ESC Congress 2011 SIMULTANEOUS HYBRID REVASCULARIZATION OF CAROTID AND CORONARY DISEASE INITIAL RESULTS OF A NEW THERAPEUTIC APPROACH

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1 ESC Congress 2011 SIMULTANEOUS HYBRID REVASCULARIZATION OF CAROTID AND CORONARY DISEASE IN PATIENTS WITH ACUTE CORONARY SYNDROME: INITIAL RESULTS OF A NEW THERAPEUTIC APPROACH AUTHORS: Marta Ponte 1, RICARDO FONTES-CARVALHO 1, Gustavo Pires de Morais, Alberto Rodrigues 1, Pedro Braga 1, Aníbal Albuquerque 1, Miguel Veloso 2, Luís Vouga 3, Vasco Gama Ribeiro 1 CARDIOLOGY DEPARTMENT GAIA HOSPITAL CENTRE GAIA, PORTUGAL 1 Cardiology Department CHVNG/E 2 Neurology Department CHVNG/E 3 Cardio-Thoracic Surgery Department CHVNG/E

2 Disclosures None to declare

3 Introduction: The magnitude of the problem Atherosclerosis is a systemic disease Simultaneous involvement of multiple vascular territories is frequent: 8 to 14% of CABG patients have significant carotid disease Borger et al. Ann Thorac Surg 1999;68: to 50% of patients undergoing carotid endarterectomy have coronary artery disease Cishek et al. Am Heart J 1996;131: Salasidis et al. J Vasc Surg 1995;21:154 62

4 Introduction: Perioperative Stroke in CABG PERIOPERATIVE STROKE IN CABG Prevalence: % of patients; increases nine-fold the risk of death after CABG Several studies showed an association between the degree of carotid stenosis and perioperative stroke risk: No carotid disease: < 2% Unilateral stenosis (50 to 99%): 3% Bilateral stenosis (50 to 99%): 5% Carotid occlusion: 7 11% Naylor et al. Eur J Vasc Endovasc Surg 2003;25:380-9 Roach et al. N Engl J Med 1996;335: Schwartz et al. J Vasc Surg 1995;21: D Agostino et al. Ann Thorac Surg 1996;62:1714e23

5 Introduction: Simultaneous Carotid and Coronary Disease The therapeutic strategy in patients with indication for CABG and simultaneous carotid disease is not yet fully defined Naylor et al. Eur J Vasc Endovasc Surg 2003;25:380-9 Venkatachalam et al. Heart 2011;97: In spite of the clinical relevance of this problem, there are no randomized clinical trials in this population

6 Introduction: What is Recommended by the Guidelines?

7 Introduction: Choice of Revascularization Method

8 Management Strategies: Simultaneous Carotid and Coronary Disease STAGED APPROACH 1. Carotid Endarterectomy (CEA) followed by CABG 2. Carotid Stenting (CAS) followed by CABG SIMULTANEOUS APPROACH 3. Simultaneous surgery: CEA + CABG 4. Simultaneous Hybrid Revascularization: CAS + CABG

9 Study Purpose AIMS: To evaluate effectiveness and safety of a new therapeutic strategy of simultaneous carotid and coronary revascularization using a combined hybrid procedure in high surgical risk patients

10 Methods: Population Selection Inclusion Criteria: Consecutive patients admitted for ACS with indication for CABG Simultaneous severe carotid disease (70 99% symptomatic or 80 99% asymptomatic stenosis) Logistic EuroSCORE 5 % December 2006 February 2010 Exclusion Criteria: Coagulopathy Allergy / intolerance to heparin, aspirin or clopidogrel Peripheral vascular disease precluding endovascular treatment Ischemic stroke within the previous 4 weeks Ethical Issues All patients provided informed written consent

11 Methods: Population Selection Screening for carotid disease before CABG Instution s Protocol: Age > 65 years Left main disease Peripheral vascular disease Prior stroke / transient ischemic attack (TIA) Carotid bruit Carotid Ultrassonography Multidetector AngioCT (64 slice CT scanner, Somaton Sensation 64, Siemens)

12 Methods: Population Selection Interventional Cardiologist MULTIDISCIPLINARY TEAM Cardiac surgeon Neurologist

13 Procedure Description CAROTID STENTING Precise, Precise PRO Rx (Cordis) (Percutaneous transfemoral approach) CABG Immediate Transfer to the Operating Room Distal Embolic Protection Devices Angioguard RX (Cordis)

