TY - JOUR
T1 - Comparison of Outcomes in Elective Endovascular Aortic Repair vs Open Surgical Repair of Abdominal Aortic Aneurysms
AU - Salata, Konrad
AU - Hussain, Mohamad A.
AU - De Mestral, Charles
AU - Greco, Elisa
AU - Aljabri, Badr A.
AU - Mamdani, Muhammad
AU - Forbes, Thomas L.
AU - Bhatt, Deepak L.
AU - Verma, Subodh
AU - Al-Omran, Mohammed
N1 - Funding Information:
This study was supported by the Institute for Clinical Evaluative Sciences (ICES), which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). This work was jointly funded by the Division of Vascular Surgery at St Michaels Hospital, Toronto, Ontario, Canada, and funds from the Department of Surgery, King Saud University, Riyadh, Kingdom of Saudi Arabia. Dr Salata is supported in part by the Canadian Institutes of Health Research Canada Graduate Scholarship Masters salary support award, the Goerc and Toronto Academic Vascular Specialists Surgeon Scientist Training Program Scholarship, and the Ontario Graduate Scholarship.
Funding Information:
Author Contributions: Dr Salata had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Salata, Hussain, Greco, Aljabri, Mamdani, Verma, Al-Omran. Acquisition, analysis, or interpretation of data: Salata, Hussain, de Mestral, Mamdani, Forbes, Bhatt, Al-Omran. Drafting of the manuscript: Salata, Verma. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: Salata, de Mestral, Mamdani. Obtained funding: Salata. Administrative, technical, or material support: Hussain, Aljabri, Mamdani, Al-Omran. Supervision: de Mestral, Greco, Forbes, Verma, Al-Omran. Conflict of Interest Disclosures: Dr Salata reported grants from the Canadian Institutes for Health Research Canada Graduate Scholarship (Master’s), Frank Goerc and Toronto Academic Vascular Specialists Scholarship, Ontario Graduate Scholarship, and James and Mari Rutka Surgeon Scientist Training Program Scholarship during the conduct of the study and grants from Physician Services Incorporated Foundation outside the submitted work. Dr Bhatt reported serving on the advisory boards of Cardax, Elsevier PracticeUpdate Cardiology, Medscape Cardiology, and Regado Biosciences; serving on the boards of directors of the Boston Department of Veterans Affairs (VA) Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; serving as chair of the American Heart Association Quality Oversight Committee, National Cardiovascular Data Registry-MI Registry Steering Committee, VA Clinical Assessment, Reporting, and Tracking Research and Publications Committee; serving on data monitoring committees for the Cleveland Clinic, Duke Clinical Research Institute, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, PORTICO trial, funded by St Jude Medical, now Abbott Laboratories), Mayo Clinic, Icahn School of Medicine at Mount Sinai (for the ENVISAGE trial, funded by Daiichi Sankyo), and Population Health Research Institute; receiving honoraria from the American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org; vice-chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications (editor in chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (editor in chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor and associate editor), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and US national coleader, funded by Bayer), Slack Publications (chief medical editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (secretary and treasurer), and WebMD (continuing medical education steering committees); serving as deputy editor for Clinical Cardiology; receiving research funding from Abbott Laboratories, Amarin Corporation, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi Farmaceutici, Eisai, Ethicon Inc, Forest Laboratories, Idorsia, Ironwood Pharmaceuticals, Ischemix, Eli Lilly and Company, Medtronic, Pfizer, PhaseBio Pharmaceuticals, Regeneron, Roche Holding, Sanofi, Synaptic Pharmaceuticals, and The Medicines Company; receiving royalties from Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); serving as site coinvestigator at Biotronik, Boston Scientific, St Jude Medical (now Abbott Laboratories), and Svelte; serving as trustee for the American College of Cardiology; and conducting unfunded research for FlowCo Solutions, Merck and Co, Novo Nordisk, PLx Pharma, and Takeda Pharmaceutical. Dr Verma reported grants and personal fees from Amgen and Boehringher Ingelheim; personal fees from AstraZeneca, Bayer, Eli Lilly and Company, Janssen, Merck and Co, Novartis, Novo Nordisk, Sanofi, Servier, and Valeant; and grants from Bristol-Myers Squibb outside the submitted work. No other disclosures were reported.
Funding Information:
Ministry of Health database containing institutional information for all healthcare institutions funded by the Ministry of Health, including numbers of acute care beds, level of care and teaching vs. non-teaching status.
Funding Information:
Funding/Support: This study was supported by the Institute for Clinical Evaluative Sciences (ICES), which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). This work was jointly funded by the Division of Vascular Surgery at St Michael’s Hospital, Toronto, Ontario, Canada, and funds from the Department of Surgery, King Saud University, Riyadh, Kingdom of Saudi Arabia. Dr Salata is supported in part by the Canadian Institutes of Health Research Canada Graduate Scholarship Master’s salary support award, the Goerc and Toronto Academic Vascular Specialists Surgeon Scientist Training Program Scholarship, and the Ontario Graduate Scholarship.
Publisher Copyright:
© 2019 JAMA Network Open. All rights reserved.
