Cardiovascular Outcomes Observed with Ticagrelor versus Clopidogrel in Type 2 Diabetes Mellitus Patients with Acute Coronary Syndrome: A Meta-analysis.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is often associated with macrovascular complications including cardiovascular diseases (CVDs), resulting in acute coronary syndrome (ACS). Newer potent antiplatelet agents have recently been approved for use in clinical practice. In this analysis, we aimed to systematically compare the cardiovascular outcomes observed with ticagrelor versus clopidogrel in T2DM patients with ACS. METHODS: From August to September 2022, electronic databases were searched for publications that compared cardiovascular outcomes observed with ticagrelor versus clopidogrel in patients with T2DM. The statistical analysis was carried out using RevMan 5.4 software. A random effect statistical model was used to analyze the data. Risk ratios (RR) with 95% confidence intervals (CIs) were used to represent the data post analysis. RESULTS: A total of 5868 participants with T2DM were included in this analysis, of which 1944 participants were assigned to the ticagrelor group and 3924 participants were assigned to the clopidogrel group. Our analysis showed that ticagrelor was associated with a significantly lower risk of major adverse cardiac events (MACEs) (RR: 0.64, 95% CI: 0.49-0.84; P = 0.001), all-cause mortality (RR: 0.65, 95% CI: 0.51-0.83; P = 0.0004), and cardiac death (RR: 0.60, 95% CI: 0.43-0.84; P = 0.003) in comparison to clopidogrel. However, the risks of repeated revascularization (RR: 1.48, 95% CI: 0.44-4.99; P = 0.53), stent thrombosis (RR: 0.70, 95% CI: 0.18-2.71; P = 0.60), reinfarction (RR: 0.85, 95% CI: 0.58-1.23; P = 0.39), and stroke (RR: 0.56, 95% CI: 0.14-2.21; P = 0.41) were similar. Ticagrelor was associated with a significantly higher risk of minor bleeding (RR: 1.53, 95% CI: 1.07-2.19; P = 0.02), whereas the risk for major bleeding (RR: 1.08, 95% CI: 0.55-2.10; P = 0.82) was not significantly different. CONCLUSIONS: In these T2DM patients with ACS, a significantly lower risk of major adverse cardiovascular events including all-cause mortality was observed in the ticagrelor group compared with the clopidogrel group. However, T2DM patients who were assigned to ticagrelor showed a significantly higher minor bleeding risk. Larger clinical trials should be able to confirm these hypotheses.

Type 2 diabetes mellitus (T2DM) is increasing all over the world, and is often associated with macrovascular complications including cardiovascular diseases (CVDs), leading to acute coronary syndrome (ACS).Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is recommended in these patients.However, due to clopidogrel hyporesponsiveness, especially in patients with T2DM, a more potent antiplatelet is needed.Recently, newer, more potent antiplatelet agents have been approved for use in clinical practice.A significantly lower risk of major adverse cardiovascular outcomes including all-cause mortality was observed with ticagrelor compared with clopidogrel in these patients with T2DM.However, ticagrelor was associated with a significantly higher minor bleeding risk.

One "misunderstood" health issue: demonstrating and communicating the safety of influenza a vaccination in pregnancy: a systematic review and meta-analysis.

BACKGROUND: The American College of Obstetricians and Gynecologists (ACOG) makes certain recommendations including the annual influenza vaccination of pregnant and pre-pregnant women during influenza (flu) season with an inactivated influenza vaccine as soon as it becomes available. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices in association with ACOG state that the vaccine is safe to be given any trimester during pregnancy. However, due to a lack of communication, the public is unaware of the effects of influenza A vaccination in pregnancy. Since this is a vital public health concern, we aimed to communicate with evidence, the safety of influenza A vaccination in pregnancy in order to improve the rate of influenza A vaccines in pregnant women. METHODS: This health communication issue was based on the impact of influenza vaccine on fetal outcomes. Therefore, a search was carried out through medical-based online databases including: Cochrane Central, EMBASE, Web of Science, MEDLINE, http://www.ClinicalTrials.gov , and Google scholar for relevant English-based publications. Adverse fetal outcomes were considered as the endpoints of this analysis. The most specific RevMan 5.3 (latest version) software was used to carry out this analysis. Risk ratios (RR) with 95% confidence intervals (CI) were involved in data and results representation and interpretation. RESULTS: A total number of 679, 992 pregnant women participated in this analysis. Based on this current analysis, premature/preterm birth (< 37 weeks) was significantly reduced in pregnant women who were vaccinated for influenza A (RR: 0.80, 95% CI: 0.69-0.92; P = 0.002) as compared to those women who were not vaccinated. Similarly, influenza A vaccination decreased the risk for very preterm birth (< 32 weeks) (RR: 0.70, 95% CI: 0.58-0.84; P = 0.0001). The risks for infants with low birth weight (RR: 0.71, 95% CI: 0.49-1.04; P = 0.08), very low birth weight (RR: 0.69, 95% CI: 0.23-2.11; P = 0.52) and infants small for gestational age (RR: 0.93, 95% CI: 0.83-1.05; P = 0.26) were not increased with the vaccine. Influenza A vaccination was not associated with increased risks of stillbirth (RR: 0.63, 95% CI: 0.38-1.03; P = 0.07), birth defects (RR: 0.67, 95% CI: 0.26-1.72; P = 0.41), admission to neonatal intensive care unit or Apgar score < 7 in 5 min. CONCLUSION: Influenza vaccine is completely safe in pregnancy. It significantly lowers premature birth and is not associated with any serious adverse neonatal outcome. Hence, this important piece of information should be communicated and conveyed to all pregnant women, for a safer and healthier pregnancy. At last, this public health issue should further be addressed to the population through media and other communication means in order to improve the rate of influenza A vaccines in pregnant women for a healthier and more productive population.

