Comparison of EVAR and open repair in patients with small abdominal aortic aneurysms

Can we predict results of the PIVOTAL trial?

Purandath Lall, Peter Gloviczki, Gautam Agarwal, Audra A. Duncan, Manju Kalra, Tanya Hoskin, Gustavo S. Oderich, Thomas C. Bower

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Objective: Data from multicenter studies support observation of small abdominal aortic aneurysms (AAAs) over open repair (OR), but the role of endovascular repair (EVAR) is unclear pending outcome of the Positive Impact of EndoVascular Options for Treating Aneurysm earLy (PIVOTAL) trial. Our goal was to predict the outcome of the trial by comparing results of small AAA repair using EVAR vs OR at a tertiary institution. Methods: Using selection criteria of PIVOTAL trial, we reviewed clinical data of 194 consecutive patients, who underwent EVAR or OR for 4.0-5.0 cm AAAs between 1997 and 2004. All-cause and aneurysm-related deaths, complications, reinterventions, ruptures, and conversions were documented; factors affecting outcome were analyzed using χ2 tests, Wilcoxon rank-sum tests, logistic regression Kaplan-Meier method with log-rank tests, and Cox proportional hazards regression. Median follow-up was 3.9 years (range, 1 month to 9 years). Results: A total of 194 patients, 162 males, 32 females (mean age: 71 years, range, 46-86) underwent 162 OR and 32 EVAR. EVAR patients were older (mean 74 ± 6 vs 71 ± 7, P = .002), had lower ejection fraction (mean 54 ± 11 vs 61 ± 13, P = .0002), and less likely to have ever smoked (69% vs 85%, P = .03) than OR patients. Thirty-day mortality was 1.3% (2/162) for OR and 0% for EVAR (0/33) (P = not significant [NS]). There were 49 systemic complications (7 EVAR, 42 OR, P = NS) and 10 local complications (3 EVAR, 7 OR, P = NS). During follow-up, there were no conversions and no ruptures. Freedom from reinterventions at 5 years was 83.1% ± 6.9% for EVAR and 95.3% ± 1.8% for OR (P = 0.02). There were 26 deaths (3 EVAR, 23 OR); but no procedure or aneurysm-related death was confirmed after 30 days (cause unknown in 16 deaths, 62%). Survival rates at 1-year were 96.6% ± 3.4% for EVAR and 97.4% ± 1.3% for OR; 5-year rates were 86.9% ± 7.2% ± EVAR and 86.9% ± 3.3% for OR (P = 0.69). Multivariate analysis revealed age (hazard ratio = 1.1 per year, P = .0496) and AAA size (hazard ratio = 13.8 per 1 cm, P = .03) were associated with death but EVAR vs OR was not (P = .23). Conclusion: For repair of small AAAs, results of EVAR vs OR are not different at 5 years at a tertiary institution. Multicenter studies confirmed OR were not superior to observation in these patients. We predict the PIVOTAL study will conclude EVAR is not superior to observation.

Original languageEnglish (US)
Pages (from-to)52-59
Number of pages8
JournalJournal of Vascular Surgery
Volume49
Issue number1
DOIs
StatePublished - Jan 1 2009
Externally publishedYes

Fingerprint

Abdominal Aortic Aneurysm
Aneurysm
Observation
Nonparametric Statistics
Multicenter Studies
Rupture
Pyridinolcarbamate
Patient Selection
Multivariate Analysis
Survival Rate
Logistic Models
Clinical Trials
Mortality

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Comparison of EVAR and open repair in patients with small abdominal aortic aneurysms : Can we predict results of the PIVOTAL trial? / Lall, Purandath; Gloviczki, Peter; Agarwal, Gautam; Duncan, Audra A.; Kalra, Manju; Hoskin, Tanya; Oderich, Gustavo S.; Bower, Thomas C.

In: Journal of Vascular Surgery, Vol. 49, No. 1, 01.01.2009, p. 52-59.

