Drug eluting stent vs drug coated balloon in primary PCI
Paclitaxel coated balloon angioplasty was compared with drug eluting stent in acute ST elevation myocardial Infarction (STEMI) in the REVELATION ( REVascularization with paclitaxEL-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarcTION) Trial . Drug coated balloons for angioplasty aims at reducing the potential disadvantages of stent implantation like stent thrombosis. It is thought improve the restenosis compared to plain old balloon angioplasty.
REVELATION was a single center prospective randomized trial in patients with STEMI. Those with a new culprit lesion in a native coronary artery without severe calcification and residual stenosis of less than 50% after predilatation were randomized to drug coated balloon or drug eluting stent strategies. Primary endpoint was fractional flow reserve (FFR) at 9 months. The study randomized 60 patients to each group. There was one abrupt vessel closure requiring treatment in the drug coated balloon group. One patient in either group needed non urgent target lesion revascularization within 9 months.
The study concluded that drug coated balloon was non inferior to drug eluting stent with respect to fractional flow reserve measured at 9 months. 18% of patients in the drug coated balloon group needed bailout stenting.