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.
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.


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]. © 2015 Wiley Periodicals, Inc.
Universitätsklinikum des Saarlandes, Homburg, Saar, Germany.
Bruno
B
Scheller
Universitätsklinikum des Saarlandes, Homburg, Saar, Germany.
Tobias
T
Fontaine
Herzzentrum Leipzig, Germany.
Norman
N
Mangner
Werner Forßmann Krankenhaus, Eberswalde, Germany.
Stefan
S
Hoffmann
Ernst Von Bergmann Klinikum, Potsdam, Germany.
Klaus
K
Bonaventura
Universitätsklinikum des Saarlandes, Homburg, Saar, Germany.
Yvonne P
YP
Clever
Instituto Dante Pazzanese De Cardiologia, Sao Paulo, Brazil.
Daniel
D
Chamie
Instituto Dante Pazzanese De Cardiologia, Sao Paulo, Brazil.
Ribamar
R
Costa
John Muir Cardiovascular Institute, Concord, California.
Gary
G
Gershony
Experimentelle Radiologie, Charite, Berlin, Germany.
Bettina
B
Kelsch
Experimentelle Radiologie, Charite, Berlin, Germany.
Maren
M
Kutschera
Columbia University and Cardiovascular Research Foundation, New York, New York.
Philippe
P
Généreux
Universitätsklinikum des Saarlandes, Homburg, Saar, Germany.
Bodo
B
Cremers
Universitätsklinikum des Saarlandes, Homburg, Saar, Germany.
Michael
M
Böhm
Experimentelle Radiologie, Charite, Berlin, Germany.
Ulrich
U
Speck
Instituto Dante Pazzanese De Cardiologia, Sao Paulo, Brazil.
Alexandre
A
Abizaid
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D001938:Brazil; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D019233:Retreatment; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D017239:Paclitaxel
balloon; drug coated/eluting; interventional devices/innovation; stent restenosis