Fundación Favaloro
Transcription
Fundación Favaloro
Revascularización en la enfermedad carotidea sintomática ¿La resurrección de la angioplastia? Gaspar Caponi Editor para el sitio web de SOLACI Staff Cardiología Intervencionista Hospital Universitario – Fundación Favaloro Buenos Aires - Argentina Octubre 2015 Fundación Favaloro Fundación Favaloro Symptomatic Carotid Stenosis Event Risk by lesion severity NASCET. NEJM 1991, 325:445-453 Fundación Favaloro Risk of Stroke after warning TIA / Minor Stroke Coull AJ et al, BMJ 2004;328:326 Fundación Favaloro Absolute Risk Reduction (ARR) conferred by CEA in the 5-year risk of Ipsilateral Ischemic Stroke / Death NACSET & ECST Pooled data (2003) Fundación Favaloro http://www.mdcalc.com/abcd2-score-for-tia Fundación Favaloro ABCD2 score ≥4 ABCD2 score <4 NICE Guidelines Fundación Favaloro The risk benefit ratio & NNT Performing CEA or CAS with a 10% risk within 14 days will prevent approximately 150 strokes at 5 years per 1000 CEAs or CAS. By contrast, if one were to defer CEA/CAS until 4 weeks had elapsed and then undertake that intervention with a 3% risk, only 100 strokes would be prevented. Fundación Favaloro A Systematic Review of Randomized Controlled Trials for Symptomatic Carotid Stenosis Pooled analysis of 6,092 pts from NASCET, ECST, and VACSP trials evaluating CEA vs. medical therapy alone. • CEA was of the most benefit in pts with 70-99% stenosis (risk reduction of 16% for ipsilateral ischemic stroke; P < 0.001). • Male sex (P = 0.003), age older than 75 (P = 0.03), and time delay less than 2 weeks from ischemic event to surgery (P = 0.009) were all associated with reduced risk of ipsilateral stroke with CEA. Conclusion: Benefit from CEA depends not only on the degree of carotid stenosis but also on several other factors, including delays to surgery. Rerkasem K, et al. Stroke 2011 Fundación Favaloro Are There Patients at High Risk for CEA? Anatomic High Risk Criteria Surgically Inaccessible Contralateral Occlusion Restenosis after CEA Previous Radiation to Carotid Area Ipsilateral Radical Neck Dissection Obese/Short Neck Spinal Immobility due to Arthritis Tracheostoma High Risk Co-morbidities Advanced age (>75-80) UA Recent MI (4-6 weeks) Abnormal stress test or 2-vessel CAD LVEF < 30-35% or NYHA Class IIIIV HF Dialysis dependent renal failure Severe COPD Need for CABG or valve surgery Need for vascular surgery Fundación Favaloro A Clinical Rule to Select Patients for Stenting vs. CEA Data from 170 observational studies used to create clinical rule known as SCAR (sex, contralateral occlusion, age, and restenosis). In validation study of over 3,000 patients, those who were SCAR-positive had higher risk of procedural stroke/death with CAS vs. CEA (RR 2.44; 1.71-3.48; P = 0.83). Similar results were seen in sensitivity analysis considering all 4 risk factors as equivalent. Contralateral occlusion or restenosis, women (but not men) aged < 75 years had lower risk with CAS vs. CEA. Conclusion: A simple rule incorporating 4 clinical risk factors may help clinicians choose between CAS and CEA. Touzé E, et al. Stroke.2013 Fundación Favaloro Fundación Favaloro Safety of Stenting and Endarterectomy by Symptomatic Status in the CREST Trial Subanalysis of 1,181 asymptomatic and 1,321 symptomatic patients. Conclusion: Carotid artery stenting or endarterectomy produce similar overall outcomes within asymptomatic and symptomatic subgroups. Silver FL, et al. Stroke. 2011. Fundación Favaloro CREST: Similar mortality to 4 years Fundación Favaloro CREST: Similar freedom from ipsilateral stroke day 31 to 4 years Fundación Favaloro Why Didn’t CREST End the Debate? Surgeons feel that CEA reduced stroke risk more than CAS and excess MI rate with CEA less of an issue. Interventionists feel that CAS performed as safely as CEA, excess stroke risk was minor stroke only and MI risk of CEA is important. Neurologists feel that although outcomes were low, medical therapy is more effective than any revascularization. Fundación Favaloro Long-term mortality: No association with minor stroke Strong association with MI Fundación Favaloro Long-term Outcomes After Stenting vs CEA for Treatment of Symptomatic Carotid Stenosis ICSS: 1,713 patients randomized to CAS (n = 855) or CEA (n = 858) at 50 centers worldwide, 2001-2008. Conclusion: Long-term data on symptomatic patients demonstrate similar rates of fatal or disabling stroke between CAS and CEA. Bonati LH, et al. Lancet.2014. Fundación Favaloro Long-term Follow-up of Endarterectomy vs Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) Trial 527 randomized patients followed for a median of 7.1 years. Conclusion: Despite higher early risk of stroke with CAS vs CEA, in the long run, both treatments provide similar stroke protection. Mas J-L, et al. Stroke. 2014. Fundación Favaloro Real world outcomes for symptomatic high risk patients: AHA guidelines met or exceeded by >500 operators N=589 Fundación Favaloro Impact of Symptoms, Gender, Comorbidities, and Operator Volume on Outcomes of CAS Data from Nationwide Inpatient Sample on 13,564 patients who underwent carotid stenting, 2006-2010. Postprocedural mortality (0.5%), complications (8%) low overall but higher in symptomatic patients and women. Higher annual operator volumes (threshold of ≥ 5 cases) were predictive of lower mortality and complications. High operator volume also associated with shorter hospital stay and lower cost. Badheka AO, et al. Am J Cardiol.2014. Fundación Favaloro Carotid Angioplasty – Fundación Favaloro Experience October 1995 – October 2015 In-Hospital Results related to previous symptoms: n=877 Symptom 21 Asymptom 69 p With Distal Protection % 80 88.5 0.003 Procedure Success % Major Stroke % Minor Stroke % 93 3.9 2.6 97.3 0.4 1.6 0.01 0.006 0.3 TIA % 3.5 0.6 0.005 Death (non-related to carotid stenting) Related Death Any Stroke or All Death % Any Stroke or Related-Death % 0.5 6.9 6.5 0.8* 0.2 2.4* 2.1 1 1 0.007 0.005 Number of Procedures % •non-related death. CV surgery the same day. # 9 cases in feasibility studies of new stent or Angioguard Fundación Favaloro Conclusions Early intervention after index event (especially cortical) may be risk-associated but will benefit the individual & society in the longer term. CAS performed within two weeks of event is feasible – and may be safe - more work is required. These are the results from experienced CAS units & might not be extrapolated to less experienced units Fundación Favaloro