weeks

56 DEMOGRAPHICS AND RESULTS Qualifying Event Age Sex Race/Ethnicity Preprocedural NIHSS/mRS Preprocedural stenosis (NASCET) Postprocedural stenosis (NASCET) 30-Day NIHSS/mRS 1 Stroke 52 M White/Hispanic 7/2 70% 30% 6/2 2 Stroke 74 M White/Hispanic 3/2 80% 0% 6/2 3 Stroke 56 F White/not Hispanic 12/2 75% 0% 12/2 4 Stroke 73 F White/not Hispanic 0/1 90% 0% 0/1 5 TIA 81 M White/Hispanic 0/0 70% 0% 0/0 6 Stroke 63 M White/Hispanic 2/1 70% 0% 2/1 7 Stroke 59 M White/Hispanic 0/1 80% 10% 0/0 8 TIA 72 F White/Hispanic 0/0 70% 0% 0/0 9 TIA 66 M White/Hispanic 0/1 90% 0% 0/1 10 Stroke 66 M White/Hispanic 1/1 80% 0% 1/1 *All cases were symptomatic and high surgical risk

57 CAS: EL PASO EXPERIENCE In conclusion, our initial experience with CAS in symptomatic severe ICA stenosis in our new Neurointerventional program at PLFSOM/TTUHSC confirmed that the procedure is safe and contributing to good technical and clinical outcomes

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61 CONCLUSION: Periprocedural outcomes are closely related to the quality and experience of the operator and volumes of the institutions. Improved technology, and rigorous training and credentialing of carotid stenting and carotid endarterectomy operators are key points to assure quality, safety and good outcomes Periprocedural stroke in CAS can be low with good patient selection. For instance, elderly patients (especially older than 70 years of age) with concomitant severe vascular tortuosity and severe vascular calcifications are at higher risk for CAS. High surgical risk patients may benefit from CAS. Advances in medical therapy and quality of intra and Postprocedural care of the carotid revascularized patient also account for a good outcome. Both CAS and CEA are durable procedures with low re-stenosis rates.

62 Category Symptomatic ( 50%-99%) Asymptomatic ( 60%-99%) Ancillary characteristi cs High surgical risk Conventional surgical risk High surgical risk Conventional surgical risk Age strata All Procedure CAS >70 yrs CEA 70 yrs CAS >70 yrs Medical Treatment 70 yrs CAS (in selected pts) >70 yrs CEA 70 yrs CAS

63 ?Medical therapy debated CEA efficacy debated?medical therapy CAS debated Carotid artery disease CEA superior to medical CEA real life debated CAS alternative or superior CAS efficacy debated

64 Thank you!