A stepwise de-escalation of dual antiplatelet therapy (DAPT) after treatment of coronary lesions with drug-coated balloons was noninferior to standard 12-month DAPT in terms of clinical events, a new study shows. Ling Tao, MD, PhD, of Xijing Hospital, Xi’an, China, reported these findings during a late-breaking trials session Wednesday at EuroPCR 2024 in Paris. DCBs have made advanced in recent years, including low 6-month late lumen loss when used to treat in-stent restenosis, similar long-term results to drug-eluting stents (DES) in treating de novo coronary lesions, lower long-term adverse events compared to DES in patients with diabetes, similar major bleeding incidence to DES in patients with high bleeding risk, and similar long-term outcomes to DES in patients with acute coronary syndromes. DCBs are also associated with faster vessel healing and less thrombotic burden compared to DES, meaning patients treated with DCBs in theory require less-intense antiplatelet therapy. However, there have not been randomized trials evaluating antiplatelet strategies with DCBs vs. DES. The investigators in this study previously summarized 41 randomized controlled trials comparing percutaneous coronary intervention (PCI) using stents or plain old balloon angioplasty to DCBs and found notable differences in these trials recommended antiplatelet regimens for patients in the DCB arm, ranging from 1 month to 12 months. Therefore, the investigators conducted an open-label, investigator-initiated, noninferiority trial, called REC-CAGEFREE II, at 41 centers in China. The study enrolled patients with ST-elevation myocardial infarction (STEMI), non-STEMI or unstable angina whom the operators deemed suitable for treatment only with DCBs. The primary efficacy endpoint was net adverse clinical events (NACE), defined as a composite of all-cause mortality, stroke, MI, revascularization or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding events, and the primary safety endpoint was a patient-oriented composite endpoint, defined as all-cause mortality, stroke, MI or revascularization. A total of 1,948 patients were randomized 1:1 to stepwise DAPT de-escalation (n=975) or standard DAPT (n=973) after DCB treatment. At 1 year, complete follow-up data were available in 99.3% (n=1,935). In addition to scheduled follow-up visits, patients were contacted monthly through a mobile app operating on the Chinese WeChat platform. Stepwise DAPT de-escalation consisted of 1 month of DAPT followed by 5 months of ticagrelor monotherapy, and then 6 months of aspirin monotherapy. At baseline, the patients’ mean age was about 59 years, about 75% were male, about 30% had diabetes, nearly a third had previous PCI, and about a fifth were considered high bleeding risk. The mean number of DCBs per patient was 1.3, and the mean DCB diameter was 2.71 mm. Most patients (about 66% received cutting or scoring balloons. The most common reasons patients were treated with DCBs were small-vessel disease (55.9%), bifurcation lesions (45.4%), in-stent restenosis (18.6%) and diffuse lesions (10.2%). The primary endpoint occurred in 9.0% of the of the stepwise de-escalation group and in 8.7% of the standard DAPT group through 1 year (difference: 0.31%; upper boundary of the one-sided 95% confidence interval [CI]: 2.43%; p-noninferiority = 0.013). A win-ratio analysis of the first secondary endpoint, which was defined as a hierarchical composite of all-cause mortality, stroke, MI, BARC type 3 or 5 bleeding, revascularization and BARC type 2 bleeding, showed significantly more wins in the stepwise de-escalation group (14.4%) as compared with the standard DAPT group (10.1%; win ratio: 1.43; 95% CI: 1.12-1.83; p=0.004). Tao said the study is the first evidence of a tailored antiplatelet regimen for patients treated with DCB, adding that if all clinically relevant ischemic or bleeding events were considered by hierarchical clinical importance, the stepwise DAPT de-escalation would show overall benefit compared with standard 12-month DAPT. Photo Credit: Screenshot by Jason Wermers/CRTonline.org Photo Caption: Chao Gao, MD, PhD, discusses the REC-CAGEFREE II trial during a news conference at EuroPCR 2024.