IMPROVE
Immediate Management of the Patient with Rupture: Open Versus Endovascular Repair
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 613 patients with a clinical diagnosis of ruptured abdominal aortic aneurysm, an endovascular-first strategy did not reduce 30-day mortality compared with emergency open repair.
N
613
Design
Open-label, pragmatic RCT
Endpunkt
30-day mortality
Relevanz
2
Ergebnis35.4 % vs 37.4 % (OR 0.92; 95 % CI 0.66–1.28; p=0.62), but more patients discharged directly home (94 % vs 77 %). At 3 years mortality 48 % vs 56 % (HR 0.57; 95 % CI 0.36–0.90) with a QALY gain and lower cost.
IMPROVE Trial Investigators. BMJ. 2014;348:f7661. 10.1136/bmj.f7661
Diskussion & Kritik
A strategy trial, not a device trial: only 174 of 316 patients randomised to the endovascular arm were anatomically suitable, diluting any true effect toward the null. The 3-year survival and cost-effectiveness advantage — not the neutral 30-day result — is what supports an endovascular-first pathway for ruptured aneurysm.