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MODEL U-SES: 3-month DAPT noninferior to standard DAPT after PCI with bioresorbable SES
SAN FRANCISCO — Among patients who underwent PCI with a bioresorbable polymer sirolimus-eluting stent, 3-month dual antiplatelet therapy was noninferior to longer DAPT, according to results from the MODEL U-SES study.
In addition, among patients who had 3-month DAPT, those who subsequently received P2Y12 inhibitor monotherapy had nearly identical outcomes to those who subsequently received aspirin monotherapy, Ken Kozuma, MD, PhD, professor of medicine at Teikyo University Hospital, Tokyo, said during a presentation at TCT 2019.
The researchers compared 1,616 patients enrolled in MODEL U-SES who were implanted with the SES (Ultimaster, Terumo) who stopped DAPT after 3 months with a control group from the CENTURY II BP-SES study of 542 patients who received the same stent but took DAPT for 1 year.
After adjustment for a propensity score subclassification, the primary endpoint of all-cause death, MI, stroke, stent thrombosis and BARC grade 3 or 5 bleeding was similar in both cohorts (MODEL U-SES, 4.3%; CENTURY II BP-SES, 5.7%; adjusted difference, –3.7; P for noninferiority < .0001), Kozuma reported.
When the researchers conducted a 90-day landmark inverse probably of treatment weighting analysis in the MODEL U-SES cohort of the primary endpoint after monotherapy began, the rate was 2.5% in both the P2Y12 monotherapy group and the aspirin monotherapy group (HR = 1.14; 95% CI, 0.58-2.22), according to the researchers.
“Recent guidelines recommend short DAPT of 3 months in high-bleeding-risk patients,” Kozuma said during the press conference. “However, short DAPT may be beneficial for any patient: High bleeding risk patients may have high ischemic risk, and low bleeding risk patients may have low thrombotic risk, so both of those types of patients may have benefit from short DAPT.”
Choice of monotherapy was made by each of the 65 centers before the study commenced.
“This study demonstrated that 3-month DAPT was noninferior to longer DAPT in clinical events, and that P2Y12 inhibitor monotherapy was almost equivalent to aspirin monotherapy after 3 months in both bleeding and thrombotic events,” Kozuma said. “Direct comparison between the two medications would be necessary to confirm the efficacy of P2Y12 inhibitor monotherapy in this population.”
The SES is not available for commercial use in the United States. – by Erik Swain
Reference:
Kozuma K, et al. Late-Breaking Science 1. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Disclosure: The study was sponsored by Terumo. Kozuma reports he receives honoraria and/or serves on advisory boards for Abbott Vascular Japan, Bayer, Boehringer Ingelheim, Boston Scientific Japan, Bristol-Myers Squibb, Daiichi Sankyo, Sanofi and Terumo.
Perspective
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This study indicates that monotherapy regimens continue to be safe, particularly with second- and third-generation DES. We can consider monotherapy sooner and more safely than ever before.
While this SES is not available in the U.S., there are others that have ultrathin struts with or without a bioresorbable polymer and look to be comparable. The limus drugs are very commonly used in these products.
These patients had DAPT discontinued after 3 months and were compared with an historical control population. Shortened DAPT was associated with less bleeding without the expense of ischemic events.
Although we want there to be a uniform answer about when we can stop DAPT after PCI, we don’t have it. There have been advances in stent technology and these products are performing better with less complications, and there are more potent P2Y12 inhibitors, so it is not clear if these gains are being driven by the evolution of antiplatelet therapy, the evolution of stents or both. We also still cannot say whether this is a class effect with P2Y12 inhibitors. We have seen positive studies with ticagrelor (Brilinta, AstraZeneca) and clopidogrel, but we are not sure if we can extrapolate to all the P2Y12 inhibitors. However, I think we can agree that the second- and third-generation DES are safer than their predecessors.