For diabetics, bypass beats stents in massive 5-year study

An NIH-funded study could end up inflicting a major hit on stent sales over time. The 5-year effort that scrutinized 1,900 patients concludes that bypass surgery beats drug-eluting stents in diabetic patients who suffer from multiple diseased arteries.

Reuters and MedPage Today are among the many news outlets that picked up the story regarding the FREEDOM trial results, which broke at the American Heart Association meeting over the weekend and are published in the New England Journal of Medicine. A second analysis presented at the conference likely gave stent makers even more anxiety, concluding that bypass surgery is far more cost effective over time compared to stents (MedPage Today outlines those details).

Those two findings amount to a collective "ouch" for medical device companies struggling to keep stent sales growing and viable in the face of a number of obstacles. Johnson & Johnson ($JNJ) and Boston Scientific ($BSX) supplied the stents for the study. But as Reuters notes, J&J has since left the stent business, choosing to focus on more lucrative device areas, underscoring the steep competition and challenges stent companies continue to face in growing their businesses.

Diabetes patients faced a 30% smaller risk of death, heart attack or stroke over the 5-year study compared to patients with stents, the articles note. About 26.6% of stent patients faced a combined rate of the stated complications, compared to 18.7% of patients who had the bypass surgery. The results build on previous work that said bypass surgery beats bare metal stents in preventing arteries from re-clogging. One check mark for bypass surgery, as noted by Reuters: Bypass patients did face more strokes.

Some observers said the data was significant enough to alter clinical practice. That, combined with the cost-effectiveness analysis, could change practice even further. As MedPage Today explains, bypass surgery has much higher upfront costs. But the procedure gains an edge over stents over the 5-year period because the stent patients needed more repeat revascularizations, which made their use ultimately far more expansive.

- read the Reuters story
- here's MedPage Today's coverage
- check out the NEJM study abstract