Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk

Ran Kornowski; Maayan Konigstein; Michael Jonas; Abid Assali; Hana Vaknin-Assa; Amit Segev; Haim Danenberg; Majdi Halabi; Ariel Roguin; Arthur Kerner; Eli Lev; Grigoris V Karamasis; Thomas W Johnson; Richard Anderson; Jonathan Blaxill; Sachin Jadhav; Stephen Hoole; Guy Witberg; Melek Ozgu Issever; Ori Ben-Yehuda; Andreas Baumbach

doi:10.1161/JAHA.122.029051

Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk

Ran Kornowski^*, Maayan Konigstein, Michael Jonas, Abid Assali, Hana Vaknin-Assa, Amit Segev, Haim Danenberg, Majdi Halabi, Ariel Roguin, Arthur Kerner, Eli Lev, Grigoris V Karamasis, Thomas W Johnson, Richard Anderson, Jonathan Blaxill, Sachin Jadhav, Stephen Hoole, Guy Witberg, Melek Ozgu Issever, Ori Ben-YehudaAndreas Baumbach

^*Corresponding author for this work

Bristol Medical School (THS)

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

Abstract

BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR.

METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% ( P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%).

CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.

Original language	English
Article number	e029051
Pages (from-to)	e029051
Journal	Journal of the American Heart Association
Volume	13
Issue number	2
Early online date	12 Jan 2024
DOIs	https://doi.org/10.1161/JAHA.122.029051
Publication status	Published - 16 Jan 2024

Bibliographical note

Publisher Copyright:
© 2024 The Authors.

Keywords

Humans
Drug-Eluting Stents
Platelet Aggregation Inhibitors/therapeutic use
Acute Coronary Syndrome/drug therapy
Prospective Studies
Treatment Outcome
Hemorrhage/chemically induced
Stents
Percutaneous Coronary Intervention/adverse effects
Thrombosis/etiology
Drug Therapy, Combination
Coronary Artery Disease/drug therapy
Sirolimus/analogs & derivatives

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Kornowski, R., Konigstein, M., Jonas, M., Assali, A., Vaknin-Assa, H., Segev, A., Danenberg, H., Halabi, M., Roguin, A., Kerner, A., Lev, E., Karamasis, G. V., Johnson, T. W., Anderson, R., Blaxill, J., Jadhav, S., Hoole, S., Witberg, G., Issever, M. O., ... Baumbach, A. (2024). Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk. Journal of the American Heart Association, 13(2), e029051. Article e029051. https://doi.org/10.1161/JAHA.122.029051

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title = "Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk",

abstract = "BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR.METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% ( P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis.REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.",

keywords = "Humans, Drug-Eluting Stents, Platelet Aggregation Inhibitors/therapeutic use, Acute Coronary Syndrome/drug therapy, Prospective Studies, Treatment Outcome, Hemorrhage/chemically induced, Stents, Percutaneous Coronary Intervention/adverse effects, Thrombosis/etiology, Drug Therapy, Combination, Coronary Artery Disease/drug therapy, Sirolimus/analogs & derivatives",

author = "Ran Kornowski and Maayan Konigstein and Michael Jonas and Abid Assali and Hana Vaknin-Assa and Amit Segev and Haim Danenberg and Majdi Halabi and Ariel Roguin and Arthur Kerner and Eli Lev and Karamasis, {Grigoris V} and Johnson, {Thomas W} and Richard Anderson and Jonathan Blaxill and Sachin Jadhav and Stephen Hoole and Guy Witberg and Issever, {Melek Ozgu} and Ori Ben-Yehuda and Andreas Baumbach",

note = "Publisher Copyright: {\textcopyright} 2024 The Authors.",

year = "2024",

month = jan,

day = "16",

doi = "10.1161/JAHA.122.029051",

language = "English",

volume = "13",

pages = "e029051",

journal = "Journal of the American Heart Association",

issn = "2047-9980",

publisher = "Wiley",

number = "2",

}

Kornowski, R, Konigstein, M, Jonas, M, Assali, A, Vaknin-Assa, H, Segev, A, Danenberg, H, Halabi, M, Roguin, A, Kerner, A, Lev, E, Karamasis, GV, Johnson, TW, Anderson, R, Blaxill, J, Jadhav, S, Hoole, S, Witberg, G, Issever, MO, Ben-Yehuda, O & Baumbach, A 2024, 'Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk', Journal of the American Heart Association, vol. 13, no. 2, e029051, pp. e029051. https://doi.org/10.1161/JAHA.122.029051

TY - JOUR

T1 - Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk

AU - Kornowski, Ran

AU - Konigstein, Maayan

AU - Jonas, Michael

AU - Assali, Abid

AU - Vaknin-Assa, Hana

AU - Segev, Amit

AU - Danenberg, Haim

AU - Halabi, Majdi

AU - Roguin, Ariel

AU - Kerner, Arthur

AU - Lev, Eli

AU - Karamasis, Grigoris V

AU - Johnson, Thomas W

AU - Anderson, Richard

AU - Blaxill, Jonathan

AU - Jadhav, Sachin

AU - Hoole, Stephen

AU - Witberg, Guy

AU - Issever, Melek Ozgu

AU - Ben-Yehuda, Ori

AU - Baumbach, Andreas

PY - 2024/1/16

Y1 - 2024/1/16

N2 - BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR.METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% ( P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis.REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.

AB - BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR.METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% ( P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis.REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.

KW - Humans

KW - Drug-Eluting Stents

KW - Platelet Aggregation Inhibitors/therapeutic use

KW - Acute Coronary Syndrome/drug therapy

KW - Prospective Studies

KW - Treatment Outcome

KW - Hemorrhage/chemically induced

KW - Stents

KW - Percutaneous Coronary Intervention/adverse effects

KW - Thrombosis/etiology

KW - Drug Therapy, Combination

KW - Coronary Artery Disease/drug therapy

KW - Sirolimus/analogs & derivatives

U2 - 10.1161/JAHA.122.029051

DO - 10.1161/JAHA.122.029051

M3 - Article (Academic Journal)

C2 - 38214256

SN - 2047-9980

VL - 13

SP - e029051

JO - Journal of the American Heart Association

JF - Journal of the American Heart Association

IS - 2

M1 - e029051

ER -

Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk

Abstract

Bibliographical note

Keywords

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