scholarly journals Better vascular healing of ultrathin strut biodegradable-polymer sirolimus-eluting stents in patients with acute coronary syndrome

2021 ◽  
Author(s):  
Akito Kawamura ◽  
Yasuyuki Egami ◽  
Shodai Kawanami ◽  
Hiroki Sugae ◽  
Kohei Ukita ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Biodegradable Polymer ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Ethics Committee ◽  
Coronary Syndrome ◽  
Neointimal Thickness ◽  
Durable Polymer ◽  
Percutaneous Coronary ◽  
Target Lesion Failure

Abstract This study aimed to compare the strut coverage between Orsiro ultrathin struts biodegradable polymer sirolimus-eluting stents (O-SES) and Xience thin struts durable polymer everolimus-eluting stents (X-EES) in acute coronary syndrome (ACS) patients using optical coherence tomography (OCT). In BIOSTEMI trial, O-SESs were superior to X-EESs with respect to target lesion failure (TLF) in ACS patients. However, there were few reports comparing intravascular imaging between the two stents in ACS. Between August 2016 and February 2020, 50 lesions from 50 ACS patients who underwent OCT-guided percutaneous coronary intervention (PCI) were enrolled. We compared mid-term vascular healing using OCT between O-SESs and X-EESs at 8-month after stenting. The protocol was approved by the Osaka Rosai Hospiral ethics committee. Among 50 lesions, the X-EES group consisted of 25 lesions and the O-SES of 25 lesions. The percentage of covered strut, the percentage of malapposed strut and mean neointimal thickness at 8-month were evaluated. In the 8-month OCT analysis, the proportion of covered strut was significantly higher in the O-SES group than in in the X-EES group (97.3% vs. 86.0%; p = 0.001). On the other hand, there were no significant differences in the frequency of malapposed strut (0.4% vs 1.0%, p = 0.238). The O-SES group had the tendency of thinner neointima compared to the X-EES group (60µm vs 76µm, p = 0.089). Compared to X-EESs, O-SESs showed better mid-term vascular healing and tended to have thinner neointima in ACS patients. Ultra-thin strut may play a key role in better vascular healing.

scholarly journals Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial

Circulation ◽  
2020 ◽  
Author(s):  
Hyo-Soo Kim ◽  
Jeehoon Kang ◽  
Doyeon Hwang ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Composite Outcome ◽  
Coronary Syndrome ◽  
Durable Polymer ◽  
Percutaneous Coronary ◽  
Drug Eluting

Background: Large scale randomized comparison of drug-eluting stents (DES) based on durable polymer (DP) versus biodegradable polymer (BP) technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study sought to prove the non-inferiority of the DP-DES compared with the BP-DES in such patients. Methods: The HOST-REDUCE-POLYTECH-ACS trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, non-inferiority trial which compared the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary endpoint was patient oriented composite outcome (POCO, a composite of all-cause death, non-fatal myocardial infarction (MI), and any repeat revascularization) at 12 months. The key secondary endpoint was device oriented composite outcome (DOCO; a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months. Results: A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, POCO occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (Absolute risk difference: -1.2%, P non-inferiority <0.001). The key secondary endpoint, DOCO, occurred less frequently in the DP-DES group (DP-DES vs. BP-DES: 2.6% vs. 3.9%, HR 0.67, 95% CI 0.46-0.98, p=0.038), mostly due to a reduction in target lesion revascularization. The rate of spontaneous non-fatal MI and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% vs. 0.8%; p=0.513 and 0.1% vs 0.4%; p=0.174, respectively). Conclusions: In ACS patients receiving percutaneous coronary intervention (PCI), DP-DES was non-inferior to BP-DES with regard to POCO at 12 months after index PCI. Clinical Trial Registration: URL: clinicaltrials.gov Unique identifier: NCT02193971

scholarly journals The 1-Year Safety and Efficacy Outcomes of Magmaris, Novel Magnesium Bioresorbable Vascular Scaffolds in Diabetes Mellitus Patients with Acute Coronary Syndrome

2021 ◽  
Vol 10 (14) ◽  
pp. 3166
Author(s):  
Adrian Włodarczak ◽  
Magdalena Łanocha ◽  
Marek Szudrowicz ◽  
Mateusz Barycki ◽  
Alicja Gosiewska ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Acute Coronary Syndrome ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
Target Lesion ◽  
Bioresorbable Scaffold ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
Coronary Syndromes ◽  
Target Lesion Failure

Background: Diabetes mellitus (DM) is one of the major risk factors contributing to Acute Coronary Syndromes (ACS) and is associated with an increased risk of adverse clinical outcomes following percutaneous coronary intervention (PCI), even when the second generation of drug-eluting stents (DES) is used. In order to overcome the disadvantages of permanent caging of a vessel with metallic DES, bioresorbable scaffold (BRS) technology has been recently developed. However, the prognosis of patients with DM and ACS treated with PCI via subsequent implantation of Magmaris (Biotronik, Berlin, Germany)—a novel magnesium-bioresorbable scaffold—is poorly investigated. Methods: A total of 193 consecutive subjects with non-ST elevation acute coronary syndrome (NSTE-ACS) who, from October 2016 to March 2020, received one or more Magmaris scaffolds were enrolled in this study. The diabetic group was compared with non-diabetic subjects. Results: There were no significant differences in the occurrence of primary endpoints (cardiovascular death, myocardial infarction, and in-stent thrombosis) and principal secondary endpoints (target-lesion failure, scaffold restenosis, death from any reason, and other cardiovascular events) between the two compared groups in a 1-year follow-up period. Conclusions: The early 1-year-outcome of magnesium bioresorbable scaffold (Magmaris) seems to be favorable and suggests that this novel BRS is safe and effective in subjects with NSTE-ACS and co-existing DM.

scholarly journals Five-Year Comparative Efficacy of Everolimus-Eluting vs. Resolute Zotarolimus-Eluting Stents in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

2021 ◽  
Vol 10 (6) ◽  
pp. 1278
Author(s):  
Endrin Koni ◽  
Wojciech Wanha ◽  
Jakub Ratajczak ◽  
Zhongheng Zhang ◽  
Przemysław Podhajski ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Primary Endpoint ◽  
Coronary Intervention ◽  
First Year ◽  
Comparative Efficacy ◽  
Coronary Syndrome ◽  
Durable Polymer ◽  
Percutaneous Coronary

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.

5-year outcomes in patients with acute coronary syndrome treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
O Muller ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Cardiac Death ◽  
Target Lesion ◽  
Funding Source ◽  
Target Vessel ◽  
Coronary Syndrome ◽  
Durable Polymer ◽  
Stable Cad

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

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