Understanding Real-World Clinical and Economic Burden of Different Devices Strategies for the Endovascular Treatment of Symptomatic Peripheral Arterial Disease in Japan: A Real-World Claims Data Analysis Protocol
Author(s)
Yirong Chen, PhD1, Eric A Secemsky, MD, MSc2, Michael R. Jaff, DO3, Qingxia HAO, MSc4, Bruce Crawford, MA, MPH5, Thathya V. Ariyaratne, PhD6.
1Vista Health, Singapore, Singapore, 2Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA, 3Boston Scientific Corporation, Marlborough, MA, USA, 4Vista Health, Beijing, China, 5Vista Health, Tokyo, Japan, 6Boston Scientific Corporation, Asia Pacific, Singapore, Singapore.
1Vista Health, Singapore, Singapore, 2Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA, 3Boston Scientific Corporation, Marlborough, MA, USA, 4Vista Health, Beijing, China, 5Vista Health, Tokyo, Japan, 6Boston Scientific Corporation, Asia Pacific, Singapore, Singapore.
OBJECTIVES: This study will evaluate the clinical and economic outcomes of peripheral arterial disease (PAD) patients who underwent endovascular revascularisation procedures (EVP) with drug-eluting stents (DES), bare-metal stents (BMS), and drug-coated balloons (DCB) in Japan using real-world data.
METHODS: A retrospective cohort study was designed using data from the Medical Data Vision (MDV) database in Japan. The analysis includes eligible PAD patients who underwent an index procedure with DES, BMS, or DCB from January 2019 to August 2023, and had a pre-existing record in MDV. Patients were followed from the date of the first procedure until their last medical record in the database, death, subsequent EVP, or the end of data availability, whichever came first. Clinical outcomes, such as all-cause mortality, repeat interventions, amputations, stent thrombosis, and composite major adverse cardiac and limb events, as well as economic outcomes, including healthcare resource use and costs, will be evaluated at 1-5-year intervals. Descriptive analyses, and adjustments through propensity-score matching and multivariable regression will be applied to compare the DES, BMS, and DCB cohorts.
RESULTS: A total of 20,317 patients treated with DES (n=2,858), BMS (n=9,863), and DCB (n=7,596) are included in the analysis. The mean ages were 75.9, 74.4, and 75.5 years, respectively (DES vs BMS: p<0.0001; DES vs DCB: p=0.0512), with 69.1%, 78.9%, and 64.6% male patients (p<0.0001; p=0.0950). Hypertension, hyperlipidaemia, and diabetes were the most common comorbidities among patients. The Charlson Comorbidity Index were 2.17, 2.01, and 2.34 among DES, BMS and DCB patients, respectively, thus revealing significantly higher comorbidity profile for DES patients compared with BMS (p<0.0001), but similarity between the DES and DCB cohorts (p=0.0887). Clinical and economic outcomes will be available at the time of presentation.
CONCLUSIONS: Large-scale real-world studies assess outcomes for complex patients who are otherwise excluded from clinical trials. Future studies may elucidate drivers of between-group differences.
METHODS: A retrospective cohort study was designed using data from the Medical Data Vision (MDV) database in Japan. The analysis includes eligible PAD patients who underwent an index procedure with DES, BMS, or DCB from January 2019 to August 2023, and had a pre-existing record in MDV. Patients were followed from the date of the first procedure until their last medical record in the database, death, subsequent EVP, or the end of data availability, whichever came first. Clinical outcomes, such as all-cause mortality, repeat interventions, amputations, stent thrombosis, and composite major adverse cardiac and limb events, as well as economic outcomes, including healthcare resource use and costs, will be evaluated at 1-5-year intervals. Descriptive analyses, and adjustments through propensity-score matching and multivariable regression will be applied to compare the DES, BMS, and DCB cohorts.
RESULTS: A total of 20,317 patients treated with DES (n=2,858), BMS (n=9,863), and DCB (n=7,596) are included in the analysis. The mean ages were 75.9, 74.4, and 75.5 years, respectively (DES vs BMS: p<0.0001; DES vs DCB: p=0.0512), with 69.1%, 78.9%, and 64.6% male patients (p<0.0001; p=0.0950). Hypertension, hyperlipidaemia, and diabetes were the most common comorbidities among patients. The Charlson Comorbidity Index were 2.17, 2.01, and 2.34 among DES, BMS and DCB patients, respectively, thus revealing significantly higher comorbidity profile for DES patients compared with BMS (p<0.0001), but similarity between the DES and DCB cohorts (p=0.0887). Clinical and economic outcomes will be available at the time of presentation.
CONCLUSIONS: Large-scale real-world studies assess outcomes for complex patients who are otherwise excluded from clinical trials. Future studies may elucidate drivers of between-group differences.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD126
Topic Subcategory
Health & Insurance Records Systems
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)