More evidence support ticagrelor monotherapy after <1-month DAPT in ACS

Dropping aspirin after <1 month of dual antiplatelet therapy (DAPT) with ticagrelor is superior to continuing both drugs through 12 months in patients with acute coronary syndrome (ACS) implanted with drug-eluting stents in the T-PASS trial.

Shorter DAPT came out ahead for the composite outcome of all-cause death, myocardial infarction (MI), stent thrombosis, stroke, and major bleeding.

“T-PASS provides evidence that stopping aspirin within 1 month after implantation of drug-eluting stents for ticagrelor monotherapy is a reasonable alternative to 12-month DAPT in terms of adverse cardiovascular and bleeding events,” said study author Dr Myeong-Ki Hong from Yonsei University College of Medicine, Seoul, Korea, who presented the findings at TCT 2023.

Shorter DAPT a game-changer

The findings build on the results of both TICO and TWILIGHT studies which support 3 months of DAPT and the post hoc analysis of GLOBAL LEADERS study that 1 month of DAPT might be safe in reducing ischaemic and bleeding risk. [JAMA 2020;323:2407-2416; N Engl J Med 2019;381:2032-2042; JAMA Cardiol 2019;4:1092-1101]

“This really gives us the confidence to push the envelope on shortening the DAPT because of the safety of the third- and fourth-generation drug-eluting stents. I really think this is a game changer in terms of changing the impact on patients,” commented Dr John Messenger from the University of Colorado School of Medicine in  Aurora, Colorado, US during the TCT press conference.

Outcomes favour ticagrelor alone

Included in the study were 2,850 ACS patients (mean age 61 years, 83 men, 40 percent with STEMI) who underwent percutaneous coronary intervention (PCI) with a biodegradable polymer sirolimus-eluting stent at 24 centres in Korea between April 2019 and May 2022. They were randomly assigned to receive either ticagrelor monotherapy 90 mg twice daily after <1 month of DAPT (n=1,426) or 12 months of ticagrelor-based DAPT (n=1,424). [Circulation 2023;doi:10.1161/CIRCULATIONAHA.123.066943]

In the ticagrelor monotherapy group, aspirin was discontinued at the clinician's discretion at a median of 16 days, with 91 percent stopping within 30 days.

Among the 2,823 patients who completed the trial, the primary composite endpoint of all-cause death, MI, definite or probable stent thrombosis, stroke, and major bleeding at 1 year after the index procedure occurred in 2.8 percent and 5.2 percent of the ticagrelor monotherapy and continued DAPT groups, respectively (hazard ratio [HR] 0.54, 95 percent confidence interval [CI], 0.37–0.80; p<0.001 for noninferiority; p=0.002 for superiority).

The rate of major bleeding (BARC* 3 or 5) was also significantly lower with ticagrelor monotherapy after <1 month of DAPT vs continued DAPT (1.2 percent vs 3.4 percent; HR, 0.35, 95 percent CI, 0.20–0.61; p<0.001).

What is unique with T-PASS is that patients were randomized at the time of PCI as opposed to when they stopped DAPT.  Experts also questioned patient selection considering that mortality and bleeding rates were much lower in T-PASS than what was observed in other studies like PLATO and ISAR-REACT 5.

Hong agreed, saying that patients in T-PASS are not that complex, with a mean number of 1.4 stents implanted. Operators were also able to choose when to stop aspirin.

Difference with STOPDAPT-3 trial

T-PASS differed from the STOPDAPT-3 trial in that the latter appeared to suggest that discontinuing aspirin and remaining on prasugrel does not reduce major bleeding and may increase the risk of coronary events. Hong said prasugrel might be a weaker drug than ticagrelor for ACS. “Prasugrel was also given at a lower dose in STOPDAPT-3, in fact, lower than what was approved for patients at high bleeding risk in the US.”

American College of Cardiology president B. Hadley Wilson said it remains unclear which features of the studies contributed to the success of ticagrelor monotherapy. “We really need to differentiate: is it ticagrelor versus prasugrel versus clopidogrel? Or is it the ultrathin stent? Is it the combination? We need to see how it fits across all patient groups.”