Background: Covered stent has become one of the mainstream therapies for aortoiliac obstructive disease (AIOD), with a higher patency rate than bare metal stent. Covered balloon-expandable (CBE) stent can be placed more accurately with higher a radial support force, while covered self-expanding (CSE) stent has greater elasticity and higher trackability. However, there is no level I evidence regarding the comparison safety and efficacy between the CSE stent and CBE stent in AIOD to date. Therefore, this study aims to compare the efficacy and safety of CBE stent (BARD®LIFESTREAM™) and CSE stent (GORE® VIABAHN™) in AIOD. Methods: This trial is a prospective, single-center, parallel, noninferiority, randomized controlled trial. A total of 106 patients will be enrolled and these patients will be randomized to either the CBE stent group or the CSE stent group. The primary end point of the study is the occurrence of target lesion revascularization (TLR) at 12 months after the intervention. Discussion: To our knowledge, the ballooN sElf cOver steNt AorToiliAc occuLusive (NEONATAL) trial is the first RCT to compare CBE and CSE stent in AIOD patients. The main aim is to compare the TLR of the target lesion between CBE stent and CSE stent at 12 months post-procedure. The results of clinical trials may contribute to establishing a strategic guideline for choosing the optimal type of covered stent in the treatment of AIOD patients. Trial registration: Chinese Clinical Trials Registry ChiCTR2100046734. Registered on 27 May 2021
Consideration for oversizing the proximal stent graft is suggested in endovascular aortic repair. However, a special recommendation for the proximal oversizing ratio (OSR) in patients with ruptured abdominal aortic aneurysm (rAAA) is ambiguous. This study aims to evaluate the effect of different degrees of the proximal oversizing ratio (OSR) on risk of type IA endoleak (TIAEL) in hemodynamically stable and unstable patients with rAAA undergoing emergency endovascular aortic repair (EVAR). Our study included 134 rAAA patients undergoing emergent EVAR, and we did not observe a significant association between hemodynamic instability and risk of T1AEL (HR 3.89, 95%CI 0.40–37.75, p = 0.24). All three T1AELs in the hemodynamically unstable subgroup were observed in patients with OSR ≤ 30%, but no significant difference was found regarding T1AEL between patients with OSR > 30% and OSR ≤ 30% (0.00% vs. 11.11%, p = 0.19). As for hemodynamically stable patients, OSR > 20% was associated with a significantly decreased risk of T1AEL (HR 0.03, 95%CI 0.01–0.53, p = 0.016). In conclusion, a proximal OSR > 20% is associated with a decreased risk of T1AEL in hemodynamically stable patients, while an OSR > 30% did not add an additional advantage of lowering the risk of T1AEL in hemodynamically unstable patients.
Introduction Endovascular therapy has emerged as a prominent strategy for managing femoropopliteal peripheral artery disease, offering acceptable safety and efficacy compared with open surgical bypass. Both paclitaxel-eluting stents and heparin-bonded covered stents have exhibited enhanced clinical outcomes compared with bare metal stents. However, there is currently a lack of level I evidence comparing the safety and efficacy of paclitaxel-eluting stents and heparin-bonded covered stents. Therefore, the primary objective of this study is to systematically evaluate the efficacy and safety outcomes of these two types of stents. Methods and analysis The ELITE trial is a prospective, multicentre, parallel, randomised controlled trial. A total of 450 patients will be recruited. The primary endpoints of the study include primary patency at 1 year post-index procedure. Ethics and dissemination Ethical approval for this study was obtained from the Ethics Committee of West China Hospital of Sichuan University (approval number: 2023–1186). The results will be submitted to a major clinical journal for peer review and publication. Trial registration ELITE trial was registered on 27 September 2023 in the Chinese Clinical Trials Registry (ChiCTR2300076236).
Background: Current evidence regarding gender difference in retroperitoneal liposarcoma (RLPS) is scarce, so we sought to investigate whether gender may affect prognosis after primary resection of RLPS. Methods: We used the Surveillance, Epidemiology, and End Results (SEER) database to identify RLPS patients from January 1973 to December 2015. Multivariate cox proportional hazard analysis was adopted to generate adjusted hazard ratio (AHR) and 95% confidence intervals (CIs) of survival outcomes. Results: In total, 2108 RLPS patients, including 971 women and 1137 men, were identified, with a median follow-up of 45.0 (17.0-92.0) months. The 5-year and 10-year overall survival rates were 50.5% and 31.5% for men and 60.4% and 42.5% for women. The 5-year and 10-year disease-specific survival rates for men and women were 71.5%, 57.3% and 76.3%, 62.1%, respectively. We found men were associated with an increased risk of all-cause mortality (AHR 1.3, 95% CI 1.0-1.6, P = .017) but not disease-specific mortality (AHR 1.2, 95% CI .9-1.6, P = .246). The subgroup analyses revealed that men were associated with an increased risk of all-cause mortality in patients with low-grade tumors (AHR 1.8, 95% CI 1.3-2.5) or patients who received non-radical resection (AHR 1.6, 95% CI 1.2-2.1). In the subgroup of low-grade tumors, men were also associated with an increased risk of disease-specific mortality (AHR 2.0, 95% CI 1.2-3.3). Conclusion: Men may have worse survival after primary resection of RLPS compared with women, especially in patients with low-grade tumors or patients who received non-radical resection. Gender-based disparities may deserve more attention in patients with RLPS.
Background: Major adverse cardiovascular and cerebrovascular events (MACCE) following endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) are serious outcomes. The primary aim of this study was to evaluate the incidence of MACCE after EVAR and to investigate the relevant predictive factors for MACCE. Materials and Methods: This single-center retrospective cohort study included patients who were diagnosed with infrarenal AAAs and who underwent EVAR from February 2012 to February 2022. The cumulative incidence of MACCE after EVAR in this study was assessed via a competing-risk model. Results: This study included 1090 patients with AAAs who underwent EVAR. Multivariate analyses revealed that the maximum diameter of the AAA may be an independent predictor of MACCE after EVAR (hazard ratio per 10-mm increase = 1.219; 95% confidence interval [CI] = 1.072-1.397; P = .002). During a median follow-up of 42 months, 323 patients experienced at least 1 MACCE, whereas 767 patients did not experience MACCE. The cumulative risks of MACCE excluding noncardiovascular/noncerebrovascular mortality at 12, 36, and 60 months after EVAR were 5.4%, 9.1%, and 19.0%, respectively. Conclusion: The cumulative incidence of MACCE after EVAR for AAAs is relatively high, and the maximum diameter of the AAAs is a predictor of MACCE. Clinical Impact: Major adverse cardiovascular and cerebrovascular events remain an important long-term concern after EVAR. In this large retrospective cohort, approximately one in five patients experienced MACCE within 5 years, after accounting for competing noncardiovascular/noncerebrovascular mortality. Importantly, larger maximum AAA diameter was independently associated with a higher risk of subsequent MACCE. These findings suggest that aneurysm diameter may provide additional information for cardiovascular risk stratification beyond its established role in determining aneurysm-related treatment. Patients with larger AAAs may therefore warrant closer cardiovascular surveillance and more intensive management of modifiable risk factors after EVAR.