A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis

Results from the multi-center randomized controlled PATENT-C first in human trial

Bruno Scheller, Tobias Fontaine, Norman Mangner, Stefan Hoffmann, Klaus Bonaventura, Yvonne P. Clever, Daniel Chamie, Ribamar Costa, Gary Gershony, Bettina Kelsch, Maren Kutschera, Philippe Genereux, Bodo Cremers, Michael Böhm, Ulrich Speck, Alexandre Abizaid

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation. Methods and Results: SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug-coated SB group (P = 0.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% P = 0.004). Conclusions: A novel paclitaxel-coated coronary SB has been developed and successfully used in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533].

Original languageEnglish (US)
Pages (from-to)51-59
Number of pages9
JournalCatheterization and Cardiovascular Interventions
Volume88
Issue number1
DOIs
StatePublished - Jul 1 2016
Externally publishedYes

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Stents
Paclitaxel
Pharmaceutical Preparations
Coronary Restenosis
Therapeutics
Excipients
Coronary Angiography
Germany
Brazil
Angiography
Thrombosis
Research Design
Randomized Controlled Trials
Metals

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Scheller, Bruno ; Fontaine, Tobias ; Mangner, Norman ; Hoffmann, Stefan ; Bonaventura, Klaus ; Clever, Yvonne P. ; Chamie, Daniel ; Costa, Ribamar ; Gershony, Gary ; Kelsch, Bettina ; Kutschera, Maren ; Genereux, Philippe ; Cremers, Bodo ; Böhm, Michael ; Speck, Ulrich ; Abizaid, Alexandre. / A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis : Results from the multi-center randomized controlled PATENT-C first in human trial. In: Catheterization and Cardiovascular Interventions. 2016 ; Vol. 88, No. 1. pp. 51-59.
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title = "A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial",
abstract = "Background: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation. Methods and Results: SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72{\%}, and presence of diabetes 39{\%}. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41{\%} in the uncoated SB group versus 7{\%} in the drug-coated SB group (P = 0.004). The MACE rate was 32{\%} with the uncoated SB vs. 6{\%} in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3{\%} vs. 32{\%} P = 0.004). Conclusions: A novel paclitaxel-coated coronary SB has been developed and successfully used in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533].",
author = "Bruno Scheller and Tobias Fontaine and Norman Mangner and Stefan Hoffmann and Klaus Bonaventura and Clever, {Yvonne P.} and Daniel Chamie and Ribamar Costa and Gary Gershony and Bettina Kelsch and Maren Kutschera and Philippe Genereux and Bodo Cremers and Michael B{\"o}hm and Ulrich Speck and Alexandre Abizaid",
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Scheller, B, Fontaine, T, Mangner, N, Hoffmann, S, Bonaventura, K, Clever, YP, Chamie, D, Costa, R, Gershony, G, Kelsch, B, Kutschera, M, Genereux, P, Cremers, B, Böhm, M, Speck, U & Abizaid, A 2016, 'A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial', Catheterization and Cardiovascular Interventions, vol. 88, no. 1, pp. 51-59. https://doi.org/10.1002/ccd.26216

A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis : Results from the multi-center randomized controlled PATENT-C first in human trial. / Scheller, Bruno; Fontaine, Tobias; Mangner, Norman; Hoffmann, Stefan; Bonaventura, Klaus; Clever, Yvonne P.; Chamie, Daniel; Costa, Ribamar; Gershony, Gary; Kelsch, Bettina; Kutschera, Maren; Genereux, Philippe; Cremers, Bodo; Böhm, Michael; Speck, Ulrich; Abizaid, Alexandre.

In: Catheterization and Cardiovascular Interventions, Vol. 88, No. 1, 01.07.2016, p. 51-59.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis

T2 - Results from the multi-center randomized controlled PATENT-C first in human trial

AU - Scheller, Bruno

AU - Fontaine, Tobias

AU - Mangner, Norman

AU - Hoffmann, Stefan

AU - Bonaventura, Klaus

AU - Clever, Yvonne P.

AU - Chamie, Daniel

AU - Costa, Ribamar

AU - Gershony, Gary

AU - Kelsch, Bettina

AU - Kutschera, Maren

AU - Genereux, Philippe

AU - Cremers, Bodo

AU - Böhm, Michael

AU - Speck, Ulrich

AU - Abizaid, Alexandre

PY - 2016/7/1

Y1 - 2016/7/1

N2 - Background: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation. Methods and Results: SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug-coated SB group (P = 0.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% P = 0.004). Conclusions: A novel paclitaxel-coated coronary SB has been developed and successfully used in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533].

AB - Background: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation. Methods and Results: SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug-coated SB group (P = 0.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% P = 0.004). Conclusions: A novel paclitaxel-coated coronary SB has been developed and successfully used in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533].

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DO - 10.1002/ccd.26216

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SN - 1522-1946

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