Discontinuing Aspirin After Short Term Use Versus Continuous Use with a P2Y12 Inhibitor for the Treatment of Patients with Type 2 Diabetes Mellitus Following Percutaneous Coronary Intervention: A Meta-analysis.

INTRODUCTION: In this analysis, we aimed to compare the efficacy and safety of discontinuing aspirin (ASA) after short-term use versus its continuous use with a P2Y12 inhibitor for the treatment of patients with type 2 diabetes mellitus (T2DM) following percutaneous coronary intervention (PCI). METHODS: From May to June 2020, electronic databases were searched for related publications. The cardiovascular and bleeding outcomes representing efficacy and safety, respectively, were the endpoints of this study. The new RevMan software version 5.4 was used to analyze the data. Risk ratios (RR) and 95% confidence intervals (CI) were used to represent the results following data analysis. RESULTS: A total of 9774 participants with T2DM were included in this analysis, whereby 4941 patients were assigned to the ASA discontinuation group and 4833 patients to the dual antiplatelet (DAPT) group. Our result showed that compared to a longer duration (12 months) of DAPT (ASA + P2Y12 inhibitor) use in these patients with T2DM, discontinuing ASA after short-term use (1-3 months) thereafter using only a P2Y12 inhibitor (mono-therapy) was not associated with a significant increase in the risk of major adverse cardiovascular and cerebrovascular events (RR 0.92, 95% CI 0.76-1.12; P = 0.39), myocardial infarction (RR 0.98, 95% CI 0.75-1.26; P = 0.86), all-cause mortality (RR 0.78, 95% CI 0.60-1.02; P = 0.07), cardiac death (RR 0.76, 95% CI 0.43-1.35; P = 0.35), stroke (RR 1.06, 95% CI 0.67-1.67; P = 0.80) and stent thrombosis (RR 0.98, 95% CI 0.58-1.65; P = 0.93). However, discontinuing ASA after short-term use in these patients with T2DM was associated with a lower risk of bleeding defined according to the Academic Research Consortium (BARC) type 2-5 (RR 0.55, 95% CI 0.41-0.73; P = 0.0001), and thrombolysis in myocardial infarction (TIMI) defined as major (RR 0.55, 95% CI 0.41-0.75; P = 0.0001) and minor bleeding (RR 0.58, 95% CI 0.43-0.78; P = 0.0004). CONCLUSION: Discontinuing ASA after short-term use for the treatment of patients with T2DM following PCI was not associated with any increased cardiovascular outcomes. Also, discontinuing ASA after short-term use and continuing the use of a P2Y12 inhibitor were somewhat safer in these patients with T2DM. Further research should follow.

Aspirin Versus Clopidogrel Monotherapy for the Secondary Prevention of Recurrent Cerebrovascular Attack Following Previous Ischemic Stroke in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) and stroke are two different diseases, but have many aspects in common. Aspirin is recommended as an initial treatment for the secondary prevention of recurrent ischemic stroke in patients with T2DM. However, clopidogrel is an oral antiplatelet drug that might be another choice in case of aspirin intolerance. In this analysis, we aimed to systematically compare aspirin versus clopidogrel monotherapy for the secondary prevention of recurrent cerebrovascular attack following previous ischemic stroke in patients with T2DM. METHODS: Online medical databases including Web of Science, MEDLINE, Cochrane central, EMBASE and http://www.ClinicalTrials.com were searched for published articles that satisfied the inclusion and exclusion criteria of this study. Recurrent stroke, fatal stroke, cerebral hemorrhage, myocardial infarction and mortality were considered the main end points in these patients with T2DM. RevMan 5.3 software was used to statistically analyze the data representing each subgroup. Risk ratios (RRs) with 95% confidence intervals (CIs) were used to represent the results following analysis. RESULTS: A total of 9218 participants with T2DM who were previously affected by ischemic stroke were included in this analysis, whereby 4917 were assigned to aspirin and 4301 to clopidogrel. This current analysis showed that there was no significant difference in recurrent stroke rate (RR: 0.79, 95% CI: 0.61-1.02; P = 0.07) observed with aspirin versus clopidogrel in these patients with T2DM. The risk of fatal stroke (RR: 0.88, 95% CI: 0.39-1.98; P = 0.76), cerebral hemorrhage (RR: 0.65, 95% CI: 0.38-1.11; P = 0.12), myocardial infarction (RR: 0.88, 95% CI: 0.43-1.79; P = 0.71) and mortality (RR: 1.07, 95% CI: 0.90-1.27; P = 0.44) were also similarly manifested. CONCLUSION: Clopidogrel monotherapy was neither inferior nor superior to aspirin monotherapy for the secondary prevention of recurrent cerebrovascular attack following previous ischemic stroke in patients with T2DM. Hence, clopidogrel or aspirin monotherapy is equally safe and effective in these patients with T2DM.

