AHA Journals, Author Interviews, Duke, Outcomes & Safety, Stroke, Surgical Research / 04.11.2015
Studies Evaluates Outcomes of Carotid Artery Stenting in Real World Settings
MedicalResearch.com Interview with:
Soko Setoguchi-Iwata, M.D MPH
Adjunct Associate Professor
Department of Medicine
Duke Clinical Research Institute
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 vs Carotid Endarterectomy 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 performing stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated Carotid Artery Stenting 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 an 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.
(more…)