1.
First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial.
Gao, RL, Xu, B, Sun, Z, Guan, C, Song, L, Gao, L, Li, C, Cui, J, Zhang, Y, Dou, K, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2023;(3):222-231
Abstract
BACKGROUND The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes. AIMS We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions. METHODS The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months. RESULTS A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%. CONCLUSIONS In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.
2.
Thinner Strut Sirolimus-Eluting BRS Versus EES in Patients With Coronary Artery Disease: FUTURE-II Trial.
Song, L, Xu, B, Chen, Y, Zhou, Y, Jia, S, Zhong, Z, Su, X, Ma, Y, Zhang, Q, Liu, J, et al
JACC. Cardiovascular interventions. 2021;(13):1450-1462
Abstract
OBJECTIVES The aim of the present study was to evaluate the safety and efficacy of thinner strut Firesorb (100/125 μm) sirolimus-eluting bioresorbable scaffolds (BRS) versus cobalt-chromium everolimus-eluting stents (CoCr-EES) in patients with coronary artery disease. BACKGROUND First-generation thicker strut BRS were associated with unexpected device-related adverse outcomes at long-term follow-up. METHODS Eligible patients with 1 or 2 de novo noncomplex coronary lesions were randomized to the Firesorb BRS group or CoCr-EES group in a 1:1 ratio. The primary endpoint was 1-year angiographic in-segment late loss (LL), powered for noninferiority testing. The key secondary endpoint was the 1-year proportion of covered struts assessed on optical coherence tomography, powered for noninferiority and subsequent superiority testing. RESULTS A total of 433 participants from 28 Chinese centers were randomized to the Firesorb BRS group (n = 215) or CoCr-EES group (n = 218). Patient-level 1-year in-segment LL was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.18 ± 0.37 mm in the CoCr-EES group (difference -0.01 mm; 95% confidence interval [CI]: -0.07 to 0.06; pnoninferiority < 0.0001) in the intention-to-treat population and was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.19 ± 0.37 mm in the CoCr-EES group (difference -0.005 mm; 95% CI: -0.07 to 0.06; pnoninferiority < 0.0001) in the per-protocol set. The proportion of covered struts was 99.3% in the Firesorb BRS group and 98.8% in the CoCr-EES group (difference 0.8%; 95% CI: -0.5% to 2.1%; pnoninferiority < 0.0001; psuperiority = 0.21). One-year clinical outcomes were similar between groups. CONCLUSIONS The thinner strut Firesorb BRS was noninferior to the CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL and the key secondary endpoint of 1-year proportion of covered struts by optical coherence tomography. (A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II [FUTURE-II]; NCT02890160).
3.
A preoperative whey protein and glucose drink before hip fracture surgery in the aged improves symptomatic and metabolic recovery.
Deng, Y, Fang, Y, Li, H, Chen, J, An, J, Qiao, S, Wang, C
Asia Pacific journal of clinical nutrition. 2020;(2):234-238
Abstract
BACKGROUND AND OBJECTIVES We investigated the effects of a carbohydrate-whey protein solution on aged patients undergoing hip fracture surgery. METHODS AND STUDY DESIGN Forty patients were randomly assigned to the carbohydrate-whey protein (CHP) group or the control group (CTL). In the CHP group, a mixed solution of CHP was orally administered to patients before surgery: 400 mL was administered on the day before surgery, and 200 mL was administered 3 h before surgery. The size of the liquid dark area in the gastric antrum was measured by ultrasound, and the bleeding volume during surgery was assayed. The incidence of nausea, vomiting, thirst, hunger, and days of hospitalization and the levels of blood glucose, C-reactive protein (CRP) and serum albumin were assessed. RESULTS There was no obvious liquid dark space in the gastric antrum. CHP administration improved postoperative thirst and hunger and resulted in increased albumin levels and decreased CRP concentrations and blood glucose fluctuations. CONCLUSIONS Oral CHP before hip fracture surgery reduces the incidence of postoperative thirst and hunger and improves recovery in the aged.