BACKGROUND Carotid-artery stenting and carotid endarterectomy are both options for treating carotid-artery stenosis, an important cause of stroke. METHODS We randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization. RESULTS For 2502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary end point between the stenting group and the endarterectomy group (7.2% and 6.8%, respectively; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81 to 1.51; P = 0.51). There was no differential treatment effect with regard to the primary end point according to symptomatic status (P = 0.84) or sex (P = 0.34). The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P = 0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P = 0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P = 0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P = 0.18), for stroke (4.1% vs. 2.3%, P = 0.01), and for myocardial infarction (1.1% vs. 2.3%, P = 0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P = 0.85). CONCLUSIONS Among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of myocardial infarction with endarterectomy. (ClinicalTrials.gov number, NCT00004732.)

BACKGROUND In the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years. METHODS Among patients with carotid-artery stenosis who had been randomly assigned to stenting or endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period. RESULTS Among 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the endarterectomy group (9.9%; 95% CI, 7.9 to 12.2) over 10 years of follow-up (hazard ratio, 1.10; 95% CI, 0.83 to 1.44). With respect to the primary long-term end point, postprocedural ipsilateral stroke over the 10-year follow-up occurred in 6.9% (95% CI, 4.4 to 9.7) of the patients in the stenting group and in 5.6% (95% CI, 3.7 to 7.6) of those in the endarterectomy group; the rates did not differ significantly between the groups (hazard ratio, 0.99; 95% CI, 0.64 to 1.52). No significant between-group differences with respect to either end point were detected when symptomatic patients and asymptomatic patients were analyzed separately. CONCLUSIONS Over 10 years of follow-up, we did not find a significant difference between patients who underwent stenting and those who underwent endarterectomy with respect to the risk of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. The rate of postprocedural ipsilateral stroke also did not differ between groups. (Funded by the National Institutes of Health and Abbott Vascular Solutions; CREST ClinicalTrials.gov number, NCT00004732.)

To determine risk factors for restenosis, we studied 998 patients who underwent elective coronary angioplasty (PTCA) No. 4, 710-717, 1986. PERCUTANEOUS transluminal coronary angioplasty (PTCA) has become an attractive therapeutic option in selected patients with coronary artery disease. Despite the undoubted initial and long-term efficacy of PTCA, the problem of restenosis remains. Reported rates of restenosis in various subsets of patients range from 17% to 47%,t1-but there is limited information on factors that predispose to recurrence of lesions. Most reported studies include relatively few patients,' I-' and data from the National Heart, Lung, and Blood Institute (NHLBI) PTCA Registry,2 apart from representing early experience with the procedure, included results from many centers in which PTCA procedures and angiographic interpretations were not optimally standardized. This study was undertaken to determine

We prospectively recorded all in-hospital complications of the first 3500 consecutive patients to undergo elective coronary angioplasty (PTCA) at Emory University Hospitals from July 14, 1980, to August 28, 1984, by

To determine the hemodynamic derangement associated with right ventricular diastolic collapse and to assess the value of right ventricular and right atrial collapse in identifying cardiac tamponade, two-dimensional echocardiograms were recorded simultaneously with measurement of right atrial, pulmonary capillary wedge, intrapericardial, and systemic arterial pressures and cardiac output in 16 patients as they underwent pericardiocentesis. Twelve patients (group I) had evidence of right ventricular or right atrial collapse or both on their echocardiograms and hemodynamic evidence of cardiac tamponade before pericardiocentesis. All hemodynamic parameters improved after pericardiocentesis (p less than or equal to .05). Continuous monitoring during pericardiocentesis in three of these patients showed significant improvement in all parameters except heart rate (p less than or equal to .02) at the point of disappearance of right ventricular diastolic collapse, with further improvement in cardiac output as pericardiocentesis continued (p less than .01). Right atrial collapse persisted after right ventricular collapse disappeared but was no longer present when pericardiocentesis was completed. Three patients (group II) had no right ventricular or right atrial collapse, no hemodynamic evidence of cardiac tamponade, and no improvement in hemodynamic parameters after pericardiocentesis. A single patient (group III) was found to have elevated right heart pressures and right ventricular hypertrophy before pericardiocentesis. Although there was hemodynamic evidence of cardiac tamponade in this patient, there was no evidence of right ventricular or right atrial collapse. In this study, the sensitivity of right ventricular collapse as a marker for cardiac tamponade was 92%, its specificity 100%, its accuracy 94%, and its predictive value 100%.(ABSTRACT TRUNCATED AT 250 WORDS)

