August 15, 2011 (Kansas City, Missouri) — Compared with 2004–2006, when drug-eluting stents (DES) were implanted in almost all patients undergoing PCI, more selective use of these devices in 2007 was cost-effective and did not increase risk of death or MI, researchers report in a study published online August 15, 2011 in Circulation .
"The simple message is that, with a very large reduction in the number of drug-eluting stents, we really saw very little falloff in clinical benefit," author Dr David J Cohen (University of Missouri, Kansas City, MO) told heartwire . "How much were we spending with the 2004–2006 strategy compared with the 2007 strategy, to get the benefit? The answer was--more than we needed to spend."
The team used data from the national Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry to compare use of DES in 2004–2006 vs 2007--before and after the US Food and Drug Administration issued an advisory statement in January 2007 cautioning about off-label use of DES. They found that use of these new devices plummeted from 92% of stents implanted to 68% of stents implanted, in the two periods.
"We were concerned that perhaps with this very large drop-off in the use of drug-eluting stents there would be a much greater increase in the rate of restenosis," said Cohen. However, the rate of revascularization procedures to treat restenosis at the same coronary artery site increased by only 1%, and the rates of death or MI were unchanged.
Current DES use is probably about the same as in 2007, he speculated. The study was not designed to determine the optimal rate of DES use.
DES for All or for a Select Few?
To examine the impact of the change from near-universal DES use to more selective use, the team compared one-year clinical outcomes and cardiovascular-related costs in 10 144 patients enrolled in the EVENT registry who underwent PCI from 2004 to 2007.
To calculate costs, they estimated that a DES cost $2287 and a bare-metal stent cost $850, based on average hospital acquisition costs in 2007.
Their study showed that "doctors were being selective in using drug-eluting stents in the later time period," Cohen noted. "They were choosing patients who had factors that predisposed them to increased risk of restenosis--that is, patients with longer lesions, smaller vessels, or diabetes and younger patients," which resulted in a more cost-effective use of these devices.
Compared with patients treated in 2004–2006, those treated in 2007 were more likely to require target lesion revascularization (5.1% vs 4.1%, p=0.03), but there were no significant differences in target vessel revascularization, repeat revascularization, death, or MI.
On average, the annual cardiovascular cost for each patient treated in the earlier period was $401 higher per patient, compared with costs for patients treated in 2007. This translates into an approximately $400-million/year cost saving with selective DES use, since nearly one million PCIs are performed every year in the US.
To Cut Care Costs, Use New Technology Wisely
This was an "elegant . . . very careful . . . important" analysis that if anything was cautious in its conclusions, said Dr Peter Groeneveld (Philadelphia VA Medical Center, PA), when asked for a comment. "If we are ever to cut down on healthcare cost growth . . . to prevent a national calamity, this is the kind of thing that needs to be looked at really carefully," he said.
"If there really was no measurable difference [in repeat restenosis] from the patient perspective, then we are really talking about money that was spent that didn't do anyone any good," he added.
"There's a long tradition in this country to permit physicians discretion and to use drugs and devices off label," Groeneveld said. "This study simply says it's fine to give physicians that discretion, but in this case, it costs the country half a billion dollars a year, and it's unclear whether that is in the long-term interest of a country that needs to cut down on its healthcare spending."
The UK and Canada have policies that limit the use of new technologies to patients who meet certain criteria. "Maybe we need to be much more directive in the use of new technologies to ensure that they aren't being used in cases where the evidence does not support their use," he concluded.
EVENT was funded by Millennium Pharmaceuticals and Schering Plough. Cohen has received research grant support from Boston Scientific, Abbott Vascular, Edwards Lifesciences, Eli Lilly/Daiichi-Sankyo, and Merck/Schering Plough and has been a consultant to Cordis, Medtronic, Eli Lilly, Merck/Schering Plough, and the Medicines Company. Disclosures for the coauthors are listed in the paper. Groeneveld reports no conflict of interest.
Heartwire from Medscape © 2011 Medscape, LLC
Cite this: Selective DES Use Saves the US $400 Million/Year - Medscape - Aug 16, 2011.