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Five-year clinical efficacy and safety of contemporary thin-strut biodegradable polymer versus durable polymer drug-eluting stents: a systematic review and meta-analysis of 9 randomized controlled trials

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Abstract

Very long-term data of the biodegradable polymer drug-eluting stents (BP-DES) in comparison with the contemporary durable polymer DES (DP-DES) are still to be investigated. We aimed to investigate the very long-term clinical performance of contemporary BP-DES against the DP-DES. We performed a systematic review to evaluate very long-term clinical outcomes of BP-DES versus DP-DES. Inclusion criteria were randomized design comparing BP-DES against DP-DES and follow-up duration ≥ 36 months. MEDLINE, EMBASE, and CENTRAL without restricting language or publication status were searched up to December 2018. The primary efficacy and safety endpoints were target lesion failure (TLF; a composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization) and definite/probable stent thrombosis (ST), respectively. Primary analysis was done for the contemporary thin-strut BP- and DP-DES (strut thickness < 100 µm). A total of 9 trials comprising 10,699 patients (BP-DES, n = 6241 versus DP-DES, n = 4458) were analyzed. The mean follow-up duration was 63 months. No significant difference was found in TLF [Odds ratio (95% CI) 1.04 (0.89–1.21)] and definite/probable ST (odds ratio (95% CI) 0.78 (0.59–1.01)] between the BP- and DP-DESs. The present meta-analysis suggested that the contemporary thin-strut BP- and DP-DES have similar efficacy and safety profile at 5-year follow-up.

Clinical trial registration PROSPERO; CRD42018101983 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=101983.

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Authors and Affiliations

  1. Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, Osaka, 543-0035, Japan

    Tomoaki Kobayashi, Yohei Sotomi, Satoshi Suzuki, Shimpei Nakatani, Atsushi Hirayama & Yoshiharu Higuchi

  2. Northern Region Heart Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

    Pannipa Suwannasom

  3. Department of Internal Medicine, Division of Cardiology, Iwate Medical University, Morioka, Japan

    Yoshihiro Morino

  4. Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan

    Junya Ako

  5. Department of Medicine, Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan

    Ken Kozuma

  6. Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan

    Yasushi Sakata

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  1. Tomoaki Kobayashi
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  2. Yohei Sotomi
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Correspondence to Yohei Sotomi.

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Conflict of interest

Y Sotomi, S. Nakatani, and Y. Higuchi received speaker honoraria from Abbott Vascular Japan, Boston Scientific Japan, TERUMO, Cardinal Health, and Medtronic. Y. Morino received research grant from Boston Scientific Japan and TERUMO, consultant fee from Japan Lifeline, and lecture fee from Abbott Vascular Japan and Medtronic. J. Ako received speaker honoraria from Abbott Vascular Japan, Boston Scientific Japan, TERUMO. K. Kozuma received speaker honoraria from Abbott Vascular Japan, Boston Scientific Japan, TERUMO and clinical search grant from Abbott Vascular Japan, TERUMO. Medtronic, and NIPRO. A. Hirayama reports grants and personal fees from Boston Scientific Japan, Abbott Vascular Japan, Japan Lifeline, and Medtronic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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Kobayashi, T., Sotomi, Y., Suzuki, S. et al. Five-year clinical efficacy and safety of contemporary thin-strut biodegradable polymer versus durable polymer drug-eluting stents: a systematic review and meta-analysis of 9 randomized controlled trials. Cardiovasc Interv and Ther 35, 250–258 (2020). https://doi.org/10.1007/s12928-019-00613-w

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