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

doi: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

Division of Heart & Lungs

Research output: Contribution to journal › Article › Academic › peer-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 language	English
Pages (from-to)	1679-1687
Number of pages	9
Journal	JACC. Cardiovascular Interventions
Volume	12
Issue number	17
DOIs	https://doi.org/10.1016/j.jcin.2019.05.001
Publication status	Published - 9 Sept 2019

Keywords

Absorbable Implants
Aged
Cardiovascular Agents/administration & dosage
Coronary Artery Disease/diagnostic imaging
Coronary Thrombosis/etiology
Drug-Eluting Stents
Dual Anti-Platelet Therapy
Europe
Everolimus/administration & dosage
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention/adverse effects
Polymers/chemistry
Prospective Studies
Prosthesis Design
Risk Factors
Sirolimus/administration & dosage
Time Factors
Treatment Outcome
everolimus-eluting stent
drug-eluting stent
Firehawk
clinical outcome

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10.1016/j.jcin.2019.05.001

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@article{c4eea9cf225f4d59b61ba8fc02c013d9,

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.",

keywords = "Absorbable Implants, Aged, Cardiovascular Agents/administration & dosage, Coronary Artery Disease/diagnostic imaging, Coronary Thrombosis/etiology, Drug-Eluting Stents, Dual Anti-Platelet Therapy, Europe, Everolimus/administration & dosage, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention/adverse effects, Polymers/chemistry, Prospective Studies, Prosthesis Design, Risk Factors, Sirolimus/administration & dosage, Time Factors, Treatment Outcome, everolimus-eluting stent, drug-eluting stent, Firehawk, clinical outcome",

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 Pawe{\l} Buszman and Holge Thiele and Volker Sch{\"a}chinger and Alexandra Lansky and William Wijns",

note = "Publisher Copyright: {\textcopyright} 2019 American College of Cardiology Foundation",

year = "2019",

month = sep,

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",

number = "17",

}

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

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.

KW - Absorbable Implants

KW - Aged

KW - Cardiovascular Agents/administration & dosage

KW - Coronary Artery Disease/diagnostic imaging

KW - Coronary Thrombosis/etiology

KW - Drug-Eluting Stents

KW - Dual Anti-Platelet Therapy

KW - Europe

KW - Everolimus/administration & dosage

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Percutaneous Coronary Intervention/adverse effects

KW - Polymers/chemistry

KW - Prospective Studies

KW - Prosthesis Design

KW - Risk Factors

KW - Sirolimus/administration & dosage

KW - Time Factors

KW - Treatment Outcome

KW - everolimus-eluting stent

KW - drug-eluting stent

KW - Firehawk

KW - clinical outcome

UR - http://www.scopus.com/inward/record.url?scp=85071232609&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2019.05.001

DO - 10.1016/j.jcin.2019.05.001

M3 - Article

C2 - 31129092

SN - 1936-8798

VL - 12

SP - 1679

EP - 1687

JO - JACC. Cardiovascular Interventions

JF - JACC. Cardiovascular Interventions

IS - 17

ER -

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

Abstract

Keywords

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