Carotid endarterectomy versus carotid stenting: an updated review of randomized trials and subgroup analyses

Atherosclerotic disease of the carotid arteries is responsible for a significant portion of ischemic strokes. Carotid endarterectomy (CEA) is currently the accepted standard of treatment for patients with severe symptomatic carotid stenosis. In the past few years, however, carotid angioplasty and stenting (CAS) has emerged as a potential alternative endovascular treatment strategy for this disorder. In fact, spurred by the positive results of single center studies and small, pivotal randomized trials, some even consider CAS as the treatment modality of choice, especially in presumably surgical high-risk patients. Yet, randomized trials directly comparing CAS with CEA are sparse and have produced conflicting results. The aim of this article is to review the current trial data on this issue and to define the role of these techniques for the management of two important subgroups of patients. An updated meta-analysis of seven randomized trials comparing CEA with CAS demonstrates that CAS is associated with a significantly increased risk of any stroke or death within 30 days (OR. 1.41, 95% CI 1.07-1.87, p < 0.05). Focusing on patients with a symptomatic carotid stenosis, there was also a significant difference in the odds of treatment-related stroke and death between CAS and CEA (OR, 1.41 ; CI 1.05 to 1.88, p < 0.05). Data on all disabling strokes and deaths within 30 days was available from five trials. The odds of disabling stroke or death at 30 days were similar in the endovascular and surgical group (OR, 1.33, 95% CI 0.89 to 1.98). Overall, these data do not justify a blind enthusiasm for CAS and a widespread use of this procedure for the treatment of carotid artery stenosis. On the other hand, a closer inspection of the current literature on elderly patients and those with a contralateral carotid occlusion clearly indicates that CAS and CEA already now have a complementary role. While elderly patients should preferentially be treated with CEA, CAS appears to be the treatment of choice in patients with a symptomatic carotid artery stenosis and a contralateral carotid occlusion in experienced centers.     

Carotid artery stenting after carotid endarterectomy

Atherosclerotic carotid artery disease remains an important cause of cerebrovascular ischemic disease. We present a patient with residual stenosis of the distal internal carotid artery following carotid endarterectomy that was treated with stenting. The case highlights the potential complimentary benefits of carotid endarterectomy and carotid stenting.     

颈动脉内膜剥脱术和颈动脉支架的前瞻性随机对照研究

目的 评价颈动脉内膜剥脱术和颈动脉支架治疗颈动脉狭窄的近期和中期临床效果.方法 前瞻性单中心随机对照研究,自2004年5月至2006年12月,将同意入组的40例有症状(狭窄程度>50%)和无症状(狭窄程度>70%)颈动脉狭窄患者随机分为两组,即颈动脉内膜剥脱术组(CEA)和颈动脉支架组(CAS).一期观察终点是术后30 d内出现严重脑梗死或死亡;二期观察终点是各种手术并发症、急性脑缺血发作、偏瘫、急性心肌梗死和术后18个月内的脑卒中、死亡和再狭窄等,同时回顾性分析两组总的住院费用.结果 CEA和CAS两组患者术前一般资料、临床症状、伴随疾病等因素均无差异.CEA组20例23支颈动脉手术(3例分别行双侧CEA),术中应用转流管9条(39.1%),颈动脉补片12条(52.2%);CAS组20例23支颈动脉支架(3例行双侧CAS),应用脑保护装置21个(91.3%).CEA和CAS两组术后30 d内神经系统并发症(4.3%对8.7%,P=0.46)、急性心肌梗死(4.3%对0,P=0.31)和伤口血肿(8.7%对0,P=0.14)等差异均无统计学意义,至术后18个月无短暂性脑缺血发作和再狭窄病例.CEA和CAS两组平均住院费用分别为(16 450.95±6188.76)和(70 130.15±11 999.02)元人民币,差异有统计学意义(P<0.01).结论 CEA和CAS术后30 d和术后18个月的并发症、病死率和临床疗效无明显差异,但CAS的住院花费明显高于CEA.     

