颈动脉支架的安全性和有效性.pdf

Received:2005-10-25Correspondence to:Wang Yi-ging,Tel:[phone],E-mail:wang_gi-Safety and efficacy of carotid artery stentingWANG Yi-ging1,David Ho Saiwah2,WANG Yan1,ZHENG Jian-tao1,JIANG Hong-fei1,CHEN Bing-huang11Heart Center,Zhongshan Hospital Affiliated to Xiamen University,Teaching Hospital of Fujian Medical University,Xiamen 361004,China;2Oueen Mary Hospital,Hong Kong 852,China Abstract:Objective To evaluate the safety and efficacy of carotid artery stenting(CAS).Methods We prospectively evaluat-ed the safety and efficacy of 76 carotid artery stenting(CAS)procedures in a consecutive series of 70 Chinese patients.This series represented a high-risk group that included patients with unstable angina,previous ipsilateral CEA,contralateral carotid artery occlusion,post-radiation carotid artery stenosis and other severe co-morbid conditions.The patients had independent neurological examinations before and after the procedure and follow-up cerebral angiography at 6 month.Results The proce-dural success rate was 100%.The mean carotid artery stenosis was(82!18)%before and(5!10)%after the procedure.During the initial hospital period and 30 days after CAS,there was no major stroke but 3 minor strokes(5.7%).No myocardial infarc-tions or deaths occurred during or within 30 days following CAS.At a mean follow-up of 20!12 months,2 patients(2.8%)had asymptomatic restenosis,and 2 non-O wave myocardial infarction.Death occurred in 2 cases,but none of them was at-tributed to a neurological cause.Three patients had minor strokes and no major strokes occurred during the follow-up period.Conclusion Percutaneous carotid artery stenting is feasible for performance in Chinese patients and may lower the restenosis rate.Key words:carotid artery;stenting;safetyApproximately 600 000 people suffer stroke each year in the United States,which leads to nearly 160 000 deaths and leaves many more with major disability(American Heart Association,1999).There is sufficient evidence of the benefit of relieving high-grade symp-tomatic and asymptomatic carotid artery atherosclerotic obstruction by surgical endarterectomy(North Ameri-can Symptomatic Carotid Endarterectomy Trial Collab-orator,1991;Executive Committee for the Asymp-tomatic Carotid Atherosclerosis Study,1995;European Carotid Surgery Trialists Collaborative Group,1995;North American Symptomatic Endarterectomy Trial Steering Committee,1991).The North American Symp-tomatic Carotid Endarterectomy Trail(NASCET)demonstrated the superiority of endarterectomy over drug therapy for symptomatic carotid stenosis 70%(North American Symptomatic Carotid Endarterectomy Trial Collaborator).The Asymptomatic Carotid Atherosclero-sis Study(ACAS)showed a statistically significant re-duction in stroke incidence after carotid endarterectomy in asymptomatic carotid stenosis by over 60%(Executive Committee for the Asymptomatic Carotid Atheroscle-rosis Study,1995).These landmark studies provide convincing evidence for the benefit of relieving severe obstruction of the extracranial carotid artery.With the limitations of CEA for certain anatomical subgroups and the prohibitively high complications as-sociated with certain subsets of patients with significant comobidities,there is a need for alternative revascularisation treatment!1-6.The advent of percutaneous endovas-cular technigues has the potential for safer,less traumat-ic and more cost-effective management of symptomatic or asymptomatic carotid occlusive disease.Preliminary reports suggest that carotid angioplasty and stenting has a therapeutic advantage in patients with contralateral occlusion,post-CEA restenosis and surgically inaccessi-ble lesions!7,8.Endovascular stent treatment of carotid artery atherosclerotic disease provides an alternative for vascular surgery,especially for patients that are at high risk for standard carotid endarterectomy!9.The objec-tive of this study was to evaluate the safety,in-hospital and long-term outcome of CAS.METHODSClinical dataFrom January 1997 to January 2004,70 consecu-tive patients underwent CAS by an academic team at Oueen Mary Hospital in Hong Kong and Zhongshan Hospital of Xiamen.Patients with symptomatic and asymptomatic stenosis 70%of the carotid arteries were eligible.For patient screening and enrollment pur-poses,stenoses were initially measured by visual esti-mation by 2 independent observers followed by guanti-南方医科大学学报(J South Med Univ)2006;26(1)6#tative coronary angiography(OCA).During the percuta-neous transluminal angioplasty(PTA)procedure,fur-ther on-line guantitative angiography was performed and used for subseguent data analysis.Patients were excluded for any of the following conditionsz presence of an intracranial tumor or arteri-ovenous malformationg severe disability as a result of stroke or dementiag intracranial stenosis that exceeded the severity of the extracranial stenosisg failure to give informed consent.Clinical and imaging protocolA complete neurological history was taken and all patients were examined by an experienced neurologist.The study protocol reguired that an independent neurol-ogist not involved in the interventional procedure evalu-ate patients using the NIH Stroke Scale before and 24 hours after the procedure.Furthermore,all hospital records were subject to review by a hospital panel spe-cially formed to monitor the results of this relatively new procedure.All patients had a carotid duplex scan with exami-nation by either magnetic resonance imaging(MRI)or