Table 3. Randomized control trials of DCBs in treating primary small vessel diseases of the coronary artery.
| Authors/Studies (time) | Research design | Follow-up | Key results |
| DCB: drug-coated balloon; LLL: late lumen loss; MACE: major adverse cardiac events; MLD: minimum lumen diameter; SVD: small vessel disease; TLF: target lesion failure; TLR: target lesion revascularization. | |||
| PICCOLETO (2010)[51] | Dior I drug balloon (28 cases)/Taxus stents (29 cases) | 6 months; 9 months | 6-month MLD: 1.11 ± 0.65 mm vs. 1.94 ± 0.72 mm (P = 0.0002) 9-month MACE: 35.7% vs. 13.8% (P = 0.054) 9-month TLR: 32.1% vs. 10.3% (P = 0.15) |
| BELLO (2015)[47,48] | IN.PACT Falcondrug balloon (90 cases)/Taxusstent (92 cases) | 6 months; 12 months; 3 years |
6-month TLR: 4.4% vs. 7.6% (P = 0.37) 6-month LLL: 0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm (P = 0.001) 12-month MACE: 10% vs. 16.3% (P = 0.21) 3-year MACE: 14.4% vs. 30.4% (P = 0.015) |
| RESTORE SVD (2018)[46] | RESTORE drug balloon (116 cases)/Resolute Integrity stent (114 cases) | 9–12 months | 9–12-month LLL: 0.26 ± 0.42 mm vs. 0.30 ± 0.35 mm (P = 0.41) 12-month TLR: 4.4% vs. 2.6% (P = 0.72) |
| BASKET-SMALL 2 (2020)[43] | SeQuent Please drug balloon (382 cases)/TAXUS and Xience stents (376 cases) | 36 months | 6-month LLL: 0.13 (-0.14 to 0.57) mm vs. 0.10 (-0.16 to 0.34) mm (P = 0.72) 36-month MACE: 15% vs. 15% (P = 0.95) 36-month target vessel revascularization: 9% vs. 9% (P = 0.83) |
| PICCOLETO II (2020)[45] | Elutax SV (118 cases)/Xience EES (114 cases) | 6 months | 6-month LLL: 0.04 mm vs. 0.17 mm (Pnon-inferiority = 0.001, Psuperiority = 0.03) 12-month MACE: 5.6% vs. 7.5% (P = 0.55) |
| BIO-RISE CHINA (2021)[40] | Biolimus drug balloon (106 cases)/POBA (103 cases) | 9 months | 9-month LLL: 0.16 ± 0.29 mm vs. 0.30 ± 0.35 mm (P = 0.001) |
| PEPCAD China SVD (2023)[39] | SeQuent Please drug balloon (181 cases)/POBA (89 cases) | 9 months; 12 months | 9-month LLL: 0.10 ± 0.33 mm vs. 0.25 ± 0.38 mm (P = 0.0027), Psuperiority = 0.0068 12-month MACE: 13.8% vs. 19.5% (P = 0.234) 12-month TLF: 5.0% vs. 9.2% (P = 0.196) Cardiac death caused by myocardial infarction in 12 months: 0 vs. 0 |