Tiny Wireless Pacemaker Shows Early Promise

By Dennis Thompson
HealthDay Reporter

MONDAY, March 24, 2014 (HealthDay News) -- A new wireless pacemaker appears safe and feasible for use, potentially advancing the technology that cardiologists use to maintain heart rhythm in patients, according to results from a new clinical trial.

Doctors successfully implanted the device in 32 out of 33 patients. Of these, two people who received the pacemaker developed side effects -- a complication-free rate of 94 percent. Complications for the patient with unsuccessful implantation, however, proved to be severe.

After three months, the new pacemakers continued to function well, the researchers reported in the April 8 issue of the journal Circulation. They expect to report longer-term outcomes later this year.

The concept of a self-contained wireless pacemaker has been around more than 40 years, and this first successful use of such a device to treat humans is considered a step forward for cardiology.

"This is an advance that will have a huge impact on the field," said Dr. Bradley Knight, a cardiologist at the Northwestern University Feinberg School of Medicine and a spokesman for the American Heart Association. "This opens up a whole bunch of new potential opportunities for pacing a patient's heart."

Today's pacemakers maintain the heart's rhythm by sending electrical signals through wires that run from the device into the heart through a person's veins, said the study's lead author, Dr. Vivek Reddy, director of the cardiac arrhythmia service at Mount Sinai Hospital in New York City.

"These leads are the weak link for the whole system," Reddy said of the wires. The leads tend to break over time, and when they do doctors must extract and replace them.

Unfortunately, the wires sometimes grow into the wall of the vein, and laser surgery could be required to cut them free.

This new wireless pacemaker contains its own pulse generator, and is affixed directly inside the right ventricle of the heart through a catheter run up a vein from a patient's leg or groin, Reddy said. The nonsurgical procedure is faster and easier than the surgery currently required to implant a pacemaker, the researchers said.

The unit itself is smaller than a triple-A battery -- 6 millimeters in diameter and about 42 millimeters long. "The total amount of space it displaces is about 1 cc of fluid, so it's very, very small," Reddy said.

The wireless pacemaker is expected to operate for eight to 14 years before it runs out of juice, Reddy said.

The pacemaker is manufactured by Nanostim Inc., of Sunnyvale, Calif. The study was funded by Nanostim, which, according to the study, employs two of the researchers and has provided several more with grant support. Reddy also has stock options in the company.

The clinical trial for the device involved 33 patients at two hospitals in Prague and one in Amsterdam. The average age of the patients was 77, and two-thirds were men.

One patient experienced complications during the implant procedure, and this case highlights one of the potential problems with the new pacemaker, Reddy and Knight said.

Since the device must be placed inside the heart, there is a risk that the heart muscle can be torn during the procedure. That's what happened to the 33rd patient, who underwent emergency surgery to repair the tear but later died after suffering a stroke.

Two patients who successfully received the implant later developed complications.

In one patient, the pacemaker drifted into another heart chamber through a hole in the person's heart wall left by a birth defect. Doctors discovered the problem, removed the device in about six minutes and replaced it with another wireless pacemaker, according to the study.

The second patient with complications experienced fainting and rapid heart beat, and doctors ended up replacing the pacemaker with an implantable cardioverter-defibrillator.

Also, the pacemaker initially would be of limited use in the United States because it can only provide pacing to one chamber of the heart. Between 75 percent and 80 percent of patients in the United States need pacemakers that help control the rhythm of both the upper and lower chambers of their heart, Reddy said.

This wireless pacemaker would at first be useful in treating people who have atrial fibrillation -- an irregular heartbeat -- since they need pacing only in their right ventricle, Knight said. It also could help people with less severe heart problems who need only intermittent pacing.

Knight said he believes problems related to heart tears and single-chamber pacing will be resolved as newer, smaller models of wireless pacemaker become available.

"This is just the beginning," he said. "These things will get smaller and be able to be placed in multiple locations in the heart."

For example, dual-chamber pacemaking could be achieved using a pair of the wireless devices -- one in the upper atrial chamber and another in the lower ventricular chamber -- if communication is established between them to sync their pulses.

Clinical trials for the device already have begun in the United States, Reddy said. The first American received a wireless pacemaker about a month ago at Mount Sinai Hospital.

Researchers hope the device can receive approval from the U.S. Food and Drug Administration by 2016. The wireless pacemaker currently is available to patients outside the United States, Reddy said.

