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Original research
Antithrombotic therapy after femoropopliteal artery stenting: 12-month results from Japan Postmarketing Surveillance
  1. Osami Kawarada1,
  2. Michikazu Nakai2,
  3. Kunihiro Nishimura2,
  4. Hideki Miwa3,
  5. Yusuke Iwasaki4,
  6. Daitaro Kanno5,
  7. Tatsuya Nakama6,
  8. Yoshito Yamamoto7,
  9. Nobuhiko Ogata8,
  10. Masato Nakamura9,
  11. Satoshi Yasuda1
  1. 1Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan
  2. 2Department of Statistics and Data Analysis, Center for Cerebral and Cardiovascular Disease Information, National Cerebral and Cardiovascular Center, Osaka, Japan
  3. 3Clinical Development Department, Terumo Corporation, Tokyo, Japan
  4. 4Division of Cardiology, Osaka General Medical Center, Osaka, Japan
  5. 5Cardiovascular Medicine, Sapporo Cardiovascular Clinic, Hokkaido, Japan
  6. 6Department of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan
  7. 7Department of Cardiology, Iwaki Kyoritsu General Hospital, Fukushima, Japan
  8. 8Department of Cardiology, Ageo Central General Hospital, Saitama, Japan
  9. 9Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan
  1. Correspondence to Osami Kawarada, Department of Cardiovascular Medicine, Ikuwakai Memorial Hospital, 3-20-29 Tatsumikita, Ikunoku, Osaka city, Osaka, 544-0004, Japan; osamikawarada{at}yahoo.co.jp

Abstract

Objective To investigate the effects of antithrombotic therapy on target lesion revascularisation (TLR) and major adverse cardiovascular and cerebrovascular events (MACCEs) at 12 months after femoropopliteal intervention with second-generation bare metal nitinol stents.

Methods A total of 277 lesions in 258 limbs of 248 patients with de novo atherosclerosis in the above-the-knee femoropopliteal segment were analysed from the Japan multicentre postmarketing surveillance.

Results At discharge, dual antiplatelet therapy (DAPT) was prescribed in 68.5% and cilostazol in 30.2% of patients. At 12 months of follow-up, prescriptions of DAPT significantly (p=0.0001) decreased to 51.2% and prescription of cilostazol remained unchanged (p=0.592) at 28.0%. Prescription of warfarin also remained unchanged (14.5% at discharge, 13.3% at 12 months, p=0.70). At 12 months, freedoms from TLR and MACCE were 89.4% and 89.7%, respectively. In a multivariate Cox proportional hazards model, neither DAPT nor cilostazol at discharge was associated with both TLR and MACCE at 12 months. However, warfarin at discharge was only independently associated with TLR at 12 months. Kaplan-Meier estimates demonstrated that warfarin at discharge yielded a significantly (p=0.013) lower freedom from TLR at 12 months than no warfarin at discharge. Freedom from TLR at 12 months by the Kaplan-Meier estimates was 77.8% (95% CI 59.0% to 88.8%) in patients with warfarin at discharge and 91.2% (95% CI 86.3% to 94.3%) in those without warfarin at discharge.

Conclusions Clinical benefits of DAPT or cilostazol might be small in terms of TLR and MACCE at 12 months. Anticoagulation with warfarin at discharge might increase TLR at 12 months.

  • peripheral artery disease
  • femoropopliteal artery disease
  • medical treatment

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/heartasia-2018-011114

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    Footnotes

    • Contributors The contribution of each author is as follow: (1) conception and design or analysis and interpretation of data, or both: OK, MN and KN; (2) drafting of the manuscript or revising it critically for important intellectual content: OK, NO, MN and SY and (3) data collection: OK, HM, YI, DK, TN and YY.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests OK reports honorarium of lectures and advisory board fees from Boston Scientific Corporation, honorarium of lectures and research grants from Terumo, and a consultancy fee from Medtronic. MN and KN report consigned research funds from Terumo. TN reports honorarium of lectures from Abbott Vascular, Boston Scientific and Medtronic and consulting fee from Boston Scientific and Century Medical Inc.

    • Patient consent Not required.

    • Ethics approval National Cerebral and Cardiovascular Center.