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Arm B: Medical treatment is the mainstay for asymptomatic high grade carotid stenosis

Management of Asymptomatic High Grade Carotid Stenosis. Arm B: Medical treatment is the mainstay for asymptomatic high grade carotid stenosis. Joseph J. Naoum , MD, FACS, RPVI Assistant Professor of Surgery Lebanese American University Division of Vascular & Endovascular Surgery

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Arm B: Medical treatment is the mainstay for asymptomatic high grade carotid stenosis

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  1. Management of Asymptomatic High Grade Carotid Stenosis Arm B: Medical treatment is the mainstay for asymptomatic high grade carotid stenosis Joseph J. Naoum, MD, FACS, RPVI Assistant Professor of Surgery Lebanese American University Division of Vascular & Endovascular Surgery University Medical Center Rizk Hospital Beirut, Lebanon joseph.naoum@umcrh.com +961 76933937

  2. Is NOT wet

  3. Medical management: • Antiplatelet therapy with high dose aspirin only. • Treatment of hypercholesterolemic patients. • Diabetic management • NO DETAILS ON THE OUTCOMES OF THERAPY (HA1C, HTN, CHOL, TRIG, Metabolic syndrome) • Perioperative major stroke and death ≤ 2.1 %

  4. Medical Management: • 325 mg Aspirin • Risk factor reduction counseling • NO DETAILS ON THE OUTCOMES OF THERAPY (HA1C,HTN, CHOL, TRIG, Metabolic syndrome) Stroke. 1989;20:844-849

  5. All MEDICAL patients received Aspirin 330 mg and 75 mg dipyridamole (Asasantin) three times daily for the duration of the 3 year follow-up.

  6. Essentially, the early trials we base our current standard of care therapy used a small water hose (best medical therapy) to put out a large fire (prevent a stroke)

  7. …..and don’t forget that CEA always had medical therapy Guay J, Ochroch EA. J cariothoracVascAnest2012;26(5):935-44

  8. BEST Medical Therapy has changed and evolved since ACAS and NASCET

  9. A randomized, blinded, trial of clopidogrel versus aspirin in patients at risk of ischemic events (CAPRIE) • 19,185 patients, with more than 6300 in each of the clinical subgroups, were recruited over 3 years. • Long-term administration of clopidogrel to patients with atherosclerotic vascular disease is more effective than aspirin in reducing the combined risk of ischemic stroke, myocardial infarction, or vascular death. The Lancet 1996; 348(9038): 1329 - 1339

  10. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomized placebo-controlled trial(COMMIT) • Allocation to clopidogrel produced a highly significant 9% (95% CI 3—14) proportional reduction in death, re-infarction, or stroke (2121 [9·2%] clopidogrelvs 2310 [10·1%] placebo; p=0·002). • Adding clopidogrel 75 mg daily to aspirin and other standard treatments significantly reduced the occurrence major vascular events in hospital and should be considered routinely. The Lancet 2005;366(9497): 1607-21

  11. Effect of Simvastatin on eNOS Naoum JJ, Surgery 2004;136:323-328

  12. Effect of Simvastatin on NOS Effect of Simvastatin on eNOS Naoum JJ, Surgery 2004;136:323-328

  13. Plaque Histology Control Simvastatin

  14. Atherosclerotic Plaque Rupture • Trigger for plaque rupture: • Endothelial vasodilator dysfunction. • Paradoxical vasoconstriction. • Enhanced endothelial stimulation by apoptotic stimuli. Improvement in endothelial dysfunction precedes regression of atherosclerosis. Hoffman J et al.Circ Res 2001;89:709-715.

  15. STATIN Therapy • Statin therapy is associated with a 25% risk reduction of fatal and non fatal stroke. • Statin therapy is safe and is associated with significant reduction of the First stroke. Straus S, et al. JAMA 2002; 288(11):1388-95

  16. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomized placebo-controlled trial. • There were highly significant reductions for non-fatal or fatal stroke (p<0.0001) • Adding simvastatin to existing treatments safely produces substantial additional benefits for a wide range of high-risk patients, irrespective of their initial cholesterol concentrations. • Allocation to 40 mg simvastatin daily reduced the rates of myocardial infarction, of stroke, and of revascularization by about one-quarter. • After making allowance for non-compliance, actual use of this regimen would probably reduce these rates by about one-third. • Lancet. 2002 ;360(9326):7-22.

