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

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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

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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

Zocca, Paolo ; Kok, Marlies M. ; van der Heijden, Liefke C. ; Danse, Peter W. ; Schotborgh, Carl E. ; Scholte, Martijn ; Hartmann, Marc ; Linssen, Gerard C.M. ; Doggen, Carine J.M. ; von Birgelen, Clemens. / High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial. In: Cardiovascular Drugs and Therapy. 2018 ; Vol. 32, No. 6. pp. 567–576.

@article{a8a32b69e83a475fa3dd0bb23b08c316,

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",

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

language = "English",

volume = "32",

pages = "567–576",

journal = "Cardiovascular Drugs and Therapy",

issn = "0920-3206",

publisher = "Kluwer Academic Publishers",

number = "6",

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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.; Danse, Peter W.; Schotborgh, Carl E.; Scholte, Martijn; Hartmann, Marc; Linssen, Gerard C.M.; Doggen, Carine J.M.; von Birgelen, Clemens (Corresponding Author).

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

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U2 - 10.1007/s10557-018-6823-9

DO - 10.1007/s10557-018-6823-9

M3 - Article

AN - SCOPUS:85052327210

VL - 32

SP - 567

EP - 576

JO - Cardiovascular Drugs and Therapy

JF - Cardiovascular Drugs and Therapy

SN - 0920-3206

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

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