Two-year Outcomes of Endovascular Therapy for Femoropopliteal Arterial Lesions for Patients with High Bleeding Risk

Overview

Journal Cardiovasc Interv Ther

Publisher Springer

Specialty Cardiology & Vascular Diseases

Date 2024 Apr 17

PMID 38630431

Authors

Yuki Shima

Narumi Taninobu

Akihiro Ikuta

Kazunori Mushiake

Hiroyuki Tanaka

Kazushige Kadota

Affiliations

Soon will be listed here.

Abstract

The Academic Research Consortium (ARC) recently published a definition of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. However, the prevalence of the ARC-HBR criteria in patients undergoing endovascular therapy (EVT) for femoropopliteal arterial lesions has not been thoroughly investigated. The study population comprised 165 patients undergoing initial EVT for femoropopliteal lesions between June 2018 and June 2020. They were divided into two groups according to the ARC-HBR criteria. The primary end point was a composite of all-cause death, Bleeding Academic Research Consortium type 3 or 5 bleeding, and target lesion revascularization (TLR) within 2 years of EVT. The 165 patients were divided into two groups: 125 (75.8%) patients at HBR (HBR group) and 40 (24.2%) patients at no HBR (non-HBR group). The cumulative incidence of the primary endpoint was significantly higher in the HBR group than in the non-HBR group (40.6% vs. 0%, log-rank p < 0.001). The HBR group had a significantly higher risk of all-cause death, major bleeding, and TLR than the non-HBR group (25.2% vs. 0%, log-rank p = 0.004, 13.9% vs. 0%, log-rank p = 0.047, 16.8% vs. 0%, log-rank p = 0.035). Most patients with peripheral artery disease were classified as HBR patients, and HBR patients were at higher risk of death, major bleeding, and TLR than non-HBR patients.

References

Bhardwaj B, Spertus J, Kennedy K, Jones W, Safley D, Tsai T . Bleeding Complications in Lower-Extremity Peripheral Vascular Interventions: Insights From the NCDR PVI Registry. JACC Cardiovasc Interv. 2019; 12(12):1140-1149. PMC: 7176493. DOI: 10.1016/j.jcin.2019.03.012. View

Urban P, Mehran R, Colleran R, Angiolillo D, Byrne R, Capodanno D . Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019; 40(31):2632-2653. PMC: 6736433. DOI: 10.1093/eurheartj/ehz372. View

Cao D, Mehran R, Dangas G, Baber U, Sartori S, Chandiramani R . Validation of the Academic Research Consortium High Bleeding Risk Definition in Contemporary PCI Patients. J Am Coll Cardiol. 2020; 75(21):2711-2722. DOI: 10.1016/j.jacc.2020.03.070. View

Natsuaki M, Morimoto T, Shiomi H, Yamaji K, Watanabe H, Shizuta S . Application of the Academic Research Consortium High Bleeding Risk Criteria in an All-Comers Registry of Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019; 12(11):e008307. DOI: 10.1161/CIRCINTERVENTIONS.119.008307. View

Miura K, Shimada T, Ohya M, Murai R, Amano H, Kubo S . Prevalence of the Academic Research Consortium for High Bleeding Risk Criteria and Prognostic Value of a Simplified Definition. Circ J. 2020; 84(9):1560-1567. DOI: 10.1253/circj.CJ-20-0395. View

Nakamura M, Kadota K, Nakao K, Nakagawa Y, Shite J, Yokoi H . High bleeding risk and clinical outcomes in East Asian patients undergoing percutaneous coronary intervention: the PENDULUM registry. EuroIntervention. 2020; 16(14):1154-1162. PMC: 9725071. DOI: 10.4244/EIJ-D-20-00345. View

Shima Y, Miura K, Shimada T, Ohya M, Murai R, Kubo S . Impact of ischemic risk factors on long-term outcomes in patients with and without high bleeding risk. Int J Cardiol. 2020; 326:12-18. DOI: 10.1016/j.ijcard.2020.10.073. View

Ueki Y, Bar S, Losdat S, Otsuka T, Zanchin C, Zanchin T . Validation of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria in patients undergoing percutaneous coronary intervention and comparison with contemporary bleeding risk scores. EuroIntervention. 2020; 16(5):371-379. DOI: 10.4244/EIJ-D-20-00052. View

Hashimoto R, Numasawa Y, Yokokura S, Daigo K, Sakata S, Imaeda S . Prevalence of the Academic Research Consortium high bleeding risk criteria in patients undergoing endovascular therapy for peripheral artery disease in lower extremities. Heart Vessels. 2021; 36(9):1350-1358. DOI: 10.1007/s00380-021-01813-2. View

10.