Duration of Dual Antiplatelet Therapy and Late Stent Thrombosis Following Percutaneous Coronary Intervention with Second-Generation Drug-Eluting Stents: A Simple Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: The aim of this simple meta-analysis was to systematically compare the occurrence of late and very late stent thrombosis with a short versus a longer duration of dual anti-platelet therapy (DAPT) use following the implantation of second-generation drug-eluting stents (DES). METHODS: Randomized controlled trials that compared short- and long-term DAPT use following percutaneous coronary intervention (PCI) with DES and that reported late (> 30 days but < 1 year) and very late (> 1 year) stent thromboses were searched from the bibliographic database of life sciences and biomedical information, which is also known as MEDLINE, as well as other searched databases including EMBASE, the Cochrane Central and http://www.ClinicalTrials.com . Statistical analysis was carried out using RevMan software [odds ratios (OR) and 95% confidence intervals (CIs) represented the results]. RESULTS: This simple analysis consisted of five randomized controlled trials with a total of 7142 patients. The current results showed no significant difference in late stent thrombosis associated with a shorter or longer duration of DAPT use (OR 0.98, 95% CI 0.30-3.18; P = 0.97, I2 = 0%). The result for very late stent thrombosis was also not significantly different (OR 0.30, 95% CI 0.03-2.95; P = 0.31). CONCLUSIONS: This simple analysis showed no impact of DAPT duration on the occurrence of late and very late stent thrombosis. Similar late and very late stent thrombosis rates were observed with 6-month versus 12-month duration of DAPT use following PCI with second-generation DES.

Short-Term Versus Long-Term Adverse Cardiovascular Outcomes Post Percutaneous Coronary Intervention in Patients with Insulin-Treated Type 2 Diabetes Mellitus: A Simple Meta-Analysis.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a major health issue, especially in patients with coexisting coronary artery disease (CAD). Patients with insulin-treated T2DM (ITDM) have worse outcomes than those with non-insulin-treated T2DM. Very few studies have compared short-term to long-term adverse cardiovascular outcomes following percutaneous coronary intervention (PCI) in patients on insulin therapy. Therefore, in this meta-analysis, we systematically compared short-term to long-term adverse cardiovascular outcomes in a population of patients with ITDM following PCI. METHODS: We searched for English-language publications focusing on PCI in patients with ITDM using specific search terms/phrases. All the participants accepted for inclusion in this meta-analysis were treated with a drug-eluting stent. Post-intervention adverse cardiovascular outcomes observed during short-term and long-term follow-up periods were assessed and compared. Statistical analysis was carried out using the popular RevMan 5.3 software. Odd ratios (OR) with 95% confidence intervals (CI) were calculated. RESULTS: Six studies comprising 1568 participants with ITDM in total were included in this simple meta-analysis. Patient enrollment periods varied but enrollment occurred during the years 1993-2012. When a fixed-effects statistical model was used, post-PCI adverse cardiovascular outcomes-such as major adverse cardiac events (MACEs) (OR 3.33, 95% CI 2.64-4.21; P = 0.00001), all-cause mortality (OR 5.73, 95% CI 3.37-9.73; P = 0.00001), myocardial infarction (MI) (OR 1.47, 95% CI 1.05-2.07; P = 0.02), and repeated revascularization (OR 4.78, 95% CI 3.29-6.94; P = 0.00001)-were found to be significantly more likely during the long-term follow-up period. A similar result was observed with a random-effects statistical model. CONCLUSION: Adverse cardiovascular outcomes post PCI were significantly more likely during the long-term follow-up period than during the short-term follow-up period in these patients with T2DM on insulin therapy. This hypothesis requires confirmation via new comparative trials that consider short-term and long-term follow-up periods.

Tobacco smoking and semen quality in infertile males: a systematic review and meta-analysis.

BACKGROUND: Nowadays, the total number of couples visiting an infertility clinic is on the rise. Tobacco smoking is considered one of the major factors leading to male infertility. In this study, we aimed to systematically investigate the impact of tobacco smoking on semen quality in infertile male participants. METHODS: Online databases (Cochrane Central database of Randomized Controlled Trials and the databases of MEDLINE and EMBASE respectively) were searched for relevant English publications that satisfied the inclusion and exclusion criteria of this analysis. The clinical endpoints which were assessed included semen parameters (oligozoospermia, asthenozoospermia, teratozoospermia, and azoospermia), morphological defects of spermatozoa and the hormones involved in reproduction. RevMan 5.3 software was used to analyze the data whereby mean difference (MD) and risk ratios (RR) with 95% confidence intervals (CI) were generated to represent the results. RESULTS: Sixteen studies with a total number of 10,823 infertile male participants (5257 smokers and 5566 non-smokers) were included. Results of this analysis showed oligozoospermia to be significantly higher in smokers (RR: 1.29, 95% CI: 1.05-1.59; P = 0.02). Morphological defect of spermatozoa (MD: 2.44, 95% CI: 0.99-3.89; P = 0.001) was also significantly higher in smokers whereby significant head (MD: 1.76, 95% CI: 0.32-3.20; P = 0.02), neck (MD: 1.97, 95% CI: 0.75-3.18; P = 0.002) and tail (MD: 1.29, 95% CI: 0.35-2.22; P = 0.007) defects were observed. However, smoking did not affected the pH (MD: 0.04, 95% CI: [- 0.03-0.11]; P = 0.30) and motility (RR: 1.42, 95% CI: 0.97-2.09; P = 0.07) of spermatozoa. Additionally, tobacco smoking did not cause any dis-balance in hormones which were involved in reproduction. CONCLUSIONS: In conclusion, with reference to the clinical endpoints which were studied in this analysis, tobacco smoking was associated with a lower sperm count and an increase in the number of morphological defects of spermatozoa. However, the pH and motility of spermatozoa as well as the production of hormones which were involved in reproduction were not affected in this population of infertile males.

Adverse Drug Events Associated with sitagliptin Versus canagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus: A Systematic Comparison Through a Meta-Analysis.

