A study presented at ACC 2007 in New Orleans showed that medical devices such as stents are not more effective than medications to help heart patients extend their lives and to avoid heart attacks. In fact, the study indicated that Percutaneous coronary interventions (PCI) combined with optimal medical therapy (OMT) are not more effective than OMT alone.
During PCI, a doctor inserts a catheter into an artery in a patient’s arm or leg and advances the catheter into the coronary arteries where a balloon is inflated to clear the blockage. Usually, a stent (small, lattice-shaped, metal tube) is implanted into an artery to help keep it open. The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial enrolled 2,287 patients at 50 hospitals in the United States and Canada. The group was divided with one undergoing PCI and OMT together, while the other underwent OMT alone.
Most participants in the study were men (85 percent) and had experienced chest pain for about two years.
Results of the study showed a similar rate of death, heart attack or stroke for both groups. There were 211 primary events in the PCI group and 202 events in the medical therapy group. The 4.6-year cumulative primary rates of death or non-fatal heart attack were 19 percent and 18.5 percent in the PCI and medical therapy groups.
Hospitalization rates for acute coronary syndrome were similar for both groups as well, at 12.4 percent and 11.8 percent, respectively. There was no statistically significant difference between the rates of heart attack.
The one benefit found for the PCI group was less angina compared with the medical therapy group, suggesting that medical devices such as stents do not allow patients to live longer or reduce their chances for a heart attack, yet they do improve their symptoms and quality of life.
"Conventional wisdom would indicate that PCI and OMT together would be superior to OMT alone. Indeed, that was our initial hypothesis," said Dr. William Boden at Buffalo General Hospital/Kaleida Health in Buffalo, N.Y., lead investigator of the study, which was supported by the Department of Veterans Affairs. "But results of the COURAGE trial demonstrate that two treatments are not always better than one. These findings, along with data from recent studies of more than 5,000 patients combined, show that PCI has no impact on reducing major cardiovascular events."
The announcement of these results has had a negative impact on the shares of both Natick, Mass.-based Boston Scientific and New Brunswick, N.J.-based J &J, who both produce drug eluting stents. Both companies have come out swinging against the study’s findings.
David E. Kandzari, chief medical office of J &J’s cardiology division, criticized the study in a releases statement to physicians. “To assume that a higher use of drug-eluting stents in the study would have yielded similar results is to ignore the large body of clinical evidence that demonstrates the significant benefits of drug-eluting stents over bare-metal stents,'' said Kandzari.
Boston Scientific has also called the study flawed, with Donald Baim, the company’s chief medical officer stating that it was “entirely expected that the Courage trial would fail to prove its unlikely thesis — that stents would decrease death and heart attack by more than 20 percent, compared to drugs,'' Bloomberg reports.
The impact of the study remains to be seen. In a release from the American College of Cardiology Annual Scientific Session, the organization stated that it is unlikely that the findings will alter the approach that interventional cardiologists take in treating most patients with chronic stable angina.
"Patients with chronic stable angina represent a minority of those treated by interventional cardiologists, perhaps up to 30 percent," said SCAI President Gregory J. Dehmer, MD. "More frequently, patients treated by interventional cardiologists have heart attacks or another serious problem called unstable angina. The COURAGE study did not evaluate this type of patient; however, the study’s investigators acknowledged that PCI is the best therapy for patients suffering heart attack."
Dehmer urged those in the medical community to keep the results in the proper perspective. "We are concerned that many seem to be interpreting this study as part of a huge battle among cardiologists that will shift therapy in a dramatic way, but I don’t really see it shaping up that way. Although