Picking the Good Apples

Howard, George; Voeks, Jenifer H.; Meschia, James F.; Howard, Virginia J.; Brott, Thomas G.

doi:10.1161/strokeaha.114.006807

Cited by 6 publications

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References 15 publications

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“…11, 17 We were concerned that the event rates could be higher for these less experienced sites; however, an analysis separating sites into those admitted early, middle and late in the study failed to detect significant change (Supplemental Table III). …”

Section: Discussionmentioning

confidence: 99%

Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial

Howard

Hopkins

Moore

et al. 2015

Stroke

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Background and Purpose Post-hoc, we hypothesized that over the recruitment period of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), increasing experience and improved patient selection with carotid stenting (CAS), and to a lesser extent, carotid endarterectomy (CEA) would contribute to lower periprocedural event rates. Methods Three study periods with approximately the same number of patients were defined to span recruitment. Composite and individual rates of periprocedural stroke, myocardial infarction and death rate were calculated separately by treatment assignment (CAS/CEA). Temporal changes in unadjusted event rates, and rates after adjustment for temporal changes in patient characteristics, were assessed. Results For patients randomized to CAS, there was no significant temporal change in the unadjusted composite rates, that declined from 6.2% in the first period, to 4.9% in the second, and 4.6% in the third (p = 0.28). Adjustment for patient characteristics attenuated the rates to 6.0%, 5.9%, and 5.6% (p = 0.85). For CEA-randomized patients, both the composite and the combined stroke and death outcome decreased between period 1 and 2, and then increased in period 3. Conclusion The hypothesized temporal reduction of stroke + death events for CAS-treated patients was not observed. Further adjustment for changes in patient characteristics between periods, including the addition of asymptomatic patients and a > 50% decrease in proportion of octogenarians enrolled, resulted in practically identical rates. Clinical Trial Registration URL: http://clinicaltrials.gov. Unique Identifier:NCT00004732.

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Section: Discussionmentioning

confidence: 99%

Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial

Howard

Hopkins

Moore

et al. 2015

Stroke

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Editor's Choice – Overview of Primary and Secondary Analyses From 20 Randomised Controlled Trials Comparing Carotid Artery Stenting With Carotid Endarterectomy

Batchelder

Saratzis

Naylor

2019

European Journal of Vascular and Endovascular Surgery

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This paper provides an overview of primary/secondary outcome data from 20 randomised controlled trials comparing carotid endarterectomy (CEA) with carotid artery stenting (CAS) in symptomatic and asymptomatic patients, including meta-analyses for peri-operative risks and late ipsilateral stroke. Secondary analyses include (i) risk factors for stroke after CEA/CAS; (ii) the effect of peri-operative stroke or myocardial infarction on long term survival; (iii) non-stroke complications; (iv) the significance of new white matter lesions on late stroke and cognitive impairment; and (v) whether asymptomatic 70%e99% restenoses increase the risk of ipsilateral stroke after CEA and CAS. Objectives: The aim of this review was to carry out primary and secondary analyses of 20 randomised controlled trials (RCTs) comparing carotid endarterectomy (CEA) with carotid artery stenting (CAS). Methods: A systematic review and meta-analysis of data from 20 RCTs (126 publications) was carried out. Results: Compared with CEA, the 30 day death/stroke rate was significantly higher after CAS in seven RCTs involving 3467 asymptomatic patients (odds ratio [OR] 1.64, 95% confidence interval [CI] 1.02e2.64) and in 10 RCTs involving 5797 symptomatic patients (OR 1.71, 95% CI 1.38e2.11). Excluding procedural risks, late ipsilateral stroke was about 4% at 9 years for both CEA and CAS, i.e., CAS was durable. Reducing procedural death/stroke after CAS may be achieved through better case selection, e.g., performing CEA in (i) symptomatic patients aged > 70 years; (ii) interventions within 14 days of symptom onset; and (iii) situations where stroke risk after CAS is predicted to be higher (segmental/remote plaques, plaque length > 13 mm, heavy burden of white matter lesions [WMLs], where two or more stents might be needed). New WMLs were significantly more common after CAS (52% vs. 17%) and were associated with higher rates of late stroke/transient ischaemic attack (23% vs. 9%), but there was no evidence that new WMLs predisposed towards late cognitive impairment. Restenoses were more common after CAS (10%) but did not increase late ipsilateral stroke. Restenoses (70%e99%) after CEA were associated with a small but significant increase in late ipsilateral stroke (OR 3.87, 95% CI 1.96e7.67; p < .001). Conclusions: CAS confers higher rates of 30 day death/stroke than CEA. After 30 days, ipsilateral stroke is virtually identical for CEA and CAS. Key issues to be resolved include the following: (i) Will newer stent technologies and improved cerebral protection allow CAS to be performed < 14 days after symptom onset with risks similar to CEA? (ii) What is the optimal volume of CAS procedures to maintain competency? (iii) How to deliver better risk factor control and best medical treatment? (iv) Is there a role for CEA/CAS in preventing/reversing cognitive impairment?

