Table 3.
Peripheral atherectomy studies (randomized controlled and registries)
| Study | Design | Treatment | Patients and lesions | Bailout stent | Immediate outcomes | Clinical outcomes |
|---|---|---|---|---|---|---|
| Shammas et al. [13]. | RCT | SilverHawk versus angioplasty | 46 IC and 12 CLI femoropopliteal | 27.6 versus 62.1% (p = 0.017) | Embolization: 64.7 versus 0.0% (p < 0.001) | 1-year TLR: 11.1 versus 16.7% |
| DEFINITIVE LE [19] | Multicenter registry | SilverHawk | 598 IC 201 CLI 655 femoropopliteal 145 infrapopliteal |
3.2% | Embolization: 3.8% Perforation: 5.3% |
1-year patency: 78% Amputation: 5% |
| DEFINITIVE-CA [22] | Multicenter registry | SilverHawk under filter protection | 133 patients 168 calcified femoropopliteal |
<50% residual stenosis in 92% cases | 30-day MAE: 6.9% | N/A |
| DEFINITIVE AR | RCT | Hawk + DCB versus DCB alone | 102 femoropopliteal | Dissection: 2 versus 19% | N/A | 1-year patency: 82.4 versus 71.8% |
| TALON [18] | Multicenter registry | SilverHawk | 601 IC + CLI (748 limbs) Femoropopliteal and infrapopliteal | 6.3% | Success 97.6% | 1-year TLR: 20% |
| Zeller et al. [23] | Registry | SilverHawk | 84 patients IC + CLI (100 limbs) |
N/A | Success 100% | 1-year patency: 84% de novo 54% restenotic |
| VISION-IDE | Registry | OCT-guided Pantheris | 130 patients 130 lesions |
4.0% stenting | N/A | N/A |
| OASIS [27] | Multicenter registry | Orbital atherectomy | 124 patients 201 stenoses Infrapopliteal |
2.5% stenting | 30-day MAE: 3.2% | 6-month improvement 78.2% |
| COMPLIANCE 360 [15] | RCT | Orbital versus angioplasty | 50 patients 65 lesions Femoropopliteal |
5.3 versus 77.8% (p < 0.0001) | N/A | 1-year TLR: 18.8 versus 21.7% (p = 0.99) |
| CALCIUM 360 [14] | RCT | Orbital versus angioplasty | 50 CLI Infrapopliteal vessels |
6.9 versus 14.3% (p = 0.44) | Success: 93.1 versus 82.4% (p = 0.27) | 1-year TVR: 93.3 versus 80.0% (p = 0.14) |
| PATHWAY [24] | Multicenter registry | Pathway (Jetstream) |
172 IC + CLI Femoropopliteal and Infrapopliteal |
7% | Success: 99% 30-day MAE: 1% |
1-year TLR: 26% Patency: 61.8% |
| EXCITE-ISR [16] | RCT | Excimer laser versus angioplasty | 250 IC + CLI In-stent restenosis |
4.1% | 30-day MAE: 5.8 versus 20.5% (p < 0.0001) | 6-month TLR: 26.5 versus 48.2% (p < 0.005) |
| LACI [28] | Multicenter registry | Excimer laser | 145 patients 155 limbs Femoropopliteal and infrapopliteal |
45% | Success 86% (<50% residual stenosis) |
6-month limb salvage: 93% |
| CELLO [31] | Multicenter registry | Excimer laser | 65 IC patients Femoropopliteal |
23.3% | N/A | 1-year Patency: 54% TLR: 23.1% |