Aims. Insulin degludec (IDeg) and insulin glargine (IGlar) are both proved to be effective in diabetes. This study aimed to assess the effects and safety of IDeg versus IGlar. Methods. A systematic literature search was conducted using the PubMed, EMBASE, and Cochrane Library electronic databases to identify all randomized controlled trials (RCTs). Results. Fifteen RCTs were identified. The combined data showed that the decrease in the glycosylated hemoglobin (HbA1c) level was slightly different, and the proportion of patients who achieved HbA1c < 7% was similar between the IDeg and IGlar groups. Further, a statistically significant decrease in the fasting plasma glucose level was observed in the IDeg group as compared to the IGlar group. In patients with T2DM, IDeg was associated with lower rates of overall hypoglycemia. Nocturnal hypoglycemia was significantly lower in the case of IDeg than in the case of IGlar in both T1DM and T2DM patients. No statistically significant differences were observed between the groups. Conclusions. Compared with IGlar, IDeg is associated with equivalent glycemic control and a statistically significantly lower rate of nocturnal hypoglycemia in patients with T1DM and T2DM. In T2DM patients, IDeg also provides better results in terms of overall hypoglycemia.

Background. The effect of metformin in combination with insulin in adolescents with type 1 diabetes (T1DM) is controversial.Methods and Results. The PubMed and EMBASE online databases were searched. Five double-blind randomized controlled trials (RCTs) that included 301 adolescents with T1DM were identified. Metformin plus insulin was associated with reduced hemoglobin A1C levels, total daily insulin dosage, body mass index (BMI), and body weight. However, the subgroup analysis demonstrated that HbA1c levels were not significantly changed in overweight/obese adolescents and were significantly reduced in the general patients. On the contrary, BMI and body weight were significantly reduced in overweight/obese adolescents but not in the general patients. Metformin was associated with higher incidence of adverse events.Conclusions. Among adolescents with T1DM, administering adjunctive metformin therapy in addition to insulin was associated with improved HbA1c levels, total daily insulin dosage, BMI, and body weight. However, there may be differences in the effects of this regimen between overweight/obese and nonobese adolescents. The risk of an adverse event may be increased with metformin treatment. These results provide strong evidence supporting future high-quality, large-sample trials.

Objective. This study aimed to compare the effectiveness of drug-coated balloons (DCB) with everolimus-eluting stents (EES) in the treatment of in-stent restenosis (ISR) and the differential relative effect of DCB in patients with drug-eluting stents (DES)-ISR and bare metal stents (BMS)-ISR. Background. The efficiency and safety of DCB and EES need to be assessed for the treatment of ISR. Methods. A systematic literature search was conducted using PubMed and EMBASE to identify all relevant studies. Angiographic results and clinical events were separately assessed. Subgroup meta-analyses were performed according to the type of restenosed stent. Results. Six randomized trials with 1134 patients were included. The overall pooled outcomes indicated that DCB was associated with lower minimum lumen diameter (mean difference MD=−0.17, 95% CI = −0.29 to −0.05, P=0.006) and higher target lesion revascularization (risk ratio RR=2.38, 95% CI = 1.36 to 4.18, P=0.002) than EES. However, the subgroup meta-analyses showed that DCB was inferior to EES only in DES-ISR patients, with lower minimum lumen diameter (MD=−0.25, 95% CI = −0.37 to −0.14, P<0.001), higher percent diameter stenosis (MD=5.37, 95% CI = 1.33 to 9.42, P=0.009), more binary restenosis (RR=2.07, 95% CI = 1.20 to 3.58, P=0.009), and higher incidence of target vessel revascularization (RR=2.07, 95% CI = 1.22 to 3.50, P=0.007) and target lesion revascularization (RR=2.43, 95% CI = 1.28 to 4.22, P=0.002). No differences in angiographic results and clinical events were found between DCB and EES in BMS-ISR patients. Conclusions. DCB was inferior to EES in DES-ISR and comparable in BMS-ISR in terms of angiographic results and clinical events.

