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
Catheter Cardiovasc Interv
; 88(1): 51-59, 2016. ilus, tab, graf
Article
in En
| SES-SP, SESSP-IDPCPROD, SES-SP
| ID: biblio-1061852
Responsible library:
BR79.1
Localization: BR79.1
ABSTRACT
Scoring balloons produce excellent acute results in the treatment of instentrestenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown toaffect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developedand tested to overcome this limitation. Methods and Results:
SB were coatedwith paclitaxel admixed with a specific excipient. Patients at four clinical sites inGermany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized11 to treatment with either a drug-coated or uncoated SB. Baseline and 6-monthfollow-up quantitative coronary angiography was performed by an independent blindedcore lab and all patients will be evaluated clinically for up to one year. The primaryendpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite ofmajor adverse cardiovascular events (MACE), stent thrombosis and other variables.Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, insegmentLLL was 0.48 6 0.51 mm in the uncoated SB group versus 0.17 6 0.40 mm inthe drug-coated SB group (P 5 0.01; ITT analysis). The rate of binary restenosis was41% in the uncoated SB group versus 7% in the drug-coated SB group (P 5 0.004). TheMACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group(P 5 0.016). This difference was primarily due to the reduced need for clinically drivenTLR in the coated SB group (3% vs. 32% P 5 0.004).Conclusions:
A novel paclitaxelcoatedcoronary SB has been developed and successfully used in a first-in-human randomized controlled trial...
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Collection:
06-national
/
BR
Database:
SES-SP
/
SESSP-IDPCPROD
Main subject:
Coronary Disease
/
Diffusion of Innovation
Type of study:
Clinical_trials
/
Sysrev_observational_studies
Language:
En
Journal:
Catheter Cardiovasc Interv
Year:
2016
Document type:
Article