Prospective randomized trial of ACUSEAL (Gore-Tex) versus Hemashield-Finesse patching during carotid endarterectomy: early results

BACKGROUND/PURPOSE: Several studies have reported that carotid endarterectomy (CEA) with patch angioplasty produces superior results compared with primary closure. Conventional polytetrafluoroethylene (PTFE) patching has been shown to have results comparable to autogenous vein patching; however, it requires a prolonged hemostasis time. Therefore, many surgeons use collagen-impregnated Dacron patching (Hemashield [HP]). Recently, we reported a satisfactory hemostasis time using the new hemostatic PTFE patch (ACUSEAL by Gore). This study is the first prospective randomized trial comparing the ACUSEAL patch with the HP Finesse patch. METHODS: 200 CEAs were 1:1 randomized into two patch closure groups (ACUSEAL or Finesse). All patients underwent immediate and 1 month postoperative duplex ultrasound studies. Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery and length of arteriotomy. RESULTS: The overall perioperative ipsilateral stroke rate was 2% (2% ACUSEAL, 2% Finesse; P = 1.0). The perioperative ipsilateral TIA rates were 0% for the ACUSEAL and 2% for the Finesse patch (P = .5). The combined perioperative neurological event (TIA + stroke) rates were 2% for ACUSEAL and 4% for the Finesse (P = .68). The early >or=50% restenosis rate was 0% for ACUSEAL vs 4% for Finesse patching. Two perioperative carotid thromboses were noted with Finesse patching vs none with ACUSEAL patching (P = .50). The combined early morbidity rate (TIA, stroke, and >or=50% restenosis or thrombosis) was 2% for the ACUSEAL patch vs 8% for the Finesse patch (P = .10). The mean hemostasis time for the ACUSEAL and Finesse patches was 5.1 vs 3.7 minutes (P = .01), however, the mean operative times were similar for both groups (P = .61). CONCLUSION: The perioperative neurological events and overall short-term morbidity associated with CEA when using ACUSEAL or Finesse patches were similar. Both patches have short hemostasis times.     

Prospective randomized trial of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated dacron (Hemashield) patching: late follow-up

OBJECTIVE: To compare the late clinical outcome and incidence of recurrent stenosis after carotid endarterectomy (CEA) with polytetrafluoroethylene (PTFE) versus Hemashield patching. SUMMARY BACKGROUND DATA: Several randomized trials have confirmed the advantages of patching over primary closure when performing CEA. METHODS: Two hundred CEAs (180 patients) were randomized into 100 with PTFE patching and 100 with Hemashield. All patients underwent postoperative color duplex ultrasounds at 1, 6, and 12 months, and every year thereafter. The mean follow-up was 26 months. Kaplan-Meier analysis was used to estimate the risk of re-stenosis, stroke, and stroke-free survival. A multivariate analysis of various risk factors was also done. RESULTS: Demographic and clinical characteristics were similar in both groups. The incidence of all ipsilateral strokes (early and late) was 8% (7% perioperative) for Hemashield versus 0% for PTFE patching. Both groups had similar mortality rates. The cumulative stroke-free rates at 6, 12, 24, and 36 months were 93%, 93%, 93%, and 89% for Hemashield versus 100%, 100%, 100%, and 100% for PTFE patching. The cumulative stroke-free survival rates at 6, 12, 24, and 36 months were 90%, 89%, 87%, and 79% for Hemashield versus 98%, 98%, 92%, and 92% for PTFE patching. Kaplan-Meier analysis also showed that freedom from 50% or greater re-stenosis at 6, 12, 24, and 36 months was 89%, 81%, 73%, and 66% for Hemashield versus 100%, 100%, 100%, and 92% for PTFE. Similarly, the freedom from 70% or greater re-stenosis at 6, 12, 24, and 36 months was 93%, 91%, 86%, and 78% for Hemashield versus 100%, 100%, 100%, and 100% for PTFE. Univariate and multivariate analyses of demographic and preoperative risk factors showed that only Hemashield was significantly associated with a higher incidence of 70% or greater recurrent stenosis. CONCLUSIONS: PTFE patching was superior to Hemashield in lowering the incidence of postoperative ipsilateral strokes and late recurrent stenosis.     

