ACC: 10-year coronary stent outcomes similar to bypass surgery, but less durable

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With a median follow-up of 11.3 years, 16.1% of stented patients needed a second procedure to reopen the same artery compared with 8% who had a surgical bypass. (Pixabay)

In one of the longest studies to date in high-risk heart disease, researchers found no significant difference in death rates over more than 10 years—as well as in cases of heart attack or stroke—between people that had received a drug-eluting stent for their blocked coronary artery compared with those who underwent standard bypass surgery.

The South Korean trial, known as Precombat and funded by the Cardiovascular Research Foundation, also showed that stenting was less durable in patients with left main coronary artery disease, or LMCAD, with the procedure being repeated more often.

“Our extended follow-up provides important insights on long-term outcomes, which may aid in decisionmaking about the optimal treatment strategy for patients with LMCAD,” said the study’s first author, Duk-Woo Park of the Asan Medical Center in Seoul. The trial was presented virtually at the American College of Cardiology’s annual scientific meeting, hosted together with the World Congress of Cardiology, and was also published in the journal Circulation.

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Six-hundred patients were randomly assigned to treatment with a sirolimus-eluting stent or coronary artery bypass surgery between 2004 and 2009. At the one- and five-year marks, researchers saw no significant differences between the two groups, except in retreatments.

Now, with a median follow-up of 11.3 years, 29.8% of stented patients and 24.7% of surgery patients had either died, had a heart attack or stroke or needed a second procedure to unblock the same artery—which, taken all together, did not have a statistically significant difference. But examined alone, 16.1% of stented patients needed a second procedure compared with 8% who had surgical bypass. 

Researchers described the 16-year old implants used in the study as “first-generation” drug-coated stents compared with the newer, safer ones available today. Park also said additional studies are needed to assess the 10-year outcomes of patients treated with these second-generation stents.

The 10-year Precombat trial data follow two other recently published and conflicting long-term studies comparing stents’ performance to surgery.

The five-year Excel trial, published in The New England Journal of Medicine last November, tested Abbott’s newer everolimus-eluting coronary stent, Xience, and similarly saw no significant safety differences compared with bypass graft surgery.

However, The Lancet’s December publication of data from the Noble study found that percutaneous coronary intervention with a biolimus-eluting biodegradable polymer stent was inferior to surgery after five years, with higher rates of heart attack, stroke and revascularization.

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