Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial

Abstract

Background: Stopping aspirin within 1 month after implantation of a drug-eluting stent (DES) for ticagrelor monotherapy has not been exclusively evaluated for patients with acute coronary syndrome (ACS). The aim of this study was to investigate whether ticagrelor monotherapy after <1 month of dual antiplatelet therapy (DAPT) is noninferior to 12 months of ticagrelor-based DAPT for adverse cardiovascular and bleeding events in patients with ACS. Methods: In this randomized, open-label, non-inferiority trial, 2850 patients with ACS who underwent DES implantation at 24 centres in South Korea were randomly assigned (1:1) to receive either ticagrelor monotherapy (90 mg twice daily) after <1 month of DAPT (n=1426) or 12 months of ticagrelor-based DAPT (n=1424) between Apr 24, 2019, and May 31, 2022. The primary endpoint was the net clinical benefit as a composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, stroke, and major bleeding at 1 year after the index procedure in the intention-to-treat population. Key secondary endpoints were the individual components of the primary endpoint. Results: Among 2850 patients who were randomized (mean age, 61 years; 40% ST-elevation myocardial infarction), 2823 (99.0%) completed the trial. Aspirin was discontinued at a median of 16 days (interquartile range, 12 to 25 days) in the group receiving ticagrelor monotherapy after <1 month of DAPT. The primary endpoint occurred in 40 patients (2.8%) in the group receiving ticagrelor monotherapy after <1-month DAPT, and in 73 patients (5.2%) in the ticagrelor-based 12-month DAPT group (hazard ratio [HR], 0.54 [95% CI, 0.37–0.80]; P <0.001 for noninferiority; P =0.002 for superiority). This finding was consistent in the per-protocol population as a sensitivity analysis. The occurrence of major bleeding was significantly lower in the ticagrelor monotherapy after <1-month DAPT group compared with the 12-month DAPT group (1.2% versus 3.4%; HR, 0.35 [95% CI, 0.20–0.61]; P <0.001). Conclusions: This study provides evidence that stopping aspirin within 1 month for ticagrelor monotherapy is both noninferior and superior to 12-month DAPT as for the 1-year composite outcome of death, myocardial infarction, stent thrombosis, stroke, and major bleeding, primarily due to a significant reduction in major bleeding, among ACS patients receiving DES implantation. Low event rates which may suggest enrolment of relatively non-high-risk patients should be considered in interpreting the trial.

Antiplatelet De-Escalation Strategies in Patients Undergoing Percutaneous Coronary Intervention

“…The benefits of ticagrelor monotherapy were confirmed by 2 additional studies including patients with ST-segment–elevation myocardial infarction, the TICO trial ([Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome]; N=3056), 20,21 and the T-PASS trial ([Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome]; N=2850) 22 ; of note, these latter studies were conducted in East Asian patients only and were underpowered to detect differences in ischemic events (Table S1).…”

The Evolving Field of Acute Coronary Syndrome Management: A Critical Appraisal of the 2023 European Society of Cardiology Guidelines for the Management of Acute Coronary Syndrome

“…The primary endpoint was a composite of adverse events including all-cause death, myocardial infarction, stent thrombosis, stroke, and major bleeding at one-year postprocedure. The trial found that short-term DAPT followed by ticagrelor monotherapy was both noninferior and superior to the longer DAPT regimen, primarily driven by a significant reduction in major bleeding events [35]. These results raise doubts about generically referring to any P2Y12i after the DAPT period, given the different pharmacokintetic profiles and efficacies in large trials (e.g., ticagrelor and clopidogrel).…”

Antiplatelet Therapy After PCI: The Art and Science of De-Escalation

“…In the T-PASS trial (Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome), Hong et al 2 have further challenged the need for prolonged ticagrelor-based DAPT after PCI by studying the impact of stopping aspirin much earlier after PCI than was studied in the analyses by Baber et al Despite cessation of aspirin and subsequent use of ticagrelor monotherapy at a median of 16 days after PCI and <20% use of intravascular imaging, only 2 cases of definite or probable stent thrombosis were reported among 1426 patients in this arm, with the same number of stent thrombosis cases reported in the 1424 patients randomized to receive 12 months of ticagrelor-based DAPT. The rates of major adverse cardiac events were very low in both groups and numerically favored the arm with early aspirin cessation (1.5% versus 2.2%; P =0.17).…”

“…As the risk of stent thrombosis recedes or if the immediate postprocedural risk is very low, the possibility emerges of alternative strategies that reduce bleeding risk without increasing stent thrombosis risk. In this issue of Circulation , 3 papers contribute further to our knowledge in the context of contemporary clinical practice, 1–3 providing further insights into possible strategies for de-escalation of antiplatelet intensity. 4,5…”

“…As the risk of stent thrombosis recedes or if the immediate postprocedural risk is very low, the possibility emerges of alternative strategies that reduce bleeding risk without increasing stent thrombosis risk. In this issue of Circulation, 3 papers contribute further to our knowledge in the context of contemporary clinical practice, [1][2][3] providing further insights into possible strategies for de-escalation of antiplatelet intensity. 4,5 Articles, see p 562, p 574, and p 585 Baber et al have performed an individual patient data meta-analysis to assess the impact of dropping aspirin from a ticagrelor-based DAPT regimen and using ticagrelor monotherapy from 3 months after PCI for ACS, excluding those who have had an ischemic or bleeding event in the interim period since their ACS event.…”