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



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.



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).



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.
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.).
Mohamad A
MA
Hussain
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.).
Muhammad
M
Mamdani
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.).
Jack V
JV
Tu
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.).
Gustavo
G
Saposnik
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.).
Zeyad
Z
Khoushhal
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.).
Badr
B
Aljabri
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.).
Subdoh
S
Verma
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.). AlomranM@smh.ca.
Mohammed
M
Al-Omran
D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D016894:Endarterectomy, Carotid / Q000706:statistics & numerical data* / Q000639:trends; D057510:Endovascular Procedures / Q000706:statistics & numerical data* / Q000639:trends; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009864:Ontario / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic; D015607:Stents / Q000706:statistics & numerical data* / Q000639:trends
carotid endarterectomy; carotid stenosis; carotid-artery stenting; health services research; trends