Cardiovascular Events in Patients Received Combined Fibrate/Statin Treatment versus Statin Monotherapy: Acute Coronary Syndrome Israeli Surveys Data

The effect of combination of fibrate with statin on major adverse cardiovascular events (MACE) following acute coronary syndrome (ACS) hospitalization is unclear. The main aim of this study was to investigate the 30-day rate of MACE in patients who participated in the nationwide ACS Israeli Surveys (ACSIS) and were treated on discharge with a fibrate (mainly bezafibrate) and statin combination vs. statin alone.The study population comprised 8,982 patients from the ACSIS 2000, 2002, 2004, 2006, 2008 and 2010 enrollment waves who were alive on discharge and received statin. Of these, 8,545 (95%) received statin alone and 437 (5%) received fibrate/statin combination. MACE was defined as a composite measure of death, recurrent MI, recurrent ischemia, stent thrombosis, ischemic stroke and urgent revascularization.Patients from the combination group were younger (58.1±11.9 vs. 62.9±12.6 years). However, they had significantly more co-morbidities (hypertension, diabetes), current smokers and unfavorable cardio-metabolic profiles (with respect to glucose, total cholesterol, triglyceride and HDL-cholesterol). Development of MACE was recorded in 513 (6.0%) patients from the statin monotherapy group vs. 13 (3.2%) from the combination group, p = 0.01. 30-day re-hospitalization rate was significantly lower in the combination group: 68 (15.6%) vs. 1691 (19.8%) of patients, respectively; p = 0.03. Multivariable analysis identified the fibrate/statin combination as an independent predictor of reduced risk of MACE with odds ratio of 0.54, 95% confidence interval 0.32–0.94.A significantly lower risk of 30-day MACE rate was observed in patients receiving combined fibrate/statin treatment following ACS compared with statin monotherapy. However, caution should be exercised in interpreting these findings taking into consideration baseline differences between our observational study groups

Virtual Reality–Based Rehabilitation as a Feasible and Engaging Tool for the Management of Chronic Poststroke Upper-Extremity Function Recovery: Randomized Controlled Trial

BackgroundA growing number of stroke survivors are left with little to no rehabilitation services upon discharge from stroke rehabilitation, although arm deficits may persist or develop from disuse once rehabilitation services have ceased. Virtual reality (VR)–based rehabilitation, combined with new technologies such as telerehabilitation, including serious games using VR environments that encourage users to practice functional movements from home with minimal supervision, may have an important role to play in optimizing and maintaining upper extremity (UE) function. ObjectiveThe primary objective of this study is to determine the extent to which a 1-month intervention using a VR-based serious game is effective in improving UE function compared with an evidence-based home exercise program. A secondary objective is to assess the feasibility of implementing the intervention for chronic stroke rehabilitation in participants’ homes. MethodsA total of 51 chronic stroke participants were randomized to treatment (n=26, 51%; Jintronix system) or standard care (n=25, 49%; standardized Graded Repetitive Arm Supplementary Program kit home program) groups. The participants were evaluated at baseline (before), immediately after the intervention (after), and at follow-up (4 weeks). The primary outcome measure was the Fugl-Meyer Assessment for UE (FMA-UE). Secondary outcome measures included the Stroke Impact Scale and an abridged version of the Motor Activity Log-14. Self-reported number of sessions was logged for the standard care group. ResultsNo statistically significant differences between groups were found across measures. Overall time effects were found for the FMA-UE (P=.045), specifically between preintervention and postintervention time points for both groups (P=.03). A total of 9 participants in the treatment group reached or surpassed the minimal clinically important difference in scores for the FMA-UE, with 7 (78%) of them having baseline low or moderate arm function, compared with 3 (33%) participants in the standard care group. Furthermore, 56% (9/16) of the participants in the treatment group who actively engaged with the system reached the minimal clinically important difference for the FMA-UE, compared with none for the 0% (0/10) less-active participants. ConclusionsThese findings suggest that UE training for chronic stroke survivors using virtual rehabilitation in their home may be as effective as a gold standard home exercise program and that those who used the system the most achieved the greatest improvement in UE function, indicating its relevance to being included as part of ongoing rehabilitation services. Trial RegistrationClinicalTrials.gov NCT02491203; https://clinicaltrials.gov/ct2/show/NCT02491203 International Registered Report Identifier (IRRID)RR2-10.1016/j.cct.2015.12.00

Outcomes of the study population during follow-up (crude data).

<p>Data are number of events/(%).</p><p>- The primary endpoint of this study was 30-day Major Adverse Coronary Events (MACE): all-cause mortality, recurrent MI, recurrent ischemia, stent thrombosis, ischemic stroke, urgent revascularization during follow-up.</p

Baseline characteristics and co-morbidities of the study population.

<p>Data are number (%) of patients or mean ± SD.</p><p>CRF - chronic renal failure, PVD - peripheral vascular disease.</p

The applied model of multivariable logistic regression analysis of risk for 30-day MACE in patients immediately post acute coronary syndrome.

<p>The applied model of multivariable logistic regression analysis of risk for 30-day MACE in patients immediately post acute coronary syndrome.</p

Distribution of cardiovascular drugs among the study patients (on discharge).

<p>Distribution of cardiovascular drugs among the study patients (on discharge).</p

Rate (%) of 30-day Major Adverse Coronary Events (MACE) among the study patients according to the age, gender, level of HDL cholesterol, triglycerides, smoking status, presence of diabetes and hypertension.

<p>Rate (%) of 30-day Major Adverse Coronary Events (MACE) among the study patients according to the age, gender, level of HDL cholesterol, triglycerides, smoking status, presence of diabetes and hypertension.</p

Effect of combined fibrate/statin treatment vs. statin monoterapy on 30-day Major Adverse Coronary Events (MACE) in risk subgroups: odds ratio and 95% confidence interval (CI).

<p>HDL-C - high density lipoproteins cholesterol.</p

Kaplan-Meier curve of mortality rate during one year follow-up for 7243 patients from years 2000–2008 (combined fibrate/statin therapy vs. statin monotherapy, p log-rank = 0.066).

<p>Kaplan-Meier curve of mortality rate during one year follow-up for 7243 patients from years 2000–2008 (combined fibrate/statin therapy vs. statin monotherapy, p log-rank = 0.066).</p