ORIGINAL ARTICLESMRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis
Abstract
The European Carotid Surgery Trial is a multicentre trial of carotid endarterectomy for patients who, after a carotid territory non-disabling ischaemic stroke, transient ischaemic attack, or retinal infarct, are found to have a stenotic lesion in the relevant (ipsilateral) carotid artery. Over the past 10 years 2518 patients have been randomised, and the mean follow-up is now almost 3 years among the 2200 thus far available for analysis of the incidence of strokes that lasted more than 7 days. For the patients with "moderate" (30-69%) stenosis on their prerandomisation angiogram the balance of surgical risk and eventual benefit remains uncertain, and full recruitment continues. For 374 patients with only "mild" (0-29%) stenosis there was little 3-year risk of ipsilateral ischaemic stroke, even in the absence of surgery, so any 3-year benefits of surgery were small, and were outweighed by its early risks. For 778 patients with "severe" (70-99%) stenosis, however, the risks of surgery were significantly outweighed by the later benefits: although 7·5% had a stroke (or died) within 30 days of surgery, during the next 3 years the risks of ipsilateral ischaemic stroke were (by life-table analysis) an extra 2·8% for surgery-allocated and 16·8% for control patients (a sixfold reduction, p<0·0001). There was also a small reduction in other strokes, and at 3 years the total risk of surgical death, surgical stroke, ipsilateral ischaemic stroke, or any other stroke was 12·3% for surgery and 21·9% for control (difference 9·6% SD 3·3, 2p<0·01). The main concern was to avoid disabling or fatal events, and, among severe stenosis patients, 3·7% had a disabling stroke (or died) within 30 days of surgery, an extra 1·1% surgery versus 8·4% control (p<0·0001) had a disabling or fatal ipsilateral ischaemic stroke by 3 years, and the total 3-year risk of any disabling or fatal stroke (or surgical death) was 6·0% surgery versus 11·0% control (overall difference 5·0% SD 2·3, 2p<0·05); but, for disabling or fatal stroke the control risks seemed to diminish after the first year, so delay of surgery by just a few months after clinical presentation might make this overall difference non-significant.
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Cited by (3220)
Carotid Near-Occlusion: Surgical or Conservative Management? Retrospective Multicenter Study
2024, Annals of Vascular SurgeryCarotid near-occlusion (CNO) represents an anatomical-functional condition characterized by severe (more than 90%) internal carotid artery stenosis which can lead to a distal lumen diameter greater or less than 2 mm. CNO can be divided into a less severe subgroup (without lumen full collapse: diameter >2 mm) and a more severe subgroup (with lumen full collapse: diameter <2 mm). The decision for revascularization is still highly debated in Literature. The aim of the present multicenter retrospective study is to analyze the incidence of perioperative (30 days) and follow-up complications in 2 groups of patients with or without distal internal carotid lumen full collapse.
Between January 2011 and March 2023, in 5 Vascular Surgery Units, 67 patients (49 male, 73% and 18 females, 27%) with CNO underwent carotid endarterectomy: 28 (41.7%) with lumen diameter <2 mm and 39 (58.3%) with diameter >2 mm. 19 patients were symptomatic and 48 asymptomatic. The outcomes considered for comparative analysis were: perioperative neurological and cardiac complications, carotid restenosis or occlusion at follow-up. Both groups were homogeneous in terms of risk factors, morphological features and pharmacological treatments.
In the group with lumen <2 mm, 3 perioperative major events (10.7%) occurred (1 ischemic stroke, 1 hemorrhagic stroke, 1 myocardial infarction) and 2 (7.1%) at follow-up (average 11 ± 14.5 months; 1 asymptomatic carotid occlusion, 1 hemodynamic restenosis treated with stenting). No event was recorded in the group with lumen >2 mm.
According to our results CNO patients show different complication risk according to the presence or not of distal lumen collapse. The later seems to play a significant role in perioperative and follow-up complication rate. These results therefore support a surgical treatment only in patients with CNO without lumen full collapse.