Over a 5 year period at three centers, 53 patients underwent percutaneous transluminal angioplasty of a right coronary artery ostial stenosis. The procedure was successful in 42 patients (79%) and unsuccessful in 11, of whom 5 (9.4%) required emergency coronary artery bypass grafting because of abrupt closure. The right coronary ostial lesion had distinctive technical requirements to achieve success, including high pressure balloon inflation (10 +/- 4 atm) and the need for unconventional right coronary guide catheters. Technical factors that account for increased difficulty in these patients include: problems with guide catheter impaction and ostial trauma; inability to inflate the balloon with adequate guide catheter support; and need for increased intracoronary manipulation. The stenoses were quite discrete (4 +/- 5 mm) and calcified in the majority (40) of the 53 patients. Long-term follow-up (mean 12.5 months, range 4 to 60) of these patients demonstrated clinical recurrence of angina in 20 patients (48%) and angiographically proved restenosis in 16 (38%). Repeat coronary angioplasty was successful in three of six patients for relief of symptoms for over 6 months. In conclusion, angioplasty of the right coronary ostial lesion compared with nonostial dilation leads to a suboptimal early success rate; an apparent high risk of emergency bypass surgery; and a high restenosis rate. Careful assessment of the patient with this lesion and improved technology appear to be warranted.

No abstract

Obstruction to blood flow is accompanied by a pressure gradient across the obstructed site. In certain clinical settings, magnitude of pressure gradient has been used to judge severity of obstruction, and gradient reduction to judge success of an interventional procedure. In percutaneous transluminal coronary angioplasty (PTCA) the relationships between transstenotic pressure gradient, diameter stenosis, and lesion length are imprecisely known. We therefore examined 4263 sets of measurements in patients who underwent PTCA on single, discrete coronary arterial lesions. Multivar-iate regression analysis demonstrated that pressure gradient was artifactually elevated by about 12 mm Hg at low values of diameter stenosis but increased by the 4th power of stenosis as expected from fluid dynamics models. Pressure gradient was dampened and relatively constant at values of diameter stenosis of 60% or higher, probably because of total or near-total occlusion of the artery. Lesion length was not found to influence pressure gradient. Reductions in diameter stenosis (AD) and pressure gradient (AG) were related nonlinearly, with AD proportional to the square root of AG, suggesting that a reduction in gradient is directly proportional to an increase in cross-sectional area of the stenosis. The predictive value of final post-PTCA pressure gradients was found: a final gradient of 15 mm Hg or less predicted a final post-PTCA diameter stenosis of 30% or less, with 75% sensitivity and 29% specificity (p < .01). The results of this study suggest that (1) pressure gradient as currently measured during PTCA is related to diameter stenosis but not to lesion length (2) reductions in pressure gradient and diameter stenosis are nonlinearly related, and (3) reductions in pressure gradient and final post-PTCA pressure gradient are useful indicators of initial angiographic outcome. Circulation 73, No. 6, 1223-1230, 1986 THE FUNDAMENTAL aim of percutaneous transluminal coronary angioplasty (PTCA) is to enlarge a coronary artery lumen at a site of discrete, atheromatous obstruction.' By reducing obstruction, coronary blood flow is increased and, in particular, coronary flow reserve is increased.t7 Assessing enlargement of a coronary artery lumen during the course of a dilatation procedure is often difficult. Fluoroscopy with high-resolution video imaging can outline an arterial lumen but is suboptimal for quantitative analysis. Caliper or other quantitative methods for measuring a stenosis can be applied to cineangiographic film' but are unavailable during the procedure.