Cardiovascular outcomes associated with crush versus provisional stenting techniques for bifurcation lesions: a systematic review and meta-analysis.

BACKGROUND: Percutaneous coronary intervention (PCI) for bifurcation lesions has often been challenging for Interventionists. Application of the correct intra-procedural technique is vital to generate beneficial outcomes after PCI. We aimed to systematically compare the post interventional cardiovascular outcomes which were reported using crush versus provisional stenting techniques for bifurcation lesions. METHODS: A computerized search was carried out through Medical Literature Analysis and Retrieval System Online, EMBASE, the Cochrane Central and through www.ClinicalTrials.gov for English publications comparing crush versus the provisional stenting techniques for coronary bifurcation lesions during PCI. Major adverse cardiac events, all-cause mortality, cardiac death, myocardial infarction, stent thrombosis, target vessel and target lesion revascularizations were the endpoints in this analysis. Odds ratios (OR) and 95% confidence intervals (CI) were generated during statistical analysis to represent the data. RESULTS: Six studies consisting of a total number of 2220 participants (1085 participants were assigned to the crush stenting technique and 1135 participants were assigned to the provisional stenting technique) enrolled between years 2004 and 2016 were included in this analysis. During a follow-up time period from six to sixty months, major adverse cardiac events (OR: 0.73, 95% CI: 0.59-0.91; P = 0.005), target vessel revascularization (OR: 0.62, 95% CI: 0.43-0.89; P = 0.01) and target lesion revascularization (OR: 0.62, 95% CI: 0.45-0.85; P = 0.003) were significantly lower in patients who were assigned to the crush stenting technique. However, all-cause mortality (OR: 0.90, 95% CI: 0.48-1.68; P = 0.74), cardiac death (OR: 0.56, 95% CI: 0.29-1.08; P = 0.08), myocardial infarction (OR: 0.89, 95% CI: 0.62-1.27; P = 0.53) and stent thrombosis (OR: 0.72, 95% CI: 0.36-1.42; P = 0.34) were not significantly different. CONCLUSION: In patients with coronary bifurcation lesions undergoing PCI, crush stenting technique was associated with significantly lower major adverse cardiac events and repeated revascularization without any change in mortality, myocardial infarction and stent thrombosis when compared to the provisional technique showing a benefit of crush over the provisional stenting technique during PCI.

Adverse drug events associated with 5mg versus 10mg Tofacitinib (Janus kinase inhibitor) twice daily for the treatment of autoimmune diseases: A systematic review and meta-analysis of randomized controlled trials.

Several recently published clinical trials have shown tofacitinib to be effective in the treatment of autoimmune diseases. This drug is commonly prescribed either in a 5-mg or in a10-mg dosage twice daily. In this review, we aimed to systematically compare the adverse drug events which were observed with 5 mg versus 10 mg tofacitinib for the treatment of autoimmune diseases. MEDLINE, EMBASE, the Cochrane library, and www.ClinicalTrials.gov were searched (from March to April 2018) for suitable English publications (published before April 2018). The inclusion criteria were as follows: randomized controlled trials, autoimmune disorders (rheumatic arthritis, psoriatic arthritis, moderate to severe psoriasis, and ankylosing spondylitis), and comparison of adverse drug events associated with 5 mg versus 10 mg tofacitinib. This study had follow-up time periods of 3 months and ≥ 6 months. Statistical analysis was carried out by RevMan 5.3 whereby risk ratios (RRs) and 95% confidence intervals (CIs) were generated. A total number of 4287 participants were included (2144 versus 2143 participants who received 5 mg and 10 mg tofacitinib twice daily respectively). The results showed that at 3 months, similar risks of adverse drug events, serious adverse events, and adverse events leading to drug discontinuation were observed with 5 mg versus 10 mg tofacitinib (RR 1.04, 95% CI 0.98-1.10; P = 0.17, I2 = 0%; RR 1.06, 95% CI 0.77-1.48; P = 0.71, I2 = 0%; and RR 1.06, 95% CI 0.78-1.43; P = 0.73, I2 = 32%, respectively). The other outcomes including serious infection events, adjudicated herpes zoster infection, adjudicated opportunistic infection, mild and severe neutropenia, malignancies, and adjudicated major adverse cardiovascular events were also similarly manifested. However, a decreased level of hemoglobin significantly favored 5 mg tofacitinib (RR 1.75, 95% CI 1.19-2.58; P = 0.005, I2 = 49%). Even at a follow-up time period of ≥ 6 months, adverse drug events, serious adverse events, adverse drug events leading to drug discontinuation, and serious infection were still similarly observed. According to this current review, both dosages of tofacitinib were safe to use. Even if similar adverse drug events were observed with 5 mg versus 10 mg tofacitinib twice daily for the treatment of autoimmune disorders, anemia was more prominent with 10 mg tofacitinib at a 3 month follow-up. Nevertheless, future studies based on a larger population size with longer follow-up time periods should further be considered.

Correction to: Reassessing Coronary Artery Bypass Surgery Versus Percutaneous Coronary Intervention in Patients with Type 2 Diabetes Mellitus: A Brief Updated Analytical Report (2015-2017).

