MedicalResearch.com Interview with:
Jessica J. Jalbert PhD
From the Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine, Brigham and Women’s Hospital
Harvard Medical School, Boston, MA
New York, NY
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Jalbert: Landmark clinical trials have demonstrated that carotid artery stenting (CAS) is a safe and efficacious alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. Clinical trials, however, tend to enroll patients that are younger and healthier than the average Medicare patient. We therefore sought to compare outcomes following CAS and CEA among Medicare patients.
MedicalResearch.com: What are the main findings?
Dr. Jalbert: We found that outcomes among real-world Medicare patients undergoing CAS and CEA were similar. While our results were inconclusive due to small sample size, we also found some evidence suggesting that patients over the age of 80 and those with symptomatic carotid stenosis may have better outcomes following carotid endarterectomy than CAS.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Jalbert: The conclusion from the landmark clinical trials, that CAS is as safe and efficacious as CEA for the treatment of carotid artery stenosis, also seems to apply to the real-world Medicare population when the procedures are performed at certified facilities under the Center for Medicare and Medicaid Services’ (CMS’s) National Coverage Determination for CAS.
However, careful patient selection may be needed when considering carotid procedures for older and symptomatic patients as our results suggest that CAS might be less beneficial than carotid endarterectomy in these patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Jalbert: One carotid stenosis treatment modality that we did not evaluate in this study was medical management. While a clinical trial evaluating the relative performance of these treatments is currently underway, future observational studies should compare the effectiveness of CAS and CEA to medical management.
In addition, while our results were inconclusive due to limitations in power, future studies should assess the possibility that patients over the age of 80 and those with symptomatic carotid stenosis have more favorable outcomes following CEA than CAS.
MedicalResearch.com: Is there anything else you would like to add?
Response: While the findings from this study are in agreement with those of landmark clinical trials, it should not be assumed that the results from clinical trials always apply to real-world patients. Clinical trials, considered the gold standard by which to evaluate the performance of a procedure, tend to enroll younger patients with a lower comorbidity burden than the average Medicare patient such that it is important to evaluate the performance of the treatments outside of the clinical trial setting and in routine clinical practice.
Also, our study suggests that how well the procedure performs in the real-world is a function not only of the characteristics of the patient undergoing the procedure but also of the provider treating the patient.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Comparative Effectiveness of Carotid Artery Stenting Versus Carotid Endarterectomy Among Medicare Beneficiaries
Jessica J. Jalbert, Louis L. Nguyen, Marie D. Gerhard-Herman, Hiraku Kumamaru, Chih-Ying Chen, Lauren A. Williams, Jun Liu, Andrew T. Rothman, Michael R. Jaff, John D. Seeger, James F. Benenati, Peter A. Schneider, Herbert D. Aronow, Joseph A. Johnston, Thomas G. Brott,Thomas T. Tsai, Christopher J. White, and Soko Setoguchi
Circ Cardiovasc Qual Outcomes.2016;CIRCOUTCOMES.115.002336published online before print April 26 2016, doi:10.1161/CIRCOUTCOMES.115.002336
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