Four-year outcomes of multivessel percutaneous coronary intervention with Xience v everolimus-eluting stents

Michael S. Lee; Richard Shlofmitz; Ehtisham Mahmud; Kyung Woo Park; Seung Woon Rha; Anna Gaborro; Jin Wang; Weiying Zhao; Krishnankutty Sudhir

Four-year outcomes of multivessel percutaneous coronary intervention with Xience v everolimus-eluting stents

Michael S. Lee, Richard Shlofmitz, Ehtisham Mahmud, Kyung Woo Park, Seung Woon Rha, Anna Gaborro, Jin Wang, Weiying Zhao, Krishnankutty Sudhir

Department of Biomedical Sciences

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

1 Citation (Scopus)

Abstract

Objectives. We evaluated the long-term outcomes of multivessel compared with single-vessel percutaneous coronary intervention (PCI) with Xience V everolimus-eluting stents in real-world patients. Background. Treatment options for multivessel disease include PCI, coronary artery bypass grafting, and medical therapy. Patients with multivessel disease are at a higher risk for ischemic complications than those with single-vessel disease. Methods. The XIENCE V USA study was a condition-of-approval, single-arm, prospective study in unselected real-world patients. Patients who underwent multivessel PCI (n = 655) were compared with those who underwent single-vessel PCI (n = 4079). Major clinical outcomes, including mortality, stent thrombosis, and target-lesion failure (TLF), were evaluated at 4 years. Results. At 4 years, mortality was similar in both groups (11.1% in multivessel patients vs 9.8% in single-vessel patients; P=.31). The multivessel PCI group had higher rates of Academic Research Consortium (ARC)-defined TLF (24.3% vs 16.4% in single-vessel patients; P<.001) and ARC-defined definite and probable stent thrombosis (2.43% vs 1.11% in single-vessel patients; P=.02). The independent predictors of ARC-defined TLF at 4 years on multivariable analysis were prior myocardial infarction, number of treated vessels, total stent length, and sex. Conclusion. Despite significant differences in baseline characteristics, long-term mortality rates were similar in both groups. Although ischemic complications were higher in the multivessel PCI group, the overall rates were acceptable, demonstrating the safety and efficacy of Xience V everolimus-eluting stents for the treatment of multivessel disease in a real-world population.

Original language	English
Pages (from-to)	240-246
Number of pages	7
Journal	Journal of Invasive Cardiology
Volume	31
Issue number	9
Publication status	Published - 2019

Bibliographical note

Funding Information:
Funding: The XIENCE V USA study was a condition-of approval postmarket study whose operational expenses were funded by the sponsor (Abbott Vascular). The sponsor, principal investigator, and co-principal investigators actively collaborated with the Food and Drug Administration to design, conduct, and analyze the study. James Hermiller, MD, and Mitchell Krucoff, MD, were the principal investigators for the XIENCE V USA study, but did not review this paper. Abbott Vascular provided the statistical analysis of this study. The corresponding author had full access to the data, and all authors contributed to the preparation of the manuscript.

Publisher Copyright:
© 2019 HMP Communications. All rights reserved.

Keywords

Drug-eluting stent
Everolimus-eluting stent
Percutaneous coronary intervention

ASJC Scopus subject areas

Medicine(all)

Cite this

@article{0b8667360f004a829849f4e6d1988538,

title = "Four-year outcomes of multivessel percutaneous coronary intervention with Xience v everolimus-eluting stents",

abstract = "Objectives. We evaluated the long-term outcomes of multivessel compared with single-vessel percutaneous coronary intervention (PCI) with Xience V everolimus-eluting stents in real-world patients. Background. Treatment options for multivessel disease include PCI, coronary artery bypass grafting, and medical therapy. Patients with multivessel disease are at a higher risk for ischemic complications than those with single-vessel disease. Methods. The XIENCE V USA study was a condition-of-approval, single-arm, prospective study in unselected real-world patients. Patients who underwent multivessel PCI (n = 655) were compared with those who underwent single-vessel PCI (n = 4079). Major clinical outcomes, including mortality, stent thrombosis, and target-lesion failure (TLF), were evaluated at 4 years. Results. At 4 years, mortality was similar in both groups (11.1% in multivessel patients vs 9.8% in single-vessel patients; P=.31). The multivessel PCI group had higher rates of Academic Research Consortium (ARC)-defined TLF (24.3% vs 16.4% in single-vessel patients; P<.001) and ARC-defined definite and probable stent thrombosis (2.43% vs 1.11% in single-vessel patients; P=.02). The independent predictors of ARC-defined TLF at 4 years on multivariable analysis were prior myocardial infarction, number of treated vessels, total stent length, and sex. Conclusion. Despite significant differences in baseline characteristics, long-term mortality rates were similar in both groups. Although ischemic complications were higher in the multivessel PCI group, the overall rates were acceptable, demonstrating the safety and efficacy of Xience V everolimus-eluting stents for the treatment of multivessel disease in a real-world population.",

keywords = "Drug-eluting stent, Everolimus-eluting stent, Percutaneous coronary intervention",

author = "Lee, {Michael S.} and Richard Shlofmitz and Ehtisham Mahmud and Park, {Kyung Woo} and Rha, {Seung Woon} and Anna Gaborro and Jin Wang and Weiying Zhao and Krishnankutty Sudhir",

