Patients with diabetes and multi-vessel heart disease did better with cardiac bypass surgery than patients treating using drug-eluting stents, according to a 5-year study comparing the therapies.
The Freedom trial found that the CABG arm of the 1,900-patient study had fewer adverse events and lower mortality rates than the percutaneous coronary intervention cohort.
The stented group’s combined rate of stroke, heart attack and death was 18.7%, compared with 26.6% for the CABG group. But there were differences in the rates of stroke and death between the trial arms, with the CABG group showing a higher risk of stroke (5.2% vs. 2.4% for the PCI arm) and the stented group showing a higher all-cause mortality rate (16.3% vs. 10.9% for the CABG arm) – an advantage that persisted regardless of race, gender, number of blocked vessels or the severity of the disease, according to a press release.
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In a companion article published in New England Journal of Medicine, Dr. Mark Hlatky wrote that the Freedom trial is the latest in a series of trials dating back 17 years to show that CABG is superior to stenting in patients with diabetes and complex coronary disease.
"Mortality has been consistently reduced by CABG, as compared with PCI, in more than 4,000 patients with diabetes who have been evaluated in 13 clinical trials. The controversy should finally be settled," Hlatky wrote. "The results of the Freedom trial suggest that patients with diabetes ought to be informed about the potential survival benefit from CABG for the treatment of multivessel disease. These discussions should begin before coronary angiography in order to provide enough time for the patient to digest the information, discuss it with family members and members of the heart team, and come to an informed decision."
About 25% to 30% of patients needing CABG or stenting have diabetes and multi-vessel coronary heart disease, according to the National Heart, Lung, and Blood Institute.
Freedom could be just another word for nothing left to lose for the 3 major players in the coronary stent market, especially Boston Scientific (NYSE:BSX), which has been losing market share to rivals Abbott (NYSE:ABT) and Medtronic (NYSE:MDT).
Boston Scientific’s stent sales plunged 24.4% to $304 million during the 3rd quarter, while Medtronic’s coronary sales grew 11% to $433 million and sales of Abbott’s Xience stent and other coronary devices reached $541 million, about a 5% increase.
Michael Coyle, president of MDT’s cardiac & vascular group, said the company estimates its share of the coronary stent market at 27% and BSX CFO Jeff Cappello put his company’s share at the "mid- to high-30s," leaving about a 34%-38% share for Abbott and other, smaller players.
