Clinical trials and regulatory science in cardiology最新文献

Cardiovascular disease (CVD) is now the most prevalent and debilitating disease affecting the Chinese population, we aim to provide the latest nationwide estimates on the prevalence of main CVD risk factors. Using a complex, multistage, probability sampling design, a cross-sectional study was performed in a nationally representative sample of 17,708 adults aged 45 years and older from 28 provinces in 2011–2012. Overall, the age-standardized prevalence of subjects having 1, 2, 3, or ≥ 4 of the 5 risk factors was 30.5%, 29.8%, 19.7%, and 7.4%, respectively. The prevalence of being dyslipidemia, hypertension, diabetes, current smoking, and overweight or obese was 62.6%, 39.9%, 18.7%, 27.5%, and 32.6%, respectively. Clustering of CVD risk factors was a high health burden in the Chinese middle aged and elderly population. These results underscore the need for strategies aimed at the prevention, detection, and treatment of cardiovascular risk factors to reduce morbidity and mortality from cardiovascular disease.

Purpose

Evaluating the cost-effectiveness of a first-line smoking cessation drug using an electronic medical record system is very important for defining the best decision-making tree to use in the Brazilian National Health System (SUS). This study aimed to evaluate the cost effectiveness of varenicline compared with bupropion and nicotine replacement therapy (NRT) (gum and patches) in a smoking cessation program.

Methods

We included 940 patients admitted to a smoking cessation program. Smokers had access to medical consultations and prescription of nicotine replacement therapies (NRT — patch and gum), bupropion, and varenicline. Incremental cost-effectiveness ratios (ICERs) were estimated in the perspective of the Brazilian Public Health System (SUS).

Results

We were able to show that the best cost-effectiveness for one participant to quit smoking was BRL R$ 1.546,40 with varenicline plus bupropion BRL R$ 1.650,00 with varenicline alone; BRL R$ 1.971,32 with bupropion plus gum; BRL R$ 2.413,81 with bupropion plus NRT; and BRL R$ 2.414,26 with NRT alone.

Conclusion

Treatment with varenicline showed to be dominant and cost saving compared to NRT and/or bupropion.

Objectives

To compare the pharmacodynamic effects of clopidogrel reloading vs. switching to prasugrel or ticagrelor in high on treatment platelet reactivity (HTPR) patients undergoing percutaneous coronary intervention (PCI).

Methods

Prospective, single-centre study wherein consecutive patients undergoing nonemergent PCI showing HTPR on 600 mg clopidogrel loading were randomized to either clopidogrel reloading (300 mg load, 75 mg OD) or prasugrel (60 mg load, 10 mg OD-in patients > 60 kg) or ticagrelor (180 mg load, 90 mg BD). HTPR is defined as maximum platelet aggregation (MPA) > 46% assessed by 5 μmol/L adenosine diphosphate light transmission aggregometry (ADP-LTA) assay after more than 6 h of clopidogrel loading. Platelet function were assessed at baseline, 6 h or more after clopidogrel loading, 2 h after reloading, day 1 and day 30 post-PCI.

Results

107 patients enrolled in the study, 32 (29.9%) were found to have HTPR. 10 (9.3%) patients were reloaded with clopidogrel, 10 (9.3%) with prasugrel and 12 (11.2%) with ticagrelor. Mean MPA in clopidogrel, prasugrel and ticagrelor reloaded patients was 42.6 ± 12.5%, 15.8 ± 8.6% and 14.6 ± 7.2% respectively at 2 h after reloading and was 43.7 ± 13.5%, 15.4 ± 5.6% and 12.6 ± 4.6% on day 1 post-PCI. The MPA significantly reduced in prasugrel and ticagrelor cases and not in clopidogrel, also prasugrel and ticagrelor had almost similar MPA after the reload. There was no patient with continued HTPR with ticagrelor or prasugrel while 50% (5/10) of clopidogrel reloaded patients had HTPR. The pharmacodynamic efficacy of maintenance with prasugrel or ticagrelor was better than clopidogrel (MPA at day 30 post-PCI; 15 ± 9.7%, 13.9 ± 5.1% and 50.4 ± 13.1% respectively).

Conclusion

In patients undergoing PCI exhibiting HTPR after clopidogrel loading, ticagrelor or prasugrel reloading produced improved platelet inhibition which was better than clopidogrel reload and this effect was sustained during maintenance phase.

