Are Biodegradable Heart Stents Safe?
Resorbable Stents Appear Safe in 10 Year Follow-up of 50 Heart Patients
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Biodegradable Stents: Study Details continued...
Among the results:
- The survival rate was 98% for heart-related death.
- The survival rate was 87% for death from all causes.
- Half the patients did not have a major cardiac complication.
- Four patients had heart attacks.
- One year after getting their stent, the affected blood vessel had re-narrowed in 16% of patients.
- Two definite clots were found within the stents. One was related to a drug-coated stent implanted close to the biodegradable stent.
Keiji Igaki, PhD, invented and developed the new stent. He is a co-author on the study, but he had no input on the data analysis.
Biodegradable stents are already used in nine European Union countries and Turkey to treat peripheral artery disease. No countries yet have approved the resorbable stents developed by Igaki for heart arteries.
Biodegradable stents cost more, Kosuga tells WebMD. "The cost of manufacturing is about 10% higher than that of the metallic stent," he says.
Biodegradable Stents: Perspective
"These stents actually look safe," says Vincent Bufalino, MD, a spokesman for the American Heart Association and director of cardiology at Advocate Cardiovascular Institute in Chicago. The new report, he tells WebMD, ''gives us some comfort and a long view of these patients."
However, he says, the rate of re-narrowing found, 16%, is about twice that of metal drug-coated stents.
If the biodegradable stent becomes available, it could reduce the need for the blood-thinning drugs used now, Garratt says.
With the metal stents, "we think the blood clot risk falls off fairly steeply after two or three years. It's not clear if the risk ever goes to zero," Garratt says.
Garratt has served as speaker for Abbott Vascular and for Boston Scientific, which also makes heart stents.