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Analysis of drug-eluting stents data demonstrates safety, efficacy in on-and-off-label use
June 17, 2009The Cardiovascular Research Foundation (CRF) announced that results of the largest meta-analysis to date comparing mortality rates for drug-eluting stents (DES) versus bare metal stents (BMS) were published online June 15 in the journal Circulation. The study also compared the rates of myocardial infarction (MI) and target vessel revascularization (TVR).
The analysis-which includes approximately 190,000 patients from 56 studies-was performed by a team of researchers led by Ajay J. Kirtane, MD, Assistant Professor of Clinical Medicine at Columbia University College of Physicians and Surgeons; and an interventional cardiologist at NewYork-Presbyterian Hospital/Columbia University Medical Center; and Gregg W. Stone, MD, Immediate Past Chairman of the Cardiovascular Research Foundation; Professor of Medicine at Columbia University College of Physicians and Surgeons; and Director of Cardiovascular Research and Education in the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center.
Drs. Kirtane and Stone conducted two parallel meta-analyses examining DES vs. BMS use in both randomized, controlled trials and in observational registry analyses. The overall analysis represents the largest systematic overview of "real-world" (comprising both on-label and off-label) DES use to date and incorporates an overview of both the published literature as well as several unpublished studies presented at major cardiovascular meetings.
"The findings from these parallel studies are striking," said Dr. Stone.
The meta-analysis of 22 randomized trials included more than 9,000 patients with recent follow-up from previously published trials. According to the results, "DES resulted in no overall differences in death and MI, with a greater than 50% decrease in subsequent target vessel revascularization procedures," said Dr. Stone, adding that these findings are consistent with both on-label and off-label use of DES.
And in the 34-study observational meta-analysis (involving more than 180,000 "real-world" patients), "DES resulted in significant 22% and 13% reductions in death and MI, respectively, with a similar reduction in TVR (46%) as in the randomized trials, even after adjustment for confounding variables," said Dr. Stone. "These data are reassuring that DES are safe and effective for a wide-range of patients that are able to take dual antiplatelet therapy for at least one year."
The findings were consistent and robust across a variety of study designs; trials that were included were required to follow patients for at least one year.
Dr. Kirtane remarked that these findings should help to reassure patients and physicians about the safety of DES in off-label use.
"One of the interesting aspects of this analysis is that it points to significant differences between results obtained from randomized trials and observational analyses. Nonetheless, even with the stated limitations of observational data, the bottom line from both randomized trials and observational analyses is consistent: we can reduce the need for repeat procedures and we do not appear to be harming patients with DES," he added.
Cardiovascular Research Foundation
"The findings from these parallel studies are striking," said Dr. Stone.
The meta-analysis of 22 randomized trials included more than 9,000 patients with recent follow-up from previously published trials. According to the results, "DES resulted in no overall differences in death and MI, with a greater than 50% decrease in subsequent target vessel revascularization procedures," said Dr. Stone, adding that these findings are consistent with both on-label and off-label use of DES.
And in the 34-study observational meta-analysis (involving more than 180,000 "real-world" patients), "DES resulted in significant 22% and 13% reductions in death and MI, respectively, with a similar reduction in TVR (46%) as in the randomized trials, even after adjustment for confounding variables," said Dr. Stone. "These data are reassuring that DES are safe and effective for a wide-range of patients that are able to take dual antiplatelet therapy for at least one year."
The findings were consistent and robust across a variety of study designs; trials that were included were required to follow patients for at least one year.
Dr. Kirtane remarked that these findings should help to reassure patients and physicians about the safety of DES in off-label use.
"One of the interesting aspects of this analysis is that it points to significant differences between results obtained from randomized trials and observational analyses. Nonetheless, even with the stated limitations of observational data, the bottom line from both randomized trials and observational analyses is consistent: we can reduce the need for repeat procedures and we do not appear to be harming patients with DES," he added.
Cardiovascular Research Foundation
Cardiovascular Current Events and Cardiovascular News RSSPivotal study for PSD502 -- the first potential treatment for premature ejaculation
At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora" - AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).
Night Beat, Overtime and a Disrupted Sleep Pattern Can Harm Officers' Health
A police officer who works the night shift, typically from 8 p.m. to 4 a.m., already is at a disadvantage when it comes to getting a good "night's" sleep.
Your Own Stem Cells Can Treat Heart Disease
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
At-risk college students reduce HBP, anxiety, depression through Transcendental Meditation
The Transcendental Meditation technique may be an effective method to reduce blood pressure, anxiety, depression, and anger among at-risk college students, according to a new study to be published in the American Journal of Hypertension, December 2009.
Vitamin B niacin offers no extra benefit to statin therapy in seniors already diagnosed with CAD
The routine prescription of extended-release niacin, a B vitamin (1,500 milligrams daily), in combination with traditional cholesterol-lowering therapy offers no extra benefit in correcting arterial narrowing and diminishing plaque buildup in seniors who already have coronary artery disease, a new vascular imaging study from Johns Hopkins experts shows.
Fat collections linked to decreased heart function
Researchers from Boston University School of Medicine (BUSM) have shown that fat collection in different body locations, such as around the heart and the aorta and within the liver, are associated with certain decreased heart functions.
Thoughtful words help couples stay fighting fit
Couples who bring thoughtful words to a fight release lower amounts of stress-related proteins, suggesting that rational communication between partners can ease the impact of marital conflict on the immune system.
Protein changes in heart strengthen link between Alzheimer's disease and chronic heart failure
A team of U.S., Canadian and Italian scientists led by researchers at Johns Hopkins report evidence from studies in animals and humans supporting a link between Alzheimer's disease and chronic heart failure, two of the 10 leading causes of death in the United States.
Heart and bone damage from low vitamin D tied to declines in sex hormones
Researchers at Johns Hopkins are reporting what is believed to be the first conclusive evidence in men that the long-term ill effects of vitamin D deficiency are amplified by lower levels of the key sex hormone estrogen, but not testosterone.
New study links vitamin D deficiency to cardiovascular disease and death
While mothers have known that feeding their kids milk builds strong bones, a new study by researchers at the Heart Institute at Intermountain Medical Center in Salt Lake City suggests that Vitamin D contributes to a strong and healthy heart as well - and that inadequate levels of the vitamin may significantly increase a person's risk of stroke, heart disease, and death, even among people who've never had heart disease.
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