Evidence must outweigh opinion

Kaitlyn Dmyterko, staff writer

“For a successful technology, reality must take precedence over public relations, for nature cannot be fooled,” said American physicist Richard P. Feynman. Likewise, successful technology must be reinforced by evidence. At last week’s 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific sessions in Washington, D.C.,the major focus surrounded stents and the comparison of drug-eluting stents and bare-metal stents to find solid outcomes.

First, the HORIZONS-AMI trial showed that use of a Taxus paclitaxel-eluting stent was just as safe as, and possibly even more effective than, a BMS at three years. Taxus stent outcomes, when compared to the Express BMS, reduced the rates of restenosis and reduced target lesion revascularization by almost 40 percent. When comparing the Taxus to the BMS, the researchers reported similar rates of death, reinfarction and stent thrombosis.

Additionally, during the APPOSITION II trial researchers found that the Stentys nitinol self-expanding stent exhibited lower rates of malapposed struts when compared to a balloon-expandable stent in acute MI patients.

After analysis, the researchers found a 10-fold reduction in the number of malapposed struts post-PCI when the self-expanding stent was used as compared to when the balloon-expanding stent was used. Additionally, no patients in the self-expanding arm experienced malapposed stents; however, the rate for the control group was 28 percent.

Also in the world of stenting, results of a Lancet study found that performing carotid endarterectomy (CEA) in patients younger than 75 can reduce 10-year stroke risk. Additionally, a meta-analysis showed that carotid artery stenting (CAS) is as safe as CEA, but only in patients under the age of 70.

And while the researchers found that overall incidence of stroke and death was higher in the CAS arm, when they readjusted for age they found the 120-day stroke and mortality risk to be comparable for both CEA and CAS in patients who were under the age of 70.

While the device industry is currently booming with new technologies, like Feynman said, the technology must be surrounded by evidence, not show. At this year’s TCT, research has provided us with hard evidence to help us understand what technologies are most optimal for the treatment of patients. We must base device use on clinical trials, rather than opinion and choice.

On these topics or others, please feel free to contact me.

Kaitlyn Dmyterko
Kdmyterko@cardiovascularbusiness.com