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Address 2 Optional. Yemen Zambia Zimbabwe. Multivariate logistic regression was rerun using the variables of age, degree of contralateral stenosis, any cerebrovascular disease major or minor stroke or documented cerebrovascular atherosclerosis , CHF, COPD, diabetes mellitus DM , and preadmission living in a nursing home.
Regression coefficients were obtained along with the intercept for the regression. Convenient categories were created for the interval and ordinal data. Age was divided into decades 40 to 89 years. A point system was developed using a common denominator for the regression coefficients to achieve convenient integers. Finally, the risk associated with each point was calculated using the multiple logistic regression equation, as described by Sullivan et al.
The 1-year stroke rate was 7. On further analysis, major ipsilateral and minor nonipsilateral stroke differed significantly between the two groups, five 3. Despite this, the primary end point of death, stroke, or MI at 30 days plus ipsilateral stroke or death from neurologic causes within 31 days to 1 year was similar to the VSGNE database, 30 The conventional end point, stroke or death at 30 days plus ipsilateral stroke or death from neurologic causes within 31 days to 1 year, was also similar, 11 7.
Hispanic or Latino ethnicity was similarly removed from further analysis with only six patients 0. Multivariate correlates of the primary outcome of myocardial infarction MI , stroke, or death a. The resulting weighted point system is included in Table V. The range of possible points was from 0 to 27, with an associated range in risk from 2. The parameters of the sample are within the values estimated by our bootstrapping analysis, suggesting our sample is representative at least to a similar population as that sampled by the VSGNE data set; Table V.
CEA is an effective and durable procedure for stroke prevention in symptomatic and asymptomatic patients previously validated by several reported clinical trials. The SAPPHIRE trial was used as comparison for being one of the first large-scale trials to define what constituted high-risk with a set of subjectively chosen variables.
Because this study was a retrospective review of a large-scale, self-reported database, we did find some differences amongst the studied populations. The primary end points of both studies, however, were comparable. Our population had a lower rate of stroke 3. The rate of MI among our population, conversely, was comparable to that reported by Press et al, 9 who found the postprocedure rate of MI of 1. They then evaluated 27 preoperative variables, including the defined high-risk variables, and found many SAPPHIRE variables were not significantly associated with their outcome after multivariate analysis.
Similar to our study, functional status was a significant marker of increased postoperative death odds ratio, 7. In addition, many vascular specific variables were unavailable in their database. One of the new high-risk characteristics that emerged was living in a nursing home preadmission, a surrogate for poor functional status.
Researchers have raised the question of the safety of CEA in the elderly and frail population for many years. However, findings in several other studies that evaluated octogenarians vs younger patients suggest an increased risk with CEA in younger patients. One hypothesis is that young patients with critical carotid disease may represent a population with premature atherosclerosis, labile plaques, or undiagnosed hypercoagulable disorders that place them at higher-risk for complications.
The question of the relationship between age and poor postoperative outcomes after CEA remains unanswered. Evidence strongly suggests that risks among octogenarians for poor outcomes are much higher for those undergoing CAS. In addition, even as high-risk candidates, the alternative, CAS, may not yield better outcomes. DM was the second novel high-risk factor found. The literature is, unfortunately, not clear on the potential increased risk in patients with DM undergoing carotid surgery.
Axelrod et al 30 and other investigators found DM was an independent risk factor for a poor outcome after any major vascular surgery, and patients with DM had a significantly higher incidence of death or cardiovascular complications after CEA 3. An earlier study by Ahari et al 32 also found patients with DM had a higher day mortality rate of 3.
Skydell et al 33 and Salenius et al 34 found that patients with DM had increased neurologic complications after CEA compared with their nondiabetic counterparts. Salenius et al 34 evaluated patients who underwent CEA. Tu et al 41 also found that DM was a significant independent predictor for day death or stroke after CEA odds ratio, 1. Skydell et al, 33 however, evaluated patients who presented with post-CEA hypertensive crisis and found a significant correlation with the presence of DM, most likely due to the known negative effects that DM has on cerebrovascular autoregulation.
In contrast, a few studies have disputed that DM may be an independent risk factor for poor outcomes after CEA. Akbari et al 12 reported CEAs, in patients with DM, and found there was no significant difference in perioperative stroke or mortality.
Similarly, Pistolese et al 35 reviewed CEAs, in patients with DM, and also found no significant difference in perioperative stroke MI, mortality, or long-term survival. Experimental investigation of modern and established carotid stents.
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The SAPPHIRE trial showed patients undergoing carotid stenting were comparably protected from stroke, heart attack, death, and repeat revascularization procedures as patients who underwent the traditional surgical approach endarterectomy. SAPPHIRE is the first and longest three years randomized study to compare the safety and efficacy of carotid stenting with embolic protection to surgery in high risk patients.
High risk patients are considered to be at increased risk for surgery because of prior carotid artery surgery, radiation to the neck, chronic heart failure, lung disease or severe coronary artery disease, among other criteria.
Results are consistent with one-year SAPPHIRE data and echo conclusions from other non-randomized trials supporting the use of carotid stenting, particularly in patients with multiple illnesses. We are hopeful that this news will help pave the way for expanded use of this procedure.
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