For entry, target lesions had to have a stenosis of at least 70% by visual estimation or at least 50% by quantitative coronary angiography. Lesion length was limited to less than 25 mm, and severely calcified lesions were excluded.
The primary endpoint was a composite major adverse coronary event (MACE) endpoint of cardiac death, myocardial infarction, or revascularization at 12 months of follow-up. Crossovers by discretion of the interventional team were permitted.
At 12 months, MACE had occurred in 4.4% of those in the DCB group and 11.1% of those in the DES group. All primary endpoint events in both groups involved revascularizations. The two events in the DCB group were clinically driven target vessel revascularizations. Only one of the five events in the DES group was a clinically driven target lesion revascularization; the remaining four were revascularizations performed for nontarget vessels.
Four patients (8%) in the DCB group crossed over, each because of a dissection and managed with a bare-metal stent. There were four other dissections in the DCB group; one type F dissection resulted in a bailout and three dissections were managed conservatively. There were no crossovers in the DES group, and of the two dissections in the group, both were managed with the originally assigned stenting strategy.