Long-term outcomes of carotid endarterectomy vs transfemoral carotid stenting in a Medicare-matched database
2024, Journal of Vascular SurgeryCarotid endarterectomy (CEA) is associated with lower risk of perioperative stroke compared with transfemoral carotid artery stenting (TFCAS) in the treatment of carotid artery stenosis. However, there is discrepancy in data regarding long-term outcomes. We aimed to compare long-term outcomes of CEA vs TFCAS using the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database.
We assessed patients undergoing first-time CEA or TFCAS in Vascular Quality Initiative Vascular-Vascular Implant Surveillance and Interventional Outcomes Network from January 2003 to December 2018. Patients with prior history of carotid revascularization, nontransfemoral stenting, stenting performed without distal embolic protection, multiple or nonatherosclerotic lesions, or concomitant procedures were excluded. The primary outcome of interest was all-cause mortality, any stroke, and a combined end point of death or stroke. We additionally performed propensity score matching and stratification based on symptomatic status.
A total of 80,146 carotid revascularizations were performed, of which 72,615 were CEA and 7531 were TFCAS. CEA was associated with significantly lower risk of death (57.8% vs 70.4%, adjusted hazard ratio [aHR], 0.46; 95% confidence interval [CI], 0.41-0.52; P < .001), stroke (21.3% vs 26.6%; aHR, 0.63; 95% CI, 0.57-0.69; P < .001) and combined end point of death and stroke (65.3% vs 76.5%; HR, 0.49; 95% CI, 0.44-0.55; P < .001) at 10 years. These findings were reflected in the propensity-matched cohort (combined end point: 34.6% vs 46.8%; HR, 0.53; 95% CI, 0.46-0.62) at 4 years, as well as stratified analyses of combined end point by symptomatic status (asymptomatic: 63.2% vs 74.9%; HR, 0.49; 95% CI, 0.43-0.58; P < .001; symptomatic: 69.9% vs 78.3%; HR, 0.51; 95% CI, 0.45-0.59; P < .001) at 10 years.
In this analysis of North American real-world data, CEA was associated with greater long-term survival and fewer strokes compared with TFCAS. These findings support the continued use of CEA as the first-line revascularization procedure.
Utility of the triglyceride-glucose index for predicting restenosis following revascularization surgery for extracranial carotid artery stenosis: A retrospective cohort study
2024, Journal of Stroke and Cerebrovascular DiseasesBackground: Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are effective interventions for treating extracranial carotid artery stenosis (ECAS), but long-term prognosis is limited by postoperative restenosis. Carotid restenosis is defined as carotid stenosis >50% by various examination methods in patients after carotid revascularization. This retrospective cohort study examined the value of the triglyceride-glucose (TyG) index for predicting vascular restenosis after carotid revascularization. Methods: A total of 830 patients receiving CEA (408 cases, 49.2%) or CAS (422 cases, 50.8%) were included in this study. Patients were stratified into three subgroups according to TyG index tertile (high, intermediate, and low), and predictive value for restenosis was evaluated by constructing multivariate Cox proportional hazard regression models. Results: Incidence of postoperative restenosis was significantly greater among patients with a high TyG index according to univariate analysis. Kaplan-Meier survival curve analysis revealed a progressive increase in restenosis prevalence with rising TyG index. Multivariate Cox regression models also identified TyG index as an independent predictor of restenosis, while receiver operating characteristic (ROC) curve analysis showed that TyG index predicted restenosis with moderate sensitivity (57.24%) and specificity (67.99%) (AUC: 0.619, 95% CI 0.585–0.652, z-statistic=4.745, p<0.001). Addition of the TyG index to an established risk factor model incrementally improved restenosis prediction (AUC: 0.684 (0.651–0.715) vs 0.661 (0.628–0.694), z-statistic =2.027, p = 0.043) with statistical differences. Conclusion: The TyG index is positively correlated with vascular restenosis risk after revascularization, which can be used for incremental prediction and has certain predictive value.
