Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: The nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial

Freek Nijhoff; Pierfrancesco Agostoni; Anouar Belkacemi; Hendrik M.  Nathoe; Michiel Voskuil; Mariam Samim; Pieter A. Doevendans; Pieter R. Stella

doi:10.1002/ccd.26060

Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: The nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial

Freek Nijhoff, Pierfrancesco Agostoni, Anouar Belkacemi, Hendrik M. Nathoe, Michiel Voskuil, Mariam Samim, Pieter A. Doevendans, Pieter R. Stella^*

^*Corresponding author for this work

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

Abstract

ObjectiveTo evaluate a paclitaxel drug-eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and paclitaxel eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction (DEB-AMI) trial.

BackgroundDEB-only seems an attractive strategy in PPCI, as it obviates the risk of stent thrombosis.

MethodsThis study is a prospective registry with the same inclusion/exclusion criteria used in the DEB-AMI trial, as it constitutes the fourth, nonrandomized, treatment arm of this trial. Patients presenting with ST-elevation myocardial infarction were allocated to DEB-only (DIOR II, Eurocor GmbH, Bonn, Germany) after successful thrombus aspiration and predilatation. Primary endpoint was 6-month angiographic in-balloon/stent late-luminal loss (LLL). Secondary endpoints were in-balloon/stent binary restenosis and major adverse cardiac events (MACE: death, myocardial infarction, target-vessel revascularization).

ResultsForty patients underwent PPCI by DEB-only. Procedural success was achieved in 97.5% with bail-out stenting required in 10.0% of procedures. In DEB-only, LLL was 0.510.59 mm as compared to 0.74 +/- 0.57 mm in BMS (P=0.44), 0.64 +/- 0.56 mm in DEB+BMS (P=0.88) and 0.21 +/- 0.32 mm in PES (P

ConclusionsPPCI by DEB-only in selected patients yielded an angiographic outcome comparable to BMS alone and DEB followed by BMS. PES proved angiographic superiority to DEB-only. DEB-only is therefore a potential treatment alternative during PPCI in patients with contra-indications to drug-eluting stents. (c) 2015 Wiley Periodicals, Inc.

Original language	English
Pages (from-to)	S34-S44
Number of pages	11
Journal	Catheterization and Cardiovascular Interventions
Volume	86
DOIs	https://doi.org/10.1002/ccd.26060
Publication status	Published - 1 Oct 2015

Keywords

drug-coated balloon
acute coronary syndrome
STEMI
BARE-METAL STENTS
ARTERY-DISEASE
COATED BALLOON
FOLLOW-UP
RESTENOSIS
IMPLANTATION
MULTICENTER
OPTIMIZATION
OUTCOMES
PREVENTION

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10.1002/ccd.26060

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Nijhoff, F., Agostoni, P., Belkacemi, A., Nathoe, H. M., Voskuil, M., Samim, M., Doevendans, P. A., & Stella, P. R. (2015). Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: The nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial. Catheterization and Cardiovascular Interventions, 86, S34-S44. https://doi.org/10.1002/ccd.26060

@article{ed171adc989e44cdb9911f16c3d34e4f,

title = "Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: The nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial",

abstract = "ObjectiveTo evaluate a paclitaxel drug-eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and paclitaxel eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction (DEB-AMI) trial.BackgroundDEB-only seems an attractive strategy in PPCI, as it obviates the risk of stent thrombosis.MethodsThis study is a prospective registry with the same inclusion/exclusion criteria used in the DEB-AMI trial, as it constitutes the fourth, nonrandomized, treatment arm of this trial. Patients presenting with ST-elevation myocardial infarction were allocated to DEB-only (DIOR II, Eurocor GmbH, Bonn, Germany) after successful thrombus aspiration and predilatation. Primary endpoint was 6-month angiographic in-balloon/stent late-luminal loss (LLL). Secondary endpoints were in-balloon/stent binary restenosis and major adverse cardiac events (MACE: death, myocardial infarction, target-vessel revascularization).ResultsForty patients underwent PPCI by DEB-only. Procedural success was achieved in 97.5\% with bail-out stenting required in 10.0\% of procedures. In DEB-only, LLL was 0.510.59 mm as compared to 0.74 +/- 0.57 mm in BMS (P=0.44), 0.64 +/- 0.56 mm in DEB+BMS (P=0.88) and 0.21 +/- 0.32 mm in PES (PConclusionsPPCI by DEB-only in selected patients yielded an angiographic outcome comparable to BMS alone and DEB followed by BMS. PES proved angiographic superiority to DEB-only. DEB-only is therefore a potential treatment alternative during PPCI in patients with contra-indications to drug-eluting stents. (c) 2015 Wiley Periodicals, Inc.",

keywords = "drug-coated balloon, acute coronary syndrome, STEMI, BARE-METAL STENTS, ARTERY-DISEASE, COATED BALLOON, FOLLOW-UP, RESTENOSIS, IMPLANTATION, MULTICENTER, OPTIMIZATION, OUTCOMES, PREVENTION",

author = "Freek Nijhoff and Pierfrancesco Agostoni and Anouar Belkacemi and Nathoe, \{Hendrik M.\} and Michiel Voskuil and Mariam Samim and Doevendans, \{Pieter A.\} and Stella, \{Pieter R.\}",

year = "2015",

month = oct,

day = "1",

doi = "10.1002/ccd.26060",

language = "English",

volume = "86",

pages = "S34--S44",

journal = "Catheterization and Cardiovascular Interventions",

issn = "1522-1946",

publisher = "John Wiley \& Sons Inc.",

}

Nijhoff, F, Agostoni, P, Belkacemi, A, Nathoe, HM, Voskuil, M, Samim, M, Doevendans, PA & Stella, PR 2015, 'Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: The nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial', Catheterization and Cardiovascular Interventions, vol. 86, pp. S34-S44. https://doi.org/10.1002/ccd.26060

Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: The nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial. / Nijhoff, Freek; Agostoni, Pierfrancesco; Belkacemi, Anouar et al.
In: Catheterization and Cardiovascular Interventions, Vol. 86, 01.10.2015, p. S34-S44.

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

TY - JOUR

T1 - Primary percutaneous coronary intervention by drug-eluting balloon angioplasty

T2 - The nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial

AU - Nijhoff, Freek

AU - Agostoni, Pierfrancesco

AU - Belkacemi, Anouar

AU - Nathoe, Hendrik M.

AU - Voskuil, Michiel

AU - Samim, Mariam

AU - Doevendans, Pieter A.

AU - Stella, Pieter R.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - ObjectiveTo evaluate a paclitaxel drug-eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and paclitaxel eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction (DEB-AMI) trial.BackgroundDEB-only seems an attractive strategy in PPCI, as it obviates the risk of stent thrombosis.MethodsThis study is a prospective registry with the same inclusion/exclusion criteria used in the DEB-AMI trial, as it constitutes the fourth, nonrandomized, treatment arm of this trial. Patients presenting with ST-elevation myocardial infarction were allocated to DEB-only (DIOR II, Eurocor GmbH, Bonn, Germany) after successful thrombus aspiration and predilatation. Primary endpoint was 6-month angiographic in-balloon/stent late-luminal loss (LLL). Secondary endpoints were in-balloon/stent binary restenosis and major adverse cardiac events (MACE: death, myocardial infarction, target-vessel revascularization).ResultsForty patients underwent PPCI by DEB-only. Procedural success was achieved in 97.5% with bail-out stenting required in 10.0% of procedures. In DEB-only, LLL was 0.510.59 mm as compared to 0.74 +/- 0.57 mm in BMS (P=0.44), 0.64 +/- 0.56 mm in DEB+BMS (P=0.88) and 0.21 +/- 0.32 mm in PES (PConclusionsPPCI by DEB-only in selected patients yielded an angiographic outcome comparable to BMS alone and DEB followed by BMS. PES proved angiographic superiority to DEB-only. DEB-only is therefore a potential treatment alternative during PPCI in patients with contra-indications to drug-eluting stents. (c) 2015 Wiley Periodicals, Inc.

AB - ObjectiveTo evaluate a paclitaxel drug-eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and paclitaxel eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction (DEB-AMI) trial.BackgroundDEB-only seems an attractive strategy in PPCI, as it obviates the risk of stent thrombosis.MethodsThis study is a prospective registry with the same inclusion/exclusion criteria used in the DEB-AMI trial, as it constitutes the fourth, nonrandomized, treatment arm of this trial. Patients presenting with ST-elevation myocardial infarction were allocated to DEB-only (DIOR II, Eurocor GmbH, Bonn, Germany) after successful thrombus aspiration and predilatation. Primary endpoint was 6-month angiographic in-balloon/stent late-luminal loss (LLL). Secondary endpoints were in-balloon/stent binary restenosis and major adverse cardiac events (MACE: death, myocardial infarction, target-vessel revascularization).ResultsForty patients underwent PPCI by DEB-only. Procedural success was achieved in 97.5% with bail-out stenting required in 10.0% of procedures. In DEB-only, LLL was 0.510.59 mm as compared to 0.74 +/- 0.57 mm in BMS (P=0.44), 0.64 +/- 0.56 mm in DEB+BMS (P=0.88) and 0.21 +/- 0.32 mm in PES (PConclusionsPPCI by DEB-only in selected patients yielded an angiographic outcome comparable to BMS alone and DEB followed by BMS. PES proved angiographic superiority to DEB-only. DEB-only is therefore a potential treatment alternative during PPCI in patients with contra-indications to drug-eluting stents. (c) 2015 Wiley Periodicals, Inc.

KW - drug-coated balloon

KW - acute coronary syndrome

KW - STEMI

KW - BARE-METAL STENTS

KW - ARTERY-DISEASE

KW - COATED BALLOON

KW - FOLLOW-UP

KW - RESTENOSIS

KW - IMPLANTATION

KW - MULTICENTER

KW - OPTIMIZATION

KW - OUTCOMES

KW - PREVENTION

U2 - 10.1002/ccd.26060

DO - 10.1002/ccd.26060

M3 - Article

C2 - 26119971

SN - 1522-1946

VL - 86

SP - S34-S44

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

ER -

Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: The nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial

Abstract

Keywords

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