PY - 2019/7/10
Y1 - 2019/7/10
N2 - Importance: Knowledge regarding the long-term outcomes of elective treatment of abdominal aortic aneurysm (AAA) using endovascular aortic repair (EVAR) is increasing. However, data with greater than 10 years' follow-up remain sparse and are lacking from population-based studies. Objective: To determine the long-term outcomes of EVAR compared with open surgical repair (OSR) for elective treatment of AAA. Design, Setting, and Participants: This retrospective, population-based cohort study used linked administrative health data from Ontario, Canada, to identify all patients 40 years and older who underwent elective EVAR or OSR for AAA repair from April 1, 2003, to March 31, 2016, with follow-up terminating on March 31, 2017. A total of 17683 patients were identified using validated procedure and billing codes and were propensity score matched. Analysis was conducted from June 26, 2018, to January 16, 2019. Exposures: Elective EVAR or OSR for AAA. Main Outcomes and Measures: The primary outcome was overall survival. Secondary outcomes were major adverse cardiovascular event-free survival, defined as being free of death, myocardial infarction, or stroke; reintervention; and secondary rupture. Results: Among 17683 patients who received elective AAA repairs (mean [SD] age, 72.6 [7.8] years; 14286 [80.8%] men), 6100 (34.5%) underwent EVAR and 11583 (65.5%) underwent OSR. From these patients, 4010 well-balanced propensity score-matched pairs of patients were defined, with a mean (SD) age of 73.0 (7.6) years and 6583 (82.1%) men. In the matched cohort, the mean (SD) follow-up was 4.4 (2.7) years, and maximum follow-up was 13.8 years. The overall median survival was 8.9 years. Compared with OSR, EVAR was associated with a higher survival rate up to 1 year after repair (91.0% [95% CI, 90.1%-91.9%] vs 94.0% [95% CI, 93.3%-94.7%]) and a higher major adverse cardiovascular event-free survival rate up to 4 years after repair (69.9% [95% CI, 68.3%-71.3%] vs 72.9% [95% CI, 71.4%-74.4%]). Cumulative incidence of reintervention was higher among patients who underwent EVAR compared with those who underwent OSR at the 7-year follow-up (45.9% [95% CI, 44.1%-47.8%] vs 42.2% [95% CI, 40.4%-44.0%]). Survival analyses demonstrated no statistically significant differences in long-term survival, reintervention, and secondary rupture for patients who underwent EVAR compared with those who underwent OSR. Kaplan-Meier analysis suggested superior long-term major adverse cardiovascular event-free survival among patients who underwent EVAR compared with those who underwent OSR (32.6% [95% CI, 26.9%-38.4%] vs 14.1% [95% CI, 4.0%-30.4%]; stratified log-rank P <.001) during a maximum follow-up of 13.8 years. Conclusions and Relevance: Endovascular aortic repair was not associated with a difference in long-term survival during more than 13 years' maximum follow-up. The reasons for these findings will require studies to consider specific graft makes and models, adherence to instructions for use, and types and reasons for reintervention.
AB - Importance: Knowledge regarding the long-term outcomes of elective treatment of abdominal aortic aneurysm (AAA) using endovascular aortic repair (EVAR) is increasing. However, data with greater than 10 years' follow-up remain sparse and are lacking from population-based studies. Objective: To determine the long-term outcomes of EVAR compared with open surgical repair (OSR) for elective treatment of AAA. Design, Setting, and Participants: This retrospective, population-based cohort study used linked administrative health data from Ontario, Canada, to identify all patients 40 years and older who underwent elective EVAR or OSR for AAA repair from April 1, 2003, to March 31, 2016, with follow-up terminating on March 31, 2017. A total of 17683 patients were identified using validated procedure and billing codes and were propensity score matched. Analysis was conducted from June 26, 2018, to January 16, 2019. Exposures: Elective EVAR or OSR for AAA. Main Outcomes and Measures: The primary outcome was overall survival. Secondary outcomes were major adverse cardiovascular event-free survival, defined as being free of death, myocardial infarction, or stroke; reintervention; and secondary rupture. Results: Among 17683 patients who received elective AAA repairs (mean [SD] age, 72.6 [7.8] years; 14286 [80.8%] men), 6100 (34.5%) underwent EVAR and 11583 (65.5%) underwent OSR. From these patients, 4010 well-balanced propensity score-matched pairs of patients were defined, with a mean (SD) age of 73.0 (7.6) years and 6583 (82.1%) men. In the matched cohort, the mean (SD) follow-up was 4.4 (2.7) years, and maximum follow-up was 13.8 years. The overall median survival was 8.9 years. Compared with OSR, EVAR was associated with a higher survival rate up to 1 year after repair (91.0% [95% CI, 90.1%-91.9%] vs 94.0% [95% CI, 93.3%-94.7%]) and a higher major adverse cardiovascular event-free survival rate up to 4 years after repair (69.9% [95% CI, 68.3%-71.3%] vs 72.9% [95% CI, 71.4%-74.4%]). Cumulative incidence of reintervention was higher among patients who underwent EVAR compared with those who underwent OSR at the 7-year follow-up (45.9% [95% CI, 44.1%-47.8%] vs 42.2% [95% CI, 40.4%-44.0%]). Survival analyses demonstrated no statistically significant differences in long-term survival, reintervention, and secondary rupture for patients who underwent EVAR compared with those who underwent OSR. Kaplan-Meier analysis suggested superior long-term major adverse cardiovascular event-free survival among patients who underwent EVAR compared with those who underwent OSR (32.6% [95% CI, 26.9%-38.4%] vs 14.1% [95% CI, 4.0%-30.4%]; stratified log-rank P <.001) during a maximum follow-up of 13.8 years. Conclusions and Relevance: Endovascular aortic repair was not associated with a difference in long-term survival during more than 13 years' maximum follow-up. The reasons for these findings will require studies to consider specific graft makes and models, adherence to instructions for use, and types and reasons for reintervention.
UR - http://www.scopus.com/inward/record.url?scp=85069308083&partnerID=8YFLogxK
U2 - 10.1001/jamanetworkopen.2019.6578
DO - 10.1001/jamanetworkopen.2019.6578
M3 - Article
C2 - 31290986
AN - SCOPUS:85069308083
VL - 2
JO - JAMA network open
JF - JAMA network open
SN - 2574-3805
IS - 7
M1 - e196578
ER -