Table 3

Summary of polymer-free DES

StentManufacturerPlatform materialStrut thickness (μm)Surface modificationDrug elutedDrug releaseCompleted clinical studyPrimary end pointOngoing study
Yukon Choice PFTransluminaSS87MicroporousSirolimus67% during 7 daysISAR-TEST (N=450)Non-inferiority for in-stent LLL at 6–8 M compared with TAXUS
0.48±0.61 vs 0.48±0.58 mm
ISAR-TEST 2 (N=1007)Non-inferiority for binary restenosis at 6–8 M compared with ZES and Cypher
11.0% vs 19.3%† vs 12.0%
ISAR-TEST 3 (N=605)Non-inferiority for in-stent LLL at 6–8 M compared with Cypher and BP-DES
0.47±0.56 vs 0.23±0.46 vs 0.17±0.45 mm
ISAR-TEST 5 (N=3002)Non-inferiority for TLF at 1 year compared with R-ZES
13.1% vs 13.1%
BioFreedomBiosensorsSS112MicroporousBiolimus A990% during 2 daysBIOFREEDOM-FIM (N=182)Non-inferiority for in-stent LLL at 4 M in SD and LD compared with PES
SD 0.08 vs LD 0.12 vs PES 0.37 mm
LEADERS FREE
(N=2456)
Multicentre, RCT of BioFreedom vs BMS
PE: 12 M CD/MI/ST
Cre8CIDCoCr80Abluminal reservoirsAmphilimus100% during 3 MNEXT (N=323)Superiority to in-stent LLL at 6 M compared with Taxus Liberté
0.14±0.36 vs 0.34±0.40 mm
PARTICIP8
(N=1000)
Single arm, all-comer registry of Cre8
PE: 6 M CD/TV-MI/ci-TLR
RESERVOIR
(N=112)
RCT of Cre8 vs Xience
PE: 9M NIH volume obstruction
ASSUR8
(N=1600)
RCT of Cre8 vs BMS
1 M DAPT
PE: 12 M death/non-fatal MI/TVR
Demonstr8 (N=38)Non-inferiority for %RUTTS score <30% at 3 M
RUTTS score <30%
99.78% vs 99.55%
Amazonia PaxMinvasysCoCr73Abluminal microdrop spray crystallisationPaclitaxel98% during 30 daysPAX-A (N=31)Comparison for in-stent LLL at 4 M compared with Taxus Liberté
0.77 vs 0.42 mm
PAX-B (N=103)Binary restenosis
at 9 M
19.7%
VESTAsyncMIV TherapeuticsCoCr65Nanoporous hydroxyapatiteSirolimus100% during 90 daysVESTASYNC I (SS platform) (N=15)In-stent LLL at 4 M
0.29±0.25 mm
VESTASYNC II (N=100)In-stent LLL at 8 M compared with BMS
0.39±0.20 vs 0.74±0.52 mm
  • BMS, bare metal stent; BP, biodegradable polymer; CD, cardiac death; ci-TLR, clinically indicated target lesion revascularisation; CoCr, cobalt chromium; DAPT, dual antiplatelet therapy; DES, drug eluting stent; FIM, first-in-men; LD, low dose; LLL, late lumen loss; M, months; NA, not available; NIH, neointimal hyperplasia; PE, primary end point; PES, paclitaxel eluting stent; RCT, randomised controlled trial; RUTTS, ratio of uncovered to total stent struts per cross section; R-ZES, Resolute zotarolimus eluting stent; SD, standard dose; SS, stainless steel; ST, stent thrombosis; TLR, target lesion revascularisation; TV-MI, target vessel myocardial infarction; ZES, zotarolimus eluting stent.