Rationale and design of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE): Interim analysis at 30 days of the first 180 patients enrolled

D. Böckler, R. Fitridge, Y. Wolf, P. Hayes, P. G. Silveira, F. Numan, V. Riambau

Research output: Contribution to journalArticlepeer-review

Abstract

Aim. The Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) is a long-term 1200-patient multicenter prospective study initiated to augment the knowledge base (poolable and comparable) about endovascular aortic repair (EVAR) in a real-world population implanted with a single latest-generation stent graft system (Endurant). With enrollment ongoing at 80 high-volume sites, the registry has limited inclusion/exclusion criteria or procedural specification. Technical and clinical data will be reported through 5 years. Methods. An interim analysis was performed on investigator-reported data for the first 180 patients enrolled. These patients were asymptomatic elderly males (92.1%) with considerable comorbidities. For 47.3% of the patients, the American Society of Anesthesiologists risk class was either III or IV. The Endurant stent graft was successfully deployed in 99.4% of patients for elective treatment of abdominal aortic aneurysm. Results. Through 30 days, the rate of all-cause mortality was 1.7% (N=3), with all 3 deaths classified as procedure-related but not device-related. The rate of secondary endovascular procedures was 1.1%, and the rate of conversion to open repair was 0.6%. At postprocedure and at 30-day follow-up, there were no type I or type III endoleaks and no instances of stent graft kinking, thrombosis, or occlusion. ENGAGE represents the largest real-world registry for any single EVAR stent graft. Conclusion. The interim results through 30 days of the first 180 patients enrolled are promising. Longer-term follow-up for more patients will be reported.

Original languageEnglish
Pages (from-to)481-491
Number of pages11
JournalJournal of Cardiovascular Surgery
Volume51
Issue number4
StatePublished - Aug 2010
Externally publishedYes

Keywords

  • Aortic aneurysms, abdominal
  • Registries
  • Stents
  • Surgical procedures, operative

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