Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study.

AIMS: Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented. METHODS AND RESULTS: One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.5-3.5 mm) were randomly treated with the paclitaxel-coated balloon (DCB) (3 µg/mm²) or a paclitaxel-eluting stent (DES). Clinical follow-up information was requested from the patients and from their physicians. Quantitative angiographic and demographic baseline data were statistically not different between the groups. Per intention-to-treat analysis at 12 months, the lesion-related rates of major adverse cardiac events were 7.6% and 16.9% (p=0.11) while at 36 months the respective numbers were 9.1% and 18.5% (p=0.14). These differences were primarily due to reduced target lesion revascularisation (TLR) in DCB 4/66 (6.2%) compared to DES patients 10/65 (15.4%) (p=0.10). From 12 to 36 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period. CONCLUSIONS: The six-month superiority of the paclitaxel-coated balloon compared to the paclitaxel-eluting stent in the treatment of bare metal coronary in-stent restenosis persisted throughout the three-year clinical follow-up period indicating stability of the lesions treated. (ClinicalTrials.gov Identifier: NCT00393315).

Peptide-treated stent graft for the treatment of saphenous vein graft lesions: first clinical results.

UNLABELLED: Percutaneous interventions of degenerated saphenous vein grafts (SVG) are associated with high rates of distal embolic events and in-stent restenosis. A novel ePTFE-covered stent graft has been developed to improve outcomes for these difficult lesions. The stent graft has been treated with a 15-amino acid, cell adhesion peptide (P-15) to promote endothelialization on the inner surface post-implantation. Patients with de novo lesions in SVGs were treated with a peptide-coated ePTFE stent graft. Follow-up data was collected at 30 days, 3 and 6 months. An angiographic core lab analyzed an angiographic follow-up at 6 months. RESULTS: Procedural success was achieved in all cases. No device-related major adverse cardiac events occurred in-hospital, at 30 days, or at 3 months, despite the lack of distal protection. Six-month restenosis rates were 21%, and were comparable to similar devices. CONCLUSIONS: The peptide-treated stent graft appears to be a safe and effective treatment for SVG lesions, and has the potential to reduce complications without the use of adjunct distal protection in this patient population.