Long-term safety and efficacy of sirolimus- vs. paclitaxel-eluting stent implantation for acute ST-elevation myocardial infarction: 3-year follow-up of the PROSIT trial.
BACKGROUND
Meta-analysis of randomized trials showed superior efficacy and similar safety of drug-eluting stent over bare-metal stent in acute ST-elevation myocardial infarction (STEMI) patients. However, long-term relative outcomes of sirolimus- (SES) vs. paclitaxel-eluting stent (PES) have not been fully evaluated in randomized studies. This study compared long-term safety and efficacy of these two stents in STEMI.


METHODS
A total of 308 STEMI patients were randomly treated with SES (n = 154) or PES (n = 154). Three-year clinical outcomes were assessed. Primary outcome of interest was incidence of major adverse cardiac events (MACE) including death, myocardial infarction (MI), stent thrombosis or target vessel revascularization (TVR). Secondary outcome of interest was occurrence of very late stent thrombosis.


RESULTS
Both groups had similar baseline characteristics. During follow-up, there was no difference between the two groups in terms of death (6.5% for SES and 10.4% for PES, p = 0.22), MI (2.6% vs. 3.9%, p = 0.75), stent thrombosis (1.9% vs. 3.2%, p = 0.72), TVR (3.9% vs. 8.4%, p = 0.15) and MACE (12.3% vs. 18.8%, p = 0.12). Eight patients in overall population had stent thrombosis: definite 3, probable 1, and possible 4. Cumulative incidence of stent thrombosis was gradually increased; 0.6% at 30 days, 0.6% at 1 year, 1.6% at 2 years, and 2.6% at 3 years. Very late stent thrombosis, definite or probable, occurred in 0.6% for both.


CONCLUSIONS
Among non-selected STEMI patients who underwent primary angioplasty, both SES and PES might be safe and SES showed similar three-year clinical outcomes compared to PES.
Kim
Hyun-Sook
HS
Division of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.
Lee
Jae-Hwan
JH
Lee
Seung-Whan
SW
Kim
Young-Hak
YH
Park
Jae-Hyeong
JH
Choi
Si-Wan
SW
Jeong
Jin-Ok
JO
Seong
In-Whan
IW
Rhee
Kyoung-Suk
KS
Ko
Jae-Ki
JK
Jo
Sang-Ho
SH
Choi
Young Jin
YJ
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000401:mortality*; D002423:Cause of Death; D023903:Coronary Restenosis / Q000401:mortality; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000706:statistics & numerical data*; D004562:Electrocardiography; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015994:Incidence; D053208:Kaplan-Meier Estimate; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D017239:Paclitaxel / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000401:mortality; D020123:Sirolimus / Q000627:therapeutic use*; D050257:Tubulin Modulators / Q000627:therapeutic use
D007166:Immunosuppressive Agents; D050257:Tubulin Modulators; D017239:Paclitaxel; D020123:Sirolimus