INTRODUCTION: In this meta-analysis, we aimed to systematically compare the adverse drug events associated with sitagliptin (100 mg) versus canagliflozin 100 or 300 mg in patients who were treated for type 2 diabetes mellitus (T2DM). METHODS: Online databases were searched for relevant studies comparing sitagliptin (100 mg) versus canagliflozin. Adverse drug events were considered as the clinical endpoints. The analysis was carried out by RevMan software whereby risk ratios (RR) and 95% confidence intervals (CI) were generated. RESULTS: Five studies with a total number of 2322 patients were included. When sitagliptin (100 mg) was compared with canagliflozin (100 mg), the endpoints of any adverse events, adverse events leading to drug discontinuation, serious adverse events, urinary tract infections, hypoglycemia, and adverse events related to hypovolemia were not significantly different: (RR 1.10, 95% CI 1.00-1.21; P = 0.05), (RR 1.20, 95% CI 0.67-2.16; P = 0.54), (RR 0.90, 95% CI 0.49-1.66; P = 0.73), (RR 1.26, 95% CI 0.77-2.08; P = 0.36), (RR 1.01, 95% CI 0.30-3.43; P = 0.99), and (RR 1.76, 95% CI 0.52-5.94; P = 0.36), respectively. However, canagliflozin was associated with increased genital mycotic infection (RR 4.32, 95% CI 2.11-8.83; P = 0.0001). When genital mycotic infections associated with sitagliptin versus canagliflozin were compared in male and female patients separately, the risk was still significantly higher with canagliflozin: (RR 7.00, 95% CI 2.44-20.06; P = 0.003) and (RR 4.02, 95% CI 2.22-7.27; P = 0.00001), respectively. The same results were obtained when sitagliptin (100 mg) was compared to canagliflozin 300 mg. CONCLUSIONS: Canagliflozin was associated with a significantly higher risk of genital mycotic infections when compared to sitagliptin. However, the other adverse drug events were similarly manifested when sitagliptin 100 mg was compared to either canagliflozin 100 or 300 mg.

Arterial/venous thrombosis, fetal loss and stillbirth in pregnant women with systemic lupus erythematosus versus primary and secondary antiphospholipid syndrome: a systematic review and meta-analysis.

BACKGROUND: We aimed to systematically compare arterial/venous thrombosis, fetal loss and stillbirth in pregnant women with systemic lupus erythematosus (SLE), primary anti-phospholipid syndrome (PAPS) and secondary anti-phospholipid syndrome (SAPS). METHODS: Online databases were carefully searched for relevant publications comparing SLE with PAPS and/or SAPS in pregnancy. Studies were included if: they compared SLE with APS [SLE versus PAPS or SLE versus SAPS or SLE versus PAPS and SAPS respectively] in pregnant women; and they reported specific adverse outcomes as their clinical endpoints including arterial/venous thrombosis, fetal loss and stillbirth. Risk ratios (RR) with 95% confidence intervals (CIs) were used as statistical parameters and the analysis was carried out by the RevMan 5.3 software. RESULTS: A total number of 941 pregnant women were included: 556 were candidates of SLE; 200 were candidates of PAPS; and 185 were candidates of SAPS. APS was associated with a significantly higher risk of fetal loss (RR: 4.49, 95% CI: 2.09-9.64; P = 0.0001). In addition, stillbirth and arterial/venous thrombosis were also significantly increased with APS (RR: 6.65, 95% CI: 2.14-20.60; P = 0.001) and (RR: 3.95, 95% CI: 1.28-12.16; P = 0.02) respectively. When patients with PAPS were compared with patients who suffered from SLE alone, fetal loss and arterial/venous thrombosis were still significantly higher with the former. When SAPS were compared with SLE (without anti-phospholipid antibodies), arterial/venous thrombosis, stillbirth and fetal loss were still significantly higher with SAPS. However, no significant difference was observed in arterial/venous thrombosis and fetal loss between PAPS and SAPS. CONCLUSIONS: PAPS and SAPS were associated with significantly higher arterial/venous thrombosis, fetal loss and stillbirth in comparison to SLE. However, no significant difference was observed when PAPS was compared to SAPS.

Post percutaneous coronary interventional adverse cardiovascular outcomes and bleeding events observed with prasugrel versus clopidogrel: direct comparison through a meta-analysis.

BACKGROUND: Due to limitations associated with clopidogrel following percutaneous coronary intervention (PCI), other newer oral anti-platelet agents are being studied. We aimed to systematically carry out a direct comparison of outcomes observed with prasugrel versus clopidogrel following PCI. METHODS: Common online searched databases (The Cochrane library, EMBASE, MEDLINE and Google scholar) were used to retrieve relevant publications. Primary endpoints were the adverse cardiovascular outcomes. Secondary outcomes were the bleeding events. This analysis was carried out by RevMan 5.3, whereby odds ratios (OR) and 95% confidence intervals (CI) were considered as the statistical parameters. RESULTS: Eight studies with a total number of 18,122 participants were included in this direct analysis. Prasugrel was associated with significantly lower adverse cardiovascular outcomes in comparison to clopidogrel following PCI. All-cause mortality, myocardial infarction, stroke, stent thrombosis and major adverse cardiac events were all significantly lower with prasugrel (OR: 0.47, 95% CI: 0.35-0.63; P = 0.0001), (OR: 0.68, 95% CI: 0.57-0.80; P = 0.00001), (OR: 0.60, 95% CI: 0.38-0.96; P = 0.03), (OR: 0.46, 95% CI: 0.30-0.72; P = 0.0006) and (OR: 0.61, 95% CI: 0.53-0.70; P = 0.00001) respectively. When the bleeding outcomes were analyzed, Thrombolysis in Myocardial Infarction (TIMI) defined major and minor bleeding were not significantly different (OR: 0.91, 95% CI: 0.66-1.27; P = 0.59) and (OR: 1.16, 95% CI: 0.85-1.59; P = 0.35) respectively. However, the combined 'all bleeding events' was significantly higher with prasugrel (OR: 1.32, 95% CI: 1.03-1.70; P = 0.03), but when patients with STEMI and those undergoing elective PCI were separately analyzed, no significant difference in overall bleeding was observed. CONCLUSION: Adverse cardiovascular outcomes were significantly lower with the use of prasugrel in comparison to clopidogrel following PCI. In addition, TIMI defined major and minor bleeding were not significantly different showing prasugrel to be well-tolerated following PCI especially in patients with acute coronary syndrome.