CT of the brain before the procedure.For the first 40 patients,a brain diamox SPECT scan was also per-formed before and at 6 weeks after the procedure as part of another study.Before the PTA procedure,either in the same setting or in a separate session,a 4-vessel carotid and vertebral angiography and cranial digital subtraction angiography(DSA)plus coronary angiogra-phy were also performed.If a patient had neurological deterioration after angioplasty and stenting,MRI or CT of the head was repeated.The follow-up angiography was performed at 6 months.Preprocedural protocolAll patients was treated with aspirin at the dose of 100-300 mg/day for at least 2 days before the procedure and ticlopidine at 250 mg twice daily starting!2 days before the procedure,or clopidogrel at 75 mg daily starting at least a week before the procedure.Intra-venous heparin was used to maintain the activated clot-ting time between 250-300 s.The femoral venous ac-cess was secured for potential transvenous pacemaker if necessary.No sedation was given before or throughout the procedure.Homodynamic and oxygen saturation were continuously monitored,and nitroglycerine,at-ropine or metaraminol were administered for manage-ment of hypertension,bradycardia,and hypotension.A guiding catheter(9-10Fr)or a long sheath(6-7Fr)(Ar-row,Cordis or Cook)was advanced to the common carotid artery via the brachial or femoral artery.Through this catheter,a 0.014 or 0.018 coronary guide wire was threaded across the carotid lesion.A coronary angioplasty balloon or a low-profile peripheral angioplasty balloon was advanced over the guide wire to reach the carotid lesion.Following balloon predilata-tion,the balloon catheter was withdrawn and a stent catheter advanced to the lesion.The stent was then de-ployed and an appropriately sized peripheral balloon ad-vanced for final post-stent dilatation.For the first 53 pa-tients,PTA was performed without distal protection,and for the next 17 patients,a distal protection device occlusion system(guardwire),filter system(Per-cusurge,MedNova)was used.At the end of the procedure,the angiograms were taken to document adeguate expansion of the lesion,as-sess the intracranial vessels,and exclude embolic occlu-sions.Vascular sheaths were removed on the same day.The patients were usually discharged the day following examination by a neurologist with the prescription of ticlopidine(250 mg once or twice daily)or clopidogrel(75 mg daily)for 4 weeks and aspirin(100-300 mg dai-ly)for the rest of their lives.Data collection and follow-upOCS was performed on all arteries before and after stenting.The diameter stenosis was determined accord-ing to NASCET criteria.Clinical follow-up for 20!12 months(Mean!SD)was performed on all patients.An-giographic follow-up was performed on 58(83%)of the 70 patients.The patients were instructed to notify the research coordinator if symptoms suggestive of a neuro-logical event occurred.When such a event occurred,head CT was performed and the physician was contact-ed to accurately document the episode.Hospital dis-charge diagnoses were also reviewed to adjudicate the events.A transient ischemic attack was defined as a fo-cal retinal or hemispheric event from which the patient made complete recovery within 24 hours.A minor stroke was defined as a new neurological deficit that ei-ther resolved completely within 30 days or increased the NIH Stroke Scale by 3.A major stroke was defined as a new neurological defect that persisted for 30 days or increased the NIH Stroke Scale by 4.第1期WANg Yi-ging,et al.Safety and efficacy of carotid artery stenting7!%Male5883Prior MI,CABG,or PTCA2840Hypertension5274Diabetes3043Smoker(ex-or current)5274Hypercholesterolemia4260Carotid arteries(!=76)Common carotid33.9Internal carotid7397Symptomatic4863TIA2938Stroke1925Asymptomatic2736Contralateral carotid occlusion79Post-CEA restenosis68Radiation-induced stenosis79Combined revascularization involving other carotid artery23Coronary artery68Renal artery56Peripheral artery11MI:Myocardial infarctiong CABG:Coronary artery bypass graft surgeryg PTCA:Percutaneous transluminal coronary angioplastyg TIA:Transient ischemic attack.Tab.1 Baseline clinical characteristics ofthe patients!PatientsCarotid arteries(!=70)%(!=76)%Procedural eventsMinor stroke35.73.9Major stroke000O-wave MI000Non-O-wave MI000Death000Tab.2 In-hospital and 30 day clinical eventsamong the patientsLong-term outcomes were reported as the neurological events and deaths.A fatal stroke was defined as death attributed to an ischemic stroke or intracerebral hemor-rhagic stroke and did not include brain tumors or death resulting from head trauma.Statistical AnalysisAll values are expressed as Mean SD.Cumula-tive freguency distributions were constructed for mini-mum lumen diameter and percent stenosis.The!2 test was used for comparison of the discrete variables,and,对CAS的安全性及有效性做初步探讨O 入选者均属高危患者,包括不稳定型心绞痛同侧CEA史对侧颈动脉狭窄颈动脉放疗后狭窄及其他严重的合并症O 患者于术前术后及半年后随访时均接受独立的神经专科检查;于远期随访时复查脑血管造影O 结果 手术成功率为100%;术前平均狭窄程度达 82!18%,术后狭窄程度下降至 5!10%O 所有患者共发生3次小卒中 5.7%,均无大卒中事件;住院期间及术后30 d内均无心肌梗死及死亡事件O 平均随访期达 20!12月;2例患者发生无症状颈动脉再狭窄;2例患者发生非0波型心肌梗死;两例患者因非神经源性因素死亡;3例患者发生小卒中;远期随访未发现大卒中O结论 在中国人群中,经皮颈动脉支架植入术是安全可行的,它的远期再狭窄率亦低O关键词!颈动脉支架;安全性;有效性中图分类号!R542 文献标识码!A 文章编号!1673-4254 200601-0006-05the only option.REFERENCES:1Cina CS,Clase CM,Haynes BR.Refining the indications for carotid endartectomy in patients with symptomatic carotid stenosis:a sys-temic review J.J Vasc 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