Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry. (December 2018)

• Record Type: Journal Article
• Authors: Uberoi, Raman; Setacci, Carlo; Lescan, Mario; Lorido, Antonio; Murray, David; Szeberin, Zoltán; Zubilewicz, Tomasz; Riambau, Vincent; Chartrungsan, Angsu; Tessarek, Jörg
• Other Names: Iłżecki Marek non-byline-author.; Gortz Hartmuth non-byline-author.; Thenholt Matthias non-byline-author.; Fattoum Maher non-byline-author.; Buz Semih non-byline-author.; Cao Piergiorgio non-byline-author.; Benevento Domenico non-byline-author.; Palasciano Giancarlo non-byline-author.; Abdallah Feras non-byline-author.; Boyle John non-byline-author.; Llagostera Pujol S. non-byline-author.; Esteban Carlos non-byline-author.; Mosquera Nilo non-byline-author.; Sanus Enrique Aracil non-byline-author.; Negreira Ignacio Iglesias non-byline-author.; Raymakers J.T.F.J. non-byline-author.; van Herwaarden Joost non-byline-author.; Pitoulias Georgios non-byline-author.; Kratimenos Theodoros non-byline-author.; Wahlgren Carl Magnus non-byline-author.; Forssell Claes non-byline-author.; Fulton Greg non-byline-author.; Lonn Lars non-byline-author.; Pedersen Gustav non-byline-author.; Vergara Jorge non-byline-author.; Silva Manuel Espindola non-byline-author.; Cheng Stephen Wing-Keung non-byline-author.; Anh Phan Minh non-byline-author.; Calderas Carlos David non-byline-author.; Bohan Patrick non-byline-author.
• Is Part Of: Journal of endovascular therapy. Volume 25:Number 6(2018:Dec.)
• Page Start: 726
• Page End: 734
• Publication Date: 2018-12
• Subjects: abdominal aortic aneurysm -- endograft -- endoleak -- endovascular aneurysm repair -- registry -- occlusion -- mortality -- reintervention -- stent-graft; Blood-vessels -- Endoscopic surgery -- Periodicals; Angioscopy -- Periodicals; Intravenous catheterization -- Periodicals; Peripheral vascular diseases -- Treatment -- Periodicals; Vascular Surgical Procedures -- Periodicals; Angioscopy -- Periodicals; Catheterization, Peripheral -- Periodicals; Peripheral Vascular Diseases -- therapy -- Periodicals; Angioscopie; Maladies vasculaires périphériques; 617.413
• DOI: 10.1177/1526602818803939
• Languages: English
• ISSNs: 1526-6028

Abstract

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry ( ClinicalTrials.gov ; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.