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Editor's Note
May 21, 2019

When Can Strut Thickness Really Matter in Percutaneous Coronary Intervention?

Author Affiliations
  • 1Department of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
  • 2Associate Editor, JAMA Cardiology
  • 3Icahn School of Medicine at Mount Sinai, New York, New York
JAMA Cardiol. Published online May 21, 2019. doi:10.1001/jamacardio.2019.1902

Following the first implants of metallic stents into coronary arteries more than 3 decades ago, iterations in coronary stent technology have been rapidly progressive. However, before they are introduced into clinical practice, new coronary stents undergo a sequence of testing to establish safety and efficacy. This typically consists of extensive bench testing and preclinical evaluations, first-in-man and smaller (typically prospective observational) studies with surrogate end points, and finally a randomized clinical trial against established comparator devices. If a device can sufficiently generate evidence of safety and efficacy through that testing sequence, regulatory bodies will then typically approve the device conditional on performance of postmarket surveillance.