Prospective randomized study of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated Dacron (Hemashield) patching: perioperative (30-day) results.

PURPOSE: Several studies have reported that carotid endarterectomy (CEA) with patch angioplasty has results that are superior to primary closure. Polytetrafluoroethylene (PTFE) patching has been shown to have results comparable with autogenous vein patching; however, it requires a prolonged hemostasis time. Therefore, many surgeons are using collagen-impregnated Dacron patching (Hemashield [HP]). This study is the first prospective randomized trial comparing CEA with PTFE patching versus HP patching. METHODS: Two hundred CEAs were randomized into two groups, 100 PTFE and 100 HP patching. All patients underwent immediate postoperative and 1-month postoperative color duplex ultrasound scanning studies. Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery. RESULTS: The perioperative stroke rates were 0% for PTFE, versus 7% for HP (4 major and 3 minor strokes, P =.02). The combined perioperative stroke and transient ischemic attack rates were 3% for PTFE, versus 12% for HP (P =.047). The operative mortality rate for PTFE was 0%, versus 2% for HP (P =.477). Five perioperative carotid thromboses were noted in patients undergoing HP patching, versus none in patients undergoing PTFE patching (P =.07). After 1 month of follow-up, 2% of patients in the PTFE group had a 50% or more restenosis, versus 12% of patients in the HP group (P =.013). The mean operative time for PTFE patching was 119 minutes, versus 113 minutes for HP patching (P =.081). The mean hemostasis time was significantly higher for PTFE patching than for HP patching, 14.4 versus 3.4 minutes (P <.001). CONCLUSION: CEA with HP patching had a higher incidence of perioperative strokes, carotid thrombosis, and 50% or more early restenosis than CEA with PTFE patching. However, the mean hemostasis time was higher for PTFE patching than for HP patching.     

Prospective randomized trial of ACUSEAL (Gore-Tex) vs Finesse (Hemashield) patching during carotid endarterectomy: long-term outcome

BACKGROUND: Several studies have reported that carotid endarterectomy with patch angioplasty is superior to primary closure. Conventional polytetrafluoroethylene (Gore-Tex, W. L. Gore & Associates, Flagstaff, Ariz) patching has been shown to have results similar to autogenous saphenous vein patching; however, it requires a longer hemostasis time. This study examined the long-term clinical outcome and incidence of restenosis after carotid endarterectomy using the new ACUSEAL (Gore-Tex) patching vs Hemashield Finesse (Boston Scientific Corp, Natick, Mass) patching. METHODS: The study randomized 200 patients (1:1) undergoing carotid endarterectomy to 100 with ACUSEAL patching and 100 with Hemashield-Finesse patching. All patients underwent immediate and 1-month postoperative duplex ultrasound studies, which were repeated at 6-month intervals. Kaplan-Meier analysis was used to estimate the freedom from stroke, stroke-free survival, and the risk of restenosis for both groups. RESULTS: The demographic and clinical characteristics, the mean operative diameter of the internal carotid artery, and the length of the arteriotomy were similar in both groups. The mean hemostasis time was 5.1 for the ACUSEAL patching vs 3.7 minutes for Finesse patching (P = .01); however, the mean operative times were similar for both groups (P = .61). The incidence of ipsilateral stroke was 2% for ACUSEAL patching (both early perioperative strokes) vs 3% for Finesse patching (2 early and 1 late stroke) at a mean follow-up of 21 months. The respective cumulative stroke-free rates at 1, 2, and 3 years were 98%, 98%, and 98% for ACUSEAL patching vs 97%, 97%, and 97% for Finesse patching (P = .7). The respective cumulative stroke-free survival rates at 1, 2, and 3 years were 97%, 92%, and 88% for ACUSEAL patching vs 96%, 96%, and 91% for Finesse patching (P = .6). The respective freedom from > or =70% carotid restenosis at 1, 2, and 3 years was 98%, 96%, and 89% for ACUSEAL patching vs 92%, 85%, and 79% for Finesse patching (P = .04). CONCLUSIONS: Carotid endarterectomy with ACUSEAL patching and Finesse patching had similar stroke-free rates and stroke-free survival rates. The mean hemostasis time for the ACUSEAL patch was 1.4 minutes longer than that for the Finesse patch; however, the Finesse patch had higher restenosis rates than the ACUSEAL patch.     

