Two-year clinical outcomes after implantation of an everolimus-eluting bioresorbable scaffold (Absorb) in stable angina and acute coronary syndrome patients. Single-centre real-life registry data

Abstract

AimThe aim of this long-term registry data was to evaluate 2-year clinical and angiographic outcomes after implantation of everolimus-eluting bioresorbable scaffolds (Absorb) from the Latvian Centre of Cardiology Real-life Registry.Material and methodsBetween November 2012 and December 2014 in the Centre of Cardiology Real-life Bioresorbable Vascular Scaffold Registry, 187 patients with stable angina or acute coronary syndrome and available 2-year follow-up were selected. All patients had percutaneous coronary intervention (PCI) following bioresorbable scaffold (Absorb) implantation. At 2 years, clinical parameters were analysed in stable angina and acute coronary syndrome subgroups: all-cause death, cardiac death, non-cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), scaffold thrombosis (ST), cerebral infarction, in-scaffold restenosis and bleeding.ResultsThe clinical follow-up rate at 2 years was 96.2%. In-hospital death occurred in 2 (1.1%) patients, and 1 (0.5%) patient had in-hospital MI. At 2 years, the rate of all-cause death was 3.9% (n = 7), MI 1.6% (n = 3), TLR 3.9% (n = 7), and TVR 8.4% (n = 15). Between hospital discharge and 2-year follow-up scaffold thrombosis occurred in 2 (1.1%) patients. In-hospital scaffold thrombosis occurred in 1 (0.5%) patient due to clopidogrel resistance, and 1 additional case of scaffold thrombosis occurred at 5 days after implantation (0.5%).ConclusionsBioresorbable scaffolds showed acceptable efficacy (target lesion revascularization) and safety (cardiac death, myocardial infarction, and scaffold thrombosis) results at mid-term follow-up in stable angina and acute coronary syndrome patients.

Bioresorbable vascular scaffold: a step back thinking of the future

“…Of note, none of these studies was powered for this endpoint. The rates of target vessel myocardial infarction in these studies were in the range of 5.5–7.3%, again not outside a hypothetical confidence interval of the registries by Orlik et al [ 4 ] and Briede et al [ 6 ]. Finally, their rate of scaffold restenosis was in line with another registry recently published that reported in a similar cohort a rate of 6% at 2 years and 9% at 3 years [ 17 ].…”

“…Given the small sample size and fortunately low incidence of scaffold thrombosis, a comparison with the results of these larger trials is impossible. In the study by Orlik et al [ 4 ], no thrombosis was observed; in the study by Briede et al [ 6 ], only two such events had been observed at 2 years (1.1%). In the Absorb II trial, the rate of scaffold thrombosis was 1.5%; in the ABSORB III and AIDA trials the rates of scaffold thrombosis were 1.9% and 3.5%.…”

“…In the same issue, the paper by Briede et al [ 6 ] reports the results of a single-center real-life registry of 2-year clinical outcomes after implantation of BRS in 187 stable angina and acute coronary syndrome patients. They report very good clinical outcomes at the 2-year follow-up (all-cause death 3.9%, myocardial infarction 1.6%, target-lesion revascularization 3.9%, target-vessel revascularization 8.4%, scaffold restenosis 6.0%, thrombosis 1.1%).…”

The role of serial carotid intima-media thickness assessment as surrogate marker of atherosclerosis control in patients with recent myocardial infarction

“…The CVD was defined as fatal IS, fatal MI, or other CVD (i.e., any sudden or unexpected death unless proven as non-cardiovascular on autopsy). The relationship between new onset angina and coronary status was established with coronary angiography in order to ensure coronary lesion progression, and exclude symptoms related to stenosis recurrence (restenosis or stent thrombosis as related to different mechanisms) [17, 18]. For further analysis only new angina due to CLP was taken into account.…”