Gefäß- und Thoraxchirurgie | Südtiroler Sanitätsbetrieb Thrombophlebitis Karotischirurgie
N Engl J Med ; Without strong evidence of benefit, the Thrombophlebitis Karotischirurgie of carotid endarterectomy for prophylaxis against stroke rose dramatically until the mids, then declined. Our investigation sought to determine whether carotid endarterectomy reduces the risk of stroke among patients with a recent adverse cerebrovascular event and ipsilateral carotid stenosis.
Full Text of Background. We conducted a randomized trial at 50 clinical centers throughout the United States and Behandlung von Krampfadern Wachsmotte, in patients in two predetermined strata based on the severity of carotid stenosis—30 to 69 percent and 70 to 99 percent.
We report here the results in the patients in the latter stratum, Thrombophlebitis Karotischirurgie, who had had a hemispheric or retinal transient ischemic attack or a nondisabling stroke within the days before entry and had stenosis of 70 Thrombophlebitis Karotischirurgie 99 percent in the symptomatic carotid artery.
All patients received optimal medical care, including antiplatelet therapy. Those assigned to surgical treatment underwent carotid endarterectomy performed by neurosurgeons or vascular surgeons. All patients were examined by neurologists 1, Thrombophlebitis Karotischirurgie, 3, 6, 9, Thrombophlebitis Karotischirurgie, and 12 months after entry and then every 4 months. End points were assessed by blinded, Thrombophlebitis Karotischirurgie, independent case review.
No patient was lost to follow-up. Full Text of Methods, Thrombophlebitis Karotischirurgie. For a major or fatal ipsilateral stroke, the corresponding estimates Thrombophlebitis Karotischirurgie Full Text of Results.
Carotid endarterectomy is highly beneficial to patients with recent hemispheric and retinal transient ischemic attacks or nondisabling strokes and ipsilateral high-grade Thrombophlebitis Karotischirurgie 70 to 99 percent of the internal carotid artery.
Full Text of Conclusions. CAROTID endarterectomy was introduced in as a logical procedure for the prevention of ischemic stroke Thrombophlebitis Karotischirurgie to carotid-artery stenosis. The number of patients undergoing endarterectomy in hospitals in the United States other than Veterans Affairs hospitals rose from 15, in toin A full description of the methods of the study has been published elsewhere.
The study was conducted at 50 centers in the United States and Canada. Each center had a rate of less than 6 percent for stroke and death occurring within 30 days of operation for at least 50 consecutive carotid endarterectomies performed within the previous 24 months, Thrombophlebitis Karotischirurgie, and each had obtained approval of the research protocol from its local institutional review Thrombophlebitis Karotischirurgie. To be eligible for the trial, patients had to give informed consent, be less than 80 years old, and have had Thrombophlebitis Karotischirurgie hemispheric transient ischemic attack distinct focal neurologic dysfunction or monocular blindness persisting less than 24 hours or a nondisabling stroke with persistence of symptoms or signs for more than 24 hours within the previous days, in association with stenosis of 30 to 99 percent in the ipsilateral internal carotid artery; the artery had to be technically suitable Varizen gesund leben Malyshev endarterectomy, as assessed by selective carotid angiography, Thrombophlebitis Karotischirurgie.
Using a jeweler's eyepiece marked in tenths of Thrombophlebitis Karotischirurgie millimeter, the principal neuroradiologist measured on the angiograms of each patient the luminal diameter on two views at the point of greatest stenosis and at the normal part of the artery beyond the carotid bulb. The percent stenosis was determined by calculating the ratio of these two measurements, with use of the view showing the greatest degree of narrowing. If review by the Data Management Center Robarts Institute found the stenosis to be less than 30 percent, the angiograms were submitted for independent external adjudication.
Patients were categorized at entry as being tauben Beine von Krampfadern one of two predetermined strata: Patients were excluded from the study if they 1 were mentally incompetent or unwilling to give informed consent; 2 had no angiographic visualization of both carotid arteries and their intracranial branches; 3 had an intracranial lesion that was more severe than the surgically accessible lesion; 4 had organ failure of the kidney, liver, Thrombophlebitis Karotischirurgie, or lung, or had cancer judged likely to cause death within five years; 5 had a cerebral infarction on either side that deprived the patient of all useful function in the affected territory; 6 had symptoms that could be attributed to nonatherosclerotic disease e.
Patients were temporarily ineligible if they had uncontrolled hypertension, diabetes mellitus, or unstable angina pectoris; Thrombophlebitis Karotischirurgie infarction within the previous 6 months; signs of progressive neurologic dysfunction; contralateral carotid endarterectomy within the previous 4 months; or a major surgical procedure within the previous 30 days.
Such patients could become eligible if the disorder causing their temporary ineligibility resolved within days after their qualifying cerebrovascular event. The data on all ineligible patients and all who were eligible but did not undergo randomization, including all patients undergoing carotid endarterectomy outside the trial, Thrombophlebitis Karotischirurgie, were reported to the Nonrandomized Data Center at the Mayo Clinic, Thrombophlebitis Karotischirurgie.
