Table 4. Summary of the most important studies investigating DCB for BMS/DES restenosis treatment.
| Trial (year) | Treatment and No. of patients | Type of device | ISR type | End point | Follow-up | Most important results | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| DCB | DES | BA | DCB | DES | Angiography | Clinical | |||||
| PACCOCATH ISR I [2006] | 26 | – | 26 | PACCOCATH technology | – | In-BMS | LLL; rate of restenosis, MACE, TLR | Post proc., 6 and 12 months | 6 and 12 months | LLL at 6 months 0.74±0.86 mm in BA vs. 0.03±0.48 mm in DCB (P<0.002); restenosis at 6 months 43% in BA vs. 5% in DCB (P<0.002); MACE at 12 months 31% in BA vs. 4% in DCB due to > TLR in BA group |
|
| PACCOCATH ISR II [2008] | 54 (26 from ISR-I) | – | 54 (26 from ISR-I) | PACCOCATH technology | – | In-BMS and in-DES | LLL; rate of restenosis, MACE, TLR, acute and subacute stent thrombosis | Post proc., 6 months | 12 and 24 months | LLL at 6 months 0.81±0.79 in BA vs. 0.11±0.45 mm in DCB (P<0.001); binary restenosis at 6 months 25/49 in BA vs. 3/47 in DCB (P<0.001); TLR at 12 months 20 patients in BA vs. 2 in DCB; MACE at 24 months 1 vs. 1 |
|
| Long-term clinical FU for PACCOCATH ISR I and II [2012] | 54 | – | 54 | PACCOCATH technology | – | In-BMS and in-DES | – | – | 5.4±1.2 years | MACE 59.3% in BA vs. 27.8% in DCB (P=0.009); TLR 38.9% in BA vs. 9.3% in DCB (P=0.004) |
|
| PEPCAD II [2009] | 66 | 65 | – | SequentPlease | Taxus Libertè | In-BMS | LLL; rate of restenosis, MACE, TLR, stent thrombosis | Post proc., 6 months | 12 months | LLL at 6 months was 0.38±0.61 mm in DES vs. 0.17±0.42 mm in DCB (P=0.03); binary restenosis at 6 months 20% in DES vs. 7% in DCB; MACE at 12 months 22 in DES vs. 9% in DCB (P=0.08) TLR 15 in DES vs. 6% in DCB (P=0.15) |
|
| PEPCAD-DES [2012] | 72 | – | 38 | SequentPlease | – | In-DES | LLL; rate of restenosis, MACE, TLR | Post proc., 6 months | 6 months | LLL at 6 months 0.43±0.61 mm in DCB vs. 1.03±0.77 mm in BA (P<0.001); binary restenosis 17.2% in DCB vs. 58.1% in BA (P<0.001); MACE 16.7% in DCB vs. 50% in BA (P<0.001) |
|
| Habara et al. [2011] | 25 | − | 25 | SequentPlease | – | In-DES | LLL; rate of restenosis, MACE free survival, TLR | Post proc., 6 months | 6 months | LLL at 6 months 0.18±0.45 mm in DCB vs. 0.72±0.55 mm in BA (P<0.001); binary restenos vs. is 8.7% in DCB vs. 62.5% in BA (P<0.001); TLR 4.3% in DCB vs. 41.7% in BA (P=0.003); MACE free survival 96% in DCB vs. 60% in BA (P=0.005) |
|
| Habara et al. [2013] | 137 | – | 71 | SequentPlease | – | In-DES and in-BMS | LLL; rate of restenosis, MACE, TLR, target vessel failure, stent thrombosis | Post proc., 6 months | 1, 3, and 6 months | LLL at 6 months 0.11±0.33 mm in DCB vs. 0.49±0.50 mm in BA (P<0.001); target vessel failure 6.6% in DCB vs. 31% in BA (P<0.001); recurrent restenosis 4.3% in DCB vs. 31.9% in BA (P<0.001); recurrent restenosis in PCB-treated lesions 1.1% in BMS-ISR vs. 9.1% in DES-ISR (P=0.04); LLL 0.05±0.28 mm in BMS-ISR vs. 0.18±0.38 mm in DES-ISR (P=0.03); MACE 6.6% in DCB vs. 31% in BA (P<0.001) |
|
| ISAR-DESIRE 3 [2013] | 137 | 131 | 134 | SequentPlease | Taxus Libertè | In-DES | Diameter stenosis with intention-to-treat analyses; minimum lumen diameter, binary restenosis, TLR, MACE, target lesion thrombosis | Post proc., 6–8 months | 12 months | Diameter stenosis at 6 months 39 pts in DCB, 34 in PES, 72 in BA with non-inferiority of DCB to DES (P=0.007); PCB and PES superior to BA (P=0.001); TLR at 12 months 22.1% in DCB vs. 13.5% in PES vs. 43.5% in BA, with PCB and PES superior to BA (both P=0.001); death or MI at 12 months no differences between the three groups |
|
| ISAR-DESIRE 3 3 years FU [2015] | 137 | 131 | 134 | SequentPlease | Taxus Libertè | In-DES | TLR; death or MI | – | 3 years (median) | TLR 0–3 years 33.3% in PCB vs. 24.2% in DES vs. 50.8% in BA, with PCB non inferior to PES (P=0.11) and PCB superior to BA (P<0.001); death or MI 0–3 years 10.4% in PCB vs. 18.3% in PES vs. 10.9% in BA, with lower risk of PCB to PES due to a lower risk of death (P=0.02) and no difference with PCB vs. BA |
|
| PEPCAD China [2014] | 109 | 106 | − | SequentPlease | Taxus Libertè | In-DES | LLL; acute success, diameter stenosis, binary restenosis, target lesion failure (MACE due to lesion failure) | Post proc. and 9 months | 1, 6, 9 and 12 months | LLL at 9 months 0.46±0.51 mm in PCB vs. 0.55± 0.61 mm in PES (P for non-inferiority =0.0005); binary restenosis at 9 months 18.6% in PCB vs. 23.8% in PES (P=0.39); 12 months TLR, TLF, death and MI rates not significantly different between two groups |
|
| RIBS V [2014] | 95 | 94 | − | SequentPlease | Xience Prime (2 generation everolimus-ES) | In-BMS | minimal lumen diameter; LLL, diameter stenosis, binary restenosis, MACE, TVR | Post proc., 6 and 9 months | 12 months | Minimal lumen diameter at 9 months 2.36±0.6 mm in EES vs. 2.01±0.6 mm in PCB (P<0.001); diameter stenosis 13%±17% in EES vs. 25%±20% in PCB (P<0.001); LLL at 9 months 0.04±0.5 mm in EES vs. 0.14±0.5 mm in PCB (P=0.14); binary restenosis rate at 9 months 4.7% in EES vs. 9.5% in PCB (P=0.22); MACE + TVR or need for TVR at 12 months not significantly different between two groups |
|
DCB, drug-coated balloons; BMS, bare metal stent; DES, drug-eluting stent; ISR, in-stent restenosis; LLL, late lumen loss; TLR, target lesion revascularization.