Table 8. Ongoing Studies of Endovascular Repair of Abdominal Aortic Aneurysms (EVAR)

DREAMOpen vs Endovascular Repair Trial (OVER)EVAR 1EVAR 2Anévrisme de l'aorte abdominale: Chirurgie versus Endoprothèse (ACE)
Reference Prinssen, 200275 Unpublished, LederleBrown, 200476 Unpublished
Location HollandU.S.UKUKFrance
Protocol EVAR or open repairEVAR or open repairEVAR or open repairEVAR with best medical management or best medical managementNot able to obtain any further information
Centers Required to have performed >20 EVAR, may refer to another center for procedure40 VA sites that are prepared to perform open and EVAR with at least one approved deviceRequired to have performed > 20 EVAR proceduresRequired to have performed > 20 EVAR procedures
EVAR Device European Conformité Européenne-Mark Approval or preliminary Market Approval or investigational device exemption of the FDAAny FDA approved device, including any new devices approved during studyIn-house devices or commercially available devices with CE mark, which is favoredIn-house devices or commercially available devices with CE mark, which is favored
Inclusion Criteria Asymptomatic AAA > 5.0 cm, adequate infrarenal neck, life expectation > 2 years, cleared for transabdominal interventionAAA ≥ 5.0 cm or ≥ 4.5 cm if expanded more than 0.7 cm in 6 months or 1.0 cm in 1 year, eligible for either procedure≥ 60 yrs, ≥ 5.5 cm, ≥ 5.0 cm ultrasound referred for CT scan due to under sizing with U/S, anatomical suitability for EVAR, fitness for surgery≥ 60 years, ≥ 5.5 cm, ≥ 5.0 cm ultrasound referred for CT scan due to under sizing with ultrasound, anatomical suitability for EVAR
Exclusion Criteria Juxtarenal or suprarenal AAA, inflammatory AAA, infrarenal neck unsuitable for EVAR, active infection, transplantation patients, non-iatrogenic bleeding diathesis, connective tissue diseasePrevious AAA surgery, urgent need for surgery, or evidence of AAA ruptureMyocardial infarction (MI) or angina onset within last 3 months, unstable angina, severe valve disease, significant arrhythmia, uncontrolled CHF, Severe COPD, Renal Failure FEV1 < 1.0 LMI within last 3 months, onset of angina within last 3 months, unstable angina at night or at rest
Randomization Stratified by center to either open or EVAREqual chance of open or EVARStratified by center to either open or EVARStratified by center to either open or EVAR
Sample Size 400; 200 in each arm. Based on a 10% reduction in mortality and morbidity with a statistical power of 80%1260; 85% power to detect a 25% difference in mortality.900 in EVAR Trial 1, with 80% power to detect a reduction in 2.5% mortality for EVAR280 patients in EVAR Trial 2 with 93% power to detect a difference of 10% between the two treatment regimes
Primary Outcome Combined perioperative mortality and morbidityAll-cause mortalityAll-cause mortalityAll-cause mortality
Secondary Measures QoL with SF-36, EQ-5D, and questionnaire about sexual function, cost-effectivenessMorbidity, secondary procedures, cost, health-related quality of lifeQoL through SF-36, EQ-5D, State-trait Anxiety questionnaire, and the patient generated index; cost-effectiveness of EVAR vs open repair quality-adjusted life-years (QALY)QoL through SF-36, EQ-5D, State-trait Anxiety questionnaire, and the patient generated index. Cost-effectiveness of best medical management versus EVAR plus best medical management (QALY)
Adverse Events Complications of remote/systemic and local/vascularOperative AAA mortality and all AAA repair complicationsTender AAA, ruptured AAA, conversion to open repair, MI, stroke, renal failure and amputation, growth rates, endoleaksTender AAA, ruptured AAA, conversion to open repair, MI, stroke, renal failure and amputation, growth rates, endoleaks
Duration 2 years of follow-up8 years of follow-up3.33 years/patient3.33 years/patient
Results Anticipated Early 200412 month data for all participants-early 2007, complete results 2010Mid 2005Mid 2005

CHF, congested heart failure; CT, computed tomography; FDA, Food and Drug Administration;MI, myocardial infarction; QALY, quality-adjusted life-years; QoL, quality of life; VA, Veterans Affairs.

From: 3, Results

Cover of Primary Care Screening for Abdominal Aortic Aneurysm
Primary Care Screening for Abdominal Aortic Aneurysm [Internet].
Evidence Syntheses, No. 35.
Fleming C, Whitlock E, Beil T, et al.

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