Whether body composition is associated with the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level and its prognostic performance in acute coronary syndrome (ACS) remains unknown. We aimed to investigate the influence of body composition on the NT-proBNP level and its prognostic performance among ACS patients. In total, 1623 ACS patients with NT-proBNP data were enrolled. Percent body fat and lean mass index were estimated using the Clínica Universidad de Navarra—Body Adiposity Estimator equation. Patients were divided into three groups according to the tertiles of sex-specific body mass index, percent body fat, or lean mass index. The endpoints were death from any cause and cardiovascular death. Body mass index was inversely correlated with NT-proBNP levels (β = −0.036, P = 0.003). Lean mass index, but not percent body fat, was inversely associated with NT-proBNP levels (β of lean mass index = −0.692, P = 0.002). During a median follow-up of 23 months, 161 all-cause deaths occurred, and of these, 93 (57.8 %) were attributed to cardiovascular causes. Multivariate Cox analysis showed that the NT-proBNP level independently predicted all-cause mortality or cardiovascular death in the lower body mass index, lean mass index, and percent body fat groups. However, the prognostic performance of NT-proBNP was attenuated in patients with high body mass index, lean mass index, and percent body fat. In the subgroup of patients with diabetes, inverse associations between NT-proBNP levels and body mass index or body composition were not observed. In addition, the negative influence of high body mass index and body composition on the prognostic performance of the NT-proBNP level appeared to be attenuated. Body mass index and lean mass index, but not percent body fat, are inversely associated with NT-proBNP levels. The prognostic performance of this biomarker may be compromised in patients with high body mass index, percent body fat, or lean mass index. Additionally, the influence of body composition on the NT-proBNP level and its prognostic performance might be attenuated in diabetic patients with ACS.

We try to analyse the effect of renal functions on death in CAD patients with different body compositions. A retrospective analysis was conducted in 2989 consecutive patients with CAD confirmed by coronary angiography were enrolled and were grouped into two categories: basically preserved renal function (PRF) (eGFR ≥60 ml/min) and obviously reduced renal function (RRF) (eGFR <60 ml/min). The influence of renal insufficiency on mortality of CAD was detected in every tertile of body composition, including body mass index (BMI), body fat (BF) and lean mass index (LMI). The end points were all-cause mortality. The mean follow-up time was 29.1 ± 12.5 months and death events occurred in 271 cases. The percentage of patients with RRF was positively correlated with BF and inversely correlated with the LMI, but no relationship to BMI. The survival curves showed that the risk of death was significantly higher in the RRF patients in all subgroups stratified using BMI, BF, or LMI (log rank test, all p < 0.001). The COX multivariate regression analysis showed that the risk of death was significantly higher in the RRF patients with high BF (HR 1.95, CI 1.25–3.05) and low LMI (HR 1.82, CI 1.19–2.79). Meanwhile, risk of death was significantly higher in RRF patients with a high BMI (HR 2.08, CI 1.22–3.55) or low BMI (HR 1.98, CI 1.28–3.08) but this risk was not significant in patients with a medium BMI (HR 1.12, 0.65–1.94). The subgroup analysis of patients with acute coronary syndrome (ACS) showed similar results. For patients with CAD, renal insufficiency was positively correlated with BF, inversely correlated with LMI, and unrelated to BMI. The effect of renal insufficiency on the risk of death of CAD was related to body composition.

Objective. To investigate the efficacy of drug-coated balloon (DCB) treatment for de novo coronary artery lesions in randomized controlled trials (RCTs). Background. DCB was an effective therapy for patients with in-stent restenosis. However, the efficacy of DCB in patients with de novo coronary artery lesions is still unknown. Methods. Eligible studies were searched on PubMed, Web of Science, EMBASE, and Cochrane Library Database. Systematic review and meta-analyses of RCTs were performed comparing DCB with non-DCB devices (such as plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES)) for the treatment of de novo lesions. Trial sequential meta-analysis (TSA) was performed to assess the false positive and false negative errors. Results. A total of 2,137 patients enrolled in 12 RCTs were analyzed. Overall, no significant difference in target lesion revascularization (TLR) was found, but there were numerically lower rates after DCB treatment at 6 to 12 months follow-up (RR: 0.69; 95% CI: 0.47 to 1.01; P=0.06; TSA-adjusted CI: 0.41 to 1.16). TSA showed that at least 1,000 more randomized patients are needed to conclude the effect on TLR. A subgroup analysis from high bleeding risk patients revealed that DCB treatment was associated with lower rate of TLR (RR: 0.10; 95% CI: 0.01 to 0.78; P=0.03). The systematic review illustrated that the rate of bailout stenting was lower and decreased gradually. Conclusions. DCB treatment was associated with a trend toward lower TLR when compared with controls. For patients at bleeding risk, DCB treatment was superior to BMS in TLR.