The medical device firm Medtronic has developed a competing wireless pacemaker, Reddy said, and clinical trials for that device started in late 2013.

Because of the competition, Reddy expects that the new pacemakers will be more expensive than current devices but not exorbitantly so.

"I'm sure they'll charge a premium in the beginning, but if there's any competition they can't charge too much more," he said.

Copyright © 2014 HealthDay. All rights reserved. SOURCES: Vivek Reddy, M.D., director, cardiac arrhythmia service, Mount Sinai Hospital, New York City; Bradley Knight, M.D., cardiologist, Northwestern University Feinberg School of Medicine, Chicago, and spokesman, American Heart Association; April 8, 2014, Circulation

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Treating Rheumatoid Arthritis Early May Cut Damaging Effects

SATURDAY, Oct. 26 (HealthDay News) -- Immediate and effective treatment for rheumatoid arthritis reduces the risk that patients will have joint damage and disability within a few years, a new study suggests.

The findings show the need for doctors to discourage patients from delaying treatment, according to the researchers at the Hospital for Special Surgery in New York City.

"We need to educate people diagnosed with rheumatoid arthritis about this. Some want to delay treatment because they are afraid. They haven't wrapped their heads around the fact that they have this disease, or they are reluctant to start taking medication. Some resort to non-medicinal approaches, many of which have limited effect," study lead investigator and rheumatologist Dr. Vivian Bykerk said in a hospital news release.

"Unfortunately, I have seen too many people delay effective treatment approaches and they come back a year later very disappointed, often with joint damage that could have been prevented. The longer you have inflammation in the joints, the more likely you are to have joint damage, and it is going to impact how you function down the road," she added.

The study included 833 patients with early rheumatoid arthritis -- defined as having symptoms for a year or less. Six months into the study, the patients were classified as having achieved low disease activity or not. Low disease activity means that joint pain, swelling and other signs of inflammation are significantly reduced.

The 56 percent of patients who achieved low disease activity at six months were much less likely to have joint damage and disability at two years, according to the findings to be presented Monday at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals in San Diego.

"We believe there is a window in which people have a much better chance of getting rheumatoid arthritis under good control, often with less intense therapy, and the window is within the first three months of developing joint inflammation," Bykerk said.

These findings show the need for doctors to warn patients about the hazards of delaying therapy and to follow patients more often in the early stages of treatment, she added.

Research presented at medical meetings is considered preliminary until published in a peer-reviewed journal.

-- Robert Preidt
Copyright © 2013 HealthDay. All rights reserved. SOURCE: Hospital for Special Surgery, news release, Oct. 26, 2013

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Early Course of HIV Therapy May Give Infants a Break From Drugs

WEDNESDAY, Aug. 21 (HealthDay News) -- Giving immediate drug therapy to HIV-infected infants for a limited period of time protects their immune system and delays the start of lifelong treatment, according to a new study.

HIV is the virus that causes AIDS.

Currently, infants who begin so-called antiretroviral therapy must continue for life. However, long-term use of the therapy increases their risk of drug-related toxicity and drug resistance, according to background information in the study published Aug. 22 in The Lancet.

"This important finding indicates we may be able to temporarily stop treatment and spare infants from some of the toxic effects of continuous [antiretroviral therapy] for a while, if we can monitor them carefully," study co-leader Mark Cotton, a professor at Stellenbosch University in South Africa, said in a journal news release.

"With [antiretroviral therapy] coverage in children currently at just 28 percent, our findings highlight the urgency of increasing early (within the first 3 months of life) testing and treatment of HIV-infected infants," he added.

The researchers looked at five years of follow-up data from 377 HIV-infected infants who, at ages 6 weeks to 12 weeks in 2005, were randomly selected to begin immediate short-term antiretroviral therapy of 40 weeks or 96 weeks, or to wait until they showed signs of illness or a weakened immune system before beginning treatment.

On average, infants in the delayed-treatment group needed to begin taking lifelong therapy 20 weeks after the start of the study. In comparison, those completing the immediate course of treatment for 40 weeks were able to then delay restarting treatment for an average 33 weeks, and those who completed the immediate course of 96 weeks of treatment were able to delay restarting treatment for an average 70 weeks, the investigators found.

By the end of the trial, nearly 20 percent of infants who were given 40 weeks of early treatment and about one-third of infants who received 96 weeks of initial antiretroviral treatment were still well enough to avoid restarting what would eventually become lifelong treatment.

