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March 30, 2020

PRECOMBAT Compares Stenting and CABG Events at 10 Years

March 30, 2020—The American College of Cardiology (ACC) announced that a study with the longest follow-up to date of patients with a high-risk of left main coronary artery disease (LMCAD) showed no significant differences in rates of death, heart attack, or stroke between patients who were treated with a stent and those who underwent coronary artery bypass graft (CABG) surgery. The study also showed that more patients receiving a stent had to have the procedure repeated during the study period.

The findings were simultaneously published online in Circulation with their presentation by Duk-Woo Park, MD, at the virtual conference of the ACC's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC). Dr. Park stated in the ACC announcement, “Our findings support the long-term safety and efficacy of stenting compared with bypass surgery after more than 10 years of follow-up in a patient population with a poor outlook.” The PRECOMBAT trial was funded by the Cardiovascular Research Foundation.

As summarized in the ACC press release, the PRECOMBAT trial was composed of 600 patients with LMCAD who were randomly assigned either to receive a drug-releasing stent or to undergo CABG at 13 medical centers in South Korea between 2004 and 2009. The average age of patients at treatment was 62.3 years, 76.5% were men, and 32% were being treated for diabetes.

The primary study endpoint was the combined occurrence of death from any cause, heart attack, stroke, or the need for a second procedure to unblock the same artery.

The trial was designed to determine whether outcomes with stenting were not worse than with CABG. The background of the study is that follow-up results at 1 year and 5 years, published in 2011 and 2015, found no significant differences between the two groups for the primary endpoint or for any of its components, except that patients treated with a stent were more likely to need a second procedure to unblock the same artery.

Dr. Park reported at ACC.20/WCC that the current study's median length of follow-up was 11.3 years. The study showed that 87 patients treated with a stent (29.8%) and 72 treated with bypass surgery (24.7%) had died, had a heart attack or stroke, or needed a second procedure to unblock the same artery, a difference that was not statistically significant. However, when the investigators looked only at the proportion of patients who required a second procedure, the difference between the groups was statistically significant, with 16.1% of patients receiving a stent needing a second procedure compared with 8% of those who had bypass surgery.

In the ACC announcement, Dr. Park advised that, whereas patients enrolled in the PRECOMBAT trial were treated with first-generation drug-coated stents, the second-generation stents being used today are both safer and more effective than the ones that were available 16 years ago when the PRECOMBAT study began. He added that additional studies are needed to assess the outcomes after 10 or more years of follow-up for patients treated with these second-generation stents.

“Our extended follow-up provides important insights on long-term outcomes, which may aid in decision-making about the optimal treatment strategy for patients with LMCAD,” commented Dr. Park. He noted that two other recently published studies comparing stenting with bypass surgery in patients with LMCAD had reached conflicting conclusions. The EXCEL trial, published in The New England Journal of Medicine in November 2019, found no significant difference in outcomes after 5 years of follow-up between patients who received stents and those who had bypass surgery. By contrast, the NOBLE trial, published in The Lancet in December 2019, found that bypass surgery was superior to stenting after 5 years of follow-up.

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