FDA Issues Warning About Risk from Dissolvable Stents

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Pittsburgh Tribune Review

March 23, 2017

The Food and Drug Administration has issued a letter warning about potential heart risks for people with a type of dissolvable stent that Allegheny General Hospital has implanted in patients.

The FDA letter, addressed to cardiologists, warns that the rate of heart attacks and other major cardiac events stands at 11 percent after two years for patients with the dissolving stents, versus a rate of 7.9 percent for patients with more traditional metallic stents.

AGH has recorded no adverse events in patients who have received the devices, Dr. David Lasorda, director of interventional cardiology at the hospital, wrote in an email. Allegheny Health Network announced in 2013 that AGH was participating in the ABSORB III trial, testing a device made by Illinois-based health care company Abbott Vascular Inc. Like traditional stents, the device is used to open blocked arteries, restoring blood flow to the heart. The so-called Absorb device dissolves slowly once the artery can stay open on its own.

AGH enrolled 10 patients in the trial, putting the dissolving stent in about five of them, according to Lasorda.

The FDA approved the device in July 2016 but required Abbott to follow patients for five years. The FDA letter states that adverse outcomes are more common in small heart vessels and that doctors can reduce adverse events by putting the devices in the right-sized vessels.

An Abbott news release said that when the devices were implanted in the right-sized vessels, adverse events were reported for only 9.4 percent of patients with the dissolving stents and 7 percent for the metallic stents.

Lasorda said AGH follows the trial's instructions for targeting the appropriate vessels.

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