ABSTRACT
INTRODUCTION: The paclitaxel-coated balloon catheter (DCB) based on the PACCOCATH(®) technology has yielded angiographic and clinical results superior to drug-eluting stents (DES) in situations like in-stent restenosis (ISR) and a trend towards superior results in small coronary vessels and side branches of coronary bifurcations. Using the DCB followed by cobalt-chromium stent (CoCr) deployment or with a reverse sequence may yield different outcomes in terms of late loss. METHODS: 97 patients with de-novo coronary stenosis (55.6 ± 10.7 years, 79.4% male, ≥70%, length: ≤25 mm, vessel diameter: 2.5-4.0 mm) were randomly treated with the DCB (3 µg/mm²) followed by a CoCr-stent or stent first and DCB later. Six-month angiographic and one-year clinical follow-up intention-to-treat analyses were performed. RESULTS: Angiographic and demographic baseline data was comparable between the two groups. When comparing balloon first versus stent first technique, the primary outcome variables were not statistically different for mean in-segment (0.51 ± 0.56 mm vs. 0.36 ± 0.55 mm, p = 0.23) and in-stent (0.52 ± 0.55 mm vs. 0.46 ± 0.52 mm, p = 0.65) late lumen loss. The lesion related 12-month MACE rates were 5/49 (10.2%) and 2/48 (4.2%) (p = 0.44). Lesion related thrombotic events occurred in three patients in balloon first and in one patient in stent first group, two of which were associated with early discontinuation of continuous dual anti-platelet therapy, two with suboptimal PCI, and one each were performed in a thrombotic lesion and a bifurcation type 1.1.0. CONCLUSION: Drug-coated balloon first followed by cobalt chromium stent deployment versus a reverse sequence is not associated with statistically significantly different 6-month angiographic or 12-month clinical outcomes.