Why is this study important?

• Drug-coated balloons (DCB) have emerged as a viable therapeutic option for PCI percutaneous coronary intervention (PCI), especially for treating in-stent restenosis (ISR) and de novo small vessels. The efficacy and safety of a DCB have also been explored in patients with acute coronary syndrome (ACS), high-bleeding risk (HBR), and bifurcation lesions.
• Compared to drug-eluting stents (DESs), DCBs are associated with faster vessel healing and a reduced thrombotic burden, which can be attributed to the absence of a metallic scaffold and polymer inside the coronary artery as well as the shorter local retention of the anti-proliferative drug.
• Patients treated with DCB theoretically require less intense antiplatelet therapy. However, to date, there are no randomized data exploring the tailored antiplatelet strategies for these patients and a lack of guideline recommendations.

 
What question was this study supposed to answer? 

• The study was an open-label, investigator-initiated, noninferiority trial at 41 sites in China. Patients with ACS, considered suitable by the operators according to international DCB consensus for having the DCB-only treatment and have undergone such treatment were enrolled.
• The stepwise de-escalation group completed one month of DAPT, followed by five months of ticagrelor, and finally six months of aspirin therapy. They were compared to a group who were relegated to standard DAPT for 12 months, consisting of aspirin and ticagrelor.

 
 
What did the study show?

• The REC-CAGEFREE II is the first randomized controlled trial investigating a tailored antiplatelet strategy for DCB-treated patients. 

• At 12-month follow-up amongst 1,948 ACS patients who were treated exclusively by paclitaxel-coated balloon angioplasty, the stepwise DAPT de-escalation therapy using one-month DAPT with aspirin and ticagrelor followed by five months of ticagrelor monotherapy and then aspirin was non-inferior to standard ticagrelor-based DAPT for 12 months in terms of a composite endpoint of all-cause death, myocardial infarction, stroke, revascularization, and BARC type 3 or 5 bleeding. 

Main takeaway:

When considering all clinically relevant ischemic or bleeding events, stepwise DAPT de-escalation tended to exhibit greater overall benefit than standard 12-month DAPT.