Long-Term Efficacy and Safety Outcomes After Unrestricted Use of Drug-Eluting Stents in Patients With Acute Coronary Syndrome: Mortality and Major Bleeding in a Single-Center Registry

• Published in: Circulation Journal 2014/06/25, Vol.78(7), pp.1628-1635
• Main Authors: Kawaji, Tetsuma, Shiomi, Hiroki, Morimoto, Takeshi, Tamura, Toshihiro, Nishikawa, Ryusuke, Yano, Mariko, Tazaki, Junichi, Imai, Masao, Saito, Naritatsu, Makiyama, Takeru, Shizuta, Satoshi, Ono, Koh, Kimura, Takeshi
• Format: Article
• Language: English
• Subjects: Acute coronary syndrome; Acute Coronary Syndrome - mortality; Acute Coronary Syndrome - surgery; Aged; Aged, 80 and over; Bleeding; Disease-Free Survival; Drug-eluting stents; Drug-Eluting Stents - adverse effects; Female; Follow-Up Studies; Hemorrhage - etiology; Hemorrhage - mortality; Humans; Male; Middle Aged; Myocardial Infarction - etiology; Myocardial Infarction - mortality; Registries; Survival Rate
• ISSN: 1346-9843; 1347-4820
• DOI: 10.1253/circj.CJ-13-1388

Background: Recent randomized clinical trials have reported favorable clinical outcomes after the use of drug-eluting stents (DES) in patients with acute coronary syndrome (ACS). However, the long-term efficacy and safety outcomes, bleeding outcome in particular, after DES implantation in ACS patients have not been thoroughly evaluated in a real-world population. Methods and Results: We evaluated long-term clinical outcomes in 565 consecutive ACS patients who underwent DES implantation in an emergency setting between 2004 and 2011 (ST-segment elevation acute myocardial infarction [STEMI]: n=269, non-STEMI/unstable angina pectoris: n=296). Mean clinical follow-up period in this study was 4.6±2.0 years. The cumulative incidence of all-cause death, cardiac death, myocardial infarction, stent thrombosis and target-lesion revascularization was 6.9%, 4.0%, 2.2%, 1.3% and 8.4% at 1 year, and 19.6%, 6.7%, 5.6%, 3.0% and 13.9% at 5 years, respectively. The cumulative 5-year incidence of major bleeding events was 8.4% (n=42). Fatal bleeding events, however, occurred in only 4 patients, even including 2 patients who required resuscitation upon arrival at the hospital. Of the 42 patients with major bleeding events, 39 were taking dual antiplatelet therapy (DAPT) at the time of bleeding. Conclusions: DES implantation provided favorable long-term clinical outcomes with an acceptably low incidence of fatal bleeding in a real-world population of ACS patients. However, prolonged DAPT seems to be associated with major bleeding after DES implantation. (Circ J 2014; 78: 1628–1635)