Five-year clinical follow-up from the MISSION! Intervention Study: sirolimus-eluting stent versus bare metal stent implantation in patients with ST-segment elevation myocardial infarction, a randomised controlled trial.
OBJECTIVE
To evaluate the clinical outcomes of sirolimus-eluting stent (SES) versus bare metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) at long-term follow-up.


RESULTS
After five years, 310 STEMI patients randomly assigned to implantation of either SES or BMS, were compared. Survival rates were comparable between groups (SES 94.3% vs. BMS 92.8%, p=0.57), as were the rates of reinfarction (10.6% vs. 13.7%, p=0.40), freedom of death/re-MI (84.4% vs. 79.8%, p=0.29) and target vessel failure (14.9% vs. 21.7%, p=0.11). Likewise, rates of overall stent thrombosis (ST) (5.4% vs. 2.7%, p=0.28) and very late ST (4.1% vs. 0.7%, p=0.07) did not significantly differ between the SES- and BMS-group. In 184 patients with IVUS data, definite and definite/probable VLST was more common in those with late stent malapposition versus those without late stent malapposition (4.3% and 6.6% vs. no events [p=0.018 and p=0.004], respectively). The cumulative incidences of target vessel and target lesion revascularisation (TVR and TLR) were not significantly lower in the SES-group (11.2% vs. 17.9%, p=0.09 and 7.2% vs. 12.9%, p=0.08), as was the rate of clinically driven TLR (6.6% vs. 9.5%, p=0.30).


CONCLUSIONS
SES implantation was neither associated with increased rates of major adverse cardiac events, nor with a reduction in re-intervention, compared to implantation of a BMS in patients with STEMI after five years. However, a trend of more very late stent thrombosis was observed after SES implantation (ISRCTN62825862).
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Helèn
H
Boden
Bas L
BL
van der Hoeven
Su-San
SS
Liem
Jael Z
JZ
Atary
Suzanne C
SC
Cannegieter
Douwe E
DE
Atsma
Marianne
M
Bootsma
J Wouter
JW
Jukema
Katja
K
Zeppenfeld
Pranobe V
PV
Oemrawsingh
Ernst E
EE
van der Wall
Martin J
MJ
Schalij
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D003328:Coronary Thrombosis / Q000453:epidemiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D054855:Drug-Eluting Stents / Q000009:adverse effects; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals / Q000009:adverse effects; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000503:physiopathology* / Q000628:therapy*; D012008:Recurrence; D012189:Retrospective Studies; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000009:adverse effects; D015607:Stents / Q000009:adverse effects; D015996:Survival Rate; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D008670:Metals; D020123:Sirolimus