Analysis of drug-eluting stents data demonstrates safety, efficacy in on-and-off-label use

Jun 16, 2009

The 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and off-label) DES use to date and incorporates an overview of both the published literature as well as several unpublished studies presented at major cardiovascular meetings.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.

Source: Cardiovascular Research Foundation

Explore further: UN Ebola victim leaves France after recovery

add to favorites email to friend print save as pdf

Related Stories

Better patient outcomes with drug eluting stents

Dec 18, 2008

Patients receiving drug eluting stents (DES) — stents coated with medication to prevent narrowing of the artery — as part of an angioplasty had better outcomes one year later than patients with bare metal stents, according ...

Recommended for you

US looking past Ebola to prepare for next outbreak

6 hours ago

The next Ebola or the next SARS. Maybe even the next HIV. Even before the Ebola epidemic in West Africa is brought under control, U.S. public health officials are girding for the next health disaster.

Can robots help stop the Ebola outbreak?

15 hours ago

The US military has enlisted a new germ-killing weapon in the fight against Ebola—a four-wheeled robot that can disinfect a room in minutes with pulses of ultraviolet light.

New bird flu case in Germany

15 hours ago

A worrying new strain of bird flu has been observed for the first time in a wild bird in northern Germany, the agriculture ministry said Saturday.

Mali announces new Ebola case

Nov 22, 2014

Mali announced Saturday a new case of Ebola in a man who is fighting for his life in an intensive care unit in the capital Bamako.

Plague outbreak kills 40 in Madagascar: WHO

Nov 22, 2014

An outbreak of plague has killed 40 people in Madagascar, the World Health Organization said, warning that the disease could spread rapidly in the country's densely populated capital Antananarivo.

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.