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Editor's Note
March 2017

The Importance of Long-term Follow-up Within Randomized Clinical Trials of Cardiovascular Devices

Author Affiliations
  • 1Division of Cardiology, Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York
  • 2Cardiovascular Research Foundation, New York, New York
  • 3Department of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois
JAMA Cardiol. 2017;2(3):277. doi:10.1001/jamacardio.2016.5209

Based on robust clinical trial evidence demonstrating their efficacy and safety, drug-eluting stents (DESs) have become the dominant device-based therapy for coronary revascularization by percutaneous coronary intervention. Historically, clinical trials examining the performance of various DES platforms have used designs with primary end-point assessments at 1 year of follow-up. This design standard has been supported by regulatory bodies such as the US Food and Drug Administration and has served as the basis for commercial approval of new DES platforms during the last decade.1 Nonetheless, longer-term and comparative clinical follow-up of these devices is critically important to understanding their longer-term efficacy and safety. As current generation DES have become more and more efficacious, particularly during short- and intermediate-term follow-up, the late safety profile of these devices can serve as an important differentiator between biologically active devices.

In this issue of JAMA Cardiology, von Birgelen et al2 report the late (5-year) follow-up of the TWENTE (Real-World Endeavor Resolute vs Xience V Drug-Eluting Stent Study in Twente) trial, a “more-comers” trial that randomized patients to treatment with 2 contemporary-generation DESs. In addition to demonstrating late efficacy and safety results within the randomized trial cohort, the authors include analyses on a cohort of patients who were eligible for randomization but were not enrolled within the randomized trial, providing further insights into the generalizability of their randomized trial findings. Commentary by Kerieakes3 provides some needed perspective on the importance of late follow-up of DES platforms used for percutaneous coronary interventions.

Critics of device-based studies (including those of DESs) often cite the limited data used for regulatory approvals of these devices. In this regard, we believe that the late results of a large, investigator-initiated, and adequately powered randomized trial with longer-term follow-up are of significant interest to the interventional cardiology community. As editors, we welcome the desire of these and other authors to bring to light longer-term follow-up comparing device efficacy and safety, particularly with contemporary generation (and clinically approved) devices such as DESs.

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Article Information

Corresponding Author: Ajay J. Kirtane, MD, SM, 161 Fort Washington Ave, Sixth Floor, New York, NY 10032 (akirtane@columbia.edu).

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kirtane reports receiving institutional research grants to Columbia University and the Cardiovascular Research Foundation from Boston Scientific, Medtronic, Abbott Vascular, Abiomed, St Jude Medical, Eli Lilly, and Edwards Lifesciences. No other disclosures were reported.

References
1.
US Food and Drug Administration. Guidance for Industry: coronary drug-eluting stents. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072193.pdf. Posted March 26, 2008. Accessed December 19, 2016.
2.
von Birgelen  C, van der Heijden  LC, Basalus  MWZ,  et al.  Five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients: a secondary analysis of a randomized clinical trial [published online January 18, 2017].  JAMA Cardiol. doi:10.1001/jamacardio.2016.5190Google Scholar
3.
Kereiakes  DJ.  The TWENTE trial in perspective: stents and stent trials in evolution [published online January 18, 2017].  JAMA Cardiol. doi:10.1001/jamacardio.2016.5208Google Scholar
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