Long-term results indicate safety, efficacy of two newer-generation DES

A 5-year analysis of patients enrolled in the TWENTE trial and nonenrolled eligible patients indicated that two newer-generation drug-eluting stents are safe and effective over the long term.

In the TWENTE trial, 1,391 of 1,709 eligible patients (mean age, 65 years; 72% men), most with non-ST segment elevation ACS and complex lesions, were randomly assigned a zotarolimus-eluting stent (Resolute, Medtronic) or an everolimus-eluting stent (Xience V, Abbott Vascular). The nonenrolled patients (18.6%) underwent nonrandomized treatment with the same stents.

The outcome of interest was target vessel failure, defined as cardiac death, target vessel-related MI or target vessel revascularization, at 5 years in all eligible patients, whether enrolled or not.

Outcomes similar

The rates of TVF were 16.1% in the ZES group and 18.1% in the EES group (P = .36), Clemens von Birgelen, MD, PhD, from the department of cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente in Enschede, the Netherlands, and colleagues reported.

Clemens von Birgelen

Overall rates of definite stent thrombosis were 1% in the ZES group and 0.6% in the EES group (P = .37) and stent thrombosis after 1 year occurred in 0.4% of the ZES group and 0.6% in the DES group (P = .69), according to the researchers.

Compared with those enrolled, eligible patients who were not enrolled were older, had more advanced disease, had a higher rate of TVF (23.3% vs. 17.1%; P = .02) and had a higher rate of cardiac death (7.7% vs. 4.5%; P = .03), von Birgelen and colleagues wrote.

Trial participants and nonenrolled patients had similar rates of MI (trial group, 6.7%; nonenrolled group, 7.2%; P = .8) and TVR (trial group, 9.7%; nonenrolled group, 11.4%; P = .36), according to the researchers.

The 5-year TVF rate of the trial group and the nonenrolled group combined was 18.3%, similar to the 17.1% rate for the trial group alone.

Dean J. Kereiakes

Valuable data

“The TWENTE trial investigators have set a high bar for future randomized clinical trials from the perspectives of DES trial design,” Dean J. Kereiakes, MD, medical director at the Christ Hospital Heart and Vascular Center and the Carl and Edyth Lindner Research Center, Cincinnati, and a Cardiology Today’s Intervention Editorial Board member, wrote in a related editorial. “The use of a more-comers population with protocol-driven follow-up of nonenrolled, eligible patients, combined with longer-term (5-year) follow-up, provides invaluable insights into absolute and relative efficacy and safety of these devices over time.”

Ajay J. Kirtane

In an Editor’s Note, Ajay J. Kirtane, MD, SM, director of the cath lab at NewYork-Presbyterian Hospital/Columbia University, associate professor of medicine at Columbia, co-director of Transcatheter Cardiovascular Therapeutics for the Cardiovascular Research Foundation, associate editor of JAMA Cardiology and a Cardiology Today’s Intervention Editorial Board member, and Robert O. Bonow, MD, Max and Lilly Goldberg Distinguished Professor of Cardiology at Northwestern University Feinberg School of Medicine and editor of JAMA Cardiology, wrote: “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 DES.” – by Erik Swain

Robert O. Bonow

References:

Kereiakes DJ. JAMA Cardiol. 2017;doi:10.1001/jamacardio.2016.5208.

Kirtane AJ, Bonow RO. JAMA Cardiol. 2017;doi:10.1001/jamacardio.2016.5209.

von Birgelen C, et al. JAMA Cardiol. 2017;doi:10.1001/jamacardio.2016.5190.

Disclosure: The study was initiated by the investigators and supported by grants from Abbott Vascular, AstraZeneca, Biotronik, Boston Scientific and Medtronic. von Birgelen reports unpaid consulting for Boston Scientific and Medtronic, receiving a speaker’s honorarium from AstraZeneca and Biotronik and serving as principal investigator of the TWENTE trials. The other researchers and Bonow report no relevant financial disclosures. Kereiakes reports consulting for Abbott Vascular, Boston Scientific, Micell Technologies, Sino Medical Sciences Technology and Svelte Medical Systems. Kirtane reports receiving institutional research grants from Abbott Vascular, Abiomed, Boston Scientific, Edwards Lifesciences, Eli Lilly, Medtronic and St. Jude Medical.