Table 1.
Summary of Clinical Trials of DCB on Treatment of De Novo Coronary Lesions
| Trial Name or First Author Design | Treatment | n | Angiographic Follow-up | Clinical Follow-up |
|---|---|---|---|---|
| Small vessel disease | ||||
| BASKET-SMALL 215/RCT | DCB (Sequent Please) vs DES (Xience or Taxus Element) | 382 vs 376 | - | MACE: 15% (DCB) vs 15% (DES), HR: 0.99; P = 0.95 at 3 y |
| PICCOLETO II57/RCT | DCB (Elutax SV) vs DES-E | 118 vs 114 | LLL: 0.04 mm (DCB) vs 0.17 mm (DES); P = 0.001 for noninferiority; P = 0.03 for superiority at 6 mo | MACE: 6% (DCB) vs 8% (DES); P = 0.55 at 12 mo |
| Large vessel disease | ||||
| Shin et al28/registry-observational | DCB (Sequent Please) vs BMS (Vision) or DES (Resolute Integrity or Xience Prime) | 45 vs 22 | LLL: 0.05 ± 0.27 mm (DCB) vs 0.40 ± 0.54 mm (Stent); P = 0.022; FFR: 0.85 ± 0.08 mm (DCB) vs 0.85 ± 0.05 mm (Stent); P = 0.973 at 9 mo | - |
| Her et al9/registry-observational | DCB (nonsmall) (Sequent Please) vs DCB (small) (Sequent Please) | 100 vs 127 | LLL: 0.03 ± 0.22 mm (nonsmall) vs 0.06 ± 0.25 mm (small); P = 0.384 at 6 mo | TVF: 7% (nonsmall) vs 8% (small); P = 0.596 at 6 mo |
| Gitto et al64/registry-PS matched | DCB-based (Magic Touch or Selution or IN.PACT Falcon or RESTORE) vs DES (contemporary) | 147 vs 701 | TLF: 4.1% (DCB-based) vs 9.8% (DES); P = 0.148 at 2 y | |
| Lin et al65/meta-analysis | DCB vs DES | 152 vs 169 | LLL: SMD: −0.07; P = 0.548 at 6-9 mo | TLR: RR: 1.17; P = 0.746 at 6-9 mo |
| REC-CAGEFREE I66/RCT | DCB (Swide) vs DES-S | 1,133 vs 1,139 | DoCE: 6.4% (DCB) vs 3.4% (DES); P = 0.0008 at 2 y | |
| Bifurcation disease | ||||
| PEPCAD-BIF68/RCT | DCB (Sequent Please) vs POBA in SB | 32 vs 32 | Restenosis: 6% (DCB) vs 26% (POBA); P = 0.045; LLL: 0.13 mm (DCB) vs 0.51 mm (POBA); P = 0.013 at 9 mo | TLR: n = 1 (DCB) vs n = 3 (POBA) |
| DCB-BIF70/RCT | DCB (Paclitaxel-coated balloon) vs POBA (NCB) in SB | 391 vs 393 | MACE: 7.2% (DCB) vs 12.5% (POBA); P = 0.013 at 1 y | |
| Her et al/registry-observational71 | DCB (only MV) (Sequent Please) | 16 MBs/32 SBs | SB os lumen area: 0.92 ± 0.68 mm2 (pre) vs 1.03 ± 0.77 mm2 (post) vs 1.42 ± 1.18 mm2 (at 9 mo) | - |
| Pan et al72/registry-PS matched | DCB (Sequent Please) + DES vs DES-only (new-generation) | 199 vs 398 | LLL: 0.13 ± 0.42 mm (DCB) vs 0.42 ± 0.62 mm (DES); P < 0.001 at 1 y | TLF: 7.56% (DCB) vs 14.36% (DES), log-rank P = 0.024 at 2 y; TLR: 2.91% (DCB) vs 9.42% (DES); P = 0.007 |
| Chronic total occlusion lesion | ||||
| PEPCAD-CTO77/registry-variable matching | DCB (Sequent Please) + BMS (Coroflex Blue) vs DES-P | 48 vs 48 | LLL: 0.64 ± 0.69 mm (DCB) vs 0.43 ± 0.64 mm (DES); P = 0.14; Restenosis: 28% (DCB) vs 21% (DES); P = 0.44 at 6 mo | MACE: 15% (DCB) vs 19% (DES); P = 0.58 at 12 mo |
| Shin et al79/registry-PS matched | DCB-based (Sequent Please) vs DES-only (2nd generation) | 200 vs 661 | MACE: 3.1% (DCB) vs 13.2% (DES); P = 0.001 at 2 y | |
| Diffuse long and multivessel disease | ||||
| Costopoulos et al80/registry-variable matching | DCB (IN.PACT Falcon + Pantera Lux) ± DES vs DES (2nd generation) | 93 vs 93 | - | MACE: 21% (DCB) vs 23% (DES); P = 0.74; TVR: 15% (DCB) vs 12% (DES); P = 0.44; TLR: 10% (DCB) vs 9% (DES); P = 0.84 at 2 y |
| Yang et al81/registry-observational | DCB (Sequent Please) ± DES (new-generation) vs DES (new-generation) | 360 vs 831 | LLL: 0.06 ± 0.61 mm (DCB) vs 0.41 ± 0.64 mm (DES); P < 0.001; MLD: 1.74 ± 0.59 mm (DCB) vs 1.94 ± 0.65 mm (DES); P = 0.002 at 9-12 mo | TLR: 7% (DCB) vs 8% (DES), log-rank P = 0.636; MACE: 11% (DCB) vs 14% (DES), log-rank P = 0.324; Thrombosis: 0 (DCB) vs 1% (DCB), log-rank P = 0.193 at 3 y |
| Shin et al44/registry-PS matched | DCB-based (Sequent Please) vs DES (2nd generation) | 254 vs 254 | - | MACE: 4% (DCB) vs 11% (DES); P = 0.002 at 2 y |
BMS = bare-metal stent; DCB = drug-coated balloon; DES = drug-eluting stent; DES-E = everolimus drug-eluting stent; DES-P = paclitaxel drug-eluting stents; DES-S = sirolimus drug-eluting stent; DoCE = device-oriented composite endpoint; FFR = fractional flow reserve; LLL = late lumen loss; MACE = major adverse cardiac events; MLD = minimal lumen diameter; MV = main vessel; NCB = noncompliant balloon; POBA = plain old balloon angioplasty; PS = propensity score; RCT = randomized controlled trial; SB = side-branch; SMD = standard mean deviation; TLF = target lesion failure; TLR = target lesion revascularization; TVF = target vessel failure; TVR = target vessel revascularization.