Prospective, randomized study of external jugular vein patch versus polytetrafluoroethylene patch during carotid endarterectomy: perioperative and long-term results

OBJECTIVES: The purpose of this study was to evaluate the relative risks and advantages of using external jugular vein (EJV) patch, compared with polytetrafluoroethylene (PTFE) patch, during carotid endarterectomy. The primary end point was the relevant neurologic complication rate (RNCR; fatal or disabling stroke) at any time during follow-up. Secondary end points included stroke-free survival, 30-day and long-term mortality, recurrent stenosis rate (> or =50%), occlusion, patch infection, aneurysm formation, and other local complications. METHODS: The study, a prospective randomized clinical trial carried out at a single center, was divided into two 3-year phases: December 1996 to March 1999, when patients were enrolled, and March 1999 to March 2002, which was the follow-up period. Inclusion criteria included an external jugular vein suitable for patching, defined as vein diameter 3 mm or larger and absence of collateral vessels noted on preoperative color duplex ultrasound scans. Patients were prospectively randomized 1:1 to receive either the EJV (n = 80; group A) or synthetic (n = 80; group B) patch. RESULTS: Carotid endarterectomy and patching was performed by one surgeon. At 30 months the RNCR-free rate, analyzed with the Kaplan-Meier method, was 98.7% for group A (1 ipsilateral lethal stroke) and 94.6% for group B (4 ipsilateral disabling strokes), and remained stable to 60 months. No statistical difference was observed with the log-rank test. Stroke-free survival rate was 100% for group A and 98.7% for group B at 1 year, 98.7% for group A and 93.6% for group B (1 ipsilateral minor stroke) at 30 months, and was unchanged at 60 months. Life table analysis demonstrated freedom from significant recurrent stenosis (> or =50%) of 97.5% for both groups at 6 months, 93.6% for group A and 92.2% for group B at 30 months, and 90.2% for group A and 86.7% for group B at 60 months. No statistical difference was observed with the log-rank test. In no patients was recurrent stenosis greater than 70%. No aneurysm formation was noted during follow-up. CONCLUSIONS: We can conclude, with the power limitation of the study, that carotid endarterectomy can be safely performed with either the EJV or PTFE patch. Advantages of the EJV for carotid angioplasty include no cost for material, low risk for graft infection, and preservation of the saphenous vein.     

Randomized trial of vein versus dacron patching during carotid endarterectomy: long-term results

BACKGROUND AND PURPOSE: Overviews of randomized patch trials by the Cochrane Collaboration suggest that a policy of routine patching is preferable to routine primary closure. However, there is no systematic evidence that patch type, whether prosthetic or vein, influences outcome after carotid endarterectomy (CEA). METHODS: Two hundred seventy-three patients were randomized to vein or thin-walled Dacron patch (Hemashield Finesse) closure of the arteriotomy after 276 CEA procedures. Patients were reviewed clinically and with duplex ultrasound scanning at 1, 6, 12, 24, and 36 months or until death. No patients were lost to follow-up. Cumulative statistical analyses are presented for the 264 patients (269 CEAs) who actually received a randomized treatment allocation. RESULTS: Cumulative freedom from death or ipsilateral stroke at 3 years (including operative events) was 93.0% in the Dacron patch group and 95.5% in the vein group P =.42). Cumulative freedom from death or any stroke was 91.5% after Dacron patch closure and 93.9% after vein closure (P =.46). Cumulative freedom from recurrent stenosis greater than 70% or occlusion at 3 years was 92.9% for patients randomized to the Dacron patch group and 98.4% for patients randomized to the vein group (P =.03). At 3 years the incidence of stroke in the carotid territory not operated on was 1.0% in 93 patients with no contralateral internal carotid artery disease at randomization, and increased to 1.3% in 78 patients with 1% to 69% stenosis, and 2.0% in 51 patients with contralateral 70% to 99% stenosis. No late strokes occurred distal to 42 occluded contralateral internal carotid arteries. CONCLUSIONS: Patch type has no influence on early operative risk, no association with enhanced patterns of thrombogenicity in the early postoperative period, and no influence on risk for ipsilateral or any stroke at 3 years. Dacron patches were, however, associated with a significantly higher incidence of recurrent stenosis at 3 years, with most occurring within 6 to 12 months of surgery. However, the higher incidence of recurrent stenosis was not associated with a parallel increase in late stroke, and in this study a program of serial ultrasound surveillance could not have prevented one ipsilateral stroke.     

Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: Perioperative (30-day) results

Purpose: The early outcomes of carotid endarterectomy (CEA) with primary closure (PC) versus vein patch closure (saphenous vein [SVP] and jugular vein [JVP]) and polytetrafluoroethylene patch closure (PTFE-PC) were compared.Methods: Three hundred ninety-nine CEAs were randomized into the following groups: 135 PC, 134 PTFE-PC, and 130 vein patch closure (SVP alternating with JVP). Surviving patients underwent a carotid color duplex ultrasonographic scan 1 month after surgery. Demographic characteristics were similar in all groups.Results: The incidence of perioperative cerebrovascular accidents (CVAs) was 4.4% for PC, 0.8% for PTFE-PC, and 0% for vein patch closure (PC vs vein patch, p = 0.0165; PC vs all patching [vein and PTFE], p = 0.007). The perioperative CVA and reversible ischemic neurologic deficit (RIND) combined rates for all patching were superior to PC (1.5% vs 5.2%; p = 0.04). These combined rates were also superior for vein patch closure when compared with PC (0.8% vs 5.2%; p = 0.037). The mean diameter of the internal carotid artery was similar in patients who had perioperative neurologic deficits and those who did not. After 1 month of follow-up, 11.9% of the PC arteries were narrowed 50% or more in contrast to 2.3% for PTFE-PC, 3.1% for SVP, and 10.3% for JVP (PC vs all patching, p = 0.008; PC vs PTFE-PC, p = 0.0017; PC vs SVP, p = 0.028). In contrast, early postoperative dilation of the internal carotid artery to more than twice the measured diameter was not significantly higher in patched arteries than in PC arteries. The mean operative and hemostasis times were significantly longer for patching than for PC.Conclusions: Patch closure is less likely than PC to cause perioperative CVA, RIND, and early internal carotid artery stenosis. (J Vasc Surg 1996;24;998-1007.)     

A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy

OBJECTIVE: The objective of this study was the determination of whether the choice of either autogenous saphenous vein (ASV) or synthetic material for patch angioplasty significantly influences the results after carotid endarterectomy (CEA). METHODS: With Institutional Review Board approval, 195 patients (145 men and 50 women; mean age, 69 years) who underwent 207 CEAs were prospectively randomized to arteriotomy closure with ASV or synthetic patches from July 1996 to January 2000. One hundred and one patients (52%) were randomized to the ASV cohort, and 94 (48%) were randomized to the synthetic cohort. Aside from a slight gender imbalance (70% versus 79% male in the ASV versus the synthetic group), there were no clinically important differences in baseline demographic variables, risk factors, or surgical indications between the ASV and synthetic groups. RESULTS: With all 207 randomized procedures on an intent-to-treat basis, there were two early (<30 days) postoperative deaths (1%). There were three perioperative strokes in the ASV cohort (3.0%) and two in the synthetic cohort (2.1%; P =.99). Two of these early strokes occurred in a subset of nine patients who received neither patch material, all after randomization but before CEA. Two patients in each group had late strokes. The cumulative freedom from stroke rate at 1 year (ASV, 94%; synthetic, 95%) was virtually identical for both cohorts. With the 125 patients who had at least one postoperative duplex scan, the incidence rate of recurrent (>or=60%) carotid stenosis was 4.8% (three of 62) for the ASV group and 6.3% (four of 63) for the synthetic group (P =.99). CONCLUSION: No significant differences in the stroke, mortality, or restenosis rates were shown between the ASV and the synthetic cohorts. While conceding the power limitations inherent in this study, we conclude that CEA may be safely performed with similar early results with ASV or synthetic patches.     

