Table 3.
Characteristics of randomized control trials of DCB for treatment of small vessel de novo coronary artery disease.
| Trial (year) | Patients, N | Design | DAPT duration (months) | Primary endpoint (follow-up, months) | Binary restenosis rate, % | TLR, % (follow-up, months) | ST, N (follow-up, months) |
|---|---|---|---|---|---|---|---|
| PICCOLETO (2010) (42) | 57 | DCB vs. DES | 1 in SAP and alone DCB use vs. 3 in DCB + stent implantation vs. 12 in UAP or DES | DS: 43.6 vs. 24.3%** (6) | 32.1 vs. 10.3%** | 32.1 vs. 10.3% (9) | 0 vs. 0 (9) |
| Bello (2012) (43) | 182 | DCB vs. PES | 1 in DCB only vs. 3 in DCB + BMS vs. 12 in PES | LLL: 0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm* (6) | 8.9 vs. 14.1% | 4.4 vs. 7.6% (6) 6.7 vs. 13% (36) | 0 vs. 0 (36) |
| Funatsu et al. (2017) (44) | 135 | DCB vs. POBA | 3 in both groups | TVF: 3.4 vs. 10.3% (6) | 13.3 vs. 42.5%* | 2.3 vs. 10.3% (6) | 0 vs. 0 (6) |
| BASKET-SMALL 2 (2018) (45) | 758 | DCB vs. nDES | 1 in SAP and DCB only vs. 6 in SAP and DES vs. 12 in ACS vs. 3 in DCB + BMS vs. 6 in DCB + DES | MACE: 7.3 vs. 7.5% (12) MACE: 15 vs. 15% (36) | NA | 3.4 vs. 4.5% (12) 9 vs. 9% (36) | 2 vs. 4 (13) 2 vs. 6 (36) |
| Angiographic analysis from the BASKET-SMALL 2 (2020) (46) | 111 | ditto | ditto | DS: 35.8 vs. 29.0%** (median 5.7) | 20.4 vs. 21.5% | NA | NA |
| Restore SVD China (2018) (47) | 230 | DCB vs. nDES | At least 6 in both groups | DS: 29.6 ± 2.0 vs. 24.1 ± 2.0% (9) | 11.0 vs. 8.6% | 4.4 vs. 2.6% (12) 5.2 vs. 2.8% (24) | 0 vs. 0 (24) |
| PICCOLETO II (2020) (48) | 232 | DCB vs. EES | 1 in SAP and DCB vs. 6 in EES vs. 12 in ACS | LLL: 0.04 ± 0.28 mm vs. 0.17 ± 0.39 mm** (6) | 6.3 vs. 6.5% | 5.6 vs. 5.6% (12) | 0 vs. 2 (12) |
DAPT, dual anti-platelet therapy; TLR, target lesion revascularization; ST, stent thrombosis including definite and possible; DCB, drug-coated balloon; DES, drug-eluting stent; SAP, stable angina pectoris; UAP, unstable angina pectoris; DS, diameter restenosis; PES, paclitaxel-eluting stent; BMS, bare-metal stent; POBA, plain old balloon angioplasty; TVF, target vessel failure; nDES, new-generation drug-eluting stent; ACS, acute coronary syndrome; MACE, major adverse cardiac events; EES, everolimus-eluting stent.
*
P < 0.01 vs. non-DCB group.
**
P < 0.05 vs. non-DCB group.