Polymer-free sirolimus-eluting stents in a large-scale all-comers population

Abstract

ObjectiveThe objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied.MethodsPatients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, ‘all comers’ observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated.ResultsA total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001).ConclusionsPF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).Trial registration numberNCT02629575.

9‐month results of polymer‐free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all‐comer population

“…As reported elsewhere a total of 2877 patients were recruited in the Coroflex ISAR 2000 registry. Significant differences for male gender ( P < 0.001), hypertension ( P < 0.001), and the rates of STEMI/NSTEMI ( P < 0.001) were observed across age groups (Table ).…”

“…On the basis of the international ISAR 2000 all‐comers registry population (http://ClinicalTrials.gov Identifier NCT02629575) a post‐hoc subgroup analysis was conducted in three age groups, that is, <70 years, septuagenarians (≥70 years, <80 years), and in octogenarians (≥80 years).…”

“…We report the results of a previously published large all‐comers population registry with a focus on septuagenarian and octogenarian subgroups.…”

Propensity score matched all comers population treated with ultra‐thin strut bare metal and sirolimus‐probucol coated drug‐eluting stents of identical stent architecture

“…The study protocol of a previously published all comers registry was used as the basis for the international ISAR 2000 all‐comers registry (ClinicalTrials.gov Identifier NCT02629575). Both studies prospectively enrolled patients in Europe and Asia using the same definitions for primary (9‐month TLR) and secondary endpoints. The latter included the 9‐month major adverse cardiac events (MACE) rate, the in‐hospital MACE rate and the corresponding rates of MI, target lesion revascularization (TLR) rates (coronary artery bypass grafting, and Re‐PCI).…”

“…To manage the large data sets, a dedicated and established electronic data capture system was used in both single armed studies . In case of data quality issues, investigators were immediately informed during data entry.…”