Cerebrovascular reactivity before and after carotid endarterectomy

BACKGROUND: The hemodynamic relevance of internal carotid artery (ICA) stenosis often does not correlate with anatomic features, as angiographically defined. The cerebrovascular reactivity (CVR) has been advocated as a means of defining the cerebral hemodynamic impairment. METHODS: We assessed the results of pre- and postoperative CVR evaluation, using the CO2 transcranial doppler method, in 25 patients with high-grade ICA stenosis. The patients with history of stroke, evidence of cerebral CT infarction or symptoms from the contralateral circulation or the brain stem were excluded to avoid the effects of cerebral infarction on the hemodynamic studies. Statistical analysis was used to evaluate the CVR changes after carotid endarterectomy. RESULTS: Preoperative evaluation showed that CVR was generally well correlated with the degree of ICA stenosis and concomitant contralateral carotid steno-occlusion. Before endarterectomy the mean CVR value was 66.5% (moderately reduced). After surgery the overall mean value of CVR was 84.1% (normal), with a statistically significant improvement. CONCLUSION: The results of this study suggest that the CVR evaluation allows one to obtain hemodynamic information of clinical interest in the patients with ICA stenosis and that carotid endarterectomy is effective to restore the CVR in patients with cerebral hemodynamic impairment.     

Carotid endarterectomy with patch closure versus carotid eversion endarterectomy and reimplantation: a prospective randomized study

BACKGROUND: Although carotid eversion endarterectomy (CEE) has obtained consensus providing excellent early and late results, conventional carotid endarterectomy (CEA) with or without patching continues to be considered the gold standard surgical procedure. The few studies published to date comparing CEE with CEA in a small series of patients have failed to show substantial advantages of one technique over the other, and further randomized comparative studies are still required. The purpose of this study was to compare the outcome of CEA with routine patch closure (CEAP) with that of CEE and reimplantation (CEER) of the internal carotid artery in the common carotid artery. METHODS: Three hundred thirty-six primary CEAs performed in 310 patients were randomized into 2 groups, 167 CEAPs and 169 CEERs. Surviving patients underwent duplex ultrasound scan control at 30 days, 6 months, 12 months, and every postoperative year thereafter. The mean follow-up was 34 months (range, 1 to 69 months). Demographic characteristics, risk factors, associated diseases, and indications for surgery were comparable in the 2 groups. RESULTS: Although the rate of intraoperative electroencephalogram changes was comparable in the 2 groups, the incidence of shunting was statistically higher in the CEAP group (28.1% vs 1.2%, P < .00001). The carotid cross-clamping time was significantly lower in the CEER group (P = .01). Although all deaths were in the CEAP group, the overall perioperative death and stroke-related death rates were comparable in the 2 groups. The perioperative stroke rate was statistically higher in the CEAP group (2.9% vs 0%, P = .03). Although the recurrent stenosis rate was comparable in the 2 groups (1.2% vs 0%), the CEAP group had a statistically higher rate of combined recurrent stenoses and occlusions (4.9% vs 0%, P = .003). The late mortality rate was similar in both groups. CONCLUSIONS: Although the outcome of CEAP in this series is consistent with that of the main reported trials, the CEER procedure is less likely than CEAP to cause perioperative stroke and death and seems superior in reducing the incidence of recurrent stenosis and late occlusive events.     

Carotid endarterectomy after Doppler ultrasonographic examination without angiography

We prospectively reviewed our experience with 32 carotid endarterectomies in 30 patients performed without angiography in a 7 year period. Although this represents 6.7 percent of our total experience with carotid endarterectomy in this period, carotid endarterectomy without angiography is increasing and comprises 17 percent of the last 2 years' total. We have adhered to strict criteria for patient selection that identifies circumstances for a safe operative experience in seven broad categories. Evidence is also presented to reduce an overriding concern for intracranial aneurysms and siphon stenosis if either one exists unrecognized. We are hopeful that in the future, the latter will be identified by intracranial Doppler studies currently being performed. Our experience in this small series has been favorable, with intraoperatively measured lesions equal to the preoperative noninvasive predictions. We suggest that Doppler ultrasonography in its current form can be effectively used in place of conventional angiography or digital subtraction angiography in selected patients.     

