Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-3 - STOPDAPT-3

May 20, 2024
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Abbott Medical Japan
Date Presented:
08/26/2023
Date Published:
05/07/2024
Date Updated:
05/20/2024
Original Posted Date:
08/26/2023
References

Contribution To Literature:

Highlighted text has been updated as of May 20, 2024.

The STOPDAPT-3 trial showed that prasugrel monotherapy at a dose of 3.75 mg/day was not superior to DAPT with aspirin 81-100 mg/day and prasugrel 3.75 mg/day for bleeding events among Korean patients undergoing PCI with Xience DES either for ACS or among those considered to be at high bleeding risk.

Description:

The goal of the trial was to compare the safety and efficacy of an aspirin-free strategy among patients undergoing percutaneous coronary intervention (PCI) or at high bleeding risk.

Study Design

Eligible patients were randomized in a 1:1 open-label fashion to either DAPT with aspirin and prasugrel (n = 2,982) or prasugrel monotherapy (n = 2,984). Aspirin dose was 81-100 mg/day and prasugrel 3.75 mg daily. Both groups received a loading dose of 20 mg of prasugrel.

  • Total number of enrollees: 5,966
  • Duration of follow-up: 1 month
  • Mean patient age: 71.6 years
  • Percentage female: 23%

Inclusion criteria:

  • Patients who are planned to have PCI with exclusive use of everolimus-eluting stent (Xience series)
  • Patients with high bleeding risk defined by Academic Research Consortium (ARC) or acute coronary syndrome (ACS)
  • Patients who could take dual antiplatelet therapy (DAPT) with aspirin and P2Y12 inhibitors for 1 month

Exclusion criteria:

  • Contraindication to antiplatelet drugs

Other salient features/characteristics:

  • ACS: 75.0%
  • ST-segment elevation myocardial infarction (STEMI): 42.8%
  • Previous PCI: 15%
  • Severe chronic kidney disease: 11%; hemodialysis: 6%
  • Need for oral anticoagulation: 9%

Principal Findings:

The primary bleeding endpoint, major bleeding events (BARC 3 or 5) for prasugrel monotherapy vs. DAPT was: 4.47% and 4.71% (hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.75-1.20; p for superiority = 0.66).

The co-primary cardiovascular (CV) endpoint (a composite of CV death, MI, definite stent thrombosis, or stroke) at 1 month: 4.12% and 3.69% (HR 1.12, 95% CI 0.87-1.45; p for noninferiority = 0.01).

Secondary outcomes for prasugrel monotherapy vs. DAPT at 30 days:

  • Any unplanned coronary revascularization: 1.05% vs. 0.57% (HR 1.83, 95% CI 1.01-3.30; p < 0.05)
  • Subacute definite or probable stent thrombosis: 0.58% vs. 0.17% (HR 3.40, 95% CI 1.26-9.23; p < 0.05)
  • Definite or probable stent thrombosis: 0.71% vs. 0.44% (HR 1.62, 95% CI 0.81-3.23)
  • All-cause mortality: 2.28% vs. 2.11% (HR 1.08, 95% CI 0.77-1.52)

Complex PCI subset (20.6%): Complex PCI was defined as a procedure at the index PCI and the staged PCI within 30 days with ≥1 of the following procedural criteria: three vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with two stents implanted, total stent length >60 mm, or chronic total occlusion as the target lesion. Among the criteria for complex PCI, >60 mm total stent length (16.2%), and ≥3 stents implanted were more prevalent (8.9%) than other criteria. The 1-month incidence of the co-primary CV endpoint was higher in patients with complex PCI than in those without (5.9% vs. 3.4%; HR 1.74; p < 0.001).

  • Primary bleeding endpoint for prasugrel monotherapy vs. DAPT: 5.3% vs. 3.7% (HR 1.44, 95% CI 0.84-2.47, p = 0.18; p for interaction = 0.18)
  • Co-primary CV endpoint for prasugrel monotherapy vs. DAPT: 5.8% vs. 5.9% (HR 0.98, 95% CI 0.62-1.55, p = 0.92; p for interaction = 0.48)
  • Stent thrombosis: 0.67% vs. 0.81% (p > 0.05)

Interpretation:

The results of this trial indicate that prasugrel monotherapy at a dose of 3.75 mg/day was not superior to DAPT with aspirin 81-100 mg/day and prasugrel 3.75 mg/day for bleeding events among Korean patients undergoing PCI with Xience DES either for ACS or among those considered to be at high bleeding risk. In addition, although CV events met criteria for noninferiority, they were higher in the monotherapy group at 30 days, including a potentially higher risk of subacute stent thrombosis. No difference was noted among patients defined as having undergone complex PCI.

These results indicate that while recent data support de-escalation to P2Y12 inhibitor monotherapy at 1 month following PCI among select patients, a strategy of de-escalation immediately post-PCI is not beneficial and could in fact be harmful, particularly among ACS patients. DAPT should remain the standard strategy 1 month after coronary stent implantation.

References:

Yamamoto K, Natsuaki M, Watanabe H, et al., on behalf of STOPDAPT-3 Investigators. An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention. JACC Cardiovasc Interv 2024;17:1119-30.

Editorial Comment: Gragnano F, Calabrò P. Aspirin-Free Strategies After Complex PCI: Type of P2Y12 Inhibitor Matters. JACC Cardiovasc Interv 2024;17:1131-3.

Natsuaki M, Watanabe H, Morimoto T, et al. An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial. Circulation 2024;149:585-600.

Presented by Dr. Masahiro Natsuaki at the European Society of Cardiology Congress, Amsterdam, Netherlands, August 26, 2023.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS

Keywords: Acute Coronary Syndrome, Aspirin, ESC Congress, ESC23, Platelet Aggregation Inhibitors, Percutaneous Coronary Intervention, Thrombosis


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