NORSTENT: Drug-Eluting, Bare-Metal Coronary Stents Similar for Survival

Marlene Busko

August 31, 2016

ROME, ITALY — The largest trial to compare contemporary bare-metal stents with modern drug-eluting stents (DES) for PCI found that patients who received the DES did not gain an advantage for the primary end point of MI-free survival at 6 years compared with patients who received the bare-metal stent[1].

However, in the Norwegian Coronary Stent Trial (NORSTENT) trial with >9000 patients, those treated with DES had a significantly reduced risk of repeat revascularization of any kind and of target-lesion revascularization (TLR).

The trial showed that "patients treated with DES do not live longer or better than patients treated with a bare-metal stent, and the long-term benefit of a contemporary DES over a bare-metal stent was somewhat less than expected," according to NORSTENT investigator Dr Kaare Harald Bønaa (St Olav's University Hospital, Trondheim, Norway).

Dr Kaare Harald Bønaa

Bønaa made his remarks at a press briefing prior to presenting the trial here the European Society of Cardiology (ESC) 2016 Congress; he is also lead author on the study article simultaneously published in the New England Journal of Medicine.

Despite perceptions that DES are broadly superior to bare-metal stents for PCI, the current findings make sense because earlier evidence for DES superiority for mortality and morbidity aren't very solid, according to some observers, at least not as solid as some of the more famous buildings in the Eternal City, which hosted the ESC sessions.

After Bønaa's presentation, assigned discussant Dr Stefan K James (Uppsala University Hospital, Sweden) said that the trial indicates that new-generation DES should still be recommended over bare-metal stents since they perform better in terms of revascularization, and bare-metal stents should not be recommended for patients who have a high risk of stent thrombosis or do not tolerate dual antiplatelet therapy (DAPT).

DES Performing as Expected?

These findings "will generate headlines," cochair of the press briefing Prof Andreas Baumbach (University of Bristol, UK) predicted to heartwire from Medscape. "For a while we thought that with drug-eluting stents you even get a mortality benefit, which wasn't shown here," he said.

"But let's remember, DES were created to reduce revascularization, and they do it. If I were a patient I'd still want to have one, because there's no downside to it," he said, although clinicians still need to be aware that certain patients may not be suitable candidates.

In an accompanying editorial[2], Dr Eric R Bates (University of Michigan Medical Center, Ann Arbor) agreed that the NORSTENT findings "should not be surprising," since previous evidence from trials of coronary stenting by stent type, DES vs bare-metal stent, failed to show improved survival or lower rates of MI, stroke, or hospitalization for angina, although they did show decreased revascularization.

NORSTENT is also important since it demonstrates that there is still a role for a contemporary bare-metal stents, according to Bates. "The results of this important trial should increase confidence in choosing to implant bare-metal stents in selected patients if clinical indications favor that decision and should support guideline recommendations endorsing that option."

The 2014 ESC/EACTS guidelines on myocardial revascularization state that "compared with bare-metal stents and early-generation DES, new-generation DES have also improved safety outcomes, including death, myocardial infarction, and stent thrombosis," Bønaa told the press.

However, "the evidence in favor of the newer stents over contemporary bare-metal stents may not be as strong as has been thought," he said, as it is based on small trials or indirect comparisons with older bare-metal stents.

Investigator-Initiated, Independently Funded

NORSTENT was described as investigator-initiated and funded by a not-for-profit organization and conducted in a real-world patient-care setting and as aiming to compare longer-term outcomes with modern versions of these two types of stents.

From 2008 to 2011, the trial randomized 9123 patients to receive a bare-metal stent (n=4509) or a DES (n=4504). Almost all patients (95% of patients) received a newer-generation DES, specifically Promus (Boston Scientific) (67% of patients), Xience (Abbott Vascular) (16%), or Endeavor Resolute (Medtronic) (12%).

The patients were required to have stable CAD or ACS, no previous stent, no bifurcation requiring two stents, and no contraindications to DAPT or anticoagulation therapy. They had a mean age of 63, and 75% were male.

After a median of 6 years, the rate of the composite primary outcome of all-cause death or spontaneous MI was similar in both groups: 16.6% in the DES group vs 17.1% in the bare-metal stent group (HR 0.98; 95% CI 0.88–1.09; P=0.66).

Patients in both groups also reported similar improvements in physical limitations, angina frequency, and quality of life at 6 months, which then remained stable throughout follow-up—based on replies to the Seattle Angina Questionnaire.

On the other hand, patients who received a DES vs bare-metal stent had lower rates of target-lesion revascularization (5.3% vs 10.3%, respectively; P<0.001) and any revascularization (16.5% vs 19.8%, respectively; P<0.001). The rate of definite stent thrombosis was  significantly lower in the DES group (0.8% vs 1.2%, respectively; P=0.0498).

Bare-Metal Stent Still Can Be an "Important Option"

The findings form NORSTENT "are important because they balance the claim by some observers that there is no longer a role for bare-metal stents in PCI because of the superiority of their drug-eluting counterparts," according to Bates.

Like the others, he agrees that "outcomes with second-generation DES make them preferred in most clinical situations," and he adds that recent recommendations for shorter-duration DAPT "make that choice even more attractive."

Nevertheless, "bare-metal stents remain an important option for PCI in some patients, " Bates notes, specifying that these include "patients with a large vessel diameter in whom restenosis rates are low, those who cannot complete the longer duration of [DAPT] recommended for [DES] because of noncompliance or need for noncardiac surgery, those who cannot pay for [DES] or a longer duration of [DAPT] because of increased cost, and those at increased risk for bleeding (eg, patients with recent bleeding or a need for concomitant anticoagulation therapy)."

Baumbach has no relevant financial relationships. Bønaa reports grant support from the Norwegian Research Council, the Northern Norway Health Authority, UiT–the Arctic University of Norway, the Western Norway Regional Health Authority, the Norwegian Council on Cardiovascular Disease, and St Olav's University Hospital and nonfinancial support from Northern Norway University Hospital, Haukeland University Hospital, Stavanger University Hospital, Sørlandet Hospital, Oslo University Hospital, and Feiring Heart Clinic during the conduct of the study. Disclosures for the coauthors are listed on the journal website. Bates reports personal fees from WebMD outside the submitted work. He is also vice chair, ACC/AHA guidelines on PCI.

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