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March 29, 2025
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Key takeaways:
Dual antiplatelet therapy for 1 month was inferior to 3 months for patients with high bleeding risk after PCI.
DAPT for 3 months was superior to 12 months for patients with low bleeding risk.
CHICAGO — Three months of dual antiplatelet therapy after PCI may safely balance thrombosis and bleeding risk in both patients with low and high bleeding risk, compared with 1 and 12 months of DAPT, according to new data.
To evaluate the impact of bleeding risk on DAPT duration after PCI, Hyo-Soo Kim, MD, PhD, professor of internal medicine at Seoul National University Hospital in South Korea, and colleagues conducted the HOST-BR trial. Results were presented at the American College of Cardiology Scientific Session.
Dual antiplatelet therapy for 1 month was inferior to 3 months for patients with high bleeding risk after PCI. Image: Adobe Stock
“This is the first randomized study to stratify patients according to bleeding based on the [Academic Research Consortium for High Bleeding Risk] definition and to test different durations of DAPT in either high bleeding risk or low bleeding risk populations,” Kim said during a press conference.
The trial had three primary endpoints (in hierarchical order): net adverse clinical events (NACE), which included all-cause death, MI, stent thrombosis, stroke and major bleeding; major adverse CV and cerebrovascular events (MACCE), which included CVD, MI, stent thrombosis and ischemic stroke; and Bleeding Academic Research Consortium (BARC) types 2, 3 or 5.
The trial enrolled 4,897 patients who underwent PCI with a drug-eluting stent (Xience, Abbott; Onyx, Medtronic). The most common reason for PCI with DES was stable CAD, followed by unstable angina, non-STEMI and STEMI, according to the presentation.
Patients were stratified based on bleeding risk, determined using the Academic Research Consortium for High Bleeding Risk criteria. Patients at high bleeding risk (mean age, 74 years; 34% women) were randomly assigned to DAPT for 1 or 3 months. Patients at low bleeding risk (mean age, 63 years; 20.9% women) were randomly assigned to DAPT for 3 or 12 months.
At 1 year, among patients with high bleeding risk, 1-month DAPT compared with 3-month DAPT was associated with increased risk for NACE (HR = 1.34; 95% CI, 1.04-1.71; P = .022; P for noninferiority = .818) and MACCE (HR = 1.72; 95% CI, 1.19-2.5; P = .004; P for noninferiority = .964). The researchers reported no significant difference in BARC types 2, 3 or 5 with 1 or 3 months of DAPT (HR = 0.85; 95% CI, 0.66-1.11; P = .232).
At 1 year, among patients with low bleeding risk, 3-month DAPT compared with 12-month DAPT was associated with similar outcomes for NACE (HR = 0.66; 95% CI, 0.46-0.95; P = .025; P for noninferiority < .001) and MACCE (HR = 0.98, 95% CI, 0.62-1.56; P = .95; P for noninferiority = .008), but significantly reduced BARC types 2, 3 or 5 (HR = 0.63; 95% CI, 0.5-0.79; P < .001), according to the results.“
For high-risk patients, 1-month DAPT did not meet noninferiority to 3-month DAPT for NACE. One-month DAPT was actually inferior to 3-month DAPT for NACE and MACCE at 1 year, while there was no significant difference in any actionable bleeding,” Kim said during the presentation. “In low bleeding risk patients, 3-month DAPT reduced any actionable bleeding without increasing NACE or MACCE as compared with 12-month DAPT. Overall, 3 months would be the optimal default duration of DAPT after PCI, in general, to meet the balance of thrombosis and bleeding.”
Hyo-Soo Kim
The researchers stated that the P2Y12 inhibitor used in this study was left to the doctors’ discretion and is a key limitation. Kim said clopidogrel was the most used second antiplatelet therapy, as prior research has shown that clopidogrel is superior to ticagrelor (Brilinta, AstraZeneca) in Eastern populations. Kim noted that the findings of this study may not be generalizable to all racial and ethnic groups. However, Kim said, the findings on optimal DAPT duration could potentially be applied regardless of the drug type.
After the presentation, Anna E. Bortnick, MD, PhD, MSc, FACC, associate director of structural and valvular heart disease at Montefiore Einstein and chair-elect of the ACC Interventional Council, described the 3-month DAPT strategy as a “sweet spot” for anticoagulation after PCI.
“What the study tries to show is a highly shortened duration of [DAPT], as short as a month in those with high bleeding risk, is still getting great results while avoiding the bleeding issue. … What they’re really showing with the results is the 3-month duration performed a little bit better in terms of overall adverse events, and the bleeding was acceptable,” Bortnick said. “In the low bleeding risk group … what they showed there is you could use the 3-month DAPT there as well, and you avoid the bleeding risk and you get good results in terms of adverse events. The overall message was that 3 months seems to be a sweet spot for use of aspirin and a super aspirin in high- and low-bleeding risk populations.”
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Sources/DisclosuresCollapse
Source:
Kim HS. Late-breaking clinical trials II. Presented at: American College of Cardiology Scientific Session; March 29-31, 2025; Chicago (hybrid meeting).
Disclosures:
The HOST-BR trial received funding from Abbott and Medtronic. Kim reports no relevant financial disclosures. Bortnick is chair-elect of the ACC Interventional Council; she reports receiving consultant fees/honoraria from Getinge and Zoll, unrestricted educational grants(s) to her institution from Zoll; and research/research grants from Amgen.
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