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Comparative clinical effectiveness and cost effectiveness of endovascular strategy vs open repair for ruptured abdominal aortic aneurysm: Three year results of the IMPROVE randomised trial

BMJ Nov 18, 2017

Powell JT - An inquiry was set up with regard to the three-year clinical outcomes and cost-effectiveness of a strategy of endovascular repair (if aortic morphology was suitable, open repair if not) in comparison with open repair for patients with a suspected ruptured abdominal aortic aneurysm. A link was revealed between an endovascular strategy for suspected ruptured abdominal aortic aneurysm with a survival advantage, a gain in quality adjusted life years (QALYs), similar levels of reintervention, and reduced costs, at three years, compared with open repair. The endovascular strategy was found to be cost-effective. Hence, its increasing use was supported in this trial, with wider availability of emergency endovascular repair.

Methods

  • The scheme of this research was a randomised controlled trial.
  • It was carried out at 30 vascular centres (29 in UK, one in Canada), between 2009-16.
  • Enrollment consisted of 613 patients (480 men) with a clinical diagnosis of ruptured aneurysm, of whom 502 underwent emergency repair for rupture.
  • As a part of the intervention, 316 patients were randomised to an endovascular strategy (275 with confirmed rupture) and 297 to open repair (261 with confirmed rupture).
  • The main outcome measure included mortality, with reinterventions after aneurysm repair, quality of life, and hospital costs to three years served as the secondary measures.

Results

  • Herein, the maximum follow-up for mortality was 7.1 years, with two patients in each group lost to follow-up by three years.
  • After similar mortality by 90 days, in the mid-term (three months to three years), fewer deaths were reported in the endovascular than the open repair group (hazard ratio 0.57, 95% confidence interval 0.36 to 0.90).
  • This gave rise to lower mortality at three years (48% v 56%). However, by 7 years mortality was approximately 60% in each group (hazard ratio 0.92, 0.75 to 1.13).
  • More pronounced results were yielded for the 502 patients with repaired ruptures: Three year mortality was lower in the endovascular strategy group (42% v 54%; odds ratio 0.62, 0.43 to 0.88), but after seven years no clear variation existed between the groups (hazard ratio 0.86, 0.68 to 1.08).
  • Reintervention rates up to three years did not vary prominently between the randomised groups (hazard ratio 1.02, 0.79 to 1.32); the initial rapid rate of reinterventions was followed by a much slower mid-term reintervention rate in both groups.
  • The early higher average quality of life in the endovascular strategy compared to the open repair group, coupled with the lower mortality at three years, gave rise to a gain in average quality adjusted life years (QALYs) at three years of 0.17 (95% confidence interval 0.00 to 0.33).
  • It was discovered that the endovascular strategy group spent fewer days in hospital.
  • This group reported lower average costs of -£2605 (95% confidence interval -£5966 to £702) (about €2813; $3439).
  • The probability of the endovascular strategy being cost effective was found to be >90%, at all levels of willingness to pay for a QALY gain.

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