2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent

Bo Xu, Yuichi Saito, Andreas Baumbach, Henning Kelbæk, Niels van Royen, Ming Zheng, Marie-Angèle Morel, Paul Knaapen, Ton Slagboom, Thomas W. Johnson, Georgios Vlachojannis, Karin E. Arkenbout, Lene Holmvang, Luc Janssens, Andrzej Ochala, Salvatore Brugaletta, Christoph K. Naber, Richard Anderson, Harald Rittger, Sergio Berti & 10 others Emanuele Barbato, Gabor G. Toth, Luc Maillard, Christian Valina, Paweł Buszman, Holge Thiele, Volker Schächinger, Alexandra Lansky, William Wijns, TARGET AC Investigators

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objectives: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove–filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. Background: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. Methods: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Results: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). Conclusions: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.
Original languageEnglish
Pages (from-to)1679-1687
JournalJACC: Cardiovascular Interventions
Volume12
Issue number17
DOIs
Publication statusPublished - 9 Sep 2019

Cite this

Xu, Bo ; Saito, Yuichi ; Baumbach, Andreas ; Kelbæk, Henning ; van Royen, Niels ; Zheng, Ming ; Morel, Marie-Angèle ; Knaapen, Paul ; Slagboom, Ton ; Johnson, Thomas W. ; Vlachojannis, Georgios ; Arkenbout, Karin E. ; Holmvang, Lene ; Janssens, Luc ; Ochala, Andrzej ; Brugaletta, Salvatore ; Naber, Christoph K. ; Anderson, Richard ; Rittger, Harald ; Berti, Sergio ; Barbato, Emanuele ; Toth, Gabor G. ; Maillard, Luc ; Valina, Christian ; Buszman, Paweł ; Thiele, Holge ; Schächinger, Volker ; Lansky, Alexandra ; Wijns, William ; TARGET AC Investigators. / 2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent. In: JACC: Cardiovascular Interventions. 2019 ; Vol. 12, No. 17. pp. 1679-1687.
@article{d66204678c3a48a0bb76d1f45ad10100,
title = "2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent",
abstract = "Objectives: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove–filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. Background: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. Methods: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Results: At 2-year follow-up, the incidence of target lesion failure was 8.7{\%} in the Firehawk group versus 8.6{\%} in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4{\%}) in the Firehawk group and in 7 patients (0.9{\%}) in the XIENCE group (p = 0.34). Conclusions: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.",
author = "Bo Xu and Yuichi Saito and Andreas Baumbach and Henning Kelb{\ae}k and {van Royen}, Niels and Ming Zheng and Marie-Ang{\`e}le Morel and Paul Knaapen and Ton Slagboom and Johnson, {Thomas W.} and Georgios Vlachojannis and Arkenbout, {Karin E.} and Lene Holmvang and Luc Janssens and Andrzej Ochala and Salvatore Brugaletta and Naber, {Christoph K.} and Richard Anderson and Harald Rittger and Sergio Berti and Emanuele Barbato and Toth, {Gabor G.} and Luc Maillard and Christian Valina and Paweł Buszman and Holge Thiele and Volker Sch{\"a}chinger and Alexandra Lansky and William Wijns and {TARGET AC Investigators}",
year = "2019",
month = "9",
day = "9",
doi = "10.1016/j.jcin.2019.05.001",
language = "English",
volume = "12",
pages = "1679--1687",
journal = "JACC Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "17",

}

Xu, B, Saito, Y, Baumbach, A, Kelbæk, H, van Royen, N, Zheng, M, Morel, M-A, Knaapen, P, Slagboom, T, Johnson, TW, Vlachojannis, G, Arkenbout, KE, Holmvang, L, Janssens, L, Ochala, A, Brugaletta, S, Naber, CK, Anderson, R, Rittger, H, Berti, S, Barbato, E, Toth, GG, Maillard, L, Valina, C, Buszman, P, Thiele, H, Schächinger, V, Lansky, A, Wijns, W & TARGET AC Investigators 2019, '2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent' JACC: Cardiovascular Interventions, vol. 12, no. 17, pp. 1679-1687. https://doi.org/10.1016/j.jcin.2019.05.001

2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent. / Xu, Bo; Saito, Yuichi; Baumbach, Andreas; Kelbæk, Henning; van Royen, Niels; Zheng, Ming; Morel, Marie-Angèle; Knaapen, Paul; Slagboom, Ton; Johnson, Thomas W.; Vlachojannis, Georgios; Arkenbout, Karin E.; Holmvang, Lene; Janssens, Luc; Ochala, Andrzej; Brugaletta, Salvatore; Naber, Christoph K.; Anderson, Richard; Rittger, Harald; Berti, Sergio; Barbato, Emanuele; Toth, Gabor G.; Maillard, Luc; Valina, Christian; Buszman, Paweł; Thiele, Holge; Schächinger, Volker; Lansky, Alexandra; Wijns, William; TARGET AC Investigators.

In: JACC: Cardiovascular Interventions, Vol. 12, No. 17, 09.09.2019, p. 1679-1687.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent

AU - Xu, Bo

AU - Saito, Yuichi

AU - Baumbach, Andreas

AU - Kelbæk, Henning

AU - van Royen, Niels

AU - Zheng, Ming

AU - Morel, Marie-Angèle

AU - Knaapen, Paul

AU - Slagboom, Ton

AU - Johnson, Thomas W.

AU - Vlachojannis, Georgios

AU - Arkenbout, Karin E.

AU - Holmvang, Lene

AU - Janssens, Luc

AU - Ochala, Andrzej

AU - Brugaletta, Salvatore

AU - Naber, Christoph K.

AU - Anderson, Richard

AU - Rittger, Harald

AU - Berti, Sergio

AU - Barbato, Emanuele

AU - Toth, Gabor G.

AU - Maillard, Luc

AU - Valina, Christian

AU - Buszman, Paweł

AU - Thiele, Holge

AU - Schächinger, Volker

AU - Lansky, Alexandra

AU - Wijns, William

AU - TARGET AC Investigators

PY - 2019/9/9

Y1 - 2019/9/9

N2 - Objectives: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove–filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. Background: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. Methods: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Results: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). Conclusions: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

AB - Objectives: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove–filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. Background: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. Methods: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Results: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). Conclusions: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85071232609&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/31129092

U2 - 10.1016/j.jcin.2019.05.001

DO - 10.1016/j.jcin.2019.05.001

M3 - Article

VL - 12

SP - 1679

EP - 1687

JO - JACC Cardiovascular Interventions

JF - JACC Cardiovascular Interventions

SN - 1936-8798

IS - 17

ER -