Drug-eluting stents and acute myocardial infarction: A lethal combination or friends?

Table 3 Current polymer-free stents undergoing clinical evaluation

Stent	Study	Platform	Drug	Primary endpoint	Design	Randomized ratio	Stent comparisons (n)	Result
Yukon (Translumina)	ISAR TEST[50]	316 L microporous surface	Sirolimus + Probucol	MACE/ST at 1yr	RCT	2:1	Yukon/R-ZES 3002 (2002/1000)	Noninferior
Cre 8 (CID)	NEXT[51]	CoCr abluminal reservoirs	Amphilimus	LL at 6 mo	RCT	1:1	Cre 8/PES 323 (162/161)	Superior
BioFreedom DCS (Biosensors)	BioFreedom FIM[52]	316 L microstructured surface	Biolimus A9	LL at 12 mo	RCT	1:1:1	Standard dose/low dose Biofreedom/PES 182 (60/62/60)	Noninferior
Vestasync (MIV therapeutics)	VESTASYNC Il[53]	316 L microporous nanofilm Hap	Sirolimus	LL at 4 and 9 mo	RCT	2:1	VESTAsync/BMS 75 (50/25)	Superior
Amazonia Pax (Minvasys)	Pax A and Pax B	CoCr nontextured	Paclitaxel	LL at 6 mo	RCT	1:1	PAXA/PES 30 (15/15), PAXB = 100	Noninferior
Yinyi (Liaoning Biomed.Mat)	FREEDOM[54]	316 L micropores	Paclitaxel	MACE/ST/TVR	RCT	2:1	Yinyi/SES 1626 (931/449)	Noninferior
Bicare+ (Lepu Medical)	BICARE[56]	316 L	Sirolimus + Probucol	TVF at 30 d	FIM	-	n = 32	TVF = 9.4%, LL 0.14, ISR = 3.2%
Pronova XR (Vascular Concepts)	EURONOVA XR l[55]	Co-Cr	Sirolimus	LL at 6 mo	FIM	-	n = 50	In-stent LL 0.45
Focus NP (Envision Scientific)	Nano active FIM	316 L nontextured	Sirolimus nanoparticles	LL at 6 mo	FIM	-	n = 100	Ongoing
Mitsu (Meril Medical)	-	CoCr ultrathin struts	Merilimus	-	-	-	Planned	-
Hollow-core DFS (Medtronic)	-	CoCr holes and hollow tube	Sirolimus	-	-	-	Planned	-
Nano+ (Lepu medical)	Nano+	Microporous	Sirolimus	OCT evaluation	FIM	-	n = 45	Ongoing

MACE: Major adverse cardiac events; ST: Stent thrombosis; RCT: Randomized control trial; LL: Late lumen loss; R-ZES: Resolute zotarolimus-eluting stents; PES: Paclitaxel-eluting stents; BMS: Bare metal stents; SES: Sirolimus-eluting stents; TVR: Target vessel revascularization; TVF: Target vessel failure; ISR: In-stent restenosis; OCT: Optical coherence tomography; FIM: First-in-man trial.