Less efficacy than expected in largest drug-eluting stent trial

August 30, 2016

Rome, Italy 30 August 2016: New generation drug eluting stents (new DES) did not outshine contemporary bare metal stents (BMS) as they were expected to, in a surprise finding of the largest randomized stent trial to date.

The Norwegian Coronary Stent Trial (NorStent), presented at ESC Congress 2016, and published simultaneously in the New England Journal of Medicine, "demonstrates that the efficacy of new DES versus contemporary BMS is lower than expected," noted Kaare Harald Bonaa, MD, PhD, in a Hot Line session here.

"Patients treated with DES do not live longer and they do not live better than patients treated with BMS."

"Although ESC guidelines recommend new DES over BMS as default for coronary revascularization, this recommendation may need to be modified in light of the NorStent findings," he added. "Both stent types may be recommended."

With 9,013 patients and more than 40,000 patient years of follow-up, NorStent is an all-comers study in a usual care setting "and therefore has the potential to yield outcomes of great relevance to clinical practice," added Prof Bonaa from University of Tromso - The Arctic University of Norway, and the Norwegian University of Science and Technology, Trondheim.

The multi-centre study included patients with stable angina pectoris (n=2636) or acute coronary syndromes (n=6377) who needed percutaneous coronary intervention.

Patients were randomized to receive either BMS or DES, with 83% of DES patients receiving everolimus-eluting stents and 12% receiving zotarolimus-eluting stents.

After 6 years of follow-up there was no significant difference between the DES and the BMS groups in the primary outcome of total mortality or nonfatal myocardial infarction (cumulative rate of 16.9% in the DES group vs 17.4% in the BMS group; HR 0.98), as well as secondary outcomes of unstable angina, or quality of life.

"As expected, the need for repeat revascularization was lowered by DES, but this effect was less than anticipated," noted Prof Bonaa. "The 6 year cumulative rate of repeat revascularization was 16.5 % in the DES group vs. 19.8 % in the BMS group - an absolute risk reduction of 3.3 %. On the basis of this analysis, 30 patients would need to be treated with new DES in order to prevent one repeat revascularization, as compared with contemporary BMS. This figure is 2-fold higher than previously reported."
Notes to editors

Sources of funding: The trial was investigator initiated and funded by the Norwegian Research Council and other Norwegian not-for-profit organizations.

Disclosures: Prof Bonaa reports no conflicts of interest.

ESC Press Office

For background information, please contact the ESC Press Office at media@escardio.org.

For press enquiries, please contact, the Media & Press Coordinator, Jacques Olivier Costa: +393427028575

For independent comment on site, please contact the ESC Spokesperson coordinator, Celine Colas: +393402405148

To access all the scientific resources from the sessions during the congress, visit ESC Congress 365.

About the European Society of Cardiology

The European Society of Cardiology brings together health care professionals from more than 120 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.

About ESC Congress 2016

ESC Congress is the world's largest gathering of cardiovascular professionals contributing to global awareness of the latest clinical trials and breakthrough discoveries. ESC Congress 2016 takes place 27 to 31 August at the Fiera di Roma in Rome, Italy. The scientific programme is here. More information is available from the ESC Press Office at press@escardio.org

This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2016. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.

European Society of Cardiology

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