Evaluation of Risk Factors for Limb-Specific Peripheral Vascular Events in Patients With Peripheral Artery Disease: A Post Hoc Analysis of the SEASON Prospective Observational Study
Restricted accessResearch articleFirst published online July, 2019
Evaluation of Risk Factors for Limb-Specific Peripheral Vascular Events in Patients With Peripheral Artery Disease: A Post Hoc Analysis of the SEASON Prospective Observational Study
Surveillance of cardiovascular Events in Antiplatelet-treated arterioSclerosis Obliterans patients in JapaN (SEASON) is a 2-year, prospective, real-world, registry study conducted in Japan from 2009 to 2013. This post hoc analysis evaluated risk factors for limb ischemia in patients with peripheral arterial disease (PAD) and ankle–brachial index (ABI) <0.90. Vascular events were adjudicated by an Efficacy Endpoint Review Committee. Cox regression identified predictors of limb-specific peripheral vascular events (amputation, development of critical limb ischemia, and acute limb ischemia). Patients (n = 6565) were stratified according to ABI: normal (≥1.0; n = 1300), borderline (0.90 ≤ ABI ≤ 1.0; n = 776), and abnormal (<0.90; n = 4489). Compared to normal ABI, patients with ABI <0.90 had a significantly higher risk of any vascular event, all-cause death, and any limb-specific peripheral vascular event. Risk factors for limb-specific vascular events included history of lower extremity revascularization/amputation (adjusted hazard ratio: 2.18; 95% confidence interval [CI]: 1.49-3.20), chronic kidney disease (2.00; 1.33-3.00), diabetes (1.71; 1.16-2.52), and ABI <0.4 (4.45; 2.62-7.55) or <0.7 (1.78; 1.15-2.76). These findings from a Japanese real-world population confirm the increased vascular risk of patients with PAD and ABI <0.90 and identified risk factors for limb-specific peripheral vascular events.
WeltenGMSchoutenOHoeksSE. Long-term prognosis of patients with peripheral arterial disease: a comparison in patients with coronary artery disease. J Am Coll Cardiol. 2008;51(16):1588–96.
2.
ZeymerUParhoferKGPittrowD. Risk factor profile, management and prognosis of patients with peripheral arterial disease with or without coronary artery disease: results of the prospective German REACH registry cohort. Clin Res Cardiol. 2009;98(4):249–56.
3.
WeltenGMSchoutenOChoncholM. Prognosis of patients with peripheral arterial disease. J Cardiovasc Surg (Torino). 2009;50(1):109–21.
4.
StegPGBhattDLWilsonPW. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007;297(11):1197–206.
5.
CacoubPPAbolaMTBaumgartnerI. Cardiovascular risk factor control and outcomes in peripheral artery disease patients in the Reduction of Atherothrombosis for Continued Health (REACH) Registry. Atherosclerosis. 2009;204(2):e86–92.
6.
KitrouPKatsanosKKarnabatidisDReppasLBrountzosESpiliopoulosS. Current evidence and future perspectives on anti-platelet and statin pharmacotherapy for patients with symptomatic peripheral arterial disease. Curr Vasc Pharmacol. 2017;15(5):430–45.
7.
ShammasNW. Epidemiology, classification, and modifiable risk factors of peripheral arterial disease. Vasc Health Risk Manag. 2007;3(2):229–34.
8.
SimmonsASteffenKSandersS. Medical therapy for peripheral arterial disease. Curr Opin Cardiol. 2012;27(6):592–7.
9.
HiattWRKrantzMJ. Masterclass series in peripheral arterial disease. Antiplatelet therapy for peripheral arterial disease and claudication. Vasc Med. 2006;11(1):55–60.
10.
KojimaINinomiyaTHataJ. A low ankle brachial index is associated with an increased risk of cardiovascular disease: the Hisayama study. J Atheroscler Thromb. 2014;21(9):966–73.
11.
NorgrenLHiattWRDormandyJA. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5–67.
12.
RookeTWHirschATMisraS. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. J Vasc Surg. 2011;54(5):e32–58.
13.
2011 Writing Group Members, 2005 Writing Committee Members, ACCF/AHA Task Force Members. 2011 ACCF/AHA Focused Update of the Guideline for the Management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American college of cardiology foundation/American heart association task force on practice guidelines. Circulation. 2011;124:2020–45.
14.
HigashiYMiyataTShigematsuH. Baseline characterization of Japanese peripheral arterial disease patients—analysis of Surveillance of cardiovascular Events in Antiplatelet-treated arterioSclerosis Obliterans patients in JapaN (SEASON). Circ J. 2016;80(3):712–21.
15.
Joint Working Group of the Japanese Circulation Society. Guidelines for the management of peripheral arterial occlusive diseases (JCS 2015). 2015. http://www.j-circ.or.jp/guideline/pdf/JCS2015_miyata_h.pdf. Accessed November 14, 2018.
16.
HigashiYFujitaMOrigasaH. Study design of SEASON registry: prospective Surveillance of cardiovascular Events in an Antiplatelet-treated arterioSclerosis Obliterans patients in JapaN (SEASON). Int Heart J. 2010;51(5):337–42.
17.
HigashiYMiyataTShigematsuH. Two-year follow-up of vascular events in peripheral arterial disease treated with antiplatelet agents: a prospective observational multicenter cohort study (SEASON). Sci Rep. 2017;7(1):6095.
RiceTWLumsdenAB. Optimal medical management of peripheral arterial disease. Vasc Endovascular Surg. 2006;40(4):312–27.
20.
AbtanJBhattDLElbezY. Geographic variation and risk factors for systemic and limb ischemic events in patients with symptomatic peripheral artery disease: insights from the REACH Registry. Clin Cardiol. 2017;40(9):710–8.
21.
SmolderenKGBellALeiY. One-year costs associated with cardiovascular disease in Canada: insights from the REduction of Atherothrombosis for Continued Health (REACH) registry. Can J Cardiol. 2010;26(8):297–305.
22.
SmolderenKGWangKde PouvourvilleG. Two-year vascular hospitalisation rates and associated costs in patients at risk of atherothrombosis in France and Germany: highest burden for peripheral arterial disease. Eur J Vasc Endovasc Surg. 2012;43(2):198–207.
23.
YamazakiTGotoSShigematsuH. Prevalence, awareness and treatment of cardiovascular risk factors in patients at high risk of atherothrombosis in Japan. Circ J. 2007;71(7):995–1003.
24.
UchiyamaSGotoSMatsumotoM. Cardiovascular event rates in patients with cerebrovascular disease and atherothrombosis at other vascular locations: results from 1-year outcomes in the Japanese REACH Registry. J Neurol Sci. 2009;287(1-2):45–51.
25.
ArroyoDBetriuAVallsJ. Factors influencing pathological ankle-brachial index values along the chronic kidney disease spectrum: the NEFRONA study. Nephrol Dial Transplant. 2017;32(3):513–20.
26.
ChenJMohlerERXieD. Traditional and non-traditional risk factors for incident peripheral arterial disease among patients with chronic kidney disease. Nephrol Dial Transplant. 2016;31(7):1145–51.
27.
JinXMaJHShenY. An analysis of the relationship between ankle-brachial index and estimated glomerular filtration rate in type 2 diabetes. Angiology. 2013;64(3):237–41.
28.
AboyansVHoEDenenbergJOHoLANatarajanLCriquiMH. The association between elevated ankle systolic pressures and peripheral occlusive arterial disease in diabetic and nondiabetic subjects. J Vasc Surg. 2008;48(5):1197–203.
