Bivalirudin versus heparin in patients undergoing percutaneous peripheral interventions: A systematic review and meta-analysis.

BACKGROUND: Bivalirudin may be an effective alternative anticoagulant to heparin for use in percutaneous peripheral interventions. We aimed to compare the safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing percutaneous peripheral intervention. METHODS: For this meta-analysis and systematic review, we conducted a search in PubMed, Medline, Embase, and Cochrane for all the clinical studies in which bivalirudin was compared to heparin as the procedural anticoagulant in percutaneous peripheral interventions. Outcomes studied included all-cause mortality, all-bleeding, major and minor bleeding, and access site complications. RESULTS: Eleven studies were included in the analysis, totaling 20,137 patients. There was a significant difference favoring bivalirudin over heparin for all-cause mortality (risk ratio 0.58, 95% CI 0.39-0.87), all-bleeding (risk ratio 0.62, 95% CI 0.50-0.78), major bleeding (risk ratio 0.61, 95% CI 0.39-0.96), minor bleeding (risk ratio 0.66, 95% CI 0.47-0.92), and access site complications (risk ratio 0.66, 95% CI 0.51-0.84). There was no significant difference in peri-procedural need for blood transfusions (risk ratio 0.79, 95% CI 0.57-1.08), myocardial infarction (risk ratio 0.87, 95% CI 0.59-1.28), stroke (risk ratio 0.77, 95% CI 0.59-1.01), intracranial bleeding (risk ratio 0.77, 95% CI 0.29-2.02), or amputations (OR 0.75, 95% CI 0.53-1.05). CONCLUSION: Our meta-analysis suggests that bivalirudin use for percutaneous peripheral interventions is associated with lower all-cause mortality, bleeding, and access site complications as compared to heparin. Further large randomized trials are needed to confirm the current results.

Safety Profile of Nifurtimox for Treatment of Chagas Disease in the United States.

BACKGROUND: Nifurtimox is 1 of only 2 medications available for treating Chagas disease (CD) and currently the only drug available in the United States, but its safety and tolerance have not been extensively studied. This is the first study to evaluate tolerance of nifurtimox in US patients with CD. METHODS: This investigation assessed side effects in a sample of 53 patients with CD, all Latin American immigrants, who underwent treatment with nifurtimox (8-10 mg/kg in 3 daily doses for 12 weeks) from March 2008 to July 2012. The frequency and severity of adverse events (AEs) was recorded. RESULTS: A total of 435 AEs were recorded; 93.8% were mild, 3.0% moderate, and 3.2% severe. Patients experienced a mean of 8.2 AEs; the most frequent were anorexia (79.2%), nausea (75.5%), headache (60.4%), amnesia (58.5%), and >5% weight loss (52.8%). Eleven patients (20.8%) were unable to complete treatment. Experiencing a moderate or severe AE (odds ratio [OR], 3.82; P < .05) and Mexican nationality (OR, 2.29; P < .05) were significant predictors of treatment discontinuation, but sex and cardiac progression at baseline were not. Patients who did not complete treatment experienced nearly 3 times more AEs per 30-day period (P = .05). CONCLUSIONS: Nifurtimox produces frequent side effects, but the majority are mild and can be managed with dose reduction and/or temporary suspension of medication. The high frequency of gastrointestinal symptoms and weight loss mirrors results from prior investigations. Special attention should be paid during the early stages of treatment to potentially severe symptoms including depression, rash, and anxiety.

Staged Percutaneous Intervention for Concurrent Chronic Total Occlusions in Patients With ST-Segment-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis.

BACKGROUND: Studies have shown that chronic total occlusion (CTO) in a noninfarct-related artery in patients with ST-segment-elevation myocardial infarction is linked to increased mortality. It remains unclear whether staged revascularization of a noninfarct-related artery CTO in patients with ST-segment-elevation myocardial infarction translates to improved outcomes. We performed a meta-analysis to compare outcomes between patients presenting with ST-segment-elevation myocardial infarction with concurrent CTO who underwent percutaneous coronary intervention of noninfarct-related artery CTO versus those who did not. METHOD AND RESULTS: We conducted an electronic database search of all published data. The primary end point was major adverse cardiovascular events. Secondary end points were all-cause mortality, cardiovascular mortality, myocardial infarction, repeat revascularization with either percutaneous coronary intervention or coronary artery bypass grafting, stroke, and heart failure readmission. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed. Random effects model was used and heterogeneity was considered if I2 >25. Six studies (n=1253 patients) were included in the analysis. There was a significant difference in major adverse cardiovascular events (OR, 0.54; 95% CI, 0.32-0.91), cardiovascular mortality (OR, 0.43; 95% CI, 0.20-0.95), and heart failure readmissions (OR, 0.57; 95% CI, 0.36-0.89), favoring the patients in the CTO percutaneous coronary intervention group. No significant differences were observed between the 2 groups for all-cause mortality (OR, 0.47; 95% CI, 0.22-1.00), myocardial infarction (OR, 0.78; 95% CI, 0.41-1.46), repeat revascularization (OR, 1.13; 95% CI, 0.56-2.27), and stroke (OR, 0.51; 95% CI, 0.20-1.33). CONCLUSIONS: In this meta-analysis, CTO percutaneous coronary intervention of the noninfarct-related artery in patients presenting with ST-segment-elevation myocardial infarction was associated with a significant reduction in major adverse cardiovascular events, cardiovascular mortality, and heart failure readmissions.

