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

Table 1 Randomized controlled trials of first-generation drug eluting stents in stent thrombosis elevated myocardial infarction

Study, author (Ref.)	Year	Primary endpoint	Design	Randomized ratio	Maximal length of follow-up	Stent comparators (n)	Results of the primary endpoint
Pasceri et al[19]	2003	Death, MI, recurrent ischemia at 1 yr	Single center	1:1	1 yr	BMS/SES 65 (33/32)	No significant differences between stents
TYPHOON[4]	2006	TVF at 1 yr	Multicenter, superiority	1:1	4 yr	BMS/SES 712 (355/357)	SES superior to BMS
STRATEGY[20]	2007	Death, MI, stroke, binary restenosis at 8 mo	2-center, superiority	1:1	2 yr	BMS/SES 175 (87/88)	SES superior to BMS
SESAMI[21,22]	2007	Binary restenosis at 1 yr	Single-center, superiority	1:1	5 yr	BMS/SES 320 (160/160)	SES superior to BMS
Díaz de la Llera et al[23]	2007	Death, MI, TLR at 1 yr	Single center, superiority	1:1	1 yr	BMS/SES 114 (54/60)	SES superior to BMS
MISSION[24]	2008	In-segment late luminal loss at 9 mo	Single center, noninferiority	1:1	5 yr	BMS/SES 310 (152/158)	SES superior to BMS
MULTISTRATEGY[25]	2008	Death, MI, clinically driven TVR at 8 mo	Multicenter, superiority	1:1	3 yr	BMS/SES 744 (372/372)	SES superior to BMS
HAAMU-STENT[26]	2006	Death, MI, late lumen loss, TVR at 1 yr	Single center, superiority	1:1	1 yr	BMS/PES 164 (82/82)	PES superior to BMS
SELECTION[27]	2007	Neointimal proliferation by IVUS at 7 mo	Single-center, superiority	1:1	7 mo	BMS/PES 76 (39/37)	PES superior to BMS
PASSION[28]	2008	Cardiac death, MI, TLR at 2 yr	2-center, superiority	1:1	5 yr	BMS/PES 619 (310/309)	Superiority not demonstrated
HORIZONS-AMI[5,29]	2009	TLR Death, MI, stroke, or ST at 1 yr	Multicenter, superiority (TLR) Noninferiority (Death, MI, stroke, ST)	3:1	3 yr	BMS/PES 3006 (2257/749)	PES superior for TLR and noninferior for clinical endpoints
GRACIA-3[30]	2010	In-segment binary restenosis, myocardial flow at 1 yr	Multicenter, noninferiority	1:1	1 yr	BMS/PES 419 (210/209)	BMS noninferior to PES
PROSIT[31]	2008	Death, MI, TVR, ST at 1 yr	Multicenter, superiority	1:1	3 yr	PES/SES 308 (154/154)	Superiority not demonstrated
Juwana et al[32]	2009	Late lumen loss at 9 mo	Single center, superiority	1:1	1 yr	PES/SES 397 (196/201)	SES superior to PES
PASEO[33]	2009	TLR at 12 mo	Single-center, superiority	1:1:1	4 yr	BMS/PES/SES 270 (90/90/90)	PES and SES superior to BMS

MI: Myocardial infarction; TLR: Target lesion revascularization; ST: Stent thrombosis; PES: Paclitaxel-eluting stents; SES: Sirolimus-eluting stents; BMS: Bare metal stent stents; TVR: Target vessel revascularization; IVUS: Intravascular ultrasound.

Table 2 Randomized controlled trials of second-generation drug eluting stents in ST elevated myocardial infarction

Study	Year	Primary endpoint	Design	Randomized ratio	Maximal length of follow-up	Stent comparisons (n)	Results of the primary endpoint
ZEST-AMI[38]	2009	Death, MI, and ischemia-driven TVR at 1 yr	Multicenter, safety study	1:1:1	1 yr	PES/SES/PC-ZES 328 (110/110/108)	No significant differences between stents
KOMER[39]	2011	Cardiac death, MI, ischemia-driven TLR at 1 yr	Multicenter, safety study	1:1:1	18 mo	PES/SES/PC-ZES 611 (202/204/205)	PC-ZES as safe as SES and PES
EXAMINATION[40,41]	2011	Death, MI, any revascularization at 1 yr	Multicenter, superiority	1:1	2 yr	CoCr-EES/BMS 1504 (751/747)	CoCr-EES superior to BMS
XAMI[42]	2012	Cardiac death, MI, TVR at 1 yr	Multicenter, noninferiority	2:1	1 yr	EES/SES 625 (404/221)	EES noninferior to SES
COMFORTABLE AMI[43]	2012	cardiac death, reinfarction, and TLR at 1 yr	Multicenter, superiority	1:1	1 yr	EES/BMS 1161 (575/582)	BES superior to BMS

MI: Myocardial infarction; TLR: Target lesion revascularization; CoCr-EES: Cobalt-chromium everolimus-eluting stents; PC-ZES: Phosphorylcholine polymer based zotarolimus-eluting stent; PES: Paclitaxel-eluting stents; SES: Sirolimus-eluting stents; TVR: Target vessel revascularization; BMS: Bare metal stent stents.

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.