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NORSTENT: DES not superior to BMS for death, MI in patients undergoing PCI
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In the largest randomized stent trial conducted to date, second-generation drug-eluting stents and contemporary bare-metal stents were associated with similar rates of death and MI, according to findings presented at the European Society of Cardiology Congress.
However, those assigned DES were less likely to have stent thrombosis or require repeat revascularization, according to the researchers, who simultaneously published the results in the New England Journal of Medicine.
Kaare Harald Bønaa, MD, PhD, from the University of Tromso – The Arctic University of Norway and the Norwegian University of Science and Technology, and colleagues randomly assigned 9,013 patients with stable angina pectoris (n = 2,636) or ACS (n = 6,377) to PCI with DES or BMS. Operators were allowed to use any stent currently available in Norway at the time.
The primary outcome was a composite of all-cause mortality and nonfatal spontaneous MI. Median follow-up was 5 years.
At 6 years, the primary outcome occurred in 16.6% of the DES group vs. 17.1% in the BMS group (HR = 0.98; 95% CI, 0.88-1.09). There were no significant differences between the group in all-cause death (HR = 1.1; 95% CI, 0.94-1.29) or in all spontaneous acute MI (HR = 0.91; 95% CI, 0.8-1.03).
Bønaa and colleagues found that the DES group had lower risk for repeat revascularization (16.5% vs. 19.8%; HR = 0.76; 95% CI, 0.85) and definite stent thrombosis (0.8% vs. 1.2%; HR = 0.64; 95% CI, 0.41-1; P = .0498) compared with the BMS group.
“As expected, the need for repeat revascularization was lowered by [DES], but this effect was much less than anticipated,” Bønaa said in a press release. “[Thirty-six] patients would need to be treated with new [DES] in order to prevent one repeat revascularization, as compared with contemporary [BMS].”
There was no difference between the groups in quality-of-life measures, according to the researchers.
The results “balance the claim by some observers that there is no longer a role for bare-metal stents in PCI,” Eric R. Bates, MD, from the division of cardiovascular diseases, department of internal medicine, University of Michigan Medical Center, Ann Arbor, wrote in a related editorial in NEJM. “And yet, the NORSTENT findings should not be surprising, because the historical evidence base in coronary stenting has shown a reduction in [major] clinical events on the basis of stent type. ... Rather, what the advances in stent technology have accomplished over the years is a decrease in rates of target-lesion revascularization because of restenosis and stent thrombosis.” – by James Clark
References:
Bønaa KH, et al. Hot Line: Coronary artery disease and stenting. Presented at: European Society of Cardiology Congress; Aug. 27-31, 2016; Rome.
Bates ER. N Engl J Med. 2016;doi:10.1056/NEJMe1610485.
Bønaa KH, et al. N Engl J Med. 2016;doi:10.1056/NEJMoa1607991.
Disclosure: Bønaa reports no relevant financial disclosures. Bates reports serving as vice chair of the American College of Cardiology/American Heart Association guidelines on PCI and receiving personal fees from WebMD.
Perspective
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Sripal Bangalore, MD, MHA
Most comparisons of DES vs. BMS have been with older-generation BMS. This study is important because it is a first-of-its-kind, large, randomized, head-to-head comparison of newer-generation DES and newer-generation thin-strut BMS.
The event rates were very low. A stent thrombosis rate of 1.2% in 6 years is extremely low. It’s a sign of the progress we have made in stent technology. Thinner struts have made a significant impact, which is great to see. Prior trials of older BMS and first-generation DES had higher stent thrombosis rates; in the SYNTAX trial, they were close to 6%.
The results are not surprising. There was a benefit with DES for reduction in revascularization and stent thrombosis, the latter of which has now been shown in various randomized trials and meta-analyses. That there was no difference between the two groups in the primary endpoint of death or MI has generated much discussion. But we have to be extremely careful in trying to interpret this. First, there were very few stent-related events. The stent can only prevent stent-related events. If 100 patients die, and stent-related deaths are a very small proportion of that, you need much more than 10,000 patients to show a difference; perhaps hundreds of thousands. Just because we didn’t see a difference here on the background of very low event rates, I don’t think we can completely rule out a difference in death or MI. Of interest, nonfatal spontaneous MI trended in favor of DES.
So the trends all point in the same direction, and the results will not prompt me to change anything in my clinical practice. These findings reinforce that there is an advantage — whether from a reduction in revascularization or stent thrombosis — of using a second-generation DES compared with a BMS.
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