SummaryBackgroundIf carotid artery narrowing remains asymptomatic (ie, has caused no recent stroke or other neurological symptoms), successful carotid endarterectomy (CEA) reduces stroke incidence for some years. We assessed the long-term effects of successful CEA.MethodsBetween 1993 and 2003, 3120 asymptomatic patients from 126 centres in 30 countries were allocated equally, by blinded minimised randomisation, to immediate CEA (median delay 1 month, IQR 0·3–2·5) or to indefinite deferral of any carotid procedure, and were followed up until death or for a median among survivors of 9 years (IQR 6–11). The primary outcomes were perioperative mortality and morbidity (death or stroke within 30 days) and non-perioperative stroke. Kaplan-Meier percentages and logrank p values are from intention-to-treat analyses. This study is registered, number ISRCTN26156392.Findings1560 patients were allocated immediate CEA versus 1560 allocated deferral of any carotid procedure. The proportions operated on while still asymptomatic were 89·7% versus 4·8% at 1 year (and 92·1% vs 16·5% at 5 years). Perioperative risk of stroke or death within 30 days was 3·0% (95% CI 2·4–3·9; 26 non-disabling strokes plus 34 disabling or fatal perioperative events in 1979 CEAs). Excluding perioperative events and non-stroke mortality, stroke risks (immediate vs deferred CEA) were 4·1% versus 10·0% at 5 years (gain 5·9%, 95% CI 4·0–7·8) and 10·8% versus 16·9% at 10 years (gain 6·1%, 2·7–9·4); ratio of stroke incidence rates 0·54, 95% CI 0·43–0·68, p<0·0001. 62 versus 104 had a disabling or fatal stroke, and 37 versus 84 others had a non-disabling stroke. Combining perioperative events and strokes, net risks were 6·9% versus 10·9% at 5 years (gain 4·1%, 2·0–6·2) and 13·4% versus 17·9% at 10 years (gain 4·6%, 1·2–7·9). Medication was similar in both groups; throughout the study, most were on antithrombotic and antihypertensive therapy. Net benefits were significant both for those on lipid-lowering therapy and for those not, and both for men and for women up to 75 years of age at entry (although not for older patients).InterpretationSuccessful CEA for asymptomatic patients younger than 75 years of age reduces 10-year stroke risks. Half this reduction is in disabling or fatal strokes. Net benefit in future patients will depend on their risks from unoperated carotid lesions (which will be reduced by medication), on future surgical risks (which might differ from those in trials), and on whether life expectancy exceeds 10 years.FundingUK Medical Research Council, BUPA Foundation, Stroke Association.
Objective:We evaluated the long-term impact of iliofemoral thrombosis (I-F DVT ) on walking capacity, venous hemodynamic status, CEAP class, venous clinical severity, and quality of life, and determined the prevalence of venous claudication. Materials and Methods: All patients with prior I-F DVT , assessed at our institution since 1990, were called for follow-up. Those with walking impairment due to arterial disease (ABI Ͻ 1.0 postexercise) or unrelated causes and those thrombectomized or thrombolyzed were excluded; 39 patients (22-83 years, median 46 years) were included. Median follow-up was 5 years (range 1-23 years). Investigation included classification in CEAP and Venous Clinical Severity Scoring (VCSS) systems, air-plethysmography (outflow fraction [OF], venous filling index [VFI], residual volume fraction [RVF]) and venous duplex, treadmill (3.5 km/h, 10%) to determine initial (ICD) and absolute (ACD) claudication distances, and quality of life assessment (SF-36). Nonaffected limbs of patients with unilateral I-F DVT (37 of 39) comprised the control group. Data are presented as median and interquartile range. Results: A total of 81% of limbs with I-F DVT had superficial and deep reflux and 19% superficial reflux; reflux in control limbs was 29.7% (P Ͻ 0.001) and 27% (P Ͼ 0.2), respectively; 43.6% (17 of 39; 95% CI, 27-60%) of patients developed venous claudication ipsilateral to I-F DVT (ICD: 130 m, range 105-268 m), compelling 15.4% (6 of 39; 95% CI, 3.5-27%) to discontinue treadmill (ACD: 241 m, range 137-298 m). Limbs with prior I-F DVT had a lower OF (37%, range 32.2-43%; P Ͻ 0.001), abnormally higher VFI (3.8 mL/s, range 2.5-5.7 mL/s; P Ͻ 0.001), and RVF (45%, range 32.5-51.5%; P ϭ 0.006), and clinical impairment in CEAP and VCSS systems (P Ͻ 0.0001). Patients with I-F DVT had impaired physical functioning (P ϭ 0.02) and role (P ϭ 0.033), general health (P ϭ 0.001), social function (P ϭ 0.047), and mental health (P ϭ 0.043). Conclusions:A total of 43.6% of those with prior I-F DVT developed venous claudication compelling interruption of walking in 15.4%. Prior I-F DVT caused outflow impairment and a large residual venous volume and reflux, resulting in marked clinical and quality of life compromise. Standardized challenge enabled discrimination of those with clinically relevant impairment.
Warfarin induced skin necrosis, while rare, is an important complication. All surgeons should be aware of its existence.
Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence.Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362.
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