Head to head comparison of Prasugrel versus Ticagrelor in patients with acute coronary syndrome: a systematic review and meta-analysis of randomized trials.

BACKGROUND: Prasugrel and Ticagrelor are emerging antiplatelet drugs that might have the potential to replace currently used antiplatelet agents. Previous analyses comparing prasugrel with ticagrelor mainly focused on an indirect comparison whereas direct comparison was reported only in a few recently published trials. We aimed to systematically carry out a head to head comparison of the adverse clinical outcomes which were associated with prasugrel versus ticagrelor in patients with acute coronary syndrome (ACS). METHODS: Studies comparing prasugrel with ticagrelor (head to head comparison) were searched from online databases. Adverse cardiovascular outcomes were considered as the primary endpoints whereas bleeding outcomes were considered as the secondary endpoints in this analysis. The latest version of the RevMan software was used to carry out subgroup analyses whereby odds ratios (OR) with 95% confidence intervals (CI) and the calculated probability (P) were generated. RESULTS: Four studies with a total number of 563 patients (2012 - 2016) were included (282 patients were treated with prasugrel and 281 patients were treated with ticagrelor). Results of this analysis did not show any significant difference in mortality between prasugrel and ticagrelor with OR: 1.52, 95% CI: 0.42 - 5.45; P = 0.52. In addition, myocardial infarction, major adverse cardiac events, stroke and stent thrombosis were also not significantly different with OR: 0.59, 95% CI: 0.08 - 4.58; P = 0.62, OR: 0.91, 95% CI: 0.37 - 2.21; P = 0.83, OR: 0.60, 95% CI: 0.08 - 4.58; P = 0.62 and OR: 0.59, 95% CI: 0.08 - 4.58; P = 0.62 respectively. Thrombolysis in myocardial infarction (TIMI) defined minor bleeding, and minimal bleeding were also not significantly different between these two newer antiplatelet agents with OR: 3.11, 95% CI: 0.48 - 19.94; P = 0.23, and OR: 2.39, 95% CI: 0.35 - 16.42; P = 0.38 respectively. Moreover, bleeding defined by the academic research consortium was also similarly manifested with OR: 0.92, 95% CI: 0.39 - 2.13; P = 0.84. CONCLUSION: In patients with ACS, both prasugrel and ticagrelor showed similar adverse cardiovascular outcomes and bleeding events. No significant difference was observed between these two newer antiplatelet agents during this head to head comparison. However, upcoming trials with long term follow up periods might be expected to completely solve this important clinical issue.

Should fraction flow reserve be considered an important decision-making tool to stratify patients with stable coronary artery disease for percutaneous coronary intervention?: A meta-analysis.

BACKGROUND: Nowadays, fraction flow reserve (FFR) is being discussed in every percutaneous coronary intervention (PCI) capable hospitals. Owing to recent development in the medical field, FFR-guided PCI should be able to find a place in Interventional Cardiology. At present, the importance of FFR to stratify patients who require PCI has seldom systematically been investigated. In this analysis, we aimed to compare the major adverse cardiac events (MACEs) mainly in patients with stable coronary artery disease (CAD) to whom PCI was recommended and deferred respectively based on the FFR value. METHODS: Electronic databases were searched for studies comparing FFR-recommended versus FFR-deferred coronary stenting. Long-term MACEs, mortality, and myocardial infarction (MI) were considered as the clinical endpoints in this analysis. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and the analyses were carried out by the latest version of the RevMan software. RESULTS: A total number of 1753 patients (670 patients were revascularized, whereas 1083 patients were deferred from revascularization based on the FFR value) were analyzed. Current results showed MACEs and MI were significantly higher in the FFR-recommended PCI group with OR 1.34 (95% CI: 1.05-1.72; P = .02) and OR 1.73 (95% CI: 1.19-2.51; P = .004, I = 0%), respectively. However, mortality was similarly manifested with OR 1.23 (95% CI: 0.92-1.63; P = .16, I = 0%). CONCLUSION: Significantly higher MACEs were observed in patients to whom PCI was recommended compared to those patients who were deferred from undergoing PCI based on the FFR values. Therefore, FFR might indeed be an important decision-making procedural tool, which should be used to stratify stable CAD patients with an advanced disease and who are qualified candidates for PCI. Further research should confirm this hypothesis.

