TY - JOUR
T1 - Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair
T2 - One-Year Results From the RATIONALE Registry
AU - Uberoi, Raman
AU - Setacci, Carlo
AU - Lescan, Mario
AU - Lorido, Antonio
AU - Murray, David
AU - Szeberin, Zoltán
AU - Zubilewicz, Tomasz
AU - Riambau, Vincent
AU - Chartrungsan, Angsu
AU - Tessarek, Jörg
AU - Iłżecki, Marek
AU - Gortz, Hartmuth
AU - Thenholt, Matthias
AU - Fattoum, Maher
AU - Buz, Semih
AU - Cao, Piergiorgio
AU - Benevento, Domenico
AU - Palasciano, Giancarlo
AU - Abdallah, Feras
AU - Boyle, John
AU - Llagostera Pujol, S.
AU - Esteban, Carlos
AU - Mosquera, Nilo
AU - Sanus, Enrique Aracil
AU - Negreira, Ignacio Iglesias
AU - Raymakers, J. T.F.J.
AU - van Herwaarden, Joost
AU - Pitoulias, Georgios
AU - Kratimenos, Theodoros
AU - Wahlgren, Carl Magnus
AU - Forssell, Claes
AU - Fulton, Greg
AU - Lonn, Lars
AU - Pedersen, Gustav
AU - Vergara, Jorge
AU - Silva, Manuel Espindola
AU - Cheng, Stephen Wing Keung
AU - Anh, Phan Minh
AU - Calderas, Carlos David
AU - Bohan, Patrick
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by a grant from Terumo Aortic (formerly Bolton Medical).
Publisher Copyright:
© The Author(s) 2018.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - 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.
AB - 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.
KW - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Aortic Aneurysm, Abdominal/diagnostic imaging
KW - Blood Vessel Prosthesis
KW - Blood Vessel Prosthesis Implantation/adverse effects
KW - Endovascular Procedures/adverse effects
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Postoperative Complications/mortality
KW - Product Surveillance, Postmarketing
KW - Prospective Studies
KW - Prosthesis Design
KW - Registries
KW - Risk Assessment
KW - Risk Factors
KW - Stents
KW - Time Factors
KW - Treatment Outcome
KW - Young Adult
KW - stent-graft
KW - endograft
KW - abdominal aortic aneurysm
KW - endoleak
KW - registry
KW - reintervention
KW - endovascular aneurysm repair
KW - occlusion
KW - mortality
UR - http://www.scopus.com/inward/record.url?scp=85056408910&partnerID=8YFLogxK
U2 - 10.1177/1526602818803939
DO - 10.1177/1526602818803939
M3 - Article
C2 - 30280649
AN - SCOPUS:85056408910
SN - 1526-6028
VL - 25
SP - 726
EP - 734
JO - Journal of Endovascular Therapy
JF - Journal of Endovascular Therapy
IS - 6
ER -