Italian researchers have found that high-dose atorvastatin given shortly before PCI reduces the risk of nephropathy induced by the angiography contrast medium.

Researchers had previously noticed that PCI patients on long-term statin therapy were less likely to develop postprocedure contrast-induced nephropathy. This prompted them to conduct a randomized trial of short-term, high-dose statin therapy to prevent the condition.

The trial included 241 statin-naive patients with non-ST-segment elevated ACS who underwent PCI within 48 hours. They were randomized to receive 80 mg atorvastatin or placebo 12 hours before coronary angiography, with another 40 mg atorvastatin or placebo given immediately before the procedure.

Contrast-induced nephropathy (CIN), defined as an increase in serum creatinine of at least 0.5 mg/dL or more than 25% from baseline, developed in 6 of 120 (5.0%) patients in the atorvastatin group compared with 16 of 121 (13.2%; p=0.046) in the placebo arm, the researchers found.

In general, patients with CIN had received a larger contrast load (240 vs 208 mL, p = 0.04).

When the researchers stratified patients by the presence or absence of renal failure at baseline, the atorvastatin groups did better but not to a statistically significant effect. Specifically, "in the subgroup without baseline chronic renal failure, incidence of CIN was 1% in the atorvastatin versus 7% in the placebo group (odds ratio 0.15, p = 0.11), whereas in patients with chronic renal failure it was 14% versus 26% (odds ratio 0.48, p = 0.36)."

Length of stay was 2.9 days in the atorvastatin arm compared with 3.2 days in the placebo group (p=0.007), and 3.5 days in patients who developed contrast-induced nephropathy versus 2.9 days in those who did not (p=0.001), reported researchers.

Results of the study lend further support to early use of high-dose statins as adjuvant pharmacologic therapy before percutaneous coronary revascularization, concluded researchers.

Am J Cardiol 2011. http://bit.ly/jdhwqJ

A new study published online on 21 st March 2011 in the American Journal of Cardiology showed that the use of arterial closure devices post percutaneous coronary intervention (PCI) via the femoral artery, rather than manual compression reduced the rate of major bleeding complications and pseudoaneurysms.

Arterial closure devices provide immediate hemostasis, improve comfort, and allow early ambulation after PCI. This new study which aimed to evaluate the utilization of arterial closure devices and post-PCI major bleeding, evaluated bleeding events that required transfusion, prolonged hospital stays, and/or decreases in hemoglobin =3.0 g/dl in patients who underwent PCI via the femoral approach (N = 5421) at a single institution. The p rimary end point was major bleeding as defined by National Cardiovascular Data Registry (NCDR) while major bleeding stratified by previously developed NCDR bleeding risk categories was the secondary end point. A secondary analysis of bleeding and complication rates between arterial closure devices types (suture-based vs collagen plug) was also performed. Final p ropensity matching yielded 2324 patients; i.e., 1162 patients who had arterial closure devices matched to 1162 patients who had manual compression.

The rate of major bleeding was significantly lowered in patients using arterial closure device (2.4%) compared to patients in whom manual compression was used (5.2%). Patients at highest risk for bleeding according to NCDR showed the greatest reduction in major bleeds with arterial closure device use (3.1% vs 10.3%, p<0.001) . Pseudoaneurysms were also significantly less frequent in arterial closure device patients (0.3% vs. 1.1%) vs manual compression. Besides, length of stay was significantly reduced to 1.9 days with use of arterial closure device vs. 2.3 days for manual compression.

A secondary analysis which compared the types of arterial closure devices i.e. collagen-plug (n = 741) vs suture-based device (n = 421) showed that the composite end point of major bleeding, vascular occlusion, significant dissection, pseudoaneurysm, or arteriovenous fistula development at the access site and peripheral embolization was significantly lower with suture-based devices than collagen plugs (1.4% vs. 3.4%;).

Thus, the present study showed significant reduction in major bleeding, length of stay, and pseudoaneurysms with arterial closure devices as compared to manual compressions in patients undergoing PCI via the femoral route.

Am J Cardiol 21 March 2011 [Epub Ahead of print]

A new expanded analysis of the cardiovascular risks associated with calcium supplements published in the British Medical Journal , on April 19, 2011, reported a 25%-30% increased risk of myocardial infarction and 15%-20% increased risk of stroke in individuals taking calcium supplements, with or without vitamin D.