An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis
2024, Journal of Vascular SurgeryDespite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear.
Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response.
Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered “recently symptomatic” should be reduced from the current definition of “6 months” to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence.
The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.
Effect of Treatment Choice on Short-Term and Long-Term Outcomes for Carotid Near-Occlusion: A Meta-Analysis
2024, World NeurosurgeryCurrent guidelines recommend best medical treatment (BMT) over revascularization for carotid near-occlusion (CNO); however, it remains unclear whether BMT, carotid artery stenting (CAS), or carotid endarterectomy (CEA) is the optimal treatment strategy. The present meta-analysis aimed to compare outcomes among patients with CNO receiving BMT, CAS, or CEA.
PubMed, Web of Science, Scopus, and Embase were searched. English studies with ≥1 month follow-up, that used established CNO diagnostic guidelines, that provided outcomes by treatment, and in which 95% confidence intervals (CIs) were calculable were included. Studies on acute ischemic stroke (AIS) requiring emergent reperfusion therapy, nonatherosclerotic lesions, nonprimary research articles, non-English, and nonhuman studies were excluded. Outcomes were mortality, AIS, transient ischemic attack, myocardial infarction within and beyond 30 days, and restenosis. A generalized linear mixed model, subgroup analysis, and meta-regression were used to compare outcomes.
Thirty-eight studies were included. Pooled rates for AIS beyond 30 days were 9.90% (95% CI, 4.31%–21.16%), 0.79% (95% CI, 0.24%–2.53%), and 0.80% (95% CI, 0.15%–4.07%) for BMT, CAS, and CEA, respectively. Subgroup analysis was statistically significant (P < 0.001). Meta-regression showed lower incidence favoring procedural intervention (CAS vs. BMT, P = 0.001; CEA vs. BMT, P = 0.003). Subgroup analysis for mortality beyond 30 days was also significant (P = 0.016) but meta-regression did not favor one treatment over another. Other outcomes were not statistically significant.
Revascularization for CNO may decrease long-term stroke rates. Given that current guidelines are based on randomized controlled trials from the 1990s, updated randomized trials are warranted to determine the optimal treatment for CNO.
Carotid calcium burden derived from computed tomography angiography as a predictor of all-cause mortality after carotid endarterectomy
2023, Journal of Vascular SurgeryCarotid endarterectomy (CEA) aims to reduce the risk of stroke in patients with atherosclerotic carotid disease. Preoperative risk assessments that predict complications are needed to optimize the care in this patient group. The current approach, namely relying solely on symptomatology and degree of stenosis, is outdated and calls for innovation. The Agatston calcium score was applied in several vascular specialties to assess cardiovascular risk profile but has been little studied in carotid surgery. It is hypothesized that a higher calcium burden at initial presentation equates to a worse prognosis attributable to an increased cerebrovascular and cardiovascular risk profile. The aim was to investigate the association between preoperative ipsilateral calcium score and postoperative all-cause mortality in patients undergoing CEA.
This single-center retrospective cohort study included 89 patients who underwent CEA at a tertiary referral center between 2010 and 2018. Preoperative calcium scores were measured on contrast-enhanced computed tomography images with patient-specific Hounsfield thresholds at the level of the carotid bifurcation. The association between these calcium scores and all-cause mortality was analyzed using multivariable adjusted Cox proportional hazard analysis.
Cox proportional hazard analysis demonstrated a significant association between preoperative ipsilateral carotid calcium score and all-cause mortality (hazard ratio, 1.10; 95% confidence interval, 1.03-1.16; P = .003). After adjusting for age, preoperative estimated glomerular filtration rate, and diabetes mellitus, a significant association remained (hazard ratio, 1.07; 95% confidence interval, 1.00-1.15; P = .05).
A higher calcium burden was predictive of worse outcome, which might be explained by an overall poorer health status. These results highlight the potential of calcium measurements in combination with other traditional risk factors, for preoperative risk assessment and thus for improved patient education and care.