Influence of a paclitaxel coated balloon in combination with a bare metal stent on restenosis and endothelial function: Comparison with a drug eluting stent and a bare metal stent. Issue 2 (30th September 2013)

• Record Type: Journal Article
• Authors: Clever, Yvonne P.; Cremers, Bodo; Speck, Ulrich; Dietz, Ulrich; Böhm, Michael; Scheller, Bruno
• Is Part Of: Catheterization and cardiovascular interventions. Volume 84:Issue 2(2014:Aug. 01)
• Page Start: 323
• Page End: 331
• Publication Date: 2013-09-30
• Subjects: Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.25184
• Languages: English
• ISSNs: 1522-1946

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="ccd25184-sec-0001" sec-type="section"> <title>Aims</title> <p>Different approaches of local intravascular drug delivery may influence endothelial and microvascular function. The aim of this trial was to study the influence of a paclitaxel coated balloon in combination with a bare metal stent (DCB + BMS) versus a bare metal stent (BMS) or a sirolimus‐eluting stent (DES) on coronary restenosis and endothelial function.</p> </sec> <sec id="ccd25184-sec-0002" sec-type="section"> <title>Methods and Results</title> <p>This prospective trial included 77 patients with coronary <italic>de novo</italic> lesions. The patients were assigned to either one of the treatment groups. After 9 months, patients underwent angiographic follow‐up including invasive measurement of coronary endothelial function. After 9 months, late lumen loss in‐stent was highest in the BMS group (0.85 ± 0.73 mm), lower in DCB + BMS (0.36 ± 0.46 mm); and lowest in the DES group (0.25 ± 0.34 mm; <italic>P</italic> = 0.001 [ANOVA]). When compared to the BMS group, in‐segment late lumen loss was significantly reduced in the DCB + BMS group (0.27 ± 0.43 mm vs. 0.60 ± 0.55 mm, <italic>P</italic> = 0.029) and the DES group (0.28 ± 0.40 mm, <italic>P</italic> = 0.045). Coronary flow reserve was significantly higher with the DCB + BMS treatment (3.16 ± 0.97 vs. 2.42 ± 0.99 [BMS], <italic>P</italic> = 0.036) whereas the increase in the DES group did not reach the significance level (3.06 ± 1.39, <italic>P</italic> = 0.144 vs. BMS). Parameters of endothelial function like intracoronary flow velocity and vessel diameter distal to the stented area showed similar patterns of response to adenosine, acetylcholine, and nitro in all groups.</p> </sec> <sec id="ccd25184-sec-0003" sec-type="section"> <title>Conclusion</title> <p>DES and the combination of DCB + BMS showed a significant reduction of late lumen loss as compared to a BMS alone. Furthermore, both types of local drug delivery were not associated with a deterioration of microvascular function at 9 months [<ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link> Identifier: NCT00473499]. © 2013 Wiley Periodicals, Inc.</p> </sec> </abstract>