In the original publication, conclusion was incorrectly updated in the article main text. The complete statement is given below.

Reassessing Coronary Artery Bypass Surgery Versus Percutaneous Coronary Intervention in Patients with Type 2 Diabetes Mellitus: A Brief Updated Analytical Report (2015-2017).

INTRODUCTION: In this analysis, we aimed to systematically compare percutaneous coronary intervention (PCI) versus coronary artery bypass surgery (CABG) in terms of adverse outcomes utilizing data from a recent (2015-2017) population of patients with type 2 diabetes mellitus (T2DM). METHODS: An electronic search of recent studies (2015-2017) was carried out using 'diabetes mellitus,' 'coronary artery bypass surgery,' and 'percutaneous coronary intervention' as the main search terms. Uncomplicated T2DM patients with stable coronary artery disease (CAD), left main CAD, and multi-vessel disease were included. RevMan software (version 5.3) was used to calculate odds ratios (OR) and 95% confidence intervals (CIs). RESULTS: Among a total of 13,114 T2DM patients, CABG and PCI patients did not differ significantly in their rates of mortality (OR 0.90, 95% CI 0.61-1.31; P = 0.57) and cardiac death (OR 1.00, 95% CI 0.78-1.30; P = 0.98). However, rates of major adverse events, repeat revascularization, and myocardial infarction were significantly higher in the PCI group. Stroke rates did not significantly differ between the two groups. CONCLUSION: Mortality (1-5 years) did not significantly differ between the CABG and PCI patients with T2DM. However, rates of other major adverse events were significantly higher in the PCI patients, suggesting that CABG is more advantageous than PCI in patients with T2DM.

Risk of Adverse Drug Events Observed with Baricitinib 2 mg Versus Baricitinib 4 mg Once Daily for the Treatment of Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: On 23 April 2018, the Food and Drug Administration-based Advisory Committee approved the use of baricitinib 2 mg for the treatment of rheumatoid arthritis and suggested the possibility of serious adverse events associated with baricitinib 4 mg. Hence, we aimed to systematically compare the risk of adverse drug events observed with baricitinib 2 mg versus 4 mg for the treatment of patients with rheumatoid arthritis. METHODS: Electronic databases including the Cochrane library, MEDLINE, EMBASE and http://www.ClinicalTrials.gov were searched for relevant English publications until April 2018. Adverse drug events at 12 weeks and 24 weeks were considered as the clinical endpoints. RevMan 5.3 software was used to analyze the data whereby risk ratios (RR) and 95% confidence intervals (CI) were calculated. RESULTS: Four trials consisting of a total of 959 participants were included in this analysis. At 12 weeks, no significant difference was observed between 2 mg and 4 mg baricitinib for serious adverse events (RR 1.33; 95% CI 0.63-2.78; p = 0.46), any adverse events after the start of therapy (RR 1.09; 95% CI 0.98-1.21; p = 0.13), discontinuation of drugs due to adverse events (RR 1.19; 95% CI 0.61-2.34; p = 0.60), malignancies (RR 3.03; 95% CI 0.12-73.90; p = 0.50), and major adverse cardiac events (RR 2.95; 95% CI 0.12-71.91; p = 0.51). Infections including herpes zoster infections and serious infections were also similarly manifested. At 24 weeks, serious adverse events (RR 1.84; 95% CI 1.02-3.30; p = 0.04) were significantly higher with baricitinib 4 mg compared with the 2-mg dosage. However, total adverse events after the start of therapy, discontinuation of drug due to adverse events, malignancies, major adverse cardiac events, infections including herpes zoster, and serious infections were not significantly different between the two doses. CONCLUSIONS: No significant differences in adverse drug events were observed between baricitinib 2 mg and 4 mg at 12 weeks' follow-up. However, this analysis showed the risk of serious adverse events to be significantly higher with baricitinib 4 mg compared with baricitinib 2 mg at 24 weeks' follow-up. This hypothesis should be confirmed in larger trials with longer follow-up time periods.

Does a Nurse-Led Program of Support and Lifestyle Management for patients with coronary artery disease significantly improve psychological outcomes among the patients?: A meta-analysis.

