Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter.
BACKGROUND
We are presenting an extension of a previously published trial on the efficacy and safety of a paclitaxel-coated balloon in coronary ISR in a larger patient population and after a complete follow-up of 2 years.


METHODS
Hundred eight patients were enrolled in two separately randomized, double-blind multicenter trials on efficacy and safety using an identical protocol. Patients were treated by the paclitaxel-coated (3 microg/mm(2) balloon surface; Paccocath) or an uncoated balloon. The main inclusion criteria were a diameter stenosis of >or=70% and <30 mm length with a vessel diameter of 2.5-3.5 mm. The primary endpoint was angiographic late lumen loss in-segment. Secondary endpoints included binary restenosis rate and major adverse cardiovascular events (MACE).


RESULTS
Quantitative coronary angiography revealed no differences in baseline parameters. After six months in-segment late lumen loss was 0.81 +/- 0.79 mm in the uncoated balloon group vs. 0.11 +/- 0.45 mm (P < 0.001) in the drug-coated balloon group resulting in a binary restenosis rate of 25/49 vs. 3/47 (P < 0.001). Until 12 months post procedure 20 patients in the uncoated balloon group compared to two patients in the coated balloon group required target lesion revascularization (P = 0.001). Between 12 and 24 only two MACE were recorded, a stroke in the uncoated and a target lesion revascularization in the coated balloon group.


CONCLUSIONS
Treatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2 years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981).
Scheller
Bruno
B
Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg, Saar, Germany. bruno.scheller@uks.eu
Hehrlein
Christoph
C
Bocksch
Wolfgang
W
Rutsch
Wolfgang
W
Haghi
Dariush
D
Dietz
Ulrich
U
Böhm
Michael
M
Speck
Ulrich
U
D000368:Aged; D002404:Catheterization / Q000379:methods*; D023903:Coronary Restenosis / Q000188:drug therapy* / Q000209:etiology*; D004311:Double-Blind Method; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006083:Graft Occlusion, Vascular / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D015990:Placebo Effect; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage
D050257:Tubulin Modulators; D017239:Paclitaxel