MUNICH — Percutaneous treatment of coronary stenosis with stents carries the same mortality risk as coronary bypass surgery but a significantly higher rate of later revascularization procedures, based on 5-year follow-up results from a randomized study with about 1,200 patients.
These results are the longest follow-up currently available from a study that directly compared coronary revascularization with bare-metal stents with bypass surgery, Dr. Patrick W. Serruys said at the annual congress of the European Society of Cardiology.
The finding that patients who underwent coronary revascularization by stenting had a similar rate of death during the next 5 years as patients who had bypass surgery contrasted with a report, published last year, that metaanalysis of results from several smaller studies showed that patients treated with bare-metal stents had a significantly higher rate of death, compared with those treated by surgery, said Dr. Serruys, chief of interventional cardiology at Erasmus University in Rotterdam, the Netherlands.
But although the new results showed a similar mortality risk, they also showed a clear advantage for patients treated by bypass surgery in avoiding additional revascularization procedures down the road. The stented patients also had a significantly higher rate of angina after 5 years, compared with patients who had bypass surgery.
When a patient has to choose between stenting or surgery, he or she must balance the convenience of percutaneous interventions against the increased risk of needing a second procedure, Dr. Serruys said. But some patients are afraid of invasive surgery, he noted.
The availability of drug-eluting stents, with their markedly reduced risk of restenosis, makes this decision even tougher, he added, although long-term follow-up for drug-eluting stents is not yet available.
A new study being planned will match percutaneous coronary treatment with drug-eluting stents against bypass surgery in patients with main-stem and triple-vessel disease, a situation in which the best treatment strategy is currently in doubt, he said.
The Arterial Revascularization Therapy Study began enrolling patients in April 1997 at 67 centers in Australia, Canada, Europe, New Zealand, and South America.
Two-thirds of the patients had two-vessel disease, and almost one-third had triple-vessel disease. All patients enrolled had to be considered valid candidates for both types of interventions.
After 5 years, the mortality rate was 8.0% among the 600 patients in the stent group and 7.6% among the 605 patients in the surgery group.
The rate of death, myocardial infarction, or stroke was 18.2% in the stent group and 14.9% in the surgery group, a difference that was not statistically significant. But the revascularization rate was 30.3% in the stent group and 8.8% in the surgery group, a significant difference.
The prevalence of angina 5 years after the initial treatment was 21.2% in the stent group and 15.5% in the surgery group, a statistically significant difference.
These results are limited by the fact that the enrolled patients were highly selected, excluding patients with a left ventricular ejection fraction less than 30%, commented Dr. Volkmar Falk, a heart surgeon at the University of Leipzig in Germany.
The study also involved outdated methods. Not only did it predate the availability of drug-eluting stents, but it also involved surgery that did not include current standard methods, such as off-pump surgery and bypass with two mammary arteries. In addition, 10 years of follow-up is the ideal duration for assessing patient survival over the long-term, Dr. Falk noted.