Table 2.
Summary of Clinical Trials of DCB on Treatment According to Clinical Characteristics
| Trial Name or First Author Design | Treatment | N | Angiographic Follow-up | Clinical Follow-up |
|---|---|---|---|---|
| High bleeding risk | ||||
| DEBUT83/RCT | DCB (Sequent Please) vs BMS (Integrity) | 102 vs 106 | - | MACE: 1% vs 14%; RR: 0.07; P < 0.00001 for noninferiority; P = 0.00034 for superiority at 9 mo |
| Shin et al84/RCT | DCB (Sequent Please) vs BMS (Vision) | 20 vs 20 | LLL: 0.2 ± 0.3 mm (DCB) vs 1.2 ± 0.8 mm (DES); P < 0.001; Restenosis: 0 (DCB) vs 25% (DES); P = 0.049; FFR: 0.87 ± 0.06 (DCB) vs 0.89 ± 0.06 (DES); P = 0.254 at 9 mo | TVR: 0 (DCB) vs 15% (BMS) at 12 mo |
| Diabetes mellitus | ||||
| DEAR89/Retrospective head-to-head comparison | DCB (DIOR) ± BMS vs BMS vs DES (Cypher, Taxus, Endeavor, Biodegradable Paclitaxel Eluting stent) | 92 vs 96 vs 129 | - | MACE: 13% (DCB) vs 32% (BMS); P = 0.003; 19% (DES); P = 0.29; TVF: 11% (DCB) vs 30% (BMS); P = 0.003; 19% (DES); P = 0.13 at 12 mo |
| BASKET-SMALL 290/RCT | DCB (Sequent Please) vs DES (Xience or Taxus Element) | 122 vs 130 | - | MACE: 19% (DCB) vs 22% (DES); HR: 0.82; P = 0.51; TVR: 9% (DCB) vs 15% (DES); HR: 0.40; P = 0.036 at 3 y |
| Her et al45/Registry-PS matched | DCB-based (Sequent Please) vs DES-only (2nd generation) | 104 vs 115 | MACE: 2.9% (DCB) vs 13.9% (DES), log-rank P = 0.003; Cardiac death: 0% (DCB) vs 3.5% (DES), log-rank P = 0.044 at 2 y | |
| Acute myocardial infarction | ||||
| REVELATION93/RCT | DCB (Pantera Lux) vs DES (Orsiro) | 60 vs 60 | FFR: 0.92 ± 0.05 (DCB) vs 0.91 ± 0.06 (DES); P = 0.27; LLL: 0.05 mm (DCB) vs 0.00 mm (DES); P = 0.51 at 9 mo | MACE: 3% (DCB) vs 2% (DES); P = 1.00 at 9 mo |
| PEPCAD NSTEMI94/RCT | DCB (Sequent Please and Sequent Please Neo) vs BMS or DES (new-generation limus-eluting) | 104 vs 106 | TLF: 4% (DCB) vs 7% (Stent); P = 0.53 at 9 mo | MACE: 7% (DCB) vs 14% (DES); P = 0.11 at 9 mo |
Abbreviations as in Table 1.