The researchers also found that the delayed-treatment group had a significantly higher number of deaths and hospital admissions, and had higher health care costs than the groups of infants who received immediate, temporary antiretroviral therapy.

"Early treatment followed by a break is definitely better and more cost-effective than delaying starting infants on treatment. But we do not know if a longer initial period of treatment, or early continuous treatment, might be even better," study co-leader Dr. Avy Violari, from the University of the Witwatersrand in South Africa, said in the news release.

-- Robert Preidt
Copyright © 2013 HealthDay. All rights reserved. SOURCE: The Lancet, news release, Aug. 21, 2013

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New Cholesterol-Lowering Drug Shows Early Promise

By Steven Reinberg
HealthDay Reporter

THURSDAY, Oct. 3 (HealthDay News) -- An experimental drug that lowers LDL "bad" cholesterol by helping sweep it from the bloodstream appears to be both safe and effective in its first human trial.

The drug known as ALN-PCS reduced cholesterol an average of 40 percent in the small, early study, and, if proven to work in large trials, potentially could replace or complement statins, the researchers said.

Currently, statin drugs such as Lipitor, Crestor and Zocor are widely used to control cholesterol. One heart doctor not involved with the new study said another class of drugs might be useful.

"Cardiovascular disease remains the leading cause of death of men and women globally and reduction of LDL cholesterol with statin medications has been demonstrated to substantially reduce the risk of first or recurrent cardiovascular events," said Dr. Gregg Fonarow, a professor of cardiology at the University of California, Los Angeles.

However, while statin therapy is very effective for heart risk reduction and generally well tolerated, a substantial number of people cannot achieve ideal LDL cholesterol levels despite high statin dosing, he said. And others can't take statins at all.

"As such there is an important need to develop addition therapies to lower LDL cholesterol," Fonarow said.

The new trial demonstrated dramatic reductions in LDL cholesterol on top of statin therapy, he said, and "these agents are being further evaluated in very large randomized controlled clinical outcome trials."

The report was published Oct. 3 in the online edition of The Lancet.

In this early, phase I trial, researchers tried the drug on 32 healthy patients with mild to moderate raised low-density lipoprotein (LDL) cholesterol. Patients were randomly assigned to one of six doses of ALN-PCS or an inactive placebo.

The drug, which is given intravenously, significantly reduced cholesterol. Those given the highest dose saw an average 40 percent reduction in LDL cholesterol, the researchers found.

ALN-PCS was well tolerated, and a similar number of patients in both groups had mild to moderate side effects (79 percent compared to 88 percent), such as a temporary rash. In addition, the drug didn't cause any significant changes in liver function or inflammation, the researchers said.

The investigational drug works by blocking the production of a protein called PCSK9 that regulates cholesterol. This protein destroys LDL receptors that clear the artery-clogging cholesterol from the blood, the researchers explained.

Prior studies have shown that gene mutations that cause an increase in PCSK9 lead to increased LDL cholesterol, while gene mutations causing less PCSK9 appear to lower cholesterol. In addition, statins may actually boost levels of PCSK9, which could reduce their effectiveness, the researchers noted.

RNA interference is a process of gene "silencing" using small molecules of RNA to shut off particular genes -- for example, PCSK9.

"The next step will be larger, multi-dose studies to address the long-term safety and tolerability of ALN-PCS in various patient populations, including those on statins and those who are statin-intolerant," said study co-author Kevin Fitzgerald, senior director for research at Alnylam Pharmaceuticals, which helped develop the drug and funded the new study.

"Statins work for some patients but not for everyone," he added, and new medicines are needed "to lower LDL-cholesterol and reduce the risk of coronary artery disease."

Copyright © 2013 HealthDay. All rights reserved. SOURCES: Gregg Fonarow, M.D., professor, cardiology, University of California, Los Angeles; Kevin Fitzgerald, Ph.D., senior director of research, Alnylam Pharmaceuticals, Cambridge, Mass.; Oct. 3, 2013, The Lancet, online

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5-Drug HIV Tx Given Early Cuts Viral Reservoir (CME/CE)

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Published: Jul 2, 2013 | Updated: Jul 2, 2013

Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse PlannerNote that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.Patients with primary HIV infection receiving early treatment with five-drug highly active antiretroviral therapy (HAART) achieved lower cell-associated HIV-DNA levels and a better immune reconstitution than chronically infected patients on intensified long-term suppressive HAART.

