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.