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. 2022 Aug 25;1(5):100441.
doi: 10.1016/j.jscai.2022.100441. eCollection 2022 Sep-Oct.

Patients With Diabetes at High Bleeding Risk With 1-Month Dual Antiplatelet Therapy: Onyx ONE Clear Results

Elvin Kedhi  1   2 , Stephan Windecker  3 , Azeem Latib  4 , Ajay J Kirtane  5   6 , David Kandzari  7 , Roxana Mehran  8 , Matthew J Price  9 , Alexandre Abizaid  10 , Daniel I Simon  11 , Azfar Zaman  12 , Franco Fabbiocchini  13 , Charlies Tie  14 , Arnoud van 't Hof  15 , Jose M de la Torre Hernandez  16 , Christopher J Hammett  17 , Brent McLaurin  18 , Srinivasa Potluri  19 , Timothy Smith  20 , Ron Waksman  21 , Michael Ragosta  22 , Maria Parke  23 , Te-Hsin Lung  23 , Gregg W Stone  6   8
Affiliations

Patients With Diabetes at High Bleeding Risk With 1-Month Dual Antiplatelet Therapy: Onyx ONE Clear Results

Elvin Kedhi et al. J Soc Cardiovasc Angiogr Interv. .

Erratum in

  • Correction.
    [No authors listed] [No authors listed] J Soc Cardiovasc Angiogr Interv. 2025 Aug 9;4(10Part A):103930. doi: 10.1016/j.jscai.2025.103930. eCollection 2025 Oct. J Soc Cardiovasc Angiogr Interv. 2025. PMID: 41268087 Free PMC article.

Abstract

Background: Patients with diabetes mellitus (DM) are at a higher risk of ischemic events compared with patients without DM. Percutaneous coronary intervention (PCI) with the Resolute Onyx zotarolimus-eluting stent (ZES) followed by 1-month dual antiplatelet therapy (DAPT) is safe and effective in patients with high bleeding risk. However, outcomes in patients with DM are not fully understood.

Methods: Onyx ONE Clear was a prospective, multicenter study that included patients receiving the Resolute Onyx ZES during PCI and 1-month DAPT. The primary end point was a composite of cardiac death (CD) or myocardial infarction from 1 month to 12 months.

Results: Among the Onyx ONE Clear population (N = 1506), 39% had DM. Patients with DM had a higher incidence of hypertension, hyperlipidemia, and previous PCI and a higher body mass index than patients without DM. Patients with diabetes were also younger, more likely to be anemic, and experience renal failure. After adjusting for baseline differences between the groups, the Kaplan-Meier rates of CD or myocardial infarction (9.3% vs 6.1%; P = .122, unadjusted P = .010) and target lesion failure (10.2% vs 7.7%; P = .294, unadjusted P = .056) between 1 month and 12 months were not significantly different in patients with and without DM. The rates of target lesion revascularization were also similar in both groups, and stent thrombosis was very low and comparable in both arms after adjusting for baseline differences. Non-CD and bleeding were more frequent in patients with DM.

Conclusions: Patients with diabetes treated with the Resolute Onyx ZES followed by 1-month DAPT had favorable 12-month ischemic outcomes after accounting for baseline differences between patients with and without DM, supporting the safety and efficacy of the treatment in selected patients with DM at high bleeding risk.

Keywords: diabetes mellitus; high bleeding risk; percutaneous coronary intervention; zotarolimus-eluting stent.

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Figures

None
Graphical abstract
Figure 1
Figure 1
DAPT, SAPT, and OAC usage in patients with DM versus without DM from procedure to 12 months. DAPT, dual antiplatelet therapy; DM, diabetes mellitus; OAC, oral anticoagulant; SAPT, single antiplatelet therapy.
Figure 2
Figure 2
Kaplan–Meier estimates of (A) CD/MI, (B) TLF, and (C) BARC 3-5 from 1 month through 12 months. CD, cardiac death; MI, myocardial infarction; TLF, target lesion failure; BARC, Bleeding Academic Research Consortium.
Central Illustration
Central Illustration
Diabetic, high bleeding risk patients with 1-month dual antiplatelet therapy (DAPT). DAPT after percutaneous coronary intervention (PCI) with Resolute Onyx was shown to be safe in patients with a high bleeding risk (HBR). Whether abbreviated DAPT is a suitable strategy also for HBR patients with high ischemic risk, such as diabetes mellitus (DM), is unknown. DM patients treated with 1-month DAPT after PCT had favorable 12-month ischemic outcomes (left), albeit with more bleeding events (right) compared with non-DM patients. These data support the safety and effectiveness of Resolute Onyx ZES followed by 1-month DAPT in HBR patients, including DM patients, considered to be at high ischemic risk.
See this image and copyright information in PMC

References

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