Yoshioka N, Takagi K, Morita Y, Kanzaki Y, Nagai H, Watanabe N . Bleeding events and mid-term mortality in the patients undergoing endovascular interventions for peripheral artery disease of the lower limbs based on the academic research consortium high bleeding risk criteria. Heart Vessels. 2021; 36(9):1336-1349. DOI: 10.1007/s00380-021-01804-3. View

11.

Mehran R, Rao S, Bhatt D, Gibson C, Caixeta A, Eikelboom J . Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011; 123(23):2736-47. DOI: 10.1161/CIRCULATIONAHA.110.009449. View

13.

Guo X, Xue G, Huang X, Xie H, Liang W, Zhang J . Outcomes of endovascular treatment for patients with TASC II D femoropopliteal occlusive disease: a single center study. BMC Cardiovasc Disord. 2015; 15:44. PMC: 4453767. DOI: 10.1186/s12872-015-0025-1. View

14.

Khan M, Zou F, Khan A, Moustafa A, Schmid C, Baig M . Meta-Analysis Comparing Endovascular Treatment Modalities for Femoropopliteal Peripheral Artery Disease. Am J Cardiol. 2020; 128():181-188. DOI: 10.1016/j.amjcard.2020.05.015. View

15.

Takahara M, Iida O, Kohsaka S, Soga Y, Fujihara M, Shinke T . Diabetes mellitus and other cardiovascular risk factors in lower-extremity peripheral artery disease versus coronary artery disease: an analysis of 1,121,359 cases from the nationwide databases. Cardiovasc Diabetol. 2019; 18(1):155. PMC: 6857236. DOI: 10.1186/s12933-019-0955-5. View

16.

Numasawa Y, Inohara T, Ishii H, Kuno T, Kodaira M, Kohsaka S . Comparison of Outcomes of Women Versus Men With Non-ST-elevation Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention (from the Japanese Nationwide Registry). Am J Cardiol. 2017; 119(6):826-831. DOI: 10.1016/j.amjcard.2016.11.034. View

17.

Chandiramani R, Cao D, Claessen B, Sorrentino S, Guedeney P, Blum M . Sex-Related Differences in Patients at High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Patient-Level Pooled Analysis From 4 Postapproval Studies. J Am Heart Assoc. 2020; 9(7):e014611. PMC: 7428610. DOI: 10.1161/JAHA.119.014611. View

18.

Shu J, Santulli G . Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018; 275:379-381. PMC: 6113064. DOI: 10.1016/j.atherosclerosis.2018.05.033. View

19.

Takeji Y, Yamaji K, Tomoi Y, Okazaki J, Tanaka K, Nagae A . Impact of Frailty on Clinical Outcomes in Patients With Critical Limb Ischemia. Circ Cardiovasc Interv. 2018; 11(7):e006778. DOI: 10.1161/CIRCINTERVENTIONS.118.006778. View

20.

Gebauer K, Engelbertz C, Malyar N, Meyborg M, Luders F, Freisinger E . Long-Term Mortality After Invasive Angiography and Endovascular Revascularization in Patients With PAD Having Chronic Kidney Disease. Angiology. 2015; 67(6):556-64. DOI: 10.1177/0003319715603184. View

21.

Senthong V, Wu Y, Hazen S, Tang W . Predicting long-term prognosis in stable peripheral artery disease with baseline functional capacity estimated by the Duke Activity Status Index. Am Heart J. 2016; 184:17-25. PMC: 5322238. DOI: 10.1016/j.ahj.2016.10.009. View