Author (Year) | Trial | ? vs ? | # of Pts | Clinical Indication | Results |
Dudda (2006) [55] | RCT SIRROCO | Smart vs DES (Smart) | n = 93 | Claudicants/long lesions | No difference |
Liistro (2013) [66] | DEBATE SFA RCT | DEB and BMS vs PTA and BMS | n = 104 | For restenosis Claud = 20.8% (11) vs 31.4% (16) CLI = 79.2% (42) vs 68.6% (35) | Freedom from binary restenosis better for DEB. Not significant for TLR or amp. |
Rosenfield (2015) [69] | RCT LEVANT2 | DEB vs PTA | n = 476 Randomized 2:1 | Claudicants | 12/12 primary patency 65.5% vs 52.6% p = 0.02 no significant difference for function, death/amp, thrombosis or re-intervention |
Tepe (2015) [86] | IN. PACT SFA | DEB vs PTA RCT | DEB = 220 PTA = 111 | DEB = 209/220 Rutherford 2, 3 PTA = 104/111 Rutherford 2, 3 | Freedom from Binary restenosis, TLR. DEB superior |
Dake (2016) [68] | RCT Zilver PTX | PTA + BMS vs DES, secondary bailout DES vs BMS | DES = 236 PTA = 238 | Claudicants | At 5 years DES better than PTA. Complicated randomization. Only 60% of patients available for f/u |
Kinstner (2016) [103] | RCT PACUBA | DEB vs PTA | n = 74 | Symptomatic in-stent restenosis | ABSPI no different at12/12, primary patency better for DEB, TLR or clinical improvement no different |
Muller-Hulsbeck et al. (2016) [104] & (2017) [105] | MAJESTIC | Cohort study Single arm, multicentre clinical trial | Eluvia stent n = 57 | Rutherford class 2, 3 & 4 | Primary patency at 24 months 83.5%. 36 months TLR 85.3%. |
Jongsma (2017) [106] | RCT FOREST | DEB and provisional stent vs DES | n = 254 | No results until 2019 | |
Bausback (2017) [107] | Ranger DEB | RCT DEB vs Standard PTA | DEB n = 71 SPTA n = 34 | All claudicants Rutherford class 2 - 4 | 6 months follow up only. Superior freedom from binary stenosis for DEB and primary patency. But only 56% and 66% of pts followed up by angiography. |
DeBoer (2017) [108] | RCT (RAPID) | DEB and Stent vs Standard balloon and Stent | N = 160 | Claudicants intermediate to long lesion Supera Stent | No difference between groups |
Schroeder (2017) [109] | RCT | PTA and stent, standard balloon vs DEB | DEB = 222 St Balloon = 72 | Claudicants | Superiority for DEB over Standard PTA |
Gray (2018) [110] | IMPERIAL | RCT Eluvia vs Zilver | Eluvia n = 309 Zilver PTX n = 156 | Non-inferiority trial. Rutherford class 2, 3 & 4. 12 months follow up | Claimed Eluvia equivalent to Zilver PTX. Primary patency TLR and adverse events. |