Table 4. Clinical studies on DCBs in the treatment of large coronary artery lesions.
| Authors/Studies (time) | Research design | Inclusion criteria | Rescue stenting |
Follow-up | Key results |
| DCB: drug-coated balloon; DES: drug-eluting stent; LLL: late lumen loss; MACE: major adverse cardiac events; TLF: target lesion failure; TLR: target lesion revascularization. | |||||
| Venetsanos, et al. (2018)[49] | DCB (221 lesions) | 2.51–3.00 mm (151 lesions) ≥ 3.00 mm (70 lesions) |
– | 12 months | 12-month TLR: 3% |
| Yu, et al. (2019)[60] | SeQuent Please (222 lesions) | > 2.8 mm | 1 case (0.5%) | 10 months on average |
10-month MACE: 0 10-month TLR: 0 |
| Lu, et al. (2019)[67] | SeQuent Please (92 cases) | > 2.75 mm | 6 cases (6.4%) | 9 months; 12 months |
9-month LLL: -0.02 ± 0.49 mm 12-month MACE: 4.3% 12-month TLR: 4.3% |
| Liu, et al. (2019)[61] | SeQuent Please (120 cases) | > 3.0 mm | 2 cases (1.6%) | 12 months | 12-month TLF: 3.4% |
| Rosenberg, et al. (2019)[63] | SeQuent Please (134 cases) | ≥ 2.75 | 7% | 9 months | 9-month MACE: 6.1% 9-month TLR: 1.0% |
| DEBUT (2019)[70] | SeQuent Please (102 cases)/Integrity bare stent (106 cases) | 2.5–4.0 mm | 3 cases (2%) | 9 months | 9-month MACE: 1% vs. 14% (Pnon-inferiority < 0.00001) |
| Yu, et al. (2022)[65] | SeQuent Please (85 cases)/New-generation DES of Resolute Integrity, Xience Xpedition, SYNERGY and Firehawk (85 cases) | 2.25–4.0 mm | 2 cases (2.4%) | 9 months; 12 months |
9-month LLL: −0.19 ± 0.49 mm vs. 0.03 ± 0.64 mm (P = 0.019) 9-month restenosis rate: 8.9% vs. 9.6% (P = 0.877) 12-month MACE: 2.4% vs. 6.3% (P = 0.226) |