KUALA LUMPUR -- For patients in the early stages of HIV infection, initial treatment with five antiretroviral drugs, rather than three, may be a first step toward remission, a researcher said here.

In 2-year results from a 7-year prospective trial, such intense therapy resulted in a sharp decline in HIV DNA that is integrated into cells, according to Eva Wolf, PhD, of MUC Research in Munich, Germany.

But in patients with chronic HIV infection who were also given an intensified regimen, there was no change over time in the so-called cell-associated or proviral DNA, Wolf reported at the 7th International AIDS Society Meeting on HIV Pathogenesis, Treatment, and Prevention.

The drop in proviral DNA was accompanied by a reconstitution of the immune system, Wolf told MedPage Today, and may be the first step toward remission or a "functional cure" -- the ability to control HIV replication without drug therapy.

In a French cohort of patients treated early in the course of HIV infection -- the so-called Visconti cohort -- the level of cell-associated DNA appears to be an important predictor of such a functional cure, she said.

The proviral DNA is thought to be an important part of the HIV reservoir, which forms the basis for the ability of the virus to rebound when antiretroviral therapy is stopped.

The Visconti cohort includes 14 people who were treated in the first weeks of their infection with standard antiretroviral therapy. When they later stopped therapy for various reasons, they did not have a viral rebound, although HIV was still present.

Wolf and colleagues hypothesized that intensified therapy might have a similar effect, and to test the idea, they enrolled 20 patients with primary infection as well as 20 with chronic infection, who had been on successful antiretroviral therapy for at least 3 years.

The early patients were given five drugs -- two nucleoside reverse transcriptase inhibitors, a protease inhibitor, the entry inhibitor maraviroc (Selzentry) and the integrase inhibitor raltegravir (Isentress).

The chronically infected patients remained on their stable regimen, Wolf said, with the addition of maraviroc and raltegravir.

The primary outcome measures were successful interruption of HIV replication and depletion of the proviral DNA, measured as copies per million peripheral blood mononuclear cells.

After 2 years of the study, she reported, the chronic patients had a slight but nonsignificant increase in proviral DNA. On the other hand, those with primary infection had a median decline of 1.4 log10 copies per million cells (P<0.001).

Whether that is sufficient to lead to a functional cure is an open question. Wolf said, and she and colleagues are considering "pulsed treatment" to see if there is viral rebound in the absence of antiretroviral drugs.

Outside experts, though, cautioned that intensified treatment has been tried before without a clear benefit.

First , "you can't compare the groups" because it's already known that people with chronic disease don't see a marked reduction in proviral DNA with additional therapy, commented Sharon Lewin, MD, of Monash University in Melbourne, Australia, a leader in research aimed at curing HIV.

"They've taken people with an established reservoir, added in extra drugs (and found) no change in DNA because you're already at steady state," Lewin told MedPage Today.

Meanwhile, those with primary infection already are known to have a better response even with three-drug therapy, she noted, based on a study in 2012 in Thailand.

"If you really want to say the extra drugs made a difference, you'd compare three drugs and five drugs," she said.

In fact, there is so far no evidence that so-called mega-HAART makes a difference in the size of the proviral DNA reservoir in early infection, commented John Frater, MD, PhD, of Oxford University. Frater was one of the leaders of the so-called Spartac trial that invesigated the effects of therapy in the early stages of HIV infection using three standard drugs.

That trial showed a benefit of early treatment in terms of improving immune function, and delaying the time that patients would need to go back on therapy after stopping. But it's not clear that adding drugs would have had an additional benefit, he told MedPage Today.

He and colleagues are currently planning a trial in which raltegravir will be added to standard therapy in early infection -- but not because the investigators think it will markedly affect the reservoir compared with three drugs. Instead, Frater said, they hope the rapid decline in viral replication associated with raltegravir might "tip the balance" and help limit the establishment of the reservoir.

He added it's still not known how small the reservoir of proviral DNA has to be to allow patients to go off therapy and it is still not possible to measure the size of the reservoir accurately. "The errors in our assays are enormous," he said.

The study was supported by AbbVie; Merck, Sharp & Dohme; and Pfizer/ViiV Healthcare.

Wolf made no disclosures.

Lewin has reported grant support from Gilead and Merck.

Frater has not reported recent financial links with industry.

Primary source: International AIDS Society
Source reference:
Wolf E, et al "5-drug HAART during primary HIV infection leads to a reduction of proviral DNA levels in comparison to levels achievable during chronic infection" IAS 2013; Abstract MOPE097.