Meta-analysis of randomized trials comparing carotid endarterectomy and endovascular treatment.

OBJECTIVE AND DESIGN: In order to evaluate the comparative efficacy and safety of carotid angioplasty with or without stent placement (CAS) versus carotid endarterectomy (CEA) we performed a meta-analysis of the presently available randomized studies. MATERIALS AND METHODS: A multiple electronic health database search on all randomized trials describing CAS compared with CEA in patients with symptomatic or asymptomatic carotid artery stenosis was performed. RESULTS: Seven trials totalling 2972 patients (1480 randomized to CEA and 1492 randomized to CAS) were included in the meta-analysis. Results significantly favoured CEA over CAS in terms of death or any stroke at 30 days after procedure; the risk of death, any stroke, or myocardial infarction at 30 days; ipsilateral ischaemic stroke at 30 days; any stroke at 30 days; death or stroke at 6 months; and the risk of procedural failure. There was a significantly reduced risk of cranial neuropathy at 30 days after CAS. There was no significant difference between CAS and CEA groups in the odds of death or disabling stroke at 30 days, death or stroke at 1 year after the procedure, and ipsilateral intracerebral bleeding at 30 days. CONCLUSIONS: The results of this meta-analysis suggest that CEA can be performed with more safety than CAS. As a result, CEA remains the "gold standard" treatment for suitable de novo carotid stenosis and CAS should only be performed within randomized trials of stenting versus surgery.     

A primer on randomized controlled trials

Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct and interpret randomized trials: choosing the study population, choosing the comparison group, choosing your outcome, study design, data analysis, and issues of inference. This editorial is intended to make the reader an educated consumer of such trial designs.     

Early enteral nutrition after pancreatoduodenectomy: a meta-analysis of randomized controlled trials

Purpose

The aim of our study was to evaluate the safety and effectiveness of early enteral nutrition (EN) for patients after pancreatoduodenectomy (PD).

Methods

We performed a comprehensive search of abstracts in the MEDLINE database, OVID database, Springer database, the Science Citation Index, and the Cochrane Library database. Published data of randomized clinical trials (RCTs) comparing the clinically relevant outcomes of early EN and other nutritional routes for patients after PD were analyzed. The analyzed outcome variables included gastroparesis, intra-abdominal complications (gastroparesis excluded), mortality, infection, and postoperative hospital stay. The Cochrane Collaboration’s RevMan 5.1 software was used for statistical analysis.

Results

Four RCTs published in 2000 or later were included in this meta-analysis, in which 246 patients underwent early EN and 238 patients underwent other nutritional routes following PD. In the combined results of early EN versus other nutritional routes, no significant difference could be found in gastroparesis (odds ratio (OR), 0.89; 95 % CI, 0.36–2.18; P?=?0.79), intra-abdominal complications (gastroparesis excluded) (OR, 0.82; 95 % CI, 0.53–1.26; P?=?0.37), mortality (OR, 0.43; 95 % CI, 0.11–1.62; P?=?0.21), infection (OR, 0.55; 95 % CI, 0.29–1.07; P?=?0.08), postoperative hospital stay (mean difference, ?0.93; 95 % CI, ?6.51 to 4.65; P?=?0.74).

Conclusions

Current RCTs suggests that early EN appears safe and tolerated for patients after PD, but does not show advantages in infection and postoperative hospital stay.     

