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April 2, 2007

Scaffolds for arteries condemned?

Study discussed at the American College of Cardiology meeting raises questions about the use of
stents for restoring blood flow to ailing hearts, a minimally invasive alternative to bypass surgery.

Will many patients opt out or delay stent treatment in the cath lab, first trying medical therapy?

This multibillion question is asked about the future of placing little metal scaffolding devices inside
the artery in the catheter lab. Dr. Salim Yusuf, a Canadian cardiologist argued that stents are
overused, questioned how much impact the study would have. “We’re going to have a hell of a
time putting the genie back in the bottle,” Dr. Yusuf said to the researchers gathered Tuesday,
March 27, 2007. “It’s a $15 billion to $20 billion industry. You have huge vested interests that are
going to push you back.”

Five years ago a randomized stent study called (COURAGE) was designed to evaluate the
efficacy of percutaneous coronary intervention (PCI) compared with optimal medical therapy
among patients with stable coronary artery disease. 2,287 patients did enroll, the mean follow-up
was 4.6 years (range 2.5 to 7.0 years) and the mean patient age was 62 years.

Wall Street is currently digesting the interpretation of the results of the study seems to be that
among patients with stable coronary artery disease, treatment with angioplasty was not
associated with a difference in death or heart attack compared with treatment with medical
therapy (medicine and change of life style). In other words: the results of the study did not speak
for any additional benefits of angioplasty and coronary stents.

Nevertheless, in common practice, many patients receive stents because they are sent to
interventional cardiologists for angiograms (X-rays of the blood vessels that feed the heart
muscle). Just like in the placement of stents, a thin catheter is inserted into the blood vessels to
deliver the angiogram dye to the damaged arteries. Many interventional cardiologists then
proceed with placing a stent right after the angiogram procedure if a major blockage is diagnosed.
The stent props open the blockage and blood can flow again to the heart muscles.

However, the COURAGE study shows that two-thirds of the patients did not need additional
treatment in form of stents or angioplasty. Furthermore, the remaining one-third of patients that
had worse symptoms and underwent stenting or bypass surgery, did not suffer higher rates of
death, heart attacks or hospitalization even if stenting was delayed.

Try optimal medical therapy first, the trial says. This result came unexpected in the minds of
many. Will it make patients think twice about stenting?

K.T.

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