The Women's Health Initiative Calcium/Vitamin D Supplementation (WHI CaD) Study originally found no risk associated with the supplements after studying more than 36,000 patients over seven years. This prompted millions of people to take combination of calcium and vitamin D supplements to reduce risk of fractures.

However, Dr Mark Bolland ( University of Auckland , New Zealand ) one of the authors of the study noted that 54% and 47% of subjects in the placebo arm of the WHI CaD study were taking their own calcium and vitamin D supplements, respectively, at the time of randomization. This prompted Dr Bolland et al to analyze patient-level data on baseline supplementation use. They found among, almost 17000 women who were not taking personal supplements at the time of randomization, new supplement use was associated with a significant increase in risk of clinical MI (hazard ratio 1.22; p = 0.05) and clinical MI and stroke (hazard ratio 1.16; p = 0.05). Among women already taking supplements at baseline, no such increase in events was seen. Researchers also found no relation between the dose of the supplements and the cardiovascular risk.

The authors suspect that the abrupt change in blood calcium levels after taking a supplement causes the adverse effect, rather than it being related to the total amount of calcium consumed. According to Dr Ian Reid ( University of Auckland ), senior author of the study, increased risk of stroke, a longer-term process was due to calcium accruing in the vessel walls. Also, he accredited increased risk of MI, a more acute response, to blood calcium levels, including changes in platelet function, blood coagualability, or endothelial cell activity.

To further strengthen the evidence, the researchers of the study added the newly-found data from the WHI CaD study, as well as data on concomitant calcium and vitamin-D supplementation from two other studies they'd excluded in their earlier analysis, to their 12 000-patient meta-analysis from last year looking at calcium use only, bringing the sample size up to almost 30,000. All the data was from randomized controlled trials.

The analysis showed that the use of calcium or calcium plus vitamin D was associated with increased risk of MI (patient-level data: hazard ratio 1.26, p = 0.005; trial-level data: hazard ratio 1.24, p = 0.004), stroke (patient-level data: hazard ratio 1.19, p = 0.03; trial-level data: hazard ratio 1.15, p = 0.06) and composite of MI and stroke (patient-level data: hazard ratio 1.17, p = 0.005; trial-level data: hazard ratio 1.15, p = 0.009). According to these calculations, if 1000 people take calcium with or without vitamin D, it would cause six additional MIs or strokes (a number needed to harm of 178), yet prevent only three fractures (a number needed to treat of 302).

In an editorial accompanying the current article, Dr. Bo Abrahamsen ( Gentofte Hospital , Copenhagen ) and Dr. Opinder Sahota ( Nottingham University Hospitals , England ) raised concerns about the cardiovascular adjudication and study design of the underlying trials and emphasized that insufficient evidence is available to support or refute the association. They suggested dire need for further studies to reach a conclusion.

Adapted From: BMJ 2011; DOI:doi:10.1136/bmj.d2040

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A study published in the Journal of American College of Cardiology, on April 26, 2011, reported an increasing prevalence and incidence of heart disease-related risk factors like obesity, high blood pressure and diabetes in young urban Indian population. The annual number of deaths from cardiovascular diseases (CVD) in India is projected to rise from 2.26 million in 1990 to 4.77 million in 2020.

This study which was a part of the New Delhi Birth Cohort study, followed 1,100 young adults (average age 29 yrs) from New Delhi for 6.9 ± 1.0 years.

By the end of the study follow-up, the prevalence of obesity had increased significantly from 9% to 21% in men and from 13% to 25% in women. 70% of the participants had waistlines that fit the criteria for abdominal obesity due to increase in waist circumference and central obesity.

The prevalence of hypertension also rose from 11% to 34% in men and from 5% to 15% in women. Antihypertensive drug therapy use was reported by 6% of the participants.

There was a significant increase in the prevalence of impaired glucose tolerance (IGT) among women and correspondingly the prevalence of diabetes doubled in men from 5% to 12% and from 3.5% to 7.0% in women. Yet, the use of antidiabetic drug therapy was reported by only 1.5% of the participants.

Similarly, total cholesterol increased significantly by 5.1 mg/dl in men and 5.6 mg/dl in women. HDL cholesterol significantly increased by 2.0 mg/dl in men and 2.6 mg/dl in women; on the other hand, there was a significant increase in triglycerides by 10.5 mg/dl in men and by 5.0 mg/dl in women.

The study authors emphasized that these results have huge implications as majority of the 1 billion plus population of India are young and the average age at which Indians suffer their first heart attack is 53, which is 6 years earlier than rest of the world.

