Impact of pulse pressure on outcomes following treatment with drug-coated balloon vs. drug-eluting stents: insights from the REC-CAGEFREE I trial

We investigate the impact of pulse pressure on long-term outcomes for patients treated with drug-coated balloons (DCBs) or drug-eluting stents (DESs). REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China from Feb 5, 2021, to May 1, 2022, which randomized 2272 participants to DCB or DES treatment for de novo, non-complex lesions. In this post hoc analysis, participants were stratified into three groups based on pulse pressure tertiles (< 46, 46–60, and > 60 mmHg). The primary outcome was the 2-year device-oriented composite endpoint (DoCE), including cardiovascular death, target-vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization. 2272 participants were included in the analysis. At 2 years, DoCE occurred in 35/723 (4.9%), 37/896 (4.1%), and 38/653 (5.9%) of participants in the low, intermediate, and high pulse pressure groups, respectively. Compared to DES, DCB was associated with a higher risk of DoCE in the low (28/387 [7.3%] vs. 7/336 [2.1%], HRIPTW:3.82, 95%CI 1.64–8.87) and intermediate (24/436 [5.5%] vs. 13/460 [2.8%], HRIPTW: 2.09, 95%CI 1.05–4.15) pulse pressure groups. Among patients with high pulse pressure, the incidence of DoCE was numerically higher in the DCB group compared to the DES group (20/310 [6.5%] vs. 18/343 [5.3%], HRIPTW:1.34, 95%CI 0.70–2.55). No significant interaction was observed between pulse pressure and treatment (DCB or DES) regarding DoCE (Pinteraction = 0.124). DCB was associated with a higher risk of DoCE compared with DES in patients undergoing de novo, non-complex percutaneous coronary intervention, irrespective of pulse pressure levels. Registered on clinicaltrial.gov: NCT04561739.