North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers' Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Press International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.

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Early HIV Treatment Restores Immune System (CME/CE)

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Published: Jul 5, 2013

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.Note that this prospective cohort study demonstrated superior HIV control and CD4 counts among patient initiated on HIV therapy prior to achieving CD4 counts <500/mm3 -- adding to the potential value of earlier initiation of therapy.Be aware that the study findings may reflect inherent differences between those with higher baseline CD4 counts and those with lower baseline CD4 counts as it lacked an adequate control group.

KUALA LUMPUR -- Antiretroviral therapy can restore aspects of a normal immune system in some patients with chronic HIV, as well as reduce the size of the viral reservoir, a researcher said here.

The catch is they have to start with a relatively intact immune system, with at least 500 CD4-positive T cells per microliter of blood, according to Laurent Hocqueloux, MD, of the Centre Hospitalier Régional in Orleans, France.

But the finding, from a prospective observational cohort study, suggests such patients might be most likely to benefit from future interventional trials aimed at eradicating the virus, Hocqueloux argued at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention.

Hocqueloux and colleagues have previously shown that treatment early in HIV infection leads to a weak viral reservoir and a good restoration of the immune system.

In some patients treated very early, that has led to what the researchers are calling "post-treatment control" -- the ability to go off HIV therapy without having the virus resume growing in the body.

But, Hocqueloux said, they wondered if some patients who had reached what is considered chronic infection might also see immune restoration and a weak viral reservoir.

To find out, they studied 309 patients treated with antiretroviral drugs from 2005 through 2012 and asked what proportion would regain a normal CD4 count of at least 900 cells, a normal ratio of CD4 to CD8 cells of more than 1.0, and fewer than 2.3 log10 copies of HIV DNA per million peripheral blood mononuclear cells (PBMCs).

Patients were stratified by their lowest CD4 count before starting therapy -- fewer than 200, 200 to 499, and 500 or more.

At study entry, Hocqueloux reported none of the patients met the primary endpoint.

But after 4 years of treatment, 30% of those who started with more than 500 cells did so, compared with 7% of those in the middle category, and 2% of those in the lowest group. The trend was significant at P=0.0001.

Patients who started with 500 of more CD4 cells wound up with a median count of 1,100 cells, a CD4/CD8 ratio of 1.25, and an HIV DNA load of 2.51 log10 copies per million PBMCs.

Those who started with fewer than 500 cells were significantly worse on all three benchmarks, Hocqueloux said.

He cautioned that the study had a cohort design, had short follow-up, and still needs to be confirmed in other cohorts.

But at a minimum, the study confirms the value of early treatment, before the immune system is too badly degraded, he said. And the findings may point toward good candidates for trials of therapeutic vaccines or strategies aimed at "emptying" the viral reservoir and leading to remission.

Indeed, the study found a "very dramatic difference" between those with high and low initial CD4 counts in terms of the outcome of therapy, commented Robert Murphy, MD, of Northwestern University Feinberg School of Medicine in Chicago.

But patients who met the study's endpoint are unlikely to be able to control the virus on their own, without the aid of HIV therapy, because they are already chronically infected, Murphy told MedPage Today.

Still, he agreed with Hocqueloux that they might be the best choices for proof-of-concept studies aimed eradicating the viral reservoir, he said. "To prove the concept," he said, "you have to pick the patients most likely to succeed and these are those patients."

For that reason, he added, "this is a really, really important study."

The study was supported by the French national AIDS research agency. Hocqueloux did not make any financial disclosures.

Murphy reported financial links with Gilead.

Primary source: International AIDS Society
Source reference:
Hocqueloux L, et al "In chronically HIV-1-infected patients long-term antiretroviral therapy initiated above 500 CD4/mm3 achieves better HIV-1 reservoirs' depletion and T cell count restoration" IAS 2013; Abstract WEAB0102.

North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers' Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Press International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.

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Cardio Notes: CV Risk Tied to Early Patterns

By Chris Kaiser, Cardiology Editor, MedPage Today

Eating habits of preschool children apparently have an influence on cholesterol levels. Also in the news this week, a novel acute heart failure drugs moves quickly toward approval and statins and CRP.

Preschool Diet Impacts CV Risk Later

Eating behaviors during early childhood -- from 3 to 5 years of age -- may determine future cardiovascular risk, according to a cross-sectional study.