Adverse drug effects observed with vildagliptin versus pioglitazone or rosiglitazone in the treatment of patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Vildagliptin and pioglitazone/rosiglitazone are emerging Oral Hypoglycemic Agents (OHAs) which are used to treat patients suffering from Type 2 Diabetes Mellitus (T2DM). In this analysis, we aimed to systematically compare the adverse drug events which were observed with the use of vildagliptin versus pioglitazone or rosiglitazone respectively. METHODS: Online databases were searched for studies comparing vildagliptin with pioglitazone/rosiglitazone. Adverse drug events were considered as the clinical endpoints in this analysis. We calculated Odds Ratios (OR) with 95% Confidence Intervals (CIs) using the RevMan 5.3 software. All the authors had full access to the data which were used and approved the final version of the manuscript. RESULTS: A total number of 2396 patients were analyzed (1486 and 910 patients were treated with vildagliptin and pioglitazone/rosiglitazone respectively). Vildagliptin and pioglitazone/rosiglitazone were both associated with similar overall adverse drug events (OR: 1.00, 95% CI: 0.81-1.24; P = 1.00). Headache (OR: 0.88, 95% CI: 0.60-1.27; P = 0.49) and upper respiratory tract infection (OR: 0.95, 95% CI: 0.71-1.27; P = 0.75) were similarly observed. However, dizziness was significantly lower with pioglitazone/rosiglitazone (OR: 0.63, 95% CI: 0.43-0.92; P = 0.02). Back pain, diarrhea and nausea were insignificantly lower with pioglitazone/rosiglitazone (OR: 0.81, 95% CI: 0.49-1.33; P = 0.40), (OR: 0.83, 95% CI: 0.48-1.44; P = 0.52) and (OR: 0.52, 95% CI: 0.25-1.05; P = 0.07) respectively, whereas peripheral edema and weight gain were insignificantly higher (OR: 1.21, 95% CI: 0.56-2.62; P = 0.63) and (OR: 2.29, 95% CI: 0.51-10.34; P = 0.28) respectively. Nevertheless, when pioglitazone and rosiglitazone were separately compared with vildagliptin, peripheral edema and weight gain were significantly higher with rosiglitazone (OR: 2.36, 95% CI: 1.40-3.99; P = 0.001) and (OR: 5.20, 95% CI: 2.47-10.92; P = 0.0001) respectively. CONCLUSION: Both vildagliptin and pioglitazone/rosiglitazone are acceptable for the treatment of patients with T2DM on the basis that they are not significantly different in terms of overall adverse drug events. However, weight gain and peripheral edema would have to be re-assessed in further larger randomized controlled trials.

Differences in clinical features observed between childhood-onset versus adult-onset systemic lupus erythematosus: A systematic review and meta-analysis.

BACKGROUND: Systemic lupus erythematosus (SLE) affects people in childhood (childhood onset) or in adulthood (adult onset). Observational studies that have previously compared childhood-onset versus adult-onset SLE were often restricted to 1 ethnic group, or to a particular area, with a small sample size of patients. We aimed to systematically compare childhood-onset versus adult-onset SLE through a meta-analysis. METHODS: Electronic databases were searched for relevant publications comparing childhood-onset with adult-onset SLE. Adverse clinical features were considered as the endpoints. The Newcastle Ottawa Scale (NOS) was used to assess the methodological quality of the studies and RevMan software (version 5.3) was used to carry out this analysis whereby risk ratios (RRs) and 95% confidence intervals (95% CIs) were used as the statistical parameters. RESULTS: A total number of 10,261 participants (1560 participants with childhood-onset SLE and 8701 participants with adult-onset SLE) were enrolled. Results of this analysis showed that compared with childhood-onset SLE, pulmonary involvement was significantly higher with adult-onset SLE (RR: 1.51, 95% CI: 1.18-1.93; P = .001), whereas renal involvement was significantly higher with childhood-onset SLE (RR: 0.65, 95% CI: 0.55-0.77; P = .00001). Raynaud phenomenon and photosensitivity were significantly higher in adult-onset SLE (RR: 1.29, 95% CI: 1.04-1.60; P = .02) and (RR: 1.08, 95% CI: 1.01-1.17; P = .03), respectively. Malar rash significantly favored adult-onset SLE (RR: 0.84, 95% CI: 0.75-0.94; P = .002). Childhood-onset SLE was associated with significantly higher hemolytic anemia, thrombocytopenia, leukocytopenia, and lymphopenia. Seizure and ocular manifestations were significantly higher with childhood-onset SLE (RR: 0.57, 95% CI: 0.47-0.70; P = .00001) and (RR: 0.34, 95% CI: 0.21-0.55; P = .00001), respectively, whereas pleuritis was significantly higher with adult-onset SLE (RR: 1.45, 95% CI: 1.17-1.79; P = .0008). Vasculitis and fever were significantly higher with childhood-onset SLE (RR: 0.51, 95% CI: 0.36-0.74; P = .0004) and (RR: 0.78, 95% CI: 0.68-0.89; P = .0002) respectively. CONCLUSION: Significant differences were observed between childhood-onset versus adult-onset SLE, showing the former to be more aggressive.

Does infection with human immunodeficiency virus have any impact on the cardiovascular outcomes following percutaneous coronary intervention?: a systematic review and meta-analysis.

