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Background <p>We investigate the impact of pulse pressure on long-term outcomes for patients treated with drug-coated balloons (DCBs) or drug-eluting stents (DESs).</p> Methods <p>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 (&lt; 46, 46–60, and &gt; 60&#xa0;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.</p> Results <p>2272 participants were included in the analysis. At 2&#xa0;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%], HR<sub>IPTW</sub>:3.82, 95%CI 1.64–8.87) and intermediate (24/436 [5.5%] vs. 13/460 [2.8%], HR<sub>IPTW</sub>: 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%], HR<sub>IPTW</sub>:1.34, 95%CI 0.70–2.55). No significant interaction was observed between pulse pressure and treatment (DCB or DES) regarding DoCE (P<sub>interaction</sub> = 0.124).</p> Conclusions <p>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.</p> Trial registration <p>Registered on clinicaltrial.gