48-Month Clinical Outcomes and Prognostic Factors in an All-Comers Population with Acute Coronary Syndrome and Chronic Coronary Syndrome Undergoing Percutaneous Coronary Intervention with a Sirolimus-Eluting Stent

被引:1
|
作者
Tyczynski, Maciej [1 ]
Kern, Adam [2 ]
Buller, Patryk [3 ]
Gil, Robert J. [4 ]
Bil, Jacek [1 ]
机构
[1] Ctr Postgrad Med Educ, Dept Invas Cardiol, PL-02507 Warsaw, Poland
[2] Univ Warmia & Mazury, Sch Med, Coll Med, Dept Cardiol & Internal Med, PL-10082 Olsztyn, Poland
[3] Prov Integrated Hosp, Dept Cardiol, PL-09400 Plock, Poland
[4] Minist Interior & Adm, State Med Inst, Dept Cardiol, PL-02507 Warsaw, Poland
来源
JOURNAL OF PERSONALIZED MEDICINE | 2023年 / 13卷 / 11期
关键词
SES; PCI; Alex Plus; target lesion revascularization; ACS; in-stent restenosis; thin-strut stent; ELEVATION MYOCARDIAL-INFARCTION; 5-YEAR OUTCOMES; POLYMER; RISK;
D O I
10.3390/jpm13111573
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
We characterized the performance as well as safety of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), deployed in the acute coronary syndrome (ACS) setting. We enrolled patients who were subjected to percutaneous coronary intervention (PCI) between July 2015 and March 2016 and took into consideration demographics, clinical and laboratory data, and clinical outcomes. We defined the primary endpoint as the 48-month rate of major cardiovascular adverse events (MACE), including cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were all-cause death, cardiac death, MI, and TLR rates at 12-, 24-, 36-, and 48 months. We enrolled 232 patients in whom 282 stents were implanted, including 88 ACS and 144 chronic coronary syndrome (CCS) patients. The mean age of the ACS population was 67 +/- 13 years old, and 32% of it consisted of females. Patients with ACS were characterized by lower rates of arterial hypertension (85.2% vs. 95.8%, p = 0.004), dyslipidemia (67% vs. 81.9%, p = 0.01), prior MI (34.1% vs. 57.6%, p < 0.001), and prior PCI (35.2% vs. 68.8%, p < 0.001). At 48 months, among the ACS patients, the rates of MACE, death, cardiac death, MI, and TLR were 23.9%, 11.4%, 7.9%, 9.1%, and 10.2%, respectively. No stent thrombosis cases were reported. Multivariable Cox regression revealed that the statistically significant MACE predictors were massive calcifications in coronary arteries (HR 9.0, 95% CI 1.75-46.3, p = 0.009), post-dilatation (HR 3.78, 95% CI 1.28-11.2, p = 0.016), prior CABG (HR 6.64, 95% CI 1.62-27.1, p = 0.008), vitamin K antagonist use (HR 5.99, 95% CI 1.29-27.8, p = 0.022), and rivaroxaban use (HR 51.7, 95% CI 4.48-596, p = 0.002). The study findings show that Alex Plus was effective and safe in a contemporary cohort of real-world ACS patients undergoing primary PCI. The outcomes were comparable between the ACS and chronic coronary syndrome patients, with a trend of lower TLR in ACS patients at 4 years.
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页数:13
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