14 Methods: Concomitant Therapy CAROTID STENTING CABG POSTOPERATIVE PERIOD Aspirin (100 to 150 mg) UFH (1 mg/kg / ACT s) UFH (additional therapy) Clopidogrel 300 mg bolus and then 75 mg/day (once haemostasis has been achieve)

15 Methods: Pre-Specified Endpoints Primary Endpoint Combined incidence of stroke, acute myocardial infarction or death at 30 days Secondary Endpoints 1) Death or cardiovascular events at 12 months 2) Incidence of local or systemic complications 3) Major bleeding within 30 days after treatment

16 Results Baseline Characteristics of the Patients (n=28) Age, years 71.5 ± 7.8 Cause of admission Male sex 22 (78.6%) Acute myocardial infarction 13 (46.4%) CV risk factors Unstable angina 15 (53.6% Hypertension 26 (93%) Diabetes 12 (43%) 3-vessel disease 19 (67.9%) Dyslipidemia 25 (89%) Left main disease (>50%) 17 (60.7%) Smoking 14 (50%) Logistic EuroSCORE (%) 15.4 ± 2.5 Obesity (BMI 30) 12 (43%) Ejection fraction 50.8±8.7% Comorbidities: Mean time from admission to CABG 6.0 ± 4.3 Previous stroke / TIA 10 (35.7%) Peripheral vascular disease 10 (35.7%) Surgical procedure (CABG) Chronic renal failure 4 (14.3%) Number of grafts per patient 1.64 ± 0.73 Atrial fibrillation 4 (14.3%) On-pump CABG 13 (46.5%) Bilateral carotid stenosis (>50%) 9 (32.1%) CABG + Aortic valve replacement 6 (21.4%)

17 Results The rate of procedural success was 100% ( 30% residual stenosis) PRIMARY ENDPOINT Mortality at 30 days: 2 patients (7.1%) Stroke at 30 days: 1 patient (3.6%) had a non-fatal ipsilateral stroke Acute myocardial infarction at 30 days: 0 patients SECONDARY ENDPOINTS 1) Death/major CV events at 12 months: 2 more patients (7.1%) died (infectious causes) 2) Incidence of local or systemic complications: 0 patients 3) Major bleeding at 30 days: 0 patients

18 Discussion DETAILED ANALYSIS OF THE PRIMARY ENDPOINT PATIENT A Male, 72 years Occlusion of left internal carotid artery (ICA) + 80% stenosis of right ICA Logistic EuroSCORE: 62.03% Died on the 2 nd postoperative day due to left lower limb ischemia + exacerbation of renal failure PATIENT B Female, 72 years 80% stenosis of left ICA Logistic EuroSCORE: 8.91% Died on the 4 th postoperative day (septic shock) PATIENT C Male, 76 years Symptomatic stenosis of left ICA (previous stroke ) Logistic EuroSCORE: 26.80% Ipsilateral stroke on the 1 st postoperative day (on-pump CABG + aortic valve replacement) Complete recovery at 30 days

19 Discussion: Carotid Revascularization Strategies Carotid stenting is considered a safe alternative to surgical revascularization: SAPPHIRE STUDY Carotid stenting (CAS) with embolic protection devices showed no inferiority to CEA in high risk patients Event rates were comparable between the two techniques Yadav et al. N Engl J Med 2004;351:1493e501 Stenting may be the preferred strategy for patients at high surgical risk, such as those with Acute Coronary Syndromes Ziada et al, Am J Cardiol 2005; 96: Hitinder et al. N Engl J Med 2008;358: Most studies comparing CAS versus CEA excluded patients with significant Coronary Artery Disease

20 Discussion: Coronary and Carotid Revascularization STENTING + CABG VERUS CEA + CABG 11 studies; 760 patients (87% asymptomatic) Risk of death/ any stroke at 30 days: 9.1% Risk comparable to studies CEA+CABG CAS is a less invasive procedure Naylor et al. Eur J Vas Endovasc Surg 2009;37:

21 Hybrid Coronary and Carotid Revascularization SIMULTANEOUS APPROACH Versaci et al. J Am Coll Cardiol Intv 2009;2:

22 Hybrid Coronary and Carotid Revascularization Versaci et al. J Am Coll Cardiol Intv 2009;2:

23 Hybrid Coronary and Carotid Revascularization Versaci et al. J Am Coll Cardiol Intv 2009;2:

24 Conclusion In patients at high surgical risk, hybrid revascularization using carotid stenting (CAS) immediately before CABG seems to be a feasible therapeutic approach. Randomized clinical trials are needed to further address this new therapeutic strategy, especially in very high risk patients.

25 ESC Congress 2011 Thank You for your attention