External carotid endarterectomy: indications, technique, and late results

In the past 14 years, 22 patients (25 operated sides), with occlusion of the internal carotid artery (ICA), underwent ipsilateral external carotid artery (ECA) endarterectomy at our institution. Operative indications were amaurosis fugax in 13 sides and nonlateralizing transient ischemic attacks in the remaining 12. There were no operative deaths. One patient suffered a minor stroke after operation. Follow-up ranged from 6 to 110 months (median 36 months). In 16 cases, simple endarterectomy with or without vein patch closure was performed (type I). In two cases the ostium of the ICA was occluded with interrupted sutures after endarterectomy (type II). In the remaining seven cases the ICA was transposed as a patch over the endarterectomized ECA after endarterectomy (type III). All but six patients (six sides) underwent duplex scanning or angiography during follow-up. Four of nine patients with previous nonlateralizing symptoms had persistent symptoms after operation, whereas none of those with previous amaurosis fugax did. Recurrent occlusive disease was more common in type I reconstructions (p less than 0.05). Proper ECA reconstruction results in long-term patency. In the patient with ipsilateral ICA occlusion, transposition of the ICA as a patch over the endarterectomized ECA offers a valid hemodynamic solution. Objective parameters are needed to identify patients with nonlateralizing symptoms who will benefit from operation.     

Polyester vs. bovine pericardial patching during carotid endarterectomy: early neurologic events and incidence of restenosis

PURPOSE: The aim of this report was to compare polyester vs. bovine pericardial patching during CEA with regards to the incidence of early neurologic events and recurrent stenosis. PATIENTS AND METHODS: One hundred and twenty-five consecutive patients with high grade symptomatic (14%) or asymptomatic (86%) carotid artery stenosis (>70%) who underwent 139 CEAs by a single surgeon between January 1997 and April 2001 were retrospectively reviewed. Patients were assessed postoperatively clinically and with routine follow-up duplex scanning. Recurrent stenosis was defined as a narrowing in the common or internal carotid artery of more than 50% by duplex ultrasound examination. RESULTS: From January 1997 to May 1999, a polyester patch was routinely used in 81 (58%) patients, while between June 1999 and April 2001, a bovine pericardium patch was exclusively used in 59 (42%) patients. There were no ipsilateral postoperative TIAs or strokes in either group. The combined 30-day mortality rate for both groups was 0.8%. One patient in the polyester patch group died from cardiopulmonary complications 10 days after discharge. The length of follow-up in the bovine pericardial patch group was 3-28 months (mean 12 months), while in the polyester patch group was 1-50 months (mean 24.5 month). One patient developed a carotid pseudoaneurysm of the suture line in the bovine pericardium patch group caused by a local infection after previous neck dissection and radiation. The incidence of recurrent stenosis was two patients (4%) in the bovine pericardium group as opposed to six patients (7.6%) in the polyester patch group. CONCLUSION: Although this is a preliminary report, it is concluded that bovine pericardium provides excellent perioperative results and is at least comparable to polyester patching in terms of safety. Our study with short term follow up suggests that bovine pericardium patching during carotid endarterectomy may have a lower restenosis rate compared to knitted polyester patching. Clear superiority of bovine pericardium as a patch material awaits a prospective randomised study with long-term follow-up.     