Meta-Analysis and Trial Sequential Analysis Comparing Percutaneous Ventricular Assist Devices Versus Intra-Aortic Balloon Pump During High-Risk Percutaneous Coronary Intervention or Cardiogenic Shock.

The intra-aortic balloon pump (IABP) and percutaneous ventricular assist devices (pVAD) are commonly used in different clinical scenarios. The goal of this study was to carry out a meta-analysis and Trial Sequential Analysis (TSA) comparing the IABP versus pVAD (TandemHeart and the Impella) during high-risk percutaneous coronary intervention (PCI) or cardiogenic shock (CS). Using PubMed, Cochrane Central Register of Controlled Trials, and EMBASE we searched for randomized clinical trials (RCTs) and nonrandomized studies that compared pVAD versus IABP in patients who underwent high-risk PCI or with CS. We included 5 RCTs and 1 nonrandomized study comparing pVAD versus IABP. Based on the RCTs, we demonstrated no difference in short-term (6 months) (risk ratio [RR] 1.09, 95% confidence interval [CI] 0.79 to 1.52; p = 0.59) or long-term (12 months) (RR 1.00, 95% CI 0.57 to 1.76; p = 1.00) all-cause mortality. The use of pVAD seemed associated with more adverse events (acute kidney injury, limb ischemia, infection, major bleeding, and vascular injury) compared with IABP (RR 1.65, 95% CI 1.14 to 2.39; p = 0.008) but this was not supported by TSA (random-effects RR 1.66, 95% CI 0.89 to 3.09; p = 0.11; TSA-adjusted CI 0.13 to 21.3). In conclusion there were no differences in short or long-term mortality when using IABP versus pVAD for high-risk PCI or CS. IABP showed superiority over pVAD in terms of risk of harm. However, further RCTs are needed to establish more conclusively the role of these modalities of mechanical circulatory support during high-risk PCI or CS.

Prevalence of Chagas Disease in a U.S. Population of Latin American Immigrants with Conduction Abnormalities on Electrocardiogram.

Chagas disease (CD) affects over six million people and is a leading cause of cardiomyopathy in Latin America. Given recent migration trends, there is a large population at risk in the United States (US). Early stage cardiac involvement from CD usually presents with conduction abnormalities on electrocardiogram (ECG) including right bundle branch block (RBBB), left anterior or posterior fascicular block (LAFB or LPFB, respectively), and rarely, left bundle branch block (LBBB). Identification of disease at this stage may lead to early treatment and potentially delay the progression to impaired systolic function. All ECGs performed in a Los Angeles County hospital and clinic system were screened for the presence of RBBB, LAFB, LPFB, or LBBB. Patients were contacted and enrolled in the study if they had previously resided in Latin America for at least 12 months and had no history of cardiac disease. Enzyme-linked immunosorbent assay (ELISA) and immunofluorescence assay (IFA) tests were utilized to screen for Trypanosoma cruzi seropositivity. A total of 327 consecutive patients were screened for CD from January 2007 to December 2010. The mean age was 46.3 years and the mean length of stay in the US was 21.2 years. Conduction abnormalities were as follows: RBBB 40.4%, LAFB 40.1%, LPFB 2.8%, LBBB 5.5%, RBBB and LAFB 8.6%, and RBBB and LPFB 2.8%. Seventeen patients were positive by both ELISA and IFA (5.2%). The highest prevalence rate was among those with RBBB and LAFB (17.9%). There is a significant prevalence of CD in Latin American immigrants residing in Los Angeles with conduction abnormalities on ECG. Clinicians should consider evaluating all Latin American immigrant patients with unexplained conduction disease for CD.