Background

Coronary artery disease is a devastating disease precisely because an otherwise healthy person in the prime of life may die or become disabled without warning. When the afflicted individual is under the age of 35, the tragic consequences for family, friends, and occupation are particularly catastrophic and unexpected. The purpose of the present study was to assess the risk factors, angiographic profile, and in-hospital outcome of very young patients (aged ≤ 35 years) with first acute myocardial infarction (AMI).

Methods

A cross-sectional study was conducted involving 266 young (≤ 35 years) patients with clinical diagnosis of AMI. They were studied for risk factors, clinical characteristics, and in-hospital outcome between February 2012 and October 2014 at the NHFH&RI, Dhaka, Bangladesh. Coronary angiography was done in 230 patients.

Results

The mean age of patients was 31.19 ± 3.81 years; 94.7% were male. The major risk factor was smoking, followed by dyslipidemia, family history of ischemic heart disease. The most common anatomical location for the MI was the anterior wall. Significant coronary artery disease was found in 83.04% patients, 7.39% patients had normal coronaries. Most patients had single vessel disease followed by double-vessel disease. Left anterior descending was the commonest vessel involved followed by left circumflex artery. In-hospital mortality was 2.3%.

Conclusion

AMI in very young almost exclusively occurs in male and smoking was the most common risk factor. Acute anterior MI owing to occluded left anterior descending artery was more frequent. Very young patients with an AMI have a favorable in-hospital mortality.

Objective

The aim of the study was to investigate the association of serum Pentraxin 3 and genotyping with the risk of developing AMI and its severity.

Patients and methods

Fifty patients admitted to the coronary care unit presented with STEMI (acute ST segment myocardial infarction) at the Cardiology Department, Menoufia University Hospital in the period from October 2014 to April 2015 and another 20 subjects age- and gender-matched were taken as the control group. All patients and control groups were subjected to the following: Full history taking, complete clinical examination. ECG and echocardiography and Laboratory investigation including: estimation of lipid profile, urea and creatinine, CKMB, troponin I, serum pentraxin 3 and Genotyping of pentraxin 3 A/G SNP (rs2305619).

Results

The patients with myocardial infarction had significantly higher levels of pentraxin 3 than the controls. The cut-off values for PTX3 and troponin I were 4.35 ng/ml and 0.34 μg/l respectively. Pentraxin 3 showed the highest diagnostic accuracy of coronary artery disease (96%), with sensitivity (96%) and specificity (95%). The highest serum pentraxin 3 levels were in the AA mutant homozygous type.

Conclusion

PTX3 is one of the earliest biomarkers for detecting acute coronary syndrome. rs2305619 AA genotyping of the pentraxin 3 gene might be a candidate risk factor for development of coronary artery disease, presumably by increased pentraxin 3 levels.

Purpose

To compare the effect of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) on physical fitness and quality of life (QoL) in patients with chronic heart failure (CHF).

Methods

Twenty-two male CHF patients (LVEF < 45%, mean age 53.8 ± 8 yr) were studied before and after 12 weeks of supervised aerobic training for 60 min, three times a week. Patients were randomly (1:1) to MICT (n = 10) and HIIT (n = 12). Both training programs involved treadmill exercise. The group MICT at 75% of peak heart rate (HR) and HIIT at ≈ 95% of peak HR. Outcome measurements included an assessment of QoL (Minnesota Living with Heart Failure Questionnaire (MLHFQ) and SF-36), measurements of 6-min walk test (6MWT) and peak oxygen consumption (VO₂ peak).

Results

Exercise was associated with a significant increased of 6MWT in 19.4% and 23.1% from MCIT and HIIT, respectively (p < 0.001), but not between-group differences. It was observed an improvement in VO₂ peak by 11.2% in the HIIT group and 8.3% in the MCIT group, with between-group differences (p < 0.01). Quality of life improved significantly and in all domains in both groups (p-value time-effect). All patients showed significant improvements in all domains from baseline, it was observed in both groups (p < 0.05), with between-group differences for functional capacity (SF-36). No changes were observed in pain (SF-36) for both groups.

Conclusion

Both training programs were equally effective in improving QoL and functional capacity in CHF patients.

Trial registration

(http://www.ensaiosclinicos.gov.br/): RBR-6hk9p6; registered on 15 May 2013.

Background

Contrast-induced acute kidney injury (CI-AKI) is associated with adverse outcomes. However, the problem complicating CI-AKI relates to its definition. More than 30 definitions of AKI have been used in the literature. We examined the prevalence of CI-AKI according to three criteria. Prevalence of cardiovascular events according to each criterion was also investigated.

