Impact of Clinical Trial Results on the Temporal Trends of Carotid Endarterectomy and Stenting From 2002 to 2014

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Supplemental Digital Content is available in the text.

Abstract

Background and Purpose—

Randomized trials provide conflicting data for the efficacy of carotid-artery stenting compared with endarterectomy. The purpose of this study was to examine the impact of conflicting clinical trial publications on the utilization rates of carotid revascularization procedures.

Methods—

We conducted a population-level time-series analysis of all individuals who underwent carotid endarterectomy and stenting in Ontario, Canada (2002–2014). The primary analysis examined temporal changes in the rates of carotid revascularization procedures after publications of major randomized trials. Secondary analyses examined changes in overall and age, sex, carotid-artery symptom, and operator specialty–specific procedure rates.

Results—

A total of 16 772 patients were studied (14 394 endarterectomy [86%]; 2378 stenting [14%]). The overall rate of carotid revascularization decreased from 6.0 procedures per 100 000 individuals ≥40 years old in April 2002 to 4.3 procedures in the first quarter of 2014 (29% decrease; P<0.001). The rate of endarterectomy decreased by 36% ( P<0.001), whereas the rate of carotid-artery stenting increased by 72% ( P=0.006). We observed a marked increase ( P=0.01) in stenting after publication of the SAPPHIRE trial (Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy) in 2004, whereas stenting remained relatively unchanged after subsequent randomized trials published in 2006 ( P=0.11) and 2010 ( P=0.34). In contrast, endarterectomy decreased after trials published in 2006 ( P=0.04) and 2010 ( P=0.005).

Conclusions—

Although the overall rates of carotid revascularization and endarterectomy have fallen since 2002, the rate of carotid-artery stenting has risen since the publication of stenting-favorable SAPPHIRE trial. Subsequent conflicting randomized trials were associated with a decreasing rate of carotid endarterectomy.

Related collections

Most cited references 26

Record: found
Abstract: found
Article: not found

Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study.

David Juurlink, Muhammad Mamdani, Douglas S Lee … (2004)

The Randomized Aldactone Evaluation Study (RALES) demonstrated that spironolactone significantly improves outcomes in patients with severe heart failure. Use of angiotensin-converting-enzyme (ACE) inhibitors is also indicated in these patients. However, life-threatening hyperkalemia can occur when these drugs are used together. We conducted a population-based time-series analysis to examine trends in the rate of spironolactone prescriptions and the rate of hospitalization for hyperkalemia in ambulatory patients before and after the publication of RALES. We linked prescription-claims data and hospital-admission records for more than 1.3 million adults 66 years of age or older in Ontario, Canada, for the period from 1994 through 2001. Among patients treated with ACE inhibitors who had recently been hospitalized for heart failure, the spironolactone-prescription rate was 34 per 1000 patients in 1994, and it increased immediately after the publication of RALES, to 149 per 1000 patients by late 2001 (P<0.001). The rate of hospitalization for hyperkalemia rose from 2.4 per 1000 patients in 1994 to 11.0 per 1000 patients in 2001 (P<0.001), and the associated mortality rose from 0.3 per 1000 to 2.0 per 1000 patients (P<0.001). As compared with expected numbers of events, there were 560 (95 percent confidence interval, 285 to 754) additional hyperkalemia-related hospitalizations and 73 (95 percent confidence interval, 27 to 120) additional hospital deaths during 2001 among older patients with heart failure who were treated with ACE inhibitors in Ontario. Publication of RALES was not associated with significant decreases in the rates of readmission for heart failure or death from all causes. The publication of RALES was associated with abrupt increases in the rate of prescriptions for spironolactone and in hyperkalemia-associated morbidity and mortality. Closer laboratory monitoring and more judicious use of spironolactone may reduce the occurrence of this complication. Copyright 2004 Massachusetts Medical Society

0 comments Cited 292 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Protected carotid-artery stenting versus endarterectomy in high-risk patients.

