SummaryBackgroundStents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.MethodsThe International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470.FindingsThe trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77–2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events; HR 1·69, 1·16–2·45, p=0·006). Risks of any stroke (65 vs 35 events; HR 1·92, 1·27–2·89) and all-cause death (19 vs seven events; HR 2·76, 1·16–6·56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0·0197).InterpretationCompletion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.FundingMedical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.
Recurrent varicose veins may result from inadequate assessment or inadequate surgery. In this study, 110 consecutive patients (165 limbs) were assessed pre-operatively for the presence or absence of reflux at the saphenofemoral (SF) and saphenopopliteal (SP) junctions by clinical assessment and by Doppler ultrasound. The pre-operative results where then compared with findings at the time of surgery. Doppler ultrasound as a means of predicting SF and SP incompetence was superior to clinical assessment. Doppler ultrasound detected 100% (two false positives) of incompetent SF junctions, and 100% (six false positives) of incompetent SP junctions, compared to the clinical detection of 72% (no false positives) and 64% (five false positives), respectively. Short saphenous venography was performed in 36 limbs in which SP reflux was suspected on clinical assessment and/or by Doppler ultrasound. It proved valuable in demonstrating the level and mode of termination of the short saphenous vein. This guided the placement of the skin incision.
One hundred fifty patients undergoing carotid endarterectomy were randomly assigned to receive intravenous 10% dextran 40 or placebo. Transcranial Doppler monitoring of the ipsilateral middle cerebral artery 0 to 1 hour postoperatively detected embolic signals in 57% of placebo and 42% of dextran patients, with overall embolic signal counts 46% less for dextran (p = 0.052). Two to 3 hours postoperatively, embolic signals were present in 45% of placebo and 27% of dextran patients, with embolic signal counts 64% less for dextran (p = 0.040). We conclude that dextran reduces embolic signals within 3 hours of CEA.
MES counts of greater than 50/h in the early postoperative phase of carotid endarterectomy are predictive of the development of ipsilateral focal cerebral ischaemia.
The effect of local controlled cooling on the digital systolic blood pressure in the hand was studied in 25 In an effort to make objective measurements in patients with primary or secondary Raynaud's syndrome, several workers have studied blood flow in the hand ( I , 2) before and after local cooling, blood viscosity ( 3 ) changes at low temperatures and photoelectric measurement of pulse amplitude (4) during stepwise cooling. Nielsen ( 5 ) suggested that photoplethysmography was unsuitable for detecting pulsation when finger systolic pressure was less than 30-40mmHg. He described a method (5,6) of indirectly measuring finger systolic pressure at different temperatures using a proximal occluding cuff and a proximal cooling cuff, and strain gauge plethysmography to detect distal pulsation. However, although Nielsen achieved objective pressure measurements that separated normals from patients with primary Raynaud's disease (5,7), he found it necessary to use body cooling with a cooling blanket at an ambient room temperature of 22°C to achieve this separation. We have adopted his method of local finger cooling, using photoplethysmography instead of strain gauge plethysmography to detect distal pulsation. and a lower ambient room temperature of 17.5-18 "C instead of total body cooling. The aim of our study was to measure and attempt to identify any difference in the response to cooling in controls and patients with Raynaud's syndrome. Patients and methodsTwenty-five normal volunteers (21 women, 4 men: age 20-40 years) acting as controls and 25 patients (20 women, 5 men: age 22-67 years) with Raynaud's syndrome were studied. Seven patients had systemic sclerosis. 2 had Buerger's disease and in 14 the diagnosis was unknown. In each subject the brachial systolic blood pressure and the systolic blood pressure of the cooled middle finger and of the noncooled (reference) index finger were measured. This was achieved using a thermostatically controlled culT, which could be pressurized and simultaneously perfused with water at 30°C or 10°C. on the middle digit. a non-cooled cuff pressurized by air at ambient room temperature on the index finger and photoplethysmographic (PPG) probes to detect the distal pulse on the tip of each finger. A commercially available digit cooling machine (Medimatic, Copenhagen, Denmark) was used. Both cuffs were capable of being pressurized and deflated simultaneously; cuff pressure was monitored via an Akers transducer (AE 840) and amplifier and recorded on a pen recorder (Watanabe MC611). The PPG probes (Medasonics PH77). placed on the pulp of each digit, were connected via a Photo Pulse Adaptor (Medasonics PA13) and the tracings were recorded on the same pen recorder. Thus, there were simultaneous recordings of cuff pressure and distal pulses.The pre-test conditions for all subjects involved no tobacco or alcohol (in the preceding 2 hours) and a light meal only, and for the test all were rested for 20 minutes in light clothing at a room temperature maintained at 17.5-18 "C. Cuffs on both fing...
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