In 1,076 preschool-age children, each unit increase in an eating behaviors subscore, suggesting greater nutritional risk, translated into a significant increase of 0.02 mmol/L in non-HDL cholesterol, according to Navindra Persaud MD, MSc, of the University of Toronto, and colleagues.

The eating behaviors subscore was also associated with LDL cholesterol and apolipoprotein B, but not with HDL cholesterol or apolipoprotein A1, they wrote in an study published online in CMAJ.

In addition, male sex and parental body mass index were also significantly related to serum non-HDL cholesterol levels.

No other subscales of the nutritional risk questionnaire -- dietary intake, parental concern about food, screen time, or supplements -- were associated with non-HDL cholesterol levels.

"The eating behaviors subscale included whether children were allowed to decide how much they ate, whether they ate while watching television, the number of meals they ate per day, the presence of gagging or trouble swallowing while eating, and whether the child is not hungry at meal time because of frequent drinking," according to the study.

FDA Gives Serelaxin Special Approval Pathway

The FDA has granted Breakthrough Therapy designation to serelaxin (RLX030), an investigational drug for acute heart failure, according to drug maker Novartis.

Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.

The FDA based its decision on the results of the RELAX-AHF trial, which were a mixture of statistical hits and misses, and with a pattern of benefit in some prespecified efficacy endpoints.

The RELAX-AHF trial created a buzz at the 2012 American Heart Association meeting where many in attendance said the drug would be a game-changer, but others questioned some of the trial's methods.

Outflow Tract Surgery in Cardiomyopathy Safe

Adults with symptomatic hypertrophic cardiomyopathy can expect a low event rate following surgery for relief of left ventricular outflow tract obstruction, researchers found.

In 86 patients (mean age 47), the rate of death, defibrillator discharge, and resuscitated sudden death at 30 days was 0%, and at 1 and 2 years, rates were 1.5% and 3%, respectively, according to Milind Y. Desai, MD, of the Cleveland Clinic, and colleagues.

After a mean follow-up of 6.2 years, 12% of patients met the composite endpoint of death, successful resuscitation from sudden death, appropriate ICD discharges, stroke, and congestive heart failure admission.

Of these, 7% met the hard endpoint of death, appropriate ICD discharges, and revival from sudden death, researchers wrote online in Circulation: Journal of the American Heart Association.

Multivariate analysis found older age and presence of residual atrial fibrillation to be predictors of worse outcomes.

Statin-Reduced CRP Weak Signal of CV Risk

Baseline C-reactive protein (CRP) levels were more associated with future cardiovascular risk than CRP levels after initiation of statin therapy, researchers found.

During 5.5 years of following 488 people with no previous history of CV disease, LDL cholesterol levels below the median following atorvastatin therapy was associated with a relative 42% decrease in CV risk, according to Peter S. Sever, FRCP, of the Imperial College London, and colleagues.

However, the concomitant reduction in CRP levels below the median did not confer a decreased risk in CV events, researchers wrote in the study published online in Journal of the American College of Cardiology.

Even among participants who achieved LDL-C levels below the median, CV risk did not differ when their CRP levels were below or above the median.

Extended Study of Dabigatran Shows Safety

Longer-term data from the RELY-ABLE trial showed similar safety results for the oral anticoagulant dabigatran (Pradaxa) as in the pivotal RE-LY trial.

In 5,851 patients who participated in this extension study, rates of major bleeding were 3.74% and 2.99% per year for the BID 150 mg and 110 mg, respectively, not statistically different from the pivotal trial, according to Stuart J. Connolly, MD, of McMaster University and Hamilton Health Sciences in Hamilton, Canada, and colleagues.

Other bleeding metrics -- including major gastrointestinal bleeding, total bleeding, and life-threatening bleeding -- showed similar rates as in RE-LY, with as expected higher rates for 150 BID, researchers reported online in Circulation: Journal of the American Heart Association.

Rates of stroke and death also were similar between the two doses.

These results provide "additional safety information for a large cohort of patients continuing the same dose of dabigatran as assigned in the RE-LY trial," researchers wrote in conclusion.

Chris Kaiser

Cardiology Editor

Chris has written and edited for medical publications for more than 15 years. As the news editor for a United Business Media journal, he was awarded Best News Section. He has a B.A. from La Salle University and an M.A. from Villanova University. Chris is based outside of Philadelphia and is also involved with the theater as a writer, director, and occasional actor.

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