RESULTS of the REC-CAGEFREE II trial were presented today at EuroPCR by Ling Tao, FAHA Xijing hospital, Xi’an, China on behalf all REC-CAGEFREE II investigators. Notably, this research showed that stepwise de-escalation of dual antiplatelet therapy (DAPT) is non-inferior to standard DAPT in acute coronary syndrome (ACS) patients treated with drug-coated balloon (DCB) angioplasty.
The study, the first randomised controlled trial of its kind, sought to address the lack of tailored antiplatelet strategies for DCB-treated patients, a group that theoretically requires less intense antiplatelet therapy due to faster vessel healing and reduced thrombotic burden. This open-label, investigator-initiated, non-inferiority trial, conducted across 41 sites in China, enrolled 1948 patients who had undergone paclitaxel-coated balloon angioplasty. Participants were divided into two groups: the stepwise de-escalation group, receiving one month of DAPT (aspirin and ticagrelor) followed by five months of ticagrelor monotherapy and six months of aspirin, and the standard group, which received 12 months of ticagrelor-based DAPT.
At the 12-month follow-up, the primary endpoint—comprising all-cause death, myocardial infarction, stroke, revascularisation, and major bleeding events (BARC type 3 or 5)—revealed that the stepwise de-escalation approach was non-inferior to the standard regimen. Furthermore, when all clinically relevant ischemic and bleeding events were analysed using the pre-specified Win Ratio method, the stepwise strategy showed a tendency towards greater overall benefit.
These findings suggest that a tailored, stepwise de-escalation of antiplatelet therapy can be safely adopted in DCB-treated ACS patients, potentially reducing the risk of bleeding while maintaining efficacy. This study paves the way for updated guidelines and offers a promising alternative for patients at high risk of bleeding.
Reference:
Ling Tao et al. Stepwise dual antiplatelet therapy de-escalation in acute coronary syndrome patients after drug-coated balloon angioplasty. EuroPCR 15.05.2024.