BACKGROUND: Nowadays, secondary prevention of coronary heart disease (CHD) is commonly provided by nurse-coordinated prevention programs (NCPPs). NCPPs were recommended to be incorporated into the healthcare systems by the European Society of Cardiology (ESC) as stated in their 2012 European Guideline. Even if Nurse-Led Programs of Support and Lifestyle Management are beneficial to the patients with CHD, it is not clear whether these programs significantly improve psychological outcomes among the patients. Therefore, in this analysis, we aimed to systematically compare anxiety and depression reported among CHD patients who were assigned to a Nurse-Led Programs of Support and Lifestyle Management versus patients who were assigned to a normal usual care setting. METHODS: Online databases were searched for English publications assessing anxiety and depression in CHD patients who were assigned to a Nurse Interventional program versus patients who were assigned to a normal usual care setting. This analysis was carried out by RevMan software (version 5.3). For dichotomous data, odds ratios (ORs) and 95% confidence intervals (CIs) were generated whereas for continuous data, weight mean difference (WMDs) and 95% CIs were calculated. RESULTS: A total number of 3110 patients were analyzed (1526 participants were assigned to the Nurse Interventional group whereas 1584 participants were assigned to the normal usual care group). Patients' enrollment time period varied from the year 2008 to the year 2015. Results of this analysis showed that depression among participants who were assigned to a Nurse-Led Program of Support and Lifestyle Management was not significantly different (OR: 0.90, 95% CI: 0.68-1.20; P = .47) compared to participants who were assigned to the normal usual care setting. When continuous data were used, still no significant difference was observed (WMD: -0.83, 95% CI: -1.68-0.02; P = .06). A similar result was obtained even when anxiety was assessed (WMD: -1.38, 95% CI: -3.21-0.45; P = .14). CONCLUSIONS: The current analysis did not show any significant improvement in reduction of depression and anxiety among CHD patients who were assigned to a Nurse-Led Program of Support and Lifestyle Management versus those patients who were assigned to a normal usual care setting. Therefore, according to this analysis, even if a Nurse-Led Program of Support and Lifestyle Management might be clinically effective, it does not improve mental well-being in these patients with CHD.

Artificial Pancreas as an Effective and Safe Alternative in Patients with Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

INTRODUCTION: Insulin injection is the main treatment in patients with type 1 diabetes mellitus (T1DM). Even though continuous glucose monitoring has significantly improved the conditions of these patients, limitations still exist. To further enhance glucose control in patients with T1DM, an artificial pancreas has been developed. We aimed to systematically compare artificial pancreas with its control group during a 24-h basis in patients with T1DM. METHODS: Electronic databases were carefully searched for English publications comparing artificial pancreas with its control group. Overall daytime and nighttime glucose parameters were considered as the endpoints. Data were evaluated by means of weighted mean differences (WMDs) and 95% confidence intervals (CIs) generated by RevMan 5.3 software. RESULTS: A total number of 354 patients were included. Artificial pancreas significantly maintained a better mean concentration of glucose (WMD - 1.03, 95% CI - 1.32 to - 0.75; P = 0.00001). Time spent in the hypoglycemic phase was also significantly lower (WMD - 1.23, 95% CI - 1.56 to - 0.91; P = 0.00001). Daily insulin requirement also significantly favored artificial pancreas (WMD - 3.43, 95% CI - 4.27 to - 2.59; P = 0.00001). Time spent outside the euglycemic phase and hyperglycemia phase (glucose > 10.0 mmol/L) also significantly favored artificial pancreas. Also, the numbers of hypoglycemic events were not significantly different. CONCLUSION: Artificial pancreas might be considered an effective and safe alternative to be used during a 24-h basis in patients with T1DM.

Adverse Drug Events Associated with Low-Dose (10 mg) Versus High-Dose (25 mg) Empagliflozin in Patients Treated for Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Empagliflozin is a new, emerging oral hypoglycemic agent (OHA) which has shown significant benefits in type 2 diabetes mellitus (T2DM) patients with cardiovascular disease. In this analysis, our aim was to systematically compare the adverse drug events (ADEs) associated with a low (10 mg) versus a high (25 mg) dose of empagliflozin as (1) monotherapy, (2) as an add-on to other OHAs, and (3) as an add-on specifically to metformin, in patients who were treated for T2DM. METHODS: This was a systematic review and meta-analysis of randomized controlled trials that compared empagliflozin 10 mg versus 25 mg in patients who were treated for T2DM and which reported adverse drug reactions as their clinical endpoints. Statistical analysis was carried out using the latest version of the RevMan software (ver. 5.3) whereby odds ratios (OR) and 95% confidence intervals (CI) were generated. RESULTS: Eight trials with a total number of 8514 patients treated for T2DM were included in this meta-analysis and systematic review, of whom 4261 patients received 10 mg empagliflozin and 4253 patients received 25 mg empagliflozin. Our results showed that there were no significant differences between the patients with T2DM receiving 10 empagliflozin and those receiving 25 mg empagliflozin in terms of drug-related adverse effects (OR 1.06, 95% CI 0.93-1.21; P = 0.40, I2 = 0%), adverse events leading to drug discontinuation (OR 0.99, 95% CI 0.86-1.14; P = 0.87, I2 = 0%), and serious adverse events (OR 1.06, 95% CI 0.95-1.18; P = 0.31, I2 = 0%) when empagliflozin was provided as monotherapy or as an add-on to other anti-diabetic medications. The same results were obtained when empagliflozin was used as an add-on to metformin or as monotherapy. The duration of the follow-up periods did not affect the results. However, the incidence of genital and urinary tract infections (UTIs) was significantly higher in female patients than in male patients with 10 or 25 mg empagliflozin. CONCLUSIONS: The incidence of ADEs was not significantly different in T2DM patients receiving 10 versus 25 mg empagliflozin as monotherapy or as add-on to metformin or other anti-diabetic drugs during a shorter or longer follow-up period. However, genital and UTIs were more common in female patients with T2DM irrespective of empagliflozin dosage.