Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome - T-PASS

Oct 25, 2023
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Biotronik; Yonsei University, Seoul, South Korea
Date Presented:
10/25/2023
Date Published:
10/25/2023
Original Posted Date:
10/25/2023
References

Contribution To Literature:

The T-PASS trial showed that in patients undergoing PCI with bioresorbable polymer sirolimus-eluting stents for ACS, ticagrelor monotherapy after <1 month of DAPT was both noninferior and superior for the primary ischemic plus bleeding endpoint at 12 months of DAPT, primarily driven by a reduction in significant bleeding events in the monotherapy group.

Description:

The goal of the trial was to determine whether shorter duration of dual antiplatelet therapy (DAPT) <1 month followed by ticagrelor monotherapy was noninferior and potentially superior to a conventional 12-month regimen of ticagrelor-based DAPT in patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS).

Study Design

  • Randomized
  • Multicenter
  • Open-label

Patients with ACS who underwent implantation of a bioresorbable polymer sirolimus-eluting stent (BP-SES; Orsiro series, Biotronik) were randomized to receive either <1 month of ticagrelor and aspirin followed by ticagrelor monotherapy (n = 1,426) or 12 months of ticagrelor-based DAPT (n = 1,424) . Randomization was stratified by diabetes mellitus (DM) and ST-segment elevation myocardial infarction (STEMI). Ticagrelor and aspirin were dosed at 90 mg twice daily and 100 mg daily, respectively.

  • Total number of enrollees: 2,850
  • Duration of follow-up: 12 months
  • Mean patient age: 61 years
  • Percentage female: 17%

Inclusion criteria:

  • Age 19-80 years
  • Implantation of BP-SES for ACS

Exclusion criteria:

  • Increased bleeding risk (e.g., prior intracranial hemorrhage, hemoglobin <8 g/dL, platelets <100,000/mL)
  • Need for oral anticoagulation
  • Current or anticipated pregnancy
  • Life expectancy <1 year

Other salient features/characteristics:

  • Median duration of DAPT in <1-month DAPT group: 16 days
  • Percentage with STEMI: 40%
  • Percentage with DM: 29%
  • Multivessel intervention: 16%; total number of stents: 1.4/patient

Principal Findings:

The primary outcome, net adverse cardiovascular events (composite of all-cause death, nonfatal MI, in-stent thrombosis, stroke, and Bleeding Academic Research Consortium [BARC] bleeding 3 or 5 at 12 months), was: 2.8% for <1-month vs. 5.2% for 12-month DAPT with ticagrelor (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.37–0.80; p for noninferiority < 0.001, p for superiority = 0.002).

  • Landmark analysis at 1 month: 2.0% vs. 4.1% (p for noninferiority < 0.001, p for superiority = 0.001)

Secondary outcomes for <1-month vs. 12-month DAPT with ticagrelor at 12 months:

  • Major adverse cardiac and cerebrovascular events (MACCE; all-cause death, nonfatal MI, in-stent thrombosis, or stroke): 1.8% vs. 2.2% (p = 0.51)
  • BARC bleeding 3 or 5: 1.2% vs. 3.4% (HR 0.35, 95% CI 0.20–0.61; p < 0.001)

Interpretation:

The T-PASS trial demonstrated that, in patients with ACS treated with new-generation BP-SES, a strategy of short-term DAPT <1 month followed by ticagrelor monotherapy was both noninferior and superior to a conventional regimen of ticagrelor-based DAPT for 12 months. The observed superiority with respect to the primary composite outcome was driven primarily by a reduction in bleeding complications in the short-term DAPT group, as risk of MACCE were similar. Median DAPT duration was notably only 16 days in the experimental group, with <10% of subjects still on DAPT at 30 days.

The current data extend the findings of the TICO and TWILIGHT trials, which observed similar superiority for ticagrelor monotherapy after 3 months of DAPT in ACS compared with 12 months. TICO and T-PASS were conducted only at South Korean centers, which may limit generalizability to other populations. Interestingly, the authors noted a similar reduction with abbreviated DAPT in this trial even among STEMI patients, a group where shorter-duration DAPT has raised safety signals in other trials. These results provide further evidence to support DAPT duration as short as 1 month followed by ticagrelor monotherapy in ACS treated with novel BP-SES.

References:

Hong SJ, Lee SJ, Suh Y, et al., on behalf of the T-PASS Investigators. Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial. Circulation 2023;Oct 25:[Epub ahead of print].

Presented by Dr. Myeong-Ki Hong at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2023), San Francisco, CA, October 25, 2023.

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

Keywords: Acute Coronary Syndrome, Percutaneous Coronary Intervention, TCT23, Transcatheter Cardiovascular Therapeutics


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