Patients underwent standardized history taking, physical and neurologic examinations, a point assessment of functional status, laboratory tests, lead electrocardiography, computerized tomography of Training im Zimmer für die Mädchen mit Krampfadern head, angiography and duplex ultrasonography of the carotid arteries, and chest roentgenography.
On transmission of base-line data to the Data Management Center, patients were Thrombophlebitis Karotischirurgie assigned to receive either medical care alone or medical care plus surgery, according to a computer-generated randomization schedule. Antiplatelet treatment usually mg of aspirin per day or a lower dose if necessitated by side effects and, as indicated, antihypertensive, antilipid, and antidiabetic therapy was prescribed Thrombophlebitis Karotischirurgie all patients.
Those assigned to surgery also underwent carotid endarterectomy, Thrombophlebitis Karotischirurgie. The surgical technique was left to Thrombophlebitis Karotischirurgie discretion of the surgeon, and the procedures have been described elsewhere. Patients with bilateral stenosis who were assigned to surgery could undergo bilateral endarterectomy if the symptomatic side of the carotid Thrombophlebitis Karotischirurgie operated Thrombophlebitis Karotischirurgie first.
Study surgeons completed Thrombophlebitis Karotischirurgie assessments 30 days after surgery or at the time of hospital discharge, Thrombophlebitis Karotischirurgie occurred first.
Study neurologists performed medical, neurologic, and functional-status assessments of all patients one month after entry, then every three months for the first year, and Thrombophlebitis Karotischirurgie four months thereafter. The management of cardiovascular risk factors was monitored centrally, and reminders were sent to neurologists if necessary. Computed tomography of the head was performed if cerebrovascular events were suspected.
Duplex ultrasonography was repeated one month after entry and after any cerebrovascular event in the carotid distribution. Carotid angiography was repeated after any cerebrovascular event when considered clinically appropriate. All deaths were assessed for their immediate, underlying, Thrombophlebitis Karotischirurgie, and contributing causes. Strokes were assessed for location, type, laterality, severity, and duration, according to the definitions published by the Committee on Classification of Cerebrovascular Disease of the National Institute of Neurological Disorders and Stroke.
Patient eligibility and events were assessed at three levels: The original calculations of sample size allowed for independent analyses in each of four angiographic subgroups defined by the degree of stenosis and angiographic evidence of ulceration, Thrombophlebitis Karotischirurgie.
However, the comparison of base-line angiograms and surgical specimens confirmed the insensitivity of angiography in detecting ulceration. All analyses compared medical and surgical patients with respect to the length of time before treatment failure by means of the MantelHaenszel chi-square test and Kaplan—Meier survival curves. All reported P values are two-tailed. The primary analysis defined treatment failure as any fatal or nonfatal stroke ipsilateral to the carotid lesion.
Other definitions included all strokes and all deaths as well as consideration of the severity of stroke, Thrombophlebitis Karotischirurgie. Strokes producing functional deficits persisting beyond 90 days were considered major. Each of these analyses included all strokes regardless of location and all deaths regardless of cause that occurred among surgical patients during the day postoperative period and among medical patients during a comparable period after randomization.
Patients found to be ineligible because they did not have either an appropriate carotid lesion or corresponding symptoms were Behandlung von Krampfadern Schwellungen Schmerzen from the primary analysis. Patients who were crossed over to the other treatment group were included in the primary analysis up to the date of crossover, but not after that date, Thrombophlebitis Karotischirurgie.
As dictated in the protocol, Thrombophlebitis Karotischirurgie, monthly interim analyses were initiated in January two years after the randomization of the first Thrombophlebitis Karotischirurgie. If the results of any Übungsvideos gegen Krampfadern these monthly analyses, known only to the principal biostatistical investigator and a clinical epidemiologist, showed a difference between the medical and surgical groups that had reached a level of statistical significance of 0, Thrombophlebitis Karotischirurgie.
If this difference remained at the 0. The committee was also to be convened if it became possible to rule out, with Thrombophlebitis Karotischirurgie high Thrombophlebitis Karotischirurgie of confidence, a 10 percent reduction in relative risk as a result of carotid endarterectomy.
Analyses were conducted to ascertain the importance of risk factors by dividing patients into three risk groups of approximately equal size according to a simple count of the commonly recognized risk factors with the use of Thrombophlebitis Karotischirurgie cutoff points: These risk factors and cutoff points Thrombophlebitis Karotischirurgie chosen in advance and were not derived through analysis of the data.
On February 1,the trial's preplanned rule for stopping randomization was invoked because of evidence of treatment efficacy among patients with high-grade stenosis 70 to 99 percent who underwent carotid endarterectomy.
On February 21, Thrombophlebitis Karotischirurgie, the monitoring and executive committees agreed that 1 randomization of patients with high-grade stenosis should be stopped, Thrombophlebitis Karotischirurgie, 2 a summary of the Thrombophlebitis Karotischirurgie in the patients with high-grade stenosis should be communicated immediately to the participating clinicians, along with a list of all patients given medical treatment alone to whom the results might apply, 3 reports of all strokes and deaths and all patient assessments occurring before February 21 should be collected as quickly as possible for inclusion in this report, and 4 the parallel study dealing with symptomatic patients with medium-grade stenosis 30 to 69 percent should be continued.
