ROME — Bare metal stents (BMS) and drug-eluting stents (DES) were neck and neck for several key clinical outcomes in the long run, according to the NORSTENT trialists.
Six years after stenting, the odds of composite of all-cause death and non-fatal myocardial infarction (MI) were similar between BMS and DES recipients (17.1% versus 16.6%, HR 0.98, 95% CI 0.88 to 1.09).
No significant differences were observed for either individual endpoint, either, reported Kaare H. Bønaa, MD, PhD, of St. Olav’s University Hospital in Norway, at the European Society of Cardiology (ESC) annual meeting. His data were simultaneously published in the New England Journal of Medicine.
Also tied between BMS and DES were rates of:
- Bleeding (5.6% versus 5.5%, HR 0.99, 95% CI 0.82 to 1.18)
- Hospitalization for unstable angina (5.7% versus 5.2%, HR 0.89, 95% CI 0.74 to 1.07), and
- Cardiac death (3.0% versus 2.6%, HR 1.06, 95% CI 0.80 to 1.39)
“BMS is safe but DES is also safe,” Bønaa said in a press conference, adding that even quality of life was deemed similar between groups at 6 years.
“The results of this important trial should increase confidence in choosing to implant BMS in selected patients if clinical indications favor that decision and should support guideline recommendations endorsing that option,” concluded Eric R. Bates, MD, of University of Michigan Medical Center in Ann Arbor, in an accompanying editorial.
According to Bates, BMS remains an important option for: patients with a large vessel diameter in whom restenosis rates are low; those who cannot complete the longer duration of dual-antiplatelet therapy recommended for DES; individuals who cannot pay for DES or a longer duration of dual-antiplatelet therapy because of increased cost, and patients at increased risk for bleeding.
Nevertheless, the Bønaa data did show that DES edged out BMS with a lower frequency of repeat revascularization (19.8% versus 16.5%, HR 0.76, 95% CI 0.69 to 0.85), including target lesion revascularization (10.3% versus 5.3%, HR 0.47, 95% CI 0.40 to 0.56). Definite stent thrombosis was also more likely in BMS recipients (1.2% versus 0.8%, HR 0.64, 95% CI 0.41 to 1.00).
The investigators determined that 30 patients would have to receive DES in lieu of BMS in order to prevent one repeat revascularization, which Bønaa said is “higher than what we thought.”
Even so, the fewer rehospitalizations and repeat interventions would balance the cost between the cheaper BMS and the pricier DES, he suggested, pending further investigation into the cost-effectiveness of the two strategies.
The fact remains that BMS is inferior in terms of restenosis and stent thrombosis, emphasized Francois Schiele, MD, PhD, of University Hospital of Besançon, France. “This is exactly the reason why we choose DES in the first place,” the spokesperson for the ESC told MedPage Today.
Investigators randomized 9,013 patients with coronary artery disease to stenting with BMS or DES (95% of the latter received everolimus- or zotarolimus-eluting devices) from 2008 to 2011. Participant data came from 8 Norwegian centers.
One unanswered question for Schiele was the impact of platform evolution over the course of NORSTENT enrollment.
“We don’t know if the differences between BMS and DES are due to the change in the drug or the platform,” he said.
Bønaa disclosed no competing interests.
Bates reported receiving personal fees from WebMD and serving as Vice Chair on the ACC/AHA guidelines on PCI.
New England Journal of Medicine
Bønaa KH, et al “Drug-eluting or bare-metal stents for coronary artery disease (NORSTENT)” N Engl J Med 2016; DOI: 10.1056/NEJMoa1607991.
New England Journal of Medicine
Bates ER “Balancing the evidence base on coronary stents” N Engl J Med 2016; DOI: 10.1056/NEJMe1610485.