BULgarian Carotid Artery Stenting versus Surgery Study (BULCASSS): Randomized single center trial

Transcription

1 BULgarian Carotid Artery Stenting versus Surgery Study (): Randomized single center trial Ivo Petrov, M. Konteva, H. Dimitrov, K. Kichukov Tokuda Hospital Sofia Cardiology Department

2 Background Carotid artery stenting (CAS) has shown in several trials no inferiority to the carotid endartherectomy (CEA) for patients with carotid stenosis. Still a debate persist about the safety and efficacy of CAS compared to CEA. This constant argument is substantially powered by the results of clinical trials that have lot of limitations : The low complication rate of CEA is based on ACAS, NASCET, ECST trials with highly selected study groups, low risk patients, high volume participating operators and institutions. After the promising for CAS results of the CAVATAS 1 and SAPPHIRE 2,3 trials, the intermediate results of SPACE 4 and the unsatisfactory results of EVA 3S shook the scientific community, but EVA 3S 5 had great limitations: vascular surgeon at least 25 endarterectomies performed in the year before enrollment. interventional physician at least 5 stenting procedures in the carotid artery performed altogether. Multiple therapeutic devices 5 types of stents and 7 types of EPD. The first procedures were performed without mandatory EPD with catastrophic results Only 85.4% of the pts had dual antiplatelet therapy post procedure. 1. CAVATAS Investigators. Endovascular versus surgical treatment (CAVATAS). Lancet. 2001; 357: JS. Yadav, Protected Carotid Artery Stenting versus Endarterectomy in High Risk Patients. N Engl J Med, 2004, 351;15 3. Gurm HS, Yadav JS et allong Term Results of Carotid Stenting versus Endarterectomy in High Risk Patients N Engl J Med 358:1572, April 10, day results from the SPACE trial. The Lancet 2006; 368: Jean Louis Mas et al. Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis. N Engl J Med 2006;355:

3 Background Many of the randomized trials present a significant bias from the real clinical practice comparing highly selected populations The using of historic control groups leads to rough comparison between high risk CAS procedures vs low risk surgical procedures

4 The need for a real life study In the era of evidence based medicine there is a substantial need of not only randomized clinical trials with high selective criteria but trials that bring the real life situation into science. Such a trial should compare CAS and CEA not only in selected patients but also in broad range of risk asymptomatic/ symptomatic patients. We designed and conducted a prospective, randomized, single center trial comparing CAS to standard CEA in patients with asymptomatic and symptomatic carotid stenosis without selection criteria about the risk profile. Patients were enrolled using unified selection criteria and the enrollment ratio was designed to be 1:2 (CAS to CEA) for the first 50 patients and 1:1 afterwords.

5 The need for a real life study Endpoints Primary endpoint: Comparative periprocedural incidence of any nonfatal stroke, acute myocardial infarction (AMI), transitory ischemic attack (TIA), death (combined MAE) and stroke and death for a 3 year follow up Secondary end points: Comparison of length of hospital stay Comparison of CAS procedures with and without distal EPD Analysis of the restenosis in the CAS group

6 Patient randomization schedule

7 Study design Between February 2001 and December 2004 in a single clinical center 219 patients were randomly assigned to either CAS or CEA : 101 were treated with CAS and 118 with CEA. CEA was performed by two operators with more than 200 cases individual previous experience. CAS single operator with more than 100 CAS procedures previous experience. 4 types of EPD (EPI filterwire, Angioguard, Spider, Guardwire), 4 types of stents (1 BE: Palmaz and 3 SE: Protégé, Precise, X act) Patients baseline characteristics Index CAS n= 101 СЕА n= 118 n % n % Р Value Males ns Age > 70 years ns Mean age ± 8.41 NA ± NA ns Diabetics ns Hypertension ns Dyslipidemia ns History of smoking ns Arteriitis ns

8 . Study design Baseline clinical characteristics Index CAS n= 101 СЕА n= 118 n % n % Multivessel involvement ns CAD ns Peripheral artery disease ns Neurologically symptomatic ns TIA ns Ischaemic stroke ns Neurologically asymptomatic ns Subtotal occlusion ns P value

9 Periprocedural results Entire population Index CAS n=101 CEA n=118 P value Ipsilateral stroke 2 2.0% 3 2.5% ns AMI 1 1.0% 1 0.8% ns Death 1 1.0% 1 0.8% ns ТIA 7 6.9% 7 5.9% ns МАЕ % % ns

10 Periprocedural results Patients age over 70 Index CAS n=23 CEA n=30 P Value Ipsilateral stroke 1 4.3% 2 6.7% ns AMI 1 4.3% 0 0% ns Death 1 4.3% % ns МАЕ % % ns ТIA % 3 10% ns

11 Periprocedural results Diabetic patients Index CAS n=29 СЕА n=39 P Value Ipsilateral stroke 1 3.4% 1 2.6% ns AMI 0 0% 1 2.6% ns Death 0 0% 1 2.6% ns МАЕ % % ns ТIA % 1 2.6% ns

12 BULCASS Length of Hospital Stay Patient group Hospital stay (Days) P Value CAS n= ± 3.40 p< ±4.91 CEA n= 117

13 CAS subanalysis. Early results EPD vs no EPD Index EPD n=94 W/o EPD n=7 р 0 % 2 Ipsilateral stroke % AMI 0 Death 0 ТIA 6 0 % 1 0 % % % 14.3 % 14.3 % ns ns ns МАЕ % % 0.015

14 Late results 3 year follow up Index CAS n=100 CEA n=117 P Value Ipsilateral stroke 4 4.0% 5 4.2% ns AMI 4 4.0% 5 4.2% ns Death 6 6.0% % ns МАЕ % % ns Restenosis % % ns

15 Early procedural and late results after 3 year follow up

16 CAS subanalysis. Late results. SE vs BE stents Index Stent type Self exp. n= 83 Balloon exp. n= 14 n % n % р Ipsilateral stroke ns Restenosis Death ns LМАЕ ns

17 Conclusions In experienced hands and using appropriate materials, both methods CEA and CAS could be performed at low mortality and morbidity rate This study suggests that the incidence of nonfatal stroke, death, TIA and combined MAE following carotid stenting is statistically equivalent to carotid endartherectomy. The interventional carotid treatment is associated with a significantly shorter hospital stay. The preventive role of both methods regarding stroke rate are equivalent. The balloon expandable stents are not suitable for CAS, confirmed by other studies 1 The use of distal EPD during CAS is mandatory 1. Iyer SS, Roubin GS, Yadav Js et al: Extracranial Carotid artery stenting: balloon expandable versus self expanding stents. Circulation 1996; 94(Suppl I): 485

18 final remarks The study represents a real life situation without pre selection bias for either arm CAS or CEA based on low or high operative risk, symptomatic or asymptomatic carotid lesion. Limitations of the study Low number of the study population

19 Thank you for your attention!