The sponsoring agency, the National Institute of Neurological Disorders and Stroke, independently issued a Thrombophlebitis Karotischirurgie Clinical Alert to convey immediately a summary of these interim results to physicians across North America. Six hundred sixty-two patients with high-grade carotid stenosis determined by central radiologic review were enrolled between January 1,Thrombophlebitis Karotischirurgie, and February 21, Of these, three patients 0. Randomization created balanced treatment groups with respect to the qualifying cerebrovascular events, underlying vascular lesions, and important Thrombophlebitis Karotischirurgie characteristics Table 1 Table 1 Base-Line Characteristics of the Treatment Groups.
The similarity between the patients included and those excluded, reported elsewhere, 19 confirmed that no subgroup of eligible patients was systematically excluded from the trial. No patient was lost to follow-up and none withdrew; 98 percent of the surviving patients had their last follow-up examination within 4 months of the February 21 closing date, and the average duration of follow-up was 18 months.
Twenty-one medical patients 6. Of the patients assigned to surgery, only 1 refused Thrombophlebitis Karotischirurgie operation and received medical treatment alone. All the others underwent carotid endarterectomy, Thrombophlebitis Karotischirurgie, performed an average of two days after randomization, Thrombophlebitis Karotischirurgie.
Medical regimens to reduce the risk of stroke were applied equally in both treatment groups. Over 99 percent of both medical and surgical patients were taking anti-thrombotic drugs at the last follow-up visit, most commonly aspirin, which was being used by 94 percent of the medical patients and 98 percent of the surgical patients.
The perioperative period was considered the time from randomization to 30 days after surgery which was performed a median of 2 days after randomization. None of the surgical patients had a stroke or died between randomization and surgery. In the perioperative period, Thrombophlebitis Karotischirurgie, 18 surgical patients 5. In addition, one patient died suddenly after surgery, for a rate of Thrombophlebitis Karotischirurgie. Restricting the analysis to the most serious events resulted in a rate of 2.
In the Thrombophlebitis Karotischirurgie day period after randomization among the medical patients, 11 3. This resulted in a rate of 3. Other surgical complications included cranialnerve injury 7. Of these complications, 81 percent were considered mild of no lasting consequence and not prolonging hospitalization and the Lübeck kaufen Varikosette were considered moderate of no lasting consequence but prolonging the hospital stay.
Thus, for every patients treated surgically, 17 were spared an ipsilateral stroke over the next two years. This represents Thrombophlebitis Karotischirurgie relative-risk reduction of 65 percent and shows that six such patients are the "number needed to be treated" 22 in order to prevent one adverse event by 24 months. The second through sixth rows of Table 2 show Behandlung von chronischen Thrombophlebitis carotid endarterectomy remained beneficial with respect to each of the five other definitions of outcome events.
The vast majority of first events were ipsilateral strokes 61 in medical patients vs. The inclusion of stroke in the distribution of the contralateral carotid and vertebral basilar arteries added only three Thrombophlebitis Karotischirurgie to those in the medical group and Thrombophlebitis Karotischirurgie to those in the surgical group, and the further addition of death from any cause added another Thrombophlebitis Karotischirurgie and seven events, respectively.
Survival curves for the values reflected in each of the rows in Table 2 are shown in Figure 1 Figure 1 Survival Curves for the Treatment Groups. These Kaplan—Meier survival curves show the probability of surviving six events indicating treatment failure after randomization. The number of patients who remained event-free in each treatment group is shown at six-month intervals at the bottom of each graph; the numbers at time zero are in the surgical group and in the medical group. They reveal two additional points of interest.
First, the early disadvantage to the surgical patients who faced a risk of perioperative stroke and death was rapidly overcome, with the curves for the medical and the surgical patients Thrombophlebitis Karotischirurgie about three months after randomization. Second, there was no evidence of convergence of the two curves for as long as 30 months, indicating that the beneficial effects of surgery persisted at least this long, Thrombophlebitis Karotischirurgie.
Among the patients who did not die or have a major stroke during the first month after randomization, the risk of any major or fatal stroke within two Thrombophlebitis Karotischirurgie was Thus, the immediate postoperative increase in the risk of major stroke or death among the surgical patients, 1.
Analyzing our results according to the intention-to-treat principle produced essentially the same levels of significance and standard errors for between-group differences, Thrombophlebitis Karotischirurgie. This analysis, which included the three incorrectly randomized ineligible patients and counted events occurring in a patient after crossover according to the group to which the patient had originally been assigned, added just one event to those in the medical group and two events to those in the surgical group.
The analyses reported in this paper include 30 patients found to be technically ineligible Thrombophlebitis Karotischirurgie of inadequate angiography 17 patientsThrombophlebitis Karotischirurgie, severe intracranial stenosis 4cerebral aneurysms 3cardiac Thrombophlebitis Karotischirurgie 3and other medical problems 3.
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