Jay S Yadav, Mark H Wholey, Richard E Kuntz … (2004)

Carotid endarterectomy is more effective than medical management in the prevention of stroke in patients with severe symptomatic or asymptomatic atherosclerotic carotid-artery stenosis. Stenting with the use of an emboli-protection device is a less invasive revascularization strategy than endarterectomy in carotid-artery disease. We conducted a randomized trial comparing carotid-artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent. The primary end point of the study was the cumulative incidence of a major cardiovascular event at 1 year--a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy. The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting with an emboli-protection device (cumulative incidence, 12.2 percent) and in 32 patients randomly assigned to undergo endarterectomy (cumulative incidence, 20.1 percent; absolute difference, -7.9 percentage points; 95 percent confidence interval, -16.4 to 0.7 percentage points; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, carotid revascularization was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04). Among patients with severe carotid-artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy. Copyright 2004 Massachusetts Medical Society.

0 comments Cited 281 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis.

Kenneth Rosenfield, Jon Matsumura, Seemant Chaturvedi … (2016)

Previous clinical trials have suggested that carotid-artery stenting with a device to capture and remove emboli ("embolic protection") is an effective alternative to carotid endarterectomy in patients at average or high risk for surgical complications.

0 comments Cited 123 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Journal

Journal ID (nlm-ta): Stroke

Journal ID (iso-abbrev): Stroke

Journal ID (publisher-id): STR

Title: Stroke

Publisher: Lippincott Williams & Wilkins

ISSN (Print): 0039-2499

ISSN (Electronic): 1524-4628

Publication date (Print): December 2016

Publication date (Electronic): 28 November 2016

Volume: 47

Issue: 12

Pages: 2923-2930

Affiliations

From the Divisions of Vascular Surgery (M.A.H., Z.K., B.A., M.A.-O.), Neurology (G.S.), and Cardiac Surgery (S.V.) and Li Ka Shing Knowledge Institute, St Michael’s Hospital (M.M., G.S., S.V., M.A.-O.), Toronto, Canada; Departments of Surgery (M.A.H., S.V., M.A.-O.) and Medicine (J.V.T., G.S.), University of Toronto, Toronto, Canada; Institute of Health Policy, Management, and Evaluation (M.M., J.V.T., G.S.) and Leslie Dan Faculty of Pharmacy (M.M.), University of Toronto, Canada; King Saud University-Li Ka Shing Collaborative Research Program (M.M., B.A., S.V., M.A.-O.); Department of Surgery, Taibah University, Madinah, Kingdom of Saudi Arabia (Z.K.); Department of Surgery, King Saud University, Riyadh, Kingdom of Saudi Arabia (B.A., M.A.-O.); Institute for Clinical Evaluative Sciences (M.M., J.V.T., G.S.), Toronto, Canada; and Division of Cardiology, Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Canada (J.V.T.).

Author notes

Correspondence to Mohammed Al-Omran, MD, MSc, 30 Bond St, 7–074 Bond Wing, Toronto, Ontario, M5B1W8 Canada. E-mail AlomranM@ 123456smh.ca

Article

Accession ID: 00008

DOI: 10.1161/STROKEAHA.116.014856

PMC ID: 5120767

PubMed ID: 27834754

SO-VID: 3b492c78-49b8-46ad-b963-143878cc8528

License:

Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.

History

Date received : 19 July 2016

Date revision received : 7 September 2016

Date accepted : 4 October 2016

Custom metadata

OPEN-ACCESS TRUE

Keywords: carotid-artery stenting,carotid endarterectomy,carotid stenosis,health services research,trends

Data availability:

Keywords: carotid-artery stenting, carotid endarterectomy, carotid stenosis, health services research, trends

Comments

Comment on this article

scite_

Smart Citations

Citing PublicationsSupportingMentioningContrasting

View Citations

See how this article has been cited at scite.ai

scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.

Cited by 13

See all cited by

Most referenced authors 1,017

See all reference authors

Impact of Clinical Trial Results on the Temporal Trends of Carotid Endarterectomy and Stenting From 2002 to 2014

Read this article at

Abstract

Abstract

Background and Purpose—

Methods—

Results—

Conclusions—

Related collections

The Physician

Most cited references 26

Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study.

Protected carotid-artery stenting versus endarterectomy in high-risk patients.

Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis.

Author and article information

Journal

Affiliations

Author notes

Article

History

Categories

Custom metadata

Comments

Comment on this article

Cited by 13

Most referenced authors 1,017