New-generation metallic DES (EES/BES) were not superior to BVS in terms of angiographic LLL and clinical outcomes. (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [EVERBIO II]; NCT01711931).
The 12-month incidence of ScT reached 3% and could be significantly reduced when an optimized implantation strategy was employed. (retrospective multicentric registry and Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178).
At three-year follow-up, MACE as well as safety and efficacy measures including stent thrombosis were not statistically different between the biodegradable polymer-coated BES and the durable polymer-coated EES. ClinicalTrials.gov Identifier: NCT01233453.
Purpose: Gestational Diabetes Mellitus (GDM) is a condition affecting 3-4% of pregnant women due to increased resistance to insulin caused by the growth of the fetus. Such a condition disappears just after delivery, but it is an indicator of the insurgence of diabetes type 2 (DT2) later in life: about 40% of the women affected by GDM also develop DT2 [22]. GDM brings several complications during pregnancy to both the mother and the fetus. We aim here at presenting our Personal Health System for monitoring GDM and we also present the results of outpatient monitoring and management by utilizing a personal health system (PHS) for GDM. Methods: The Personal Health System (PHS) was deployed in a feasibility study, modelled as a single-center, parallel group, open randomized controlled trial conducted in Lausanne University Hospital. Patients (n=24) were assigned to 2 different groups: standard protocol group (SP) and telemedicine group (TM). SP patients were managed by regular clinic visits. TM patients were managed with our EPHS system. The targeted feasibility outcome was whole trial feasibility, functioning of the PHS and its appropriateness for patient use. Results: Mean age was 32±5 years and patients were pregnant for 29.1±1.9 weeks at study inclusion. Patients came from 16 different countries. The follow-up rate was 100%. Acceptability in the TM-group was high, as 100% were satisfied with the care provided and equally 100% were at ease with the technology. Overall median[IQR] glucose control was 5.4 mmol/l [4.7-6.4] in the TM-group and 5.7mmol/l [4.9-6.7] in the SP-group (p<0.001). Four out of 6 daily plasma glucose values were significantly better controlled with telemedicine compared to standard care. Conclusion: The feasibility study that we conducted shows that PHSs have a great potential to improve the life of the patient by allowing a better communication of their physiological values to the caregivers. With respect to the particular case of GDM, the study suggests that use of PHS technology may improve glycaemic control in GDM, but to confirm this trend, a main trial is needed.
Background—
Everolimus-eluting bioresorbable vascular scaffolds have been developed to improve late outcomes after coronary interventions. However, recent registries raised concerns regarding an increased incidence of scaffold thrombosis (ScT). The mechanism of ScT remains unknown.
Methods and Results—
The present study investigated angiographic and optical coherence tomography findings in patients experiencing ScT. Fifteen ScT (14 patients, 79% male, age 59±10 years) occurred at a median of 16 days (25%–75% interquartile range: 1–263 days) after implantation. Early ScT (<30 days) occurred in 8 cases (53%). Possible causal factors in these patients included insufficient platelet inhibition in 2 cases and procedural factors (scaffold underexpansion, undersizing, or geographical miss) in 4 cases. No obvious cause could be found in 2 early ScT. In late (>1 month) and very late (>1 year) ScT (respectively, 5 and 2 cases), 5 scaffolds showed intimal neovessels or marked peristrut low-intensity areas. Scaffold fractures were additionally found in 2 patients, and scaffold collapse was found in 1 patient with very late ScT. Extensive strut malapposition was the presumed cause for ScT in 1 case. One scaffold did not show any morphological abnormality. Thrombectomy specimens were analyzed in 3 patients and did not demonstrate increased numbers of inflammatory cells.
Conclusions—
The mechanisms of early ScT seem to be similar to metallic stents (mechanical and inadequate antiplatelet therapy). The predominant finding in late and very late ScT is peristrut low-intensity area.
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