Description of Pantera Lux paclitaxel-releasing balloon and preliminary quantitative coronary angiography (QCA) results at six months in patients with coronary in-stent restenosis.
OBJECTIVE
Drug-eluting balloons (DEB) have recently emerged as a valuable treatment option for patients with coronary in-stent restenosis (ISR). However, little information exists on results of DEB therapy of in-stent restenosis from drug-eluting stents (DES).


RESULTS
The Pantera Lux balloon catheter, a novel DEB releasing paclitaxel with a BTHC matrix was studied in a prospective, multicentre first-in-man trial of patients with ISR either from bare metal stents (BMS) or drug-eluting stents (DES). Here we report on the clinical and angiographic follow-up of the first 45 Pantera Lux patients after six months. The mean age (± SD) of the studied ISR patients was 69 ± 9 years (82% males, 18% females). The distribution of BMS and DES in these patients was 53% and 47%, respectively. Success of deployment of the device was 100%. After six months, the major adverse cardiac event (MACE) rate was 7.7% including one post-procedural non-fatal myocardial infarction, one target lesion- and one target vessel- revascularisation (each clinically driven). Angiographic in-stent late lumen loss was 0.03 ± 0.35 mm (BMS: -0.08 ± 0.37 mm, DES: 0.15 ± 0.28 mm) as assessed by an independent angiographic core laboratory.


CONCLUSIONS
Treatment of coronary in-stent restenosis with the Pantera Lux paclitaxel-releasing balloon catheter shows very promising preliminary 6-month results, irrespective of whether the initially implanted stent was a bare metal- or a drug-eluting stent.
University Medical Center, Freiburg i.Br., Germany. christoph.hehrlein@uniklinik-freiburg.de
Christoph
C
Hehrlein
Gert
G
Richardt
Marcus
M
Wiemer
Henrik
H
Schneider
Christoph
C
Naber
Ellen
E
Hoffmann
Ulrich
U
Dietz
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D016503:Drug Delivery Systems / Q000295:instrumentation*; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D017239:Paclitaxel