The higher prevalence of CVD risk factors will impose a huge economic burden on the country as well as upon individuals. The authors added that in India , already 5% to 34% of personal income is spent on diabetes care.

The study authors said that the reasons for the increased incidence of CVD risk factors are complex, ranging from lifestyle changes associated with urbanization to the epidemiological and nutritional transitions that accompany economic development. They added that maternal under-nutrition, low birth weight and greater childhood and adolescent BMI have been previously shown to be responsible for increased CVD risk.

Such alarming changes in the prevalence of CVD risk factors over such a short period of time demonstrate the need for use of appropriate risk screening and intervention strategies beginning at younger ages. The study authors said that a life-course approach which includes health promotion during childhood and adolescence, primary prevention of individuals with CVD risk factors and secondary prevention of those with established coronary heart disease and stroke would be most beneficial.

JACC 2011; 57(17): 1765-74

In a study published in the journal, PLoS One on May 4, 2011, Prof. Nicholas Wald et. al . reported that age alone was as good a predictor of cardiovascular events as the Framingham risk score with similar screening performance and cost-effectiveness.

Cardiovascular disease (CVD) is the commonest cause of death and a major cause of morbidity worldwide. Preventive treatments should therefore be more widely used.

Guidelines recommend that primary preventive treatment should be based on assessment of absolute risk of cardiovascular events using multiple risk factor algorithms such as the Framingham risk score, which includes age, sex, smoking status, diabetic status, serum cholesterol and blood pressure. However, age is by far the strongest determinant of CVD risk in multiple risk factor algorithms. Offering preventive treatment to everyone over a specified age without measuring other risk factors would be a simpler screening strategy than offering preventive treatment to everyone exceeding a specified CVD risk cut-off based on multiple risk factor measurement.

To investigate this, the researchers compared the efficacy of offering preventive treatment based on age alone (age screening) with Framingham risk estimation ( Framingham screening) in a hypothetical sample population of 5, 00,000 individuals aged from 0 to 89 years. Risk estimates were used to identify individuals who did and did not have a CVD event over a 10-year period. For screening using age and Framingham risk scores, the researchers estimated the (i) detection rate (proportion of affected individuals with positive screening results) which determines sensitivity; (ii) false–positive rate (proportion of unaffected individuals with positive screening results); (iii) proportion of CVD-free years of life lost in affected individuals with positive results (person-years detection rate); and (iv) cost per CVD-free life year gained from preventive treatment.

Age screening with an age cut-off of 55 was found to be equivalent to 5-yearly Framingham screening using a 10 year risk cut-off of 8%. Both methods detected 86% of all first CVD events arising in the population every year (detection rate) and 72% of CVD-free years of life lost, with age screening having a 24% false positive rate compared with 21% with Framingham screening and a cost of £2000 per CVD-free year of life gained, instead of £2200. The age-specific risk of cardiovascular disease was found to be higher in men than in women. About 90% of individuals had concordant results from Framingham screening and age screening.

Presently, a 10-year CVD risk cut-off of 1 in 5 (20%) is adopted by the UK government and is recommended by the National Institute for Health and Clinical Excellence in multiple risk factor screening. However, there is little justification for using Framingham-based 20% CVD risk cut-off, as it has person-years detection rate of 45% and provided the cost of treatment is not high, is less cost-effective than the alternative of age screening using a 50 or 55 year age cut-off which would achieve a detection rate of about 85%.

The researchers therefore argue that screening based on age alone and targeting those 55 and up would be simpler and save money on the battery of tests and office visits used in Framingham risk. They added that age-based screening is also cost-effective since most prevention methods i.e. statins are inexpensive. The study however, did not specify which preventive treatments should be used when assessing risk solely by age.

Dr. Steve Nissen, MD, Cleveland Clinic, raised doubts about this strategy by pointing that not-all 60-year-olds need treatment. Also, according to the age-alone assessment tool, people less than 55 years with familial hyperlipidemia, heart disease or of South Asian origin would not be screened or treated.  

Dr. Christopher Cannon, MD, Brigham & Women's Hospital, agreed that the age-based approach for screening for CV risk seems appealing but recommended that these results should be taken as more of a reminder to physicians caring for older patients, as it could serve as a “minimum” for risk assessment.

The researches, themselves accepted that this study was limited by its use of statistical modeling and agreed that their findings would need to be validated in a cohort study.

Ref: PLoS One 2011;6(5):e18742

Adapted from: http://www.medpagetoday.com/Cardiology/Prevention/26312