Carotid artery endarterectomy in patients with contralateral carotid artery occlusion: Perioperative hazards and late results

The aim of this study was to analyze and compare the perioperative hazards and late results of internal carotid endarterectomy (CEA) in patients with and without contralateral internal carotid artery occlusion. From March 1980 to April 1990, 375 consecutive patients underwent 439 CEAs at the First Department of Vascular Surgery of Padova Medical School. Patients were divided into two groups; group 1 (61 patients) had contralateral internal carotid artery occlusion and group 2 (314 patients) did not (378 CEAs, 64 bilateral). Indications for CEA were similar in both groups. The only significant difference in patient characteristics was a higher rate of previous stroke in group 1 (11% vs. 3%,p < 0.001). General anesthesia, continuous EEG monitoring, selective intraluminal shunt, and arteriotomy closure with a polytetrafluoroethylene patch (PTFE) were used routinely in both groups. An intraluminal shunt was inserted more frequently in group 1 than in group 2 (69% vs. 17%,p <0.001). Major perioperativestroke occurred in one patient in each group (1.7% vs. 0.31%, respectively; NS). Early fatal stroke rates were 0% and 0.95% in groups 1 and 2, respectively (NS). All patients had neurologic examinations and duplex scans every 6 months (range 6 to 118 months; mean 42 months). Kaplan-Meier survival curves were virtually identical in the two groups; the majority of deaths were caused by myocardial infarction and cancer. There were no stroke-related deaths in group 1 as compared with 8.2% in group 2 (NS). New neurologic symptoms appeared in 4.7% of patients in group 1 and 6% in group 2 (NS) whereas the late stroke rates were 0% and 3.1%, respectively (NS). Restenosis was observed in two and three patients in groups 1 and 2, respectively (NS). In conclusion, CEA for ulcerated or stenotic lesions of the internal carotid artery in patients with contralateral carotid occlusion is associated with very low early and long-term neurologic morbidity and mortality, similar to findings in patients who undergo CEA with a patent contralateral carotid artery.     

Carotid endarterectomy contralateral to an occluded carotid artery: perioperative risk and late results

To define better the short-term risk and long-term benefit of carotid endarterectomy opposite an occluded carotid artery, we reviewed our experience since 1961. Angiographic data are available for 598 of 670 (89.3%) patients in our carotid registry. In 63 (10.5%) patients the internal or common carotid artery on the side opposite the endarterectomy was occluded. All operations were carried out under general anesthesia with selective shunting based on electroencephalographic criteria. Shunting was required in 29 of 63 (46.0%) patients with contralateral occlusion and 72 of 535 (13.5%) control subjects (p less than 0.0001). Perioperative strokes occurred in 3 of 63 (4.8%) patients with contralateral occlusion and 14 of 535 control subjects (2.6%) (p = 0.23). Perioperative death occurred in 0 of 63 patients with contralateral occlusion and 6 of 535 (1.1%) control subjects (p = 0.40). Life-table cumulative stroke-free rates at 1, 5, and 10 years were 95.2%, 91.0%, and 76.2% in the group with contralateral occlusion and 96.0%, 89.4%, and 84.1% in control subjects (p = 0.25). Life-table cumulative survival rates at 1, 5, and 10 years were 93.1%, 80.8%, and 75.4% in the group with contralateral occlusion and 94.8%, 77.0%, and 57.9% in control subjects (p = 0.58). Carotid endarterectomy contralateral to an occluded carotid artery may be carried out with acceptable risk and late stroke-free and survival rates comparable to those seen in other patients who have undergone carotid endarterectomy.     

Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein,jugular vein,and polytetrafluoroethylene: Long-term follow-up

Purpose: This study examines the long-term clinical outcome and the incidence of recurrent stenosis (≥50%) after carotid endarterectomy (CEA) with primary closure (PC) versus vein patch closure (VPC), saphenous (SVP), and jugular vein (JVP) and polytetrafluoroethylene patch closure (PTFE-P). Methods: A total of 399 CEAs were randomized into the following groups: 135 PC, 134 PTFE-P, and 130 VPC (SVP alternating with JVP). Postoperative duplex ultrasound scans were performed at 1, 6, and 12 months and every year thereafter. The mean follow-up was 30 months with a range of 1 to 62 months, and demographic characteristics were similar in all groups. Kaplan-Meier analysis was used to estimate the risk of restenosis and the stroke-free survival. Results: The incidence of ipsilateral stroke was 5% (seven of 135) for PC, 1% (one of 134) for PTFE-P, and 0% for VPC (PC vs VPC, p = 0.008; PC vs PTFE-P, p = 0.034). Seven strokes occurred in the perioperative period. All three groups had similar mortality rates. The cumulative stroke-free survival rate at 48 months was 82% for PC, 84% for PTFE-P, and 88% for VPC (p < 0.01 for PC vs PTFE-P or VPC). PC had a higher incidence of recurrent stenosis and occlusion (34%) than PTFE-P (2%) and VPC (9%) (SVP 9%, JVP 8%) (p < 0.001). PTFE-P had a lower recurrent stenosis rate than VPC (p < 0.045). Restenoses necessitating a redo CEA were also higher for PC (11%) than for PTFE-P (1%) and VPC (2%) (p < 0.001). Women with PC had a higher recurrent stenosis rate than men (46% vs 23%, p = 0.008). Kaplan-Meier analysis showed that freedom from recurrent stenosis at 48 months was 47% for PC, 84% for VPC, and 96% for PTFE-P (p < 0.001). The SVP and JVP results were comparable. The mean operative diameter of the internal carotid artery was similar in patients with or without restenosis. Significantly more late internal carotid artery dilatations occurred in the VPC group compared with the PC group. Conclusions: Patch closure (VPC or PTFE-P) is less likely than PC to cause perioperative stroke. Patching was also superior in lowering the incidence of late recurrent stenoses, especially in women. (J Vasc Surg 1998;27:222-34.)     

Clinical results of carotid artery stenting compared with carotid endarterectomy

OBJECTIVES: Carotid artery stenting (CAS) is an alternative to carotid endarterectomy (CEA) for treating carotid artery stenosis. We conducted a systematic review and meta-analysis of the clinical trials to date comparing these two procedures to determine their relative safety and efficacy. METHODS: Searches of the Cochrane Controlled Trials Register, MEDLINE, and EMBASE identified two cohort studies and eight randomized, controlled trials (RCTs) comparing CEA and CAS. Meta-analysis was performed for the primary outcome of 30-day stroke or death, using an intention-to-treat analysis. Between-trial heterogeneity was assessed using the chi2 test, and fixed-effects models were used to pool estimates in the absence of heterogeneity. Meta-regression was conducted to investigate potential effect differences by patient, intervention, and trial characteristics. To evaluate the effect of study design and inclusion criteria, sensitivity and subgroup analyses were performed. RESULTS: Ten trials encompassing 3580 patients were analyzed. Patients who underwent CAS had a higher risk of 30-day stroke/death relative to patients who underwent CEA (risk ratio [RR], 1.30; 95% CI, 1.01-1.67). Meta-analysis and meta-regression demonstrated no between-trial heterogeneity. Sensitivity analysis of only RCTs showed similar higher risk for stroke/death (RR, 1.38; 95% CI, 1.06-1.79) in CAS patients. Subgroup analysis of trials enrolling only symptomatic patients showed higher risk of 30-day stroke/death (RR, 1.63; 95% CI, 1.18-2.25), but trials enrolling both symptomatic and asymptomatic patients showed no significant differences (RR, 0.89; 95% CI, 0.59-1.35). CONCLUSIONS: Meta-analysis of trials to date shows CAS is associated with higher 30-day risk of stroke/death compared with CEA. Thus, for the patient at average surgical risk, the role of CAS is unproven, especially for symptomatic patients. And for the patient at high surgical risk, the role of any intervention is uncertain in the setting of competing comorbidities. The results of ongoing clinical trials in this area will likely provide additional evidence to support treatment choices for carotid artery stenosis.