BACKGROUND: A direct link between human immunodeficiency virus (HIV)-infected patients and the risk of cardiovascular diseases (CVD) has been shown in recent scientific research. However, this issue is controversial since other previous reports showed no apparent impact of HIV or its anti-retroviral drugs on the cardiovascular system. We aimed to systematically compare the postinterventional adverse cardiovascular outcomes which were observed in patients with and without HIV infection during a mean follow up period ranging from 1 year to 3 years. METHODS: Common electronic databases were searched for studies which compared postinterventional adverse cardiovascular outcomes [mortality, myocardial infarction (MI), cardiac death, target vessel revascularization (TVR), target lesion revascularization (TLR), stroke and major adverse cardiac events (MACEs)] in patients with and without HIV infection. Statistical analysis was carried out by the RevMan 5.3 software whereby Odds Ratios (OR) and 95% Confidence Intervals (CIs) were generated. RESULTS: Two thousand two hundred and sixty-eight (2268) patients (821 patients were HIV positive and 1147 patients were HIV negative) were analyzed. The current results showed that mortality was not significantly increased among patients who were HIV positive with OR: 1.13, 95% CI: 0.65-1.96; P = 0.66. Cardiac death was also similarly reported with OR: 1.16, 95% CI: 0.50-2.68; P = 0.74. However, even if recurrent MI, TVR, TLR, MACEs and stroke were higher in patients who were HIV positive, with OR: 1.32, 95% CI: 0.88-2.12; P = 0.18, OR: 1.36, 95% CI: 0.88-2.12; P = 0.17, OR: 1.22, 95% CI: 0.72-2.06; P = 0.46, OR: 1.29, 95% CI: 0.89-1.85; P = 0.17 and OR: 1.47, 95% CI: 0.44-4.89; P = 0.53 respectively, these results were not statistically significant. CONCLUSION: Patients who were infected with HIV had similar mortality post coronary intervention compared to patients who were not infected by the virus, during a mean follow-up period of 1-3 years. In addition, no significant increase in MI, TVR, TLR, MACEs and stroke were observed during this follow up period. Therefore, it might be concluded that no apparent impact of HIV on the cardiovascular outcomes was observed post coronary intervention.

Major adverse cardiac events and mortality in chronic obstructive pulmonary disease following percutaneous coronary intervention: a systematic review and meta-analysis.

BACKGROUND: We aimed to systematically compare Major Adverse Cardiac Events (MACEs) and mortality following Percutaneous Coronary Intervention (PCI) in patients with and without Chronic Obstructive Pulmonary Diseases (COPD) through a meta-analysis. METHODS: Electronic databases (Cochrane library, EMBASE and Medline/PubMed) were searched for English publications comparing in-hospital and long-term MACEs and mortality following PCI in patients with a past medical history of COPD. Statistical analysis was carried out by Revman 5.3 whereby Odds Ratio (OR) and 95% Confidence Intervals (CI) were considered the relevant parameters. RESULTS: A total number of 72,969 patients were included (7518 patients with COPD and 65,451 patients without COPD). Results of this analysis showed that in-hospital MACEs were significantly higher in the COPD group with OR: 1.40, 95% CI: 1.19-1.65; P = 0.0001, I2 = 0%. Long-term MACEs were still significantly higher in the COPD group with OR: 1.58, 95% CI: 1.38-1.81; P = 0.00001, I2 = 29%. Similarly, in-hospital and long-term mortality were significantly higher in patients with COPD, with OR: 2.25, 95% CI: 1.78-2.85; P = 0.00001, I2 = 0% and OR: 2.22, 95% CI: 1.33-3.71; P = 0.002, I2 = 97% respectively. However, the result for the long-term death was highly heterogeneous. CONCLUSION: Since in-hospital and long-term MACEs and mortality were significantly higher following PCI in patients with versus without COPD, COPD should be considered a risk factor for the development of adverse clinical outcomes following PCI. However, the result for the long-term mortality was highly heterogeneous warranting further analysis.

Long-term (2-5 years) adverse clinical outcomes associated with ZES versus SES, PES and EES: A Meta-Analysis.

Several previously published trials comparing Zotarolimus Eluting Stents (ZES) with Sirolimus Eluting Stents (SES), Paclitaxel Eluting Stents (PES) or Everolimus Eluting Stents (EES) at a follow up period of 1 year, were continually being followed up in order to assess the long-term outcomes. In this meta-analysis, we aimed to compare the long-term (2-5 years) adverse clinical outcomes which were associated with ZES versus SES, PES and EES following Percutaneous Coronary Intervention (PCI). Risk Ratios (RR) with 95% Confidence Intervals (CIs) were generated and the analysis was carried out by the RevMan 5.3 software. In this analysis with a total number of 17,606 participants, ZES and EES were associated with similar adverse outcomes including Stent Thrombosis (ST), myocardial infarction (MI), major adverse cardiac events and repeated revascularization. When ZES were compared with SES and PES during the long-term, MI and definite or probable ST were significantly lower with ZES, with RR: 1.35, 95% CI: 1.17-1.56; P = 0.0001 and RR: 1.91, 95% CI: 1.33-2.75; P = 0.0004 respectively whereas the other adverse outcomes were similarly manifested. Future research should be able to confirm this hypothesis.

Are women with type 2 diabetes mellitus more susceptible to cardiovascular complications following coronary angioplasty?: a meta-analysis.

