Debate: Should Every Stent Be a Drug-Eluting Stent?

Peggy Peck

September 22, 2003

Sept. 22, 2003 — The overwhelming take-home message from the 15th Transcatheter Cardiovascular Therapeutics (TCT 2003) meeting was that the drug-eluting stent (DES) continues to produce impressive results: less restenosis, less late loss, and low major adverse cardiac event rates. But during a week when all the DES news was good, the real world issue of when to use the DES — and how to pay for the expensive device — played out as a background theme that sometimes drowned out the positive DES news.

On Wednesday the issue was addressed head-on in a debate. Speaking in favor of DES for most, if not all, lesions, Antonio Columbo, MD, from Centro Coure Columbus in Milan, Italy, said he strongly believes that it is time to move from the era of bare metal stents into a new era of drug-eluting stents. "Sometimes we are asked to take a position simply for the sake of debate, but in this case I truly believe in this position," Dr. Columbo said.

He noted that percutaneous coronary interventions (PCIs) continue to have a higher "reintervention rate than surgery, but that is not the case with drug-eluting stents. I don't understand why anyone should be disturbed that we have now developed a technology that can overcome this gap between PCI and surgery."

He noted that in the "real world environment" of the Milan drug-eluting stent registry (320 patients, 722 lesions from April 2002 through January 2003), he said the Cypher stent reduced restenosis to 6% in the main branch and 18.7% in side branch compared with historical restenosis rates of 33.3% in both main and side branch with bare metal stents. Moreover, he predicted that results with drug-eluting stents such as Cypher and Taxus will improve as inventory increases and the 3.5-mm stents become available.

Yet, even as he argued for wider use of DES, Dr. Colombo said the stents should not be used for every lesion. For example, he cautioned that patients with lesions in the left anterior descending coronary artery "continue to be poor candidates for stenting."

Arguing the opposite position — that the use of drug-eluting stents in most lesions is not supported by evidence and is actually "economically irresponsible" — Dean J. Kereiakes, MD, from the Ohio Heart Center in Cincinnati, said even he was convinced that the interventional cardiology world is "on the verge of a tsunami of clinical trial data in support of DES." But he said that the tsunami has not yet arrived.

For example, that the difference in one-year mortality rates in the SIRIUS trial was small enough — 1.7% for bare metal stents and 0.9% for Cypher — that it could be wiped out by a beta error, Dr. Kereiakes said.

But he added that he did not want to "raise the specter of DES being unsafe," but rather wanted to emphasize the need to use this new technology cautiously, with careful attention to patient selection. Dr. Kereiakes noted that the economics of DES are staggering, adding that "we have had a 200% increase in cath lab expenses since we began using Cypher." And, in the U.S., those extra expenses are not likely to be covered by insurers. The latest update from Medicare projected a $46 incremental increase to cover the added cost of using DES, an amount that doesn't come close to covering the extra expenses, he said.

Dr. Colombo agreed that the economics, not clinical evidence, may prove to be the deciding factor in the use of DES. He noted that "in Milan the cost for Cypher is 1800 Euros compared to 600 Euros for a bare metal stent."

"We know we don't have unlimited resources and the economics of lives saved have already been done for us with the end-stage renal disease (ESRD) program: $50,000 per life saved is the benchmark established by ESRD," said Dr. Kereiakes. Using that $50,000 benchmark it is difficult to justify DES, because it prevents restenosis rather than saving lives. And restenosis prevention does not come cheap: some estimates suggest that thousands of drug-eluting stents are placed to prevent a single restenosis event.

But as expensive as the DES is — although the price has been dropping in the last few weeks in anticipation of the competition that will take off if the Food and Drug Administration approves Taxus, which Boston Scientific claims will be priced $1,000 less than the Cordis Corporation's Cypher stent — there is no denying the enthusiasm for DES among interventionalists.

Dr. Colombo illustrated this point by asking a packed room for a show of hands in answer to this question: who would continue to use bare metal stents if the price came down on DES. Only a single hand was raised.

TCT 2003: Concurrent Sessions — Real World Use of Drug-Eluting Stents. Presented Sept. 17, 2003.

Reviewed by Gary D. Vogin, MD