scholarly journals Subgroup Analysis Comparing Ultrathin, Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin, Durable Polymer Everolimus-Eluting Stents in Acute Coronary Syndrome Patients

Author(s):  
Ariel Roguin ◽  
David E. Kandzari ◽  
Erez Marcusohn ◽  
Jacques J. Koolen ◽  
Gheorghe Doros ◽  
...  
2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
O Muller ◽  
...  

Abstract Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Yamakami ◽  
S Kimura ◽  
K Hara ◽  
M Ohmori ◽  
R Tateishi ◽  
...  

Abstract Background Bioabsorbable polymer drug eluting stents (BP-DESs) were designed to reduce a vascular inflammatory reaction compared to durable polymer drug eluting stents (DP-DESs). However, few studies have compared vascular responses to BP-DESs and DP-DESs. Methods We enrolled 88 consecutive patients with single culprit coronary artery lesions (31 lesions with acute coronary syndrome) undergoing a single stent-implantation. BP-DESs and DP-DESs were implanted in 50 (57%) and 38 patients (43%), respectively. All lesions underwent optical coherence tomography examination at chronic phase and intrastent OCT findings at the follow-up were evaluated in every 1-mm cross-sections (CSs). Results A total of 1887 CSs (BP-DES: 1096, DP-DES: 791) were analyzed. The median period of follow-up OCT was 293 (250–374) days. There were no differences in the patient, lesion, and initial clinical presentation of acute coronary syndrome (ACS). BP-DESs had significantly higher percent neointimal hyperplasia area, defined as neointimal hyperplasia area divided by stent area x 100 (18.4±9.0% vs. 16.1±9.9%, p<0.001), fewer malapposed struts (1.7% vs. 3.9%, p=0.005), fewer uncovered struts (3.6% vs. 5.8%, p=0.02) but higher frequency of superficial low intensity neointima (LIN) (7.7% vs. 3.4%, p<0.001). Multivariate logistic analysis showed that BP-DES (OR: 2.5, 95% CI: 1.49–4.08, p<0.001) and the initial clinical presentation of ACS (OR: 2.31, 95% CI: 1.47–3.62, p<0.001) are independent predictive factors for LIN. Conclusion BP-DESs showed homogenous neointimal growth and complete stent coverage quantitatively. Meanwhile, the significant relationships of BP-DES with LIN may suggest that the neointimal quality remains immature in BP-DESs in this period. Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 10 (6) ◽  
pp. 1278
Author(s):  
Endrin Koni ◽  
Wojciech Wanha ◽  
Jakub Ratajczak ◽  
Zhongheng Zhang ◽  
Przemysław Podhajski ◽  
...  

Among drug-eluting stents (DESs), the durable polymer everolimus-eluting stent (EES) and resolute zotarolimus-eluting stent (R-ZES) are widely used in clinical practice and have contributed to improve the outcomes of patients undergoing percutaneous coronary intervention (PCI). Few studies addressed their long-term comparative performance in patients with acute coronary syndrome (ACS). We aimed to investigate the 5 year comparative efficacy of EES and R-ZES in ACS. We queried ACTION-ACS, a large-scale database of ACS patients undergoing PCI. The treatment groups were analyzed using propensity score matching. The primary endpoint was a composite of mortality, myocardial infarction (MI), stroke, repeat PCI, and definite or probable stent thrombosis, which was addressed at the five-year follow-up. A total of 3497 matched patients were analyzed. Compared with R-ZES, a significant reduction in the primary endpoint at 5 years was observed in patients treated with EES (hazard ratio (HR) [95%CI] = 0.62 [0.54–0.71], p < 0.001). By landmark analysis, differences between the two devices emerged after the first year and were maintained thereafter. The individual endpoints of mortality (HR [95%CI] = 0.70 [0.58–0.84], p < 0.01), MI (HR [95%CI] = 0.55 [0.42–0.74], p < 0.001), and repeat PCI (HR [95%CI] = 0.65 [0.53–0.73], p < 0.001) were all significantly lower in the EES-treated patients. Stroke risk did not differ between EES and R-ZES. In ACS, a greater long-term clinical efficacy with EES vs. R-ZES was observed. This difference became significant after the first year of the ACS episode and persisted thereafter.


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