  17. Fulcher J, Keech A. TherAdv Chronic Dis 2012; 3(5): 201–210

  18. Control HYPERTENSION • “The more the blood pressure is lowered, the greater the number of strokes that are prevented (RR 0.8 CI 0.65-0.98)” • Heart Outcomes Prevention Evaluation study (HOPE) compared ACE inhibitor with placebo in patients at high risk for cardiovascular events. • 32% reduction in the risk of stroke Yusuf S, et al. NEJM 2000; 342: 145-53 Neal B, et al. The Lancet 2000;356:1647-53

  19. Framingham Heart Study:Scoring for risk of first stroke within 10 years for SMOKERS aged 55-85 years • Smoking doubles the risk of stroke. • Risk of stroke decreases after cessation of smoking. • The elevated risk associated with smoking disappeared after 5 years independent of patient’s age. Straus S, et al. JAMA 2002; 288(11):1388-95 Vermeer SE, et al. Stroke2006; 37(6): 1413–1417 2006. Kawachi L, et al. JAMA 1993; 269:232-36

  20. We need to maximize and add new therapies to the previous standard • Medical therapy has evolved and new standards have emerged

  21. What do Clinical Trials Tell Us? • The strength of these conclusions [CEA is better] have been questioned, based on the relatively modest medical therapy arm which did not reflect contemporary medical management. • The question of whether modern medical therapy (ie: including statins, Plavix, BP control) is equivalent or superior to CEA or CAS has not yet been addressed by well-designed, appropriately funded, prospective, multicenter and randomized trials. Reiff T, et al. Int J Stroke 2009;4:294-9. Bunch CT, et al. Semin Vasc Surg 2004;17:209-13.

  22. Thank you

  23. REBUTTAL

  24. Current Guidelines (NASCET/ACAS) follow “old” data before 1993!! Publications USE of PLAVIX ± ASA CAPRIE (1996) COMMIT (2005) Nitric Oxide and Atherosclerosis Studies Statins and Stroke year Studies year

  25. Asymptomatic carotid artery stenosis treatment (3 arms): • State of the art medical treatment (BMT) • Protected CAS + BMT • CEA +BMT http://www.space-2.de/de/home/ Interven J Stroke 2009; 4:294-99

  26. Individualize Treatment:A Patient Centered Approach • Neurologically asymptomatic patients with 60% (>70%) diameter stenosis should be considered for CEA for reduction of long-term risk of stroke, provided the patient has a 3- to 5-year life expectancy and perioperative stroke/death rates ≤ 3%. (GRADE 1, Level of Evidence A) Ricotta JJ , et al. J VascSurg 2011;54:E1-E51

  27. Carotid endarterectomy in asymptomatic patients with limited life expectancy • Examined how commonly CEA is performed among asymptomatic patients with limited life expectancy. • Of 12,631 CEAs performed in asymptomatic patients, 2525 (20.0%) were in patients with life-limiting conditions or diagnoses. • The most common conditions were severe chronic obstructive pulmonary disease and American Society of Anesthesiologists Class IV designation. • Patients with life-limiting conditions had significantly higher rates of perioperative complications, including stroke (1.8% versus 0.9%, P<0.001), death (1.4% versus 0.3%, P<0.001), and stroke/death (2.9% versus 1.1%, P<0.001). Even after adjustment for other comorbidities, patients with life-limiting conditions were nearly 3 times more likely to experience perioperative stroke or death than those without these conditions (OR, 2.8; 95% CI, 2.1-3.8; P<0.001). Wallaert JB, et al. Stroke. 2012;43(7):1781-7.

  28. Randomized trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST) • Carotid endarterectomy is indicated for most patients with a recent non-disabling carotid-territory ischemic event when the symptomatic stenosis is greater than about 80%. • Age and sex should also be taken into account in decisions on whether to operateor not. Lancet. 1998 ;351(9113):1379-87.

  29. Individualize Treatment:A Patient Centered Approach • Maximize medical therapy • ASA • Plavix • Statin • Diabetic control (HA1C) • HTN control • Smoking cessation • Evaluate risk of surgery • Metabolic syndrome • Coronary history • Pulmonary issues • Co-morbidities BEST MEDICAL THERAPY + TREATMENT

  30. Thank you

  31. What do I Do?

  32. Thank you

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