Inhibition of neointimal proliferation after bare metal stent implantation with low-pressure drug delivery using a paclitaxel-coated balloon in porcine coronary arteries

Abstract

A variety of mechanical and laser-based methods remove or shift atherosclerotic plaques and reopen the artery to its original lumen. Subsequent treatment with drug-coated balloons (DCB) may smooth the vessel wall but does not require high-pressure inflation. We investigated the efficacy of paclitaxel-coated balloons inflated with only 2atm after bare metal stent implantation in coronary arteries of 24 pigs. Angiography and histomorphometry was performed on day 28. DCB inflated with 2atm caused similar reduction of late lumen loss (LLL) as high-pressure inflation with 12atm (0.89±0.58 vs. 0.72±0.39mm, p=0.34). Both DCB treatments significantly (p<0.01) reduced LLL versus uncoated balloons (1.50±0.51mm). Treatment with low-pressure DCB resulted in less maximal intimal thickness (0.45±0.15 vs. 0.67±0.25mm) and neointimal area (2.93±0.73 vs. 3.82±1.27mm(2)) than treatment with uncoated balloons (p<0.05). In conclusion, low-pressure treatment with DCB was similarly effective as high-pressure treatment justifying clinical trials in vessels which will benefit from inhibition of neointimal proliferation but may not tolerate high inflation pressure.