Cardiologists were excited when an absorbable, dissolvable stent hit the market last year, but that attitude is fading a bit. An FDA study shows that patients with it have higher rates of heart attack and thrombosis. But, one doctor says he's standing by the new technology when it’s used by the right practitioners in the right patients.
Sixty-three-year-old Charles Tasso was at his dialysis center when his heart went into a-fib.
“I mean, I thought it was an elephant sitting on my chest. That’s the first time I had experienced any pain," he says.
Doctor Michael Chan used the Absorb Stent for Charles, who already has traditional metal stents. It’s made of polylactide, which is similar to what’s in dissolvable stitches. The stent dissolves in three years, so the artery is flexible again.
Dr. Chan says, “It allows us to theoretically have less inflammation. Because of that, it also reduces the risk of clot formation that can form late on stents because of that metal exposure.”
But, an FDA review showed an eleven percent rate of cardiac problems like heart attack and a 1.9 percent rate of blood clots after two years with the absorb stent. This compares with 7.9 percent and .08 percent with a metal stent. Abbott Labs and Doctor Chan say the right implantation technique and the right patients minimize risk.
“I think that if it’s not used in the proper setting, then the risks are higher. We’ve seen that in smaller vessels that the heart attack risk as you mentioned, and risks of clotting are higher," Dr. Chan says.
He says nineteen percent of people in the study had arteries that are too small for the device under usage guidelines. Removing their results equalizes findings.
Dr. Chan adds, "As technology evolves, there are many in our field that feel like this will be the next generation.”
Doctor Chan will keep using the Absorb Stent on patients who fit the stricter criteria, while the FDA DOES more study.
In May, Abbott Laboratories restricted use of the Absorb Stent to clinical use at select sites while it monitors implantation techniques and training. Some cardiac facilities in the U.S. have stopped using the stent until more study is done. By the way, Doctor Chan has no financial interest in the stent or Abbott Labs.