97 patients with de-novo coronary stenosis (55.6聽卤聽10.7 years, 79.4% male, 鈮?0%, length: 鈮?5聽mm, vessel diameter: 2.5-4.0聽mm) were randomly treated with the DCB (3聽渭g/mm虏) 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.
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聽卤聽0.56聽mm vs. 0.36聽卤聽0.55聽mm, p聽=聽0.23) and in-stent (0.52聽卤聽0.55聽mm vs. 0.46聽卤聽0.52聽mm, p聽=聽0.65) late lumen loss. The lesion related 12-month MACE rates were 5/49 (10.2%) and 2/48 (4.2%) (p聽=聽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.
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.