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Factors influencing credentialing of interventionists in the CREST-2 trial

Lal

Meschia

Roubin³

et al. 2020

Journal of Vascular Surgery

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Background:The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a pair of randomized trials assessing the relative efficacy of carotid revascularization in the setting of intensive medical management (IMM) in patients with asymptomatic high-grade atherosclerotic stenosis. One of the trials assesses IMM with or without carotid artery stenting (CAS). Given the low risk of stroke in nonrevascularized patients receiving IMM, it is essential that there be low periprocedural risk of stroke for CAS if it is to show incremental benefit. Thus, credentialing of interventionists to ensure excellence is vital. This analysis describes the protocol-driven approach to credentialing of CAS interventionists for CREST-2 and its outcomes.Methods: To be eligible to perform stenting in CREST-2, interventionists needed to be credentialed on the basis of a detailed Interventional Management Committee (IMC) review of data from their last 25 consecutive cases during the past 24 months along with self-reported lifetime experience case numbers. When necessary, additional prospective cases performed in a companion registry were requested after webinar training. Here we review the IMC experience from the first formal meeting on March 21, 2014 through October 14, 2017. Results:The IMC had 102 meetings, and 8311 cases submitted by 334 interventionists were evaluated. Most were either cardiologists or vascular surgeons, although no single specialty made up the majority of applicants. The median total experience was 130 cases (interquartile range [IQR], 75-266; range, 25-2500). Only 9% (30/334) of interventionists were approved at initial review; approval increased to 46% (153/334) after submission of new cases with added training and rereview. The median self-reported lifetime case experience for those approved was 211.5 (IQR, 100-350), and the median number of cases submitted for review was 30 (IQR,(27)(28)(29)(30)(31)(32)(33)(34)(35). The number of CAS procedures performed per month (case rate) was the only factor associated with approval during the initial cycle of review (P < .00001).Conclusions: Identification of interventionists who were deemed sufficiently skilled for CREST-2 has required substantial oversight and a controlled system to judge current skill level that controls for specialty-based practice variability, procedural experience, and periprocedural outcomes. High-volume interventionists, particularly those with more recent experience, were more likely to be approved to participate in CREST-2. Primary approval was not affected by operator specialty.

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Picking the Good Apples

Abstract: Suppose that a particular operator is a good apple, that is his/ her true complication rate is ≤3%. However, even among the good operators, there are those who are outstanding (true by guest on

Cited by 6 publications

References 15 publications

Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial

Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial

Editor's Choice – Overview of Primary and Secondary Analyses From 20 Randomised Controlled Trials Comparing Carotid Artery Stenting With Carotid Endarterectomy

Factors influencing credentialing of interventionists in the CREST-2 trial

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