Research output: Contribution to journalArticle

Lall, Purandath ; Gloviczki, Peter ; Agarwal, Gautam ; Duncan, Audra A. ; Kalra, Manju ; Hoskin, Tanya ; Oderich, Gustavo S. ; Bower, Thomas C. / Comparison of EVAR and open repair in patients with small abdominal aortic aneurysms : Can we predict results of the PIVOTAL trial?. In: Journal of Vascular Surgery. 2009 ; Vol. 49, No. 1. pp. 52-59.
@article{b27ebf7637a84894a6c4f6bd21338e1d,
title = "Comparison of EVAR and open repair in patients with small abdominal aortic aneurysms: Can we predict results of the PIVOTAL trial?",
abstract = "Objective: Data from multicenter studies support observation of small abdominal aortic aneurysms (AAAs) over open repair (OR), but the role of endovascular repair (EVAR) is unclear pending outcome of the Positive Impact of EndoVascular Options for Treating Aneurysm earLy (PIVOTAL) trial. Our goal was to predict the outcome of the trial by comparing results of small AAA repair using EVAR vs OR at a tertiary institution. Methods: Using selection criteria of PIVOTAL trial, we reviewed clinical data of 194 consecutive patients, who underwent EVAR or OR for 4.0-5.0 cm AAAs between 1997 and 2004. All-cause and aneurysm-related deaths, complications, reinterventions, ruptures, and conversions were documented; factors affecting outcome were analyzed using χ2 tests, Wilcoxon rank-sum tests, logistic regression Kaplan-Meier method with log-rank tests, and Cox proportional hazards regression. Median follow-up was 3.9 years (range, 1 month to 9 years). Results: A total of 194 patients, 162 males, 32 females (mean age: 71 years, range, 46-86) underwent 162 OR and 32 EVAR. EVAR patients were older (mean 74 ± 6 vs 71 ± 7, P = .002), had lower ejection fraction (mean 54 ± 11 vs 61 ± 13, P = .0002), and less likely to have ever smoked (69{\%} vs 85{\%}, P = .03) than OR patients. Thirty-day mortality was 1.3{\%} (2/162) for OR and 0{\%} for EVAR (0/33) (P = not significant [NS]). There were 49 systemic complications (7 EVAR, 42 OR, P = NS) and 10 local complications (3 EVAR, 7 OR, P = NS). During follow-up, there were no conversions and no ruptures. Freedom from reinterventions at 5 years was 83.1{\%} ± 6.9{\%} for EVAR and 95.3{\%} ± 1.8{\%} for OR (P = 0.02). There were 26 deaths (3 EVAR, 23 OR); but no procedure or aneurysm-related death was confirmed after 30 days (cause unknown in 16 deaths, 62{\%}). Survival rates at 1-year were 96.6{\%} ± 3.4{\%} for EVAR and 97.4{\%} ± 1.3{\%} for OR; 5-year rates were 86.9{\%} ± 7.2{\%} ± EVAR and 86.9{\%} ± 3.3{\%} for OR (P = 0.69). Multivariate analysis revealed age (hazard ratio = 1.1 per year, P = .0496) and AAA size (hazard ratio = 13.8 per 1 cm, P = .03) were associated with death but EVAR vs OR was not (P = .23). Conclusion: For repair of small AAAs, results of EVAR vs OR are not different at 5 years at a tertiary institution. Multicenter studies confirmed OR were not superior to observation in these patients. We predict the PIVOTAL study will conclude EVAR is not superior to observation.",
author = "Purandath Lall and Peter Gloviczki and Gautam Agarwal and Duncan, {Audra A.} and Manju Kalra and Tanya Hoskin and Oderich, {Gustavo S.} and Bower, {Thomas C.}",
year = "2009",
month = "1",
day = "1",
doi = "10.1016/j.jvs.2008.07.085",
language = "English (US)",
volume = "49",
pages = "52--59",
journal = "Journal of Vascular Surgery",
issn = "0741-5214",
publisher = "Mosby Inc.",
number = "1",

}

TY - JOUR

T1 - Comparison of EVAR and open repair in patients with small abdominal aortic aneurysms

T2 - Can we predict results of the PIVOTAL trial?

AU - Lall, Purandath

AU - Gloviczki, Peter

AU - Agarwal, Gautam

AU - Duncan, Audra A.

AU - Kalra, Manju

AU - Hoskin, Tanya

AU - Oderich, Gustavo S.

AU - Bower, Thomas C.

