MedicalResearch.com Interview with:
Soko Setoguchi, MD DrPH
Assistant Professor of Medicine
Harvard Medical School and Harvard School of Public Health
Director of Safety and Outcome Research in Cardiology
Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital
Medical Research: What is the background for this study? What are the main findings?
Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting (CAS) vs Carotid endarterectomy (CEA) in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population.
Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting.
Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians peforming stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated CAS proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse.
We found that unadjusted mortality risks over study period of 5 years with a mean of 2 years of follow-up in our population was 32%. Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations.
Medical Research: What should clinicians and patients take away from your report?
Dr. Setoguchi: Mortality risks in older Medicare patients who underwent Carotid Artery Stenting were high. The benefit of Carotid Artery Stenting in older patients, especially those who are symptomatic from carotid stenosis and who may undergo urgent procedure, is likely diminished. Therefore, careful clinical assessment of risk benefit should guide the choice of therapy in older patients.
Factors such as patient’s age, symptomatic status and urgent hospitalization that we found associated with higher mortality can guide physicians and patient to make decision to consider/perform Carotid Artery Stenting. However, such guidance should not overwrite a decision based on careful clinical assessments about the prognosis of patient and patient preferences.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Setoguchi: Our study did not have comparable data to SAPPHIRE or CREST to directly apply the same proficiency criteria used in these studies. The modified criteria we applied likely underestimated the number of providers who would have been included SAPHIRE or CREST. However, our data demonstrated that the real-world providers are more diverse in their proficiency than those who were enrolled in these trials. More studies with high quality data are needed to carefully assess provider’s proficiency in real-world settings and provide guidance on the necessary level of proficiency for better outcomes after Carotid Artery Stenting.