High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial

Paolo Zocca; Marlies M. Kok; Liefke C. van der Heijden; Peter W. Danse; Carl E. Schotborgh; Martijn Scholte; Marc Hartmann; Gerard C.M. Linssen; Carine J.M. Doggen; Clemens von Birgelen

doi:10.1007/s10557-018-6823-9

High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial

Paolo Zocca
, Marlies M. Kok
, Liefke C. van der Heijden
, Peter W. Danse
, Carl E. Schotborgh
, Martijn Scholte
, Marc Hartmann
, Gerard C.M. Linssen
, Carine J.M. Doggen
, Clemens von Birgelen^* (Corresponding Author)

^*Corresponding author for this work

Health Technology & Services Research

Research output: Contribution to journal › Article › Academic › peer-review

8 Citations (Scopus)

146 Downloads (Pure)

Abstract

Purpose: Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.

Methods: Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.

Results: Of all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54–1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61–1.39], p = 0.69) and other secondary endpoints.

Conclusions: At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.

Original language	English
Pages (from-to)	567–576
Number of pages	10
Journal	Cardiovascular Drugs and Therapy
Volume	32
Issue number	6
Early online date	24 Aug 2018
DOIs	https://doi.org/10.1007/s10557-018-6823-9
Publication status	Published - 1 Dec 2018

Keywords

UT-Hybrid-D
Drug-eluting stent
Durable polymer
High bleeding risk
Percutaneous coronary intervention
Biodegradable polymer

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s10557-018-6823-9Licence: CC BY

Zocca2018highFinal published version, 0.99 MBLicence: CC BY

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Zocca, P., Kok, M. M., van der Heijden, L. C., Danse, P. W., Schotborgh, C. E., Scholte, M., Hartmann, M., Linssen, G. C. M., Doggen, C. J. M., & von Birgelen, C. (2018). High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial. Cardiovascular Drugs and Therapy, 32(6), 567–576. https://doi.org/10.1007/s10557-018-6823-9

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title = "High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial",

abstract = "Purpose: Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.Methods: Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.Results: Of all 3514 patients, 1009 (28.7\%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2\%, p = 0.003), cardiac death (1.9 vs. 0.4\%, p < 0.001), and major bleeding (3.3 vs. 1.5\%, p = 0.001). Of all 1009 HBR patients, 673 (66.7\%) received BP-DES and 336 (33.3\%) had DP-DES. The primary endpoint was met by 43/673 (6.5\%) patients treated with BP-DES and 24/336 (7.3\%) treated with DP-DES (HR 0.88 [95\%CI 0.54–1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5\%, HR 0.92 [95\%CI 0.61–1.39], p = 0.69) and other secondary endpoints.Conclusions: At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.",

keywords = "UT-Hybrid-D, Drug-eluting stent, Durable polymer, High bleeding risk, Percutaneous coronary intervention, Biodegradable polymer",

author = "Paolo Zocca and Kok, \{Marlies M.\} and \{van der Heijden\}, \{Liefke C.\} and Danse, \{Peter W.\} and Schotborgh, \{Carl E.\} and Martijn Scholte and Marc Hartmann and Linssen, \{Gerard C.M.\} and Doggen, \{Carine J.M.\} and \{von Birgelen\}, Clemens",

note = "Springer deal",

year = "2018",

month = dec,

day = "1",

doi = "10.1007/s10557-018-6823-9",

language = "English",

volume = "32",

pages = "567–576",

journal = "Cardiovascular Drugs and Therapy",

issn = "0920-3206",

publisher = "Springer",

number = "6",

}

Zocca, P, Kok, MM, van der Heijden, LC, Danse, PW, Schotborgh, CE, Scholte, M, Hartmann, M, Linssen, GCM, Doggen, CJM & von Birgelen, C 2018, 'High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial', Cardiovascular Drugs and Therapy, vol. 32, no. 6, pp. 567–576. https://doi.org/10.1007/s10557-018-6823-9

High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial. / Zocca, Paolo; Kok, Marlies M.; van der Heijden, Liefke C. et al.
In: Cardiovascular Drugs and Therapy, Vol. 32, No. 6, 01.12.2018, p. 567–576.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial

AU - Zocca, Paolo

AU - Kok, Marlies M.

AU - van der Heijden, Liefke C.

AU - Danse, Peter W.

AU - Schotborgh, Carl E.

AU - Scholte, Martijn

AU - Hartmann, Marc

AU - Linssen, Gerard C.M.

AU - Doggen, Carine J.M.

AU - von Birgelen, Clemens

N1 - Springer deal

PY - 2018/12/1

Y1 - 2018/12/1

N2 - Purpose: Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.Methods: Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.Results: Of all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54–1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61–1.39], p = 0.69) and other secondary endpoints.Conclusions: At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.

AB - Purpose: Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.Methods: Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.Results: Of all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54–1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61–1.39], p = 0.69) and other secondary endpoints.Conclusions: At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.

KW - UT-Hybrid-D

KW - Drug-eluting stent

KW - Durable polymer

KW - High bleeding risk

KW - Percutaneous coronary intervention

KW - Biodegradable polymer

UR - https://www.scopus.com/pages/publications/85052327210

U2 - 10.1007/s10557-018-6823-9

DO - 10.1007/s10557-018-6823-9

M3 - Article

AN - SCOPUS:85052327210

SN - 0920-3206

VL - 32

SP - 567

EP - 576

JO - Cardiovascular Drugs and Therapy

JF - Cardiovascular Drugs and Therapy

IS - 6

ER -

High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial

Abstract

Keywords

UN SDGs

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