Less Than 1-Month Dual Anti-Platelet Therapy Followed by Ticagrelor Monotherapy After Coronary Drug-Eluting Stent Implantation for Acute Coronary Syndrome: A Randomized T-Pass Trial—Coverage of TCT 2023 | SCAI

Why is this study important? 

Current guidelines recommend use of dual antiplatelet therapy (DAPT) with aspirin and one of the P2Y12 inhibitors for at least 12-month duration after placing drug-eluting stents (DESs) in patients with acute coronary syndrome (ACS). Acknowledging the fact that bleeding associated with prolonged DAPT therapy can lead to increased mortality and morbidity, the authors of T-PASS trial have shown that short-term (< 1 month) use of DAPT followed by use of a potent P2Y12 inhibitor, Ticagrelor, monotherapy for a duration of 1 year in conjunction with newer generation stents is a feasible option.  

What question was the study supposed to answer? 

The study objective was to show that in ACS population, a short course of DAPT (<1 month) followed by Ticagrelor monotherapy is non-inferior and perhaps superior to traditional 1 year of DAPT therapy for net adverse clinical effects (NACE), which comprised of primary ischemic (death, MI, stroke, definite or probable stent thrombosis) in addition to major bleeding endpoints at 12 months. 

What did the study show?   

T-PASS study is a randomized controlled trial with 2850 patients with acute coronary syndrome randomized to receive either traditional 12 months of DAPT (aspirin and ticagrelor)(n=1424) or <1 month of DAPT followed by Ticagrelor monotherapy(n=1426) for a total duration of 12 months. The primary composite outcome, Net Adverse Cardiovascular Events (death, non-fatal MI, stroke, definite or probable stent thrombosis, major bleeding), occurred in 2.8% for < 1 month vs. 5.2% for 12 months DAPT group with hazard ratio (HR)=0.54, 95% CI 0.37-0.80; p (non-inferiority <0.001), p (superiority = 0.02). 

Secondary outcomes of BARC bleed 3-5 were 1.2% vs 3.4% with HR=0.35, 95% CI 0.20-0.61 (p<0.001) for DAPT <1-month vs 12-month DAPT at 1 year. Secondary outcome for Major adverse cardiac events (MACE- cardiovascular death, non-fatal MI, Stent thrombosis, and ischemia-driven target vessel revascularization) was 1.5% vs 2.2% with HR=0.61, 95% CI 0.39-1.18; (P= 0.165).   

Should I change my practice because of these findings? 

The findings of the T-PASS trial build on the findings of previous similar studies like TICO and TWILIGHT , which have shown reduction in composite outcome of major bleeding and adverse cardiac and cerebrovascular events with a short DAPT course of 3 months followed by Ticagrelor monotherapy. While T-PASS and TICO trials were exclusively done in South Korean centers, TWILIGHT trial was conducted at 187 sites across 11 countries. The event rate in T-PASS study is much lower than in prior studies (PLATO, ISAR-REACT5, etc.) perhaps suggesting lower-risk patients were included in this trial. Also, in this study, the Orsiro stent, which has a biodegradable polymer with elution of Sirolimus and an ultra-thin (60 µ) struts, was used. Therefore, while the findings of this study are providing reassurance on shortening DAPT period in selected patients, we recommend caution on generalization of the findings of this study to all patients with ACS and across different DES platforms. 

All authors: Farshad Forouzandeh, MD, PhD, FSCAI and Mohammad Atif Rana, MD