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

Abstract

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.

Percutaneous Coronary Interventions with Sirolimus-Eluting Alex Plus Stents in Patients with or without Diabetes: 4-Year Results

“…In 4 subjects (5 stents), Alex Plus stents were not deployed (1 device failure—no possibility to deliver the stent to the target lesion due to calcification and tortuosity; 4 stents not implanted due to fatal cardiac arrest). Additionally, 14 subjects were excluded (20 stents) due to in-hospital death unrelated to the sirolimus-eluting stent deployment [ 15 , 16 , 22 ]. In the end, we identified 97 DM patients and 135 non-DM patients ( Figure 1 ).…”

“…We retrospectively collected data from the hospital records. We considered all consecutive patients who were subject to PCI with the sirolimus-eluting coronary stent Alex Plus (Balton, Poland) between July 2015 and March 2016, as described previously [ 15 , 16 ].…”