Three-years outcomes of diabetic patients treated with coronary bioresorbable scaffolds

et al. 2020

Cardiovasc Diabetol

Background Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus. Aim To evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES. Methods We performed a post hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST). Results A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p = 0.39; adjusted hazard ratio (HR) = 1.48 (95% confidence interval (CI): 0.77–2.87), p = 0.24), MACE (9.1 vs. 8.3 per 100 PY, p = 0.83; adjusted HR = 1.23 (95% CI: 0.70–2.17), p = 0.47), and ST (0.9 vs. 0.6 per 100 PY, p > 0.99). Conclusion In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.

Section: Discussionsupporting

confidence: 89%

Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS

et al. 2020

Cardiovasc Diabetol

“…Very late (0) (0) In the present analysis, diabetic patients treated with EES showed clinical event rates similar to those of the EES-treated diabetic patients in a pooled analysis of the SPIRIT and COMPARE trials (6). Furthermore, in our patients with diabetes the efficacy and short-and long-term safety of EE-BRS treatment were favorable and comparable to previous studies (24)(25)(26)(27). The performance of EE-BRS and EES have been compared in non-exclusive diabetes populations.…”

Section: Discussionsupporting

confidence: 85%

Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS

et al. 2020

Preprint

Background Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus. Aim To evaluate the safety and efficacy outcomes of all-comer patients with diabetes up to 2 years after treatment with EE-BRS or EES. Methods We performed a post-hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST). Results A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in EE-BRS and 464.9 PY in EES. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p=0.39; adjusted hazard ratio (HR)=1.48 (95% confidence interval (CI): 0.77-2.87), p=0.24), MACE (9.1 vs. 8.3 per 100 PY, p=0.83; adjusted HR=1.23 (95% CI: 0.70-2.17), p=0.47), and ST (0.9 vs. 0.6 per 100 PY, p>0.99). Conclusion In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.

“…In the present analysis, diabetic patients treated with EES showed clinical event rates similar to those of the EES-treated diabetic patients in a pooled analysis of the SPIRIT and COMPARE trials (6). Furthermore, in our patients with diabetes the e cacy and short-and long-term safety of EE-BRS treatment were favorable and comparable to previous studies (21)(22)(23)(24). The performance of EE-BRS and EES have been compared in non-exclusive diabetes populations.…”

Section: Discussionsupporting

confidence: 82%

Everolimus-Eluting Bioresorbable Scaffolds and Metallic Stents in Diabetic Patients: a Patient-level Pooled Analysis of the Prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS

et al. 2020

Preprint

Abstract Background: Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus.Aim: To evaluate the safety and efficacy outcomes of all-comer patients with diabetes up to 2 years after treatment with EE-BRS or EES.Methods: We performed a post-hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST).Results: A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in EE-BRS and 464.9 PY in EES. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p=0.39; adjusted hazard ratio (HR)=1.48 (95% confidence interval (CI): 0.77-2.87), p=0.24), MACE (9.1 vs. 8.3 per 100 PY, p=0.83; adjusted HR=1.23 (95% CI: 0.70-2.17), p=0.47), and ST (0.9 vs. 0.6 per 100 PY, p>0.99).Conclusion: In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.