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. 2020 Jan 13;15(1):e0226606.
doi: 10.1371/journal.pone.0226606. eCollection 2020.

Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes

Florian Krackhardt  1 , Matthias Waliszewski  1   2 , Wan Azman Wan Ahmad  3 , Viktor Kočka  4 , Petr Toušek  4 , Bronislav Janek  5 , Milan Trenčan  6 , Peter Krajči  6 , Fernando Lozano  7 , Koldobika Garcia-San Roman  8 , Imanol Otaegui Irurueta  9 , Bruno Garcia Del Blanco  9 , Lucie Wachowiak  10 , Victoria Vilalta Del Olmo  11 , Eduard Fernandez Nofrerías  11 , Myung Ho Jeong  12 , Byung-Chun Jung  13 , Kyu-Rock Han  14 , Christophe Piot  15 , Laurent Sebagh  16 , Jérôme Rischner  17 , Michel Pansieri  18 , Matthias Leschke  19 , Tae Hoon Ahn  20
Affiliations

Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes

Florian Krackhardt et al. PLoS One. .

Abstract

Background: The objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe.

Methods: Two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months.

Results: Of the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe.

Conclusions: PF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.

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Conflict of interest statement

All centers received a remuneration for each fully documented study patient. We report the following conflicts of interest: FK (lecturing fees B.Braun, Astra Zeneca), VK (consulting Medtronic, Abbott Vascular, Terumo) and MW/LW (full time employment at Medical Scientific Affairs, B.Braun Melsungen AG). All other authors have no other conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Patient flowchart.
Fig 2
Fig 2. Clinical outcomes in stable CAD and ACS patients per defined region.
See this image and copyright information in PMC

References

    1. Ananthakrishna R, Kristanto W, Liu L, Chan SP, Loh PH, Tay EL, et al. Incidence and predictors of target lesion failure in a multiethnic Asian population receiving the SYNERGY coronary stent: A prospective all-comers registry. Catheter Cardiovasc Interv. 2018;92:1097–1103. 10.1002/ccd.27577 - DOI - PubMed
    1. Klomp M, Damman P, Beijk MA, Tan KH, Balian V, de Luca G, et al.; e-HEALING investigators. Differences in cardiovascular risk factors and clinical outcomes between Western European and Southeast Asian patients treated with the Genous Bio-engineered R stent: an e-HEALING worldwide registry substudy. Coron Artery Dis. 2012;23:271–277. 10.1097/MCA.0b013e328351aaed - DOI - PubMed
    1. Pepe M, Biondi-Zoccai G, Corcione N, Nestola PL, Ferraro P, Morello A, et al. Comparative Effectiveness and Safety of Polymer-Free Biolimus-Eluting Stent and Durable Polymer Everolimus-Eluting Stent in All-Comer Patients Who Underwent Percutaneous Coronary Interventions. Am J Cardiol. 2019. April 23 pii: S0002–9149(19)30454-0. 10.1016/j.amjcard.2019.04.015 - DOI - PubMed
    1. Jensen LO, Thayssen P, Maeng M, Ravkilde J, Krusell LR, Raungaard B, et al. Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial.Circ Cardiovasc Interv. 2016;9(7). pii: e003610 10.1161/CIRCINTERVENTIONS.115.003610 - DOI - PubMed
    1. Yeh RW, Silber S, Chen L, Chen S, Hiremath S, Neumann FJ, et al. 5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program. JACC Cardiovasc Interv. 2017;10: 247–254. 10.1016/j.jcin.2016.11.004 - DOI - PubMed

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