Carotid endarterectomy after NASCET and ACAS: A statewide study

Purpose: Since the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the Asymptomatic Carotid Artery Stenosis Study (ACAS) established the efficacy of carotid endarterectomy at large academic centers, there have been two community-based studies of outcomes after this operation. The purpose of this study was to perform a statewide survey to evaluate postoperative morbidity and mortality after carotid endarterectomy among patients throughout Maine. Methods: A statewide registry was established to collect prospective data on carotid operations from January 1 to December 31, 1995. All surgeons and hospitals in the state were solicited to participate. All carotid endarterectomies were intended to be included; the only exclusion criterion was out-of-state residence. Comorbidities, preoperative studies, surgical indications, operative technique, and postoperative outcomes were analyzed. State administrative data were used to assess registry coverage. Results: Ten of 17 hospitals participated, and 58% of all carotid endarterectomies performed in the state were included. Three hundred sixty-four operations were entered into the registry. Forty-four percent of the operations were performed for transient ischemic attack, 37% for asymptomatic stenosis, and 19% for stroke. The postoperative stroke rate was 2.5% with a total neurologic complication rate of 4.7% (transient ischemic attack and stroke). There was one postoperative death (mortality rate 0.3%). Patients with symptoms had a higher incidence of postoperative stroke (4.0% vs 0% asymptomatic; p < 0.05) and transient ischemic attacks (3.8% vs 0.8% asymptomatic). Hospital stroke rates varied from 0% to 7%. Stroke rate did not differ significantly between low-volume hospitals (2 to 28 patients/year, 3.3%) and high-volume hospitals (29 to 101 patients/year, 2.3%) or between low-volume surgeons (fewer than 11 operations/year, 1.7%) and high-volume surgeons (more than 12 operations/year, 2.4%). Among 26 reporting surgeons, stroke rate varied from 0% to 10%; the absolute number of strokes per surgeon varied between zero and two. Conclusion: The statewide registry showed a postoperative stroke plus death rate of 2.8%, comparable with the NASCET and ACAS findings. Although this study had inherent limitations, the results from one state, including a variety of community practices, achieved results comparable with those of landmark trials. (J Vasc Surg 1998;27:1017-23.)     

腹腔镜胆囊切除术后放置腹腔引流随机对照试验的Meta分析

目的:系统评价腹腔镜胆囊切除术后腹腔内引流的有效性。方法:系统检索PubMed、Embase、Web of Science、Cochrane对照试验中心登记册及Cochrane图书馆(2018年11期)、CBM、CNKI、VIP等数据库。系统评价根据PRISMA指南进行,并采用固定与随机效应模型进行Meta分析。结果:共22项研究涉及3 866例患者的RCTs(其中引流组2 003例,非引流组1 863例)纳入研究。Meta分析结果显示,两组腹腔内液体发生率[RR=1.26,95%CI(0.92,1.72),P=0.16]、术后死亡率[RR=0.44,95%CI(0.04,4.72),P=0.50]差异无统计学意义。术后放置腹腔引流未能降低恶心或/和呕吐的总体发生率[RR=1.16,95%CI(0.95,1.42),P=0.15]、肩部疼痛发生率[RR=0.93,95%CI(0.71,1.23),P=0.62]。引流组具有更高的疼痛评分(通过视觉模拟评分测量)[MD=1.00,95%CI(0.58,1.42),P<0.00001],更长的手术时间[MD=6.07,95%CI(2.07,10.08),P=0.003]、术后住院时间[MD=0.73,95%CI(0.29,1.17),P=0.001]。切口感染与放置腹腔引流无关[RR=1.61,95%CI(0.97,2.69),P=0.07]。结论:腹腔镜胆囊切除术术毕放置引流管并无明显优势,腹腔引流的常规使用似乎具有不利的临床结果,对于这种措施应重新考虑。     