PY - 2009/1/1

Y1 - 2009/1/1

N2 - Objective: Data from multicenter studies support observation of small abdominal aortic aneurysms (AAAs) over open repair (OR), but the role of endovascular repair (EVAR) is unclear pending outcome of the Positive Impact of EndoVascular Options for Treating Aneurysm earLy (PIVOTAL) trial. Our goal was to predict the outcome of the trial by comparing results of small AAA repair using EVAR vs OR at a tertiary institution. Methods: Using selection criteria of PIVOTAL trial, we reviewed clinical data of 194 consecutive patients, who underwent EVAR or OR for 4.0-5.0 cm AAAs between 1997 and 2004. All-cause and aneurysm-related deaths, complications, reinterventions, ruptures, and conversions were documented; factors affecting outcome were analyzed using χ2 tests, Wilcoxon rank-sum tests, logistic regression Kaplan-Meier method with log-rank tests, and Cox proportional hazards regression. Median follow-up was 3.9 years (range, 1 month to 9 years). Results: A total of 194 patients, 162 males, 32 females (mean age: 71 years, range, 46-86) underwent 162 OR and 32 EVAR. EVAR patients were older (mean 74 ± 6 vs 71 ± 7, P = .002), had lower ejection fraction (mean 54 ± 11 vs 61 ± 13, P = .0002), and less likely to have ever smoked (69% vs 85%, P = .03) than OR patients. Thirty-day mortality was 1.3% (2/162) for OR and 0% for EVAR (0/33) (P = not significant [NS]). There were 49 systemic complications (7 EVAR, 42 OR, P = NS) and 10 local complications (3 EVAR, 7 OR, P = NS). During follow-up, there were no conversions and no ruptures. Freedom from reinterventions at 5 years was 83.1% ± 6.9% for EVAR and 95.3% ± 1.8% for OR (P = 0.02). There were 26 deaths (3 EVAR, 23 OR); but no procedure or aneurysm-related death was confirmed after 30 days (cause unknown in 16 deaths, 62%). Survival rates at 1-year were 96.6% ± 3.4% for EVAR and 97.4% ± 1.3% for OR; 5-year rates were 86.9% ± 7.2% ± EVAR and 86.9% ± 3.3% for OR (P = 0.69). Multivariate analysis revealed age (hazard ratio = 1.1 per year, P = .0496) and AAA size (hazard ratio = 13.8 per 1 cm, P = .03) were associated with death but EVAR vs OR was not (P = .23). Conclusion: For repair of small AAAs, results of EVAR vs OR are not different at 5 years at a tertiary institution. Multicenter studies confirmed OR were not superior to observation in these patients. We predict the PIVOTAL study will conclude EVAR is not superior to observation.

AB - Objective: Data from multicenter studies support observation of small abdominal aortic aneurysms (AAAs) over open repair (OR), but the role of endovascular repair (EVAR) is unclear pending outcome of the Positive Impact of EndoVascular Options for Treating Aneurysm earLy (PIVOTAL) trial. Our goal was to predict the outcome of the trial by comparing results of small AAA repair using EVAR vs OR at a tertiary institution. Methods: Using selection criteria of PIVOTAL trial, we reviewed clinical data of 194 consecutive patients, who underwent EVAR or OR for 4.0-5.0 cm AAAs between 1997 and 2004. All-cause and aneurysm-related deaths, complications, reinterventions, ruptures, and conversions were documented; factors affecting outcome were analyzed using χ2 tests, Wilcoxon rank-sum tests, logistic regression Kaplan-Meier method with log-rank tests, and Cox proportional hazards regression. Median follow-up was 3.9 years (range, 1 month to 9 years). Results: A total of 194 patients, 162 males, 32 females (mean age: 71 years, range, 46-86) underwent 162 OR and 32 EVAR. EVAR patients were older (mean 74 ± 6 vs 71 ± 7, P = .002), had lower ejection fraction (mean 54 ± 11 vs 61 ± 13, P = .0002), and less likely to have ever smoked (69% vs 85%, P = .03) than OR patients. Thirty-day mortality was 1.3% (2/162) for OR and 0% for EVAR (0/33) (P = not significant [NS]). There were 49 systemic complications (7 EVAR, 42 OR, P = NS) and 10 local complications (3 EVAR, 7 OR, P = NS). During follow-up, there were no conversions and no ruptures. Freedom from reinterventions at 5 years was 83.1% ± 6.9% for EVAR and 95.3% ± 1.8% for OR (P = 0.02). There were 26 deaths (3 EVAR, 23 OR); but no procedure or aneurysm-related death was confirmed after 30 days (cause unknown in 16 deaths, 62%). Survival rates at 1-year were 96.6% ± 3.4% for EVAR and 97.4% ± 1.3% for OR; 5-year rates were 86.9% ± 7.2% ± EVAR and 86.9% ± 3.3% for OR (P = 0.69). Multivariate analysis revealed age (hazard ratio = 1.1 per year, P = .0496) and AAA size (hazard ratio = 13.8 per 1 cm, P = .03) were associated with death but EVAR vs OR was not (P = .23). Conclusion: For repair of small AAAs, results of EVAR vs OR are not different at 5 years at a tertiary institution. Multicenter studies confirmed OR were not superior to observation in these patients. We predict the PIVOTAL study will conclude EVAR is not superior to observation.

UR - http://www.scopus.com/inward/record.url?scp=58449117375&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=58449117375&partnerID=8YFLogxK

U2 - 10.1016/j.jvs.2008.07.085

DO - 10.1016/j.jvs.2008.07.085

M3 - Article

VL - 49

SP - 52

EP - 59

JO - Journal of Vascular Surgery

JF - Journal of Vascular Surgery

SN - 0741-5214

IS - 1

ER -