Late adverse events after drug-eluting stent implantation.
Stents that elute antiproliferative drugs prevent restenosis after percutaneous coronary artery revascularization, reducing the need for repeat procedures. Randomized trials in low-risk patients supported initial regulatory approval for drug-eluting stents (DES). In 2006, meta-analyses of long-term outcomes from these trials associated DES use with adverse events, believed to be attributable to late stent thrombosis, occurring more than 9 months after the initial procedure. This article appraises these late adverse effects and illustrates the power and shortcomings of large national registries, focused, well-conducted clinical trials, and meta-analyses of clinical trial data. This timely, robust evidence base reflects an alignment of academic, industry, and public health priorities.
Kong
David F
DF
Duke Clinical Research Institute, DUMC Box 3850, Durham, NC 27710, USA. David.F.Kong@duke.edu
Eisenstein
Eric L
EL
Harrington
Robert
R
D015906:Angioplasty, Balloon, Coronary; D002986:Clinical Trials as Topic; D023903:Coronary Restenosis / Q000517:prevention & control; D003328:Coronary Thrombosis / Q000209:etiology*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D006801:Humans; D015201:Meta-Analysis as Topic; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D014481:United States