Short-term dual antiplatelet therapy (DAPT) for patients undergoing percutaneous coronary intervention (PCI) with the biodegradable-polymer rapamycin-eluting Firehawk stent is noninferior to extended-duration DAPT. The findings were presented by Feng Zhang, MD, from the Shanghai Institute of Cardiovascular Diseases at Zhongshan Hospital, China, on behalf of Junbo Ge and the TARGET-DAPT Investigators on Wednesday at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference in Washington, DC. The TARGET-DAPT trial is a multicenter, open-label randomized controlled trial designed to assess whether 3-month DAPT is noninferior to the conventional 12-month duration in patients treated with the rapamycin-eluting biodegradable-polymer Firehawk stent. The trial included patients who underwent PCI (excluding ST-segment myocardial infarction [STEMI] patients) for de novo lesions in coronary arteries of ≥2.5 mm and ≤4.0 mm in diameter, using the Firehawk stent. The primary endpoint of the study was the noninferiority of the 3-month DAPT regimen compared to the 12-month regimen in terms of net adverse clinical and cerebral events (NACCE) at 18 months. NACCE was defined as a composite outcome of all-cause mortality, myocardial infarction (MI), cerebrovascular accident (CVA) and major bleeding (Bleeding Academic Research Consortium type 2, 3, or 5). The study enrolled a total of 2,445 patients, with 1,222 randomized to the 3-month DAPT regimen and 1,223 to the 12-month DAPT regimen. All patients were included in the intention-to-treat analysis. Baseline characteristics were well balanced between the groups. The average age of participants was approximately 67 years, with 67% being male, and 78% undergoing PCI due to unstable angina. Although per protocol STEMI patients were excluded, the authors reported no cases of NSTEMI as well. The average stent diameter was 3.1 mm in the 3-month DAPT group and 3.09 mm in the 12-month DAPT group, with an average stent length of 26.19 mm and 26.31 mm, respectively. Procedural complications occurred in 0.8% of patients in both groups. The primary outcome showed that the cumulative event rate for NACCE was 10.1% in the 3-month DAPT group compared to 10.9% in the 12-month DAPT group, with a rate difference of 1.7% and a noninferiority margin of 3.5%. The log-rank p-value for noninferiority was 0.0003, indicating that the 3-month regimen was statistically noninferior to the 12-month regimen. Landmark analysis indicated no significant difference in NACCE rates pre- and post-3 months, while major bleeding was significantly lower in the 3-month DAPT group after 3 months. Subgroup analysis suggested that the 3-month DAPT regimen may be particularly beneficial for patients over 65 years of age or those with renal dysfunction, whereas patients younger than 65 years or with a history of myocardial infarction showed a trend favoring the 12-month DAPT regimen. The authors acknowledged several important limitations. In the 3-month DAPT group, adherence to the assigned treatment duration was relatively low, with only 71.0% of patients adhering compared to 95.5% in the 12-month group. Specifically, 354 out of 1,222 patients in the 3-month DAPT group received DAPT for either less than 60 days or more than 150 days. This nonadherence could have influenced the study outcomes. Additionally, the open-label design of the trial may have introduced bias, though clinical endpoints were adjudicated by an independent committee to mitigate this risk. Lastly, the use of only Firehawk stents limits the generalizability of these results to other biodegradable-polymer stents. Overall, short-term DAPT for PCI with the biodegradable-polymer rapamycin-eluting Firehawk stent was noninferior to extended-duration DAPT. Image Caption: Feng Zhang, MD, speaks during a news conference Wednesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes, CRTonline.org