note = "Funding Information: Funding: The XIENCE V USA study was a condition-of approval postmarket study whose operational expenses were funded by the sponsor (Abbott Vascular). The sponsor, principal investigator, and co-principal investigators actively collaborated with the Food and Drug Administration to design, conduct, and analyze the study. James Hermiller, MD, and Mitchell Krucoff, MD, were the principal investigators for the XIENCE V USA study, but did not review this paper. Abbott Vascular provided the statistical analysis of this study. The corresponding author had full access to the data, and all authors contributed to the preparation of the manuscript. Publisher Copyright: {\textcopyright} 2019 HMP Communications. All rights reserved.",

year = "2019",

language = "English",

volume = "31",

pages = "240--246",

journal = "Journal of Invasive Cardiology",

issn = "1042-3931",

publisher = "HMP Communications",

number = "9",

}

TY - JOUR

T1 - Four-year outcomes of multivessel percutaneous coronary intervention with Xience v everolimus-eluting stents

AU - Lee, Michael S.

AU - Shlofmitz, Richard

AU - Mahmud, Ehtisham

AU - Park, Kyung Woo

AU - Rha, Seung Woon

AU - Gaborro, Anna

AU - Wang, Jin

AU - Zhao, Weiying

AU - Sudhir, Krishnankutty

N1 - Funding Information: Funding: The XIENCE V USA study was a condition-of approval postmarket study whose operational expenses were funded by the sponsor (Abbott Vascular). The sponsor, principal investigator, and co-principal investigators actively collaborated with the Food and Drug Administration to design, conduct, and analyze the study. James Hermiller, MD, and Mitchell Krucoff, MD, were the principal investigators for the XIENCE V USA study, but did not review this paper. Abbott Vascular provided the statistical analysis of this study. The corresponding author had full access to the data, and all authors contributed to the preparation of the manuscript. Publisher Copyright: © 2019 HMP Communications. All rights reserved.

PY - 2019

Y1 - 2019

N2 - Objectives. We evaluated the long-term outcomes of multivessel compared with single-vessel percutaneous coronary intervention (PCI) with Xience V everolimus-eluting stents in real-world patients. Background. Treatment options for multivessel disease include PCI, coronary artery bypass grafting, and medical therapy. Patients with multivessel disease are at a higher risk for ischemic complications than those with single-vessel disease. Methods. The XIENCE V USA study was a condition-of-approval, single-arm, prospective study in unselected real-world patients. Patients who underwent multivessel PCI (n = 655) were compared with those who underwent single-vessel PCI (n = 4079). Major clinical outcomes, including mortality, stent thrombosis, and target-lesion failure (TLF), were evaluated at 4 years. Results. At 4 years, mortality was similar in both groups (11.1% in multivessel patients vs 9.8% in single-vessel patients; P=.31). The multivessel PCI group had higher rates of Academic Research Consortium (ARC)-defined TLF (24.3% vs 16.4% in single-vessel patients; P<.001) and ARC-defined definite and probable stent thrombosis (2.43% vs 1.11% in single-vessel patients; P=.02). The independent predictors of ARC-defined TLF at 4 years on multivariable analysis were prior myocardial infarction, number of treated vessels, total stent length, and sex. Conclusion. Despite significant differences in baseline characteristics, long-term mortality rates were similar in both groups. Although ischemic complications were higher in the multivessel PCI group, the overall rates were acceptable, demonstrating the safety and efficacy of Xience V everolimus-eluting stents for the treatment of multivessel disease in a real-world population.

AB - Objectives. We evaluated the long-term outcomes of multivessel compared with single-vessel percutaneous coronary intervention (PCI) with Xience V everolimus-eluting stents in real-world patients. Background. Treatment options for multivessel disease include PCI, coronary artery bypass grafting, and medical therapy. Patients with multivessel disease are at a higher risk for ischemic complications than those with single-vessel disease. Methods. The XIENCE V USA study was a condition-of-approval, single-arm, prospective study in unselected real-world patients. Patients who underwent multivessel PCI (n = 655) were compared with those who underwent single-vessel PCI (n = 4079). Major clinical outcomes, including mortality, stent thrombosis, and target-lesion failure (TLF), were evaluated at 4 years. Results. At 4 years, mortality was similar in both groups (11.1% in multivessel patients vs 9.8% in single-vessel patients; P=.31). The multivessel PCI group had higher rates of Academic Research Consortium (ARC)-defined TLF (24.3% vs 16.4% in single-vessel patients; P<.001) and ARC-defined definite and probable stent thrombosis (2.43% vs 1.11% in single-vessel patients; P=.02). The independent predictors of ARC-defined TLF at 4 years on multivariable analysis were prior myocardial infarction, number of treated vessels, total stent length, and sex. Conclusion. Despite significant differences in baseline characteristics, long-term mortality rates were similar in both groups. Although ischemic complications were higher in the multivessel PCI group, the overall rates were acceptable, demonstrating the safety and efficacy of Xience V everolimus-eluting stents for the treatment of multivessel disease in a real-world population.

KW - Drug-eluting stent

KW - Everolimus-eluting stent

KW - Percutaneous coronary intervention

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M3 - Article

C2 - 31478889

AN - SCOPUS:85071754241

SN - 1042-3931

VL - 31

SP - 240

EP - 246

JO - Journal of Invasive Cardiology

JF - Journal of Invasive Cardiology

IS - 9

ER -

Four-year outcomes of multivessel percutaneous coronary intervention with Xience v everolimus-eluting stents

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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