BACKGROUND: Scientific reports have shown Type 2 Diabetes Mellitus (T2DM) to be independently associated with adverse outcomes following Percutaneous Coronary Intervention (PCI). However, gender difference has also often been a controversial issue following PCI. Till date, very few meta-analyses have systematically compared the adverse cardiovascular outcomes in male versus female patients with T2DM following PCI. Therefore, we aimed to carry out this analysis in order to find out an answer to this interesting question. METHODS: Electronic databases were searched for English language publications reporting adverse cardiovascular outcomes in male versus female patients with diabetes mellitus respectively following coronary angioplasty. The RevMan 5.3 software was used to analyze selected adverse cardiovascular events whereby Odds Ratios (OR) and 95% Confidence Intervals (CI) were the statistical parameters. RESULTS: A total number of 19,304 patients with T2DM (12,986 male patients versus 6318 female patients) were included in this analysis. At baseline, female patients were older (68.7 versus 62.9 years), with a higher percentage of hypertension (75.6% versus 66.5%) and dyslipidemia (53.3% versus 50.0%) whereas majority of the male patients were smokers (46.3% versus 14.9%). Results of this analysis showed short and long-term mortality to be significantly higher in female patients with T2DM (OR: 1.71, 95% CI: 1.46-2.00; P = 0.00001), and (OR: 1.20, 95% CI: 1.07-1.35; P = 0.002) respectively. In addition, women were also more at risk for short and long-term major adverse cardiac events (MACEs) with OR: 1.49, 95% CI: 1.07-2.07; P = 0.02 and OR: 1.15, 95% CI: 1.04-1.28; P = 0.009 respectively. Subgroup analysis showed this significant result to have mainly been observed in patients with acute myocardial infarction compared to those with stable coronary artery disease. CONCLUSIONS: Following PCI, women with T2DM were indeed more susceptible to short and long-term cardiovascular complications compared to male patients with the same chronic disease. Even though this result was more applicable to patients with acute myocardial infarction, the fact that women were older with higher co-morbidities at baseline compared to men, should also not be ignored.

Application of the SYNTAX score in interventional cardiology: A systematic review and meta-analysis.

BACKGROUND: Should the SYNTAX score be integrated in Interventional Cardiology? Should it really be considered as a vital decision-making tool in percutaneous coronary intervention (PCI)? To confirm the importance of this score, we aimed to systematically compare the postinterventional adverse cardiovascular outcomes which were observed in patients who were allotted a low versus a high SYNTAX score. METHODS: Randomized controlled trials and observational studies which were published from January 2007 to January 2017 were identified from MEDLINE, EMBASE, and the Cochrane databases using the searched terms 'SYNTAX score and percutaneous coronary intervention.' Adverse cardiovascular outcomes were considered as the major endpoints. Risk ratios (RRs) with 95% confidence intervals (CIs) were used as the statistical parameters, and the main analysis was carried out by the RevMan 5.3 software. RESULTS: Sixteen studies with a total number of 19,751 participants (8589 participants with a low versus 11,162 participants with a high SYNTAX score) were included. Current results showed mortality to be significantly higher with a higher SYNTAX score (RR 2.09, 95% CI 1.78-2.46, P = .00001). Cardiac death also significantly favored a low SYNTAX score (RR 2.08, 95% CI 1.66-2.61, P = .00001. Similarly, myocardial infarction, major adverse cardiac events, repeated revascularization, and stent thrombosis were significantly higher following a high SYNTAX score (RR 1.71, 95% CI 1.45-2.03, P = .00001; RR 2.03, 95% CI 1.81-2.26, P = .00001; RR 1.96, 95% CI 1.69-2.28, P = .00001; and RR 3.16, 95% CI 2.17-4.59, P = .00001, respectively). Even when patients with ST-segment elevation myocardial infarction were separately analyzed, a low SYNTAX score was still significantly associated with lower adverse outcomes. CONCLUSIONS: This analysis is a confirmatory piece of evidence to show that the application of the SYNTAX score in Interventional Cardiology is apparently relevant. The use of this scoring system to grade patients with coronary artery disease and to further guide for revascularization should be encouraged.

Adverse cardiovascular events associated with biodegradable polymer drug-eluting stents and durable polymer everolimus-eluting stents: A systematic review and meta-analysis of 10 randomized controlled trials.

BACKGROUND: Controversies have been observed among network meta-analyses comparing biodegradable polymer drug-eluting stents (BP-DES) with durable polymer drug-eluting stents (DP-DES). We aimed to compare the adverse cardiovascular events associated with BP-DES and durable polymer everolimus-eluting stents (DP-EES) using a large number of patients obtained from randomized controlled trials (RCTs). METHODS: Electronic databases were searched for randomized trials comparing BP-DES with DP-EES. Adverse cardiovascular outcomes observed between 6 months and 3 years were considered as the clinical endpoints in this analysis. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software. All authors had full access to the data, and they have read and agreed to the manuscript as written. RESULTS: Ten trials involving a total number of 13,218 patients (7451 patients treated by BP-DES and 5767 patients treated by DP-EES) were included. No significant difference was observed when analyzing mortality and myocardial infarction between BP-DES and DP-EES with OR 1.08, 95% CI 0.87-1.34, P = .47 and OR 1.04, 95% CI 0.84-1.28, P = .72 respectively. Target vessel revascularization, target lesion revascularization, major adverse cardiac events, and stroke were also not significantly different with OR 1.11, 95% CI 0.92-1.33, P = .28; OR 1.11, 95% CI 0.94-1.33, P = .22; OR 1.12, 95% CI 0.99-1.27; P = .07; and OR 1.13, 95% CI 0.69-1.84; P = .62 respectively. In addition, total stent thrombosis (ST) was similarly reported between BP-DES and DP-EES with OR 0.85, 95% CI 0.59-1.21; P = .37. However, even if BP-DES were associated with a higher rate of definite ST with OR 1.69, 95% CI 0.92-3.08, P = .09 and DP-EES were associated with a higher rate of probable ST with OR 0.67, 95% CI 0.38-1.17, P = .16, these results were not statistically significant. CONCLUSIONS: Between 6 months and 3 years, BP-DES were similar in terms of cardiovascular outcomes compared to DP-EES. However, further long-term follow-up research is recommended.