Figure 2.

Late lumen loss and follow-up lumen diameter and its implications in clinical trials. The figure illustrates the angiographic changes after treatments with a drug-coated balloon or a metallic stent. Post stenting, there is a predetermined diameter of the metallic cage, implanted with only the biological option to develop intra-stent neointima with reduction of the lumen. However, in the absence of endoluminal prosthesis, late enlargement is feasible and will be accounted for by assessing the net gain (or acute gain + negative late loss). Therefore, net gain is suitable as a surrogate endpoint in DCB studies. DCB, drug-coated balloon; LLL, late lumen loss [Reproduced from Ono et al. (28)].