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. 2024 Feb 28;21(2):135–152. doi: 10.26599/1671-5411.2024.02.001

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)