Methods

We studied 247 consecutive patients with acute myocardial infarction (66.7 ± 9.0 years, 189 males) who underwent primary percutaneous coronary intervention in our hospital. Three definitions of CI-AKI were applied: (i) traditional CI-AKI, (ii) CI-AKI derived from RIFLE criteria, (iii) CI-AKI derived from AKIN criteria. Cardiovascular events comprised in-hospital death, sudden death, cerebral infarction, heart failure, and acute coronary syndrome.

Results

Prevalence of CI-AKI was 27.1% (67/247) according to the traditional CI-AKI definition, 23.9% (59/247) according to the CI-AKI definition derived from RIFLE criteria, and 15.8% (39/247) according to the CI-AKI definition derived from AKIN criteria. Prevalence of cardiovascular events was 13.8% (34/247). Prevalence of cardiovascular events with and without CI-AKI was 19.4% (13/67) and 11.7% (21/180) according to the traditional CI-AKI definition (P = 0.13), 22.0% (13/59) and 11.2% (21/188) in the CI-AKI definition derived from RIFLE criteria (P = 0.035), and 35.9%(14/39) and 9.6% (20/208) according to the CI-AKI derived from AKIN criteria (P = 0.00001).

Conclusion

Prevalence of CI-AKI varies widely depending on the criteria used. The CI-AKI definition derived from AKIN criteria was the most effective predictor of cardiovascular events.

Background

Information on the incidence of venous thromboembolism (VTE) following hip fractures in Asia is rare. This study will investigate the epidemiology of symptomatic VTE in Taiwanese patients experiencing hip fractures.

Methods and results

We used Taiwan's National Health Insurance Research Database to retrospectively identify patients (≧ 45 years) who experienced hip fractures from 1998 to 2007 and were followed up for 3 months after the discharge. Logistic regression analysis determined the independent risk factors of symptomatic VTE after the fractures. We identified 134,034 patients (mean age: 76.2 ± 9.7 years; female: 57.8%) who experienced hip fractures, 83.2% of whom underwent hip surgery. The overall pharmacological thromboprophylaxis rate was 2.7%. The mean length of stay was 11.3 ± 7.9 days. The 3-month cumulative incidence of symptomatic VTE was 77 events per 10,000 persons. Multivariate analysis showed that previous DVT, previous PE, varicose veins, cancer, heart failure, renal insufficiency, and older age were independent risk factors of developing VTE.

Conclusions

The incidence of symptomatic VTE after hip fractures is low in Taiwan. Patients rarely received pharmacological thromboprophylaxis following hip fractures. Universal thromboprophylaxis for patients experiencing hip fractures was not necessary in Taiwan, but it should be considered in high-risk populations.

Background

Catheter-based percutaneous renal denervation therapy (RDN) is a controversially discussed treatment-strategy for patients with resistant arterial hypertension. Home blood pressure monitoring (HBPM) is superior to office blood pressure (OBP) measurements documenting effects of drug or interventional therapy and for predicting cardiovascular morbidity and mortality. We therefore aimed at comparing effects of RDN on OBP and HBPM.

Methods

28 patients with resistant hypertension were studied; 21 patients (29–85 years, median 67 years, 5.4 ± 1.3 antihypertensive drugs) were included into the treatment arm and 7 patients (37–70 years, median 68 years, 5.1 ± 2.2 antihypertensive drugs) served as controls. RDN was performed with a Medtronic™ radiofrequency catheter-ablation-system. For OBP and HBPM measurements patients were followed up to 6 months. For controls, a mean of approximately 378 measurements in 167 ± 13.5 days was included into analysis. In RDN patients follow-up was 157.7 ± 61.8 days with a mean of approximately 323 ambulatory measurements. A mean for each week was calculated.

Results

In controls, no significant change of OBP was observed (baseline: systolic 162.2 ± 11.6 mm Hg vs. 6 months: systolic 162.8 ± 22.9 mm Hg; p > 0.05). Accordingly, HBPM values didn't change (baseline: systolic 161.2 ± 15.1 mm Hg vs. 6 months: systolic 155.8 ± 24.6 mm Hg, p > 0.05). In RDN patients a significant reduction of OBP (baseline: systolic 169 ± 12.5 mm Hg vs. 6 months: systolic 150.6 ± 19.2 mm Hg, p < 0.01) and HBPM (baseline: systolic 156.2 ± 12.9 mm Hg vs. 6 months: systolic 139.7 ± 10.2 mm Hg, p < 0.001) was observed.

Conclusion

In patients with resistant hypertension RDN significantly reduced HBPM and OBP already one week after treatment.