胰十二指肠切除术后应用胰胃吻合与胰空肠吻合的Meta分析

目的 评价胰十二指肠切除术后胰胃吻合术与胰空肠吻合术的疗效.方法 计算机检索Cochrane Library（2014年第5期）、PubMed（1978年1月至2014年5月）、EMBASE（1966年1月至2014年5月）、SCI（1961年1月至2014年5月）、中国生物医学数据库（CBM）（1978年1月至2014年5月）、中国期刊全文数据库（CNKI）（1994年1月至2014年5月）,维普（1989年1月至2014年5月）和万方数据库（1998年1月至2014年5月）,同时在Google搜索引擎进行检索,并追查纳入研究参考文献,收集胰十二指肠切除术后胰胃吻合术与胰空肠吻合术的所有随机对照试验.根据Cochrane协作网推荐的“风险评估工具”进行偏倚风险评估,用RevMan5.2软件进行统计学分析.结果 纳入7项随机对照试验,共1 121例患者.Meta分析结果显示,与胰空肠吻合组相比,胰胃吻合组能降低胰十二指肠切除术后胰瘘发生率（RR=-0.56;95％ CI：0.41～0.75; P=-0.0001）、胆漏发生率（RR=0.43;95％ CI：0.19～ 0.95;P=-0.04）腹腔内多发并发症（OR=-0.26; 95％ CI：0.12 ～ 0.56;P=-0.0007）和腹腔内积液的发生（OR=-0.54;95％ CI：0.38～ 0.77;P=0.0005）,但两者在术后并发症、胃排空延迟、围手术期病死率方面差异均无统计学意义.结论 目前随机对照试验研究显示胰十二指肠切除术后消化道重建胰胃吻合术优于胰空肠吻合术.     

Carotid endarterectomy after systemic thrombolysis in a stroke population

ObjectiveVascular specialists are increasingly being requested to perform carotid endarterectomy (CEA) after intravenous thrombolysis (IVT) for stroke patients, raising concerns about hemorrhagic complications. Few case series and registry reports have assessed the question, and even fewer studies have included a control group. The aim of this study was to evaluate the overall outcome of patients undergoing CEA after IVT and to compare them with contemporary patients with CEA after simple stroke (non-IVT group). It also aimed to evaluate the differences in outcomes of stroke patients requiring CEA between nonvascular and vascular centers.MethodsThe data of 169 consecutive patients who have undergone CEA after stroke in a single center was analyzed from January 2011 to December 2016, 27 of them (16%) having undergone previous IVT. A comparative analysis between the non-IVT and the IVT groups was performed. The time between stroke diagnosis and referral to a vascular specialist was also studied.ResultsAge, sex, and cardiovascular comorbidities were similar in both groups. Median time between stroke and CEA was 13 days (Q1-Q3, 8-23 days), with 16 of the 27 patients (59%) in the IVT group undergoing CEA less than 14 days after the initial event. There were three intracranial hemorrhages (2.1%) in the non-IVT group versus one (3.7%) in the IVT group (P = NS). The overall 30-day combined stroke and death rate was 7.1% (6.3% in the non-IVT group vs 11.1% in the IVT group; P = .70). The incidence of postoperative cervical hematoma requiring reoperation was similar in both groups (2.1% vs 3.7%; P = NS). The median time between diagnosis of stroke and referral to a vascular specialist was higher for patients in nonvascular centers compared with vascular centers (3.5 days vs 1.0 day; P < .001), which translated to fewer patients referred from nonvascular centers undergoing surgery in the 14-day window period (38% vs 67%; P < .001).ConclusionsIn this retrospective analysis, CEA after IVT showed similar outcomes when compared with the overall CEA after stroke population. Stroke patients diagnosed in nonvascular centers were referred later than those in vascular centers and, although postoperative outcomes were similar, that was correlated with fewer patients undergoing surgery in a timely fashion.     

颈动脉内膜切除术与脑保护

目前颈动脉硬化闭塞性疾病已公认为是引起脑中风的主要原因，而早期、及时的诊治是降低脑中风发病率的关键。     

Quality of assessment of randomized controlled trials in blood conservation after joint arthroplasty

Blood transfusion after joint arthroplasty occurs in up to two thirds of patients. We conducted a systematic review of the literature to determine the methodological quality of published randomized controlled trials (RCTs). We searched MEDLINE, EMBASE, and Cochrane to identify RCTs in arthroplasty with blood conservation as the primary outcome from 2001 to 2007. Methodological quality was evaluated using the Detsky index. We identified 62 RCTs. The mean Detsky score was 73% ± 14%. Epidemiology affiliation (P = .003), funding support (<.001), and year of publication (<.001) were the predictors of reporting quality, predicting 46% of the variability (R² = 0.46). This suggests poor reporting quality of trials in blood conservation. The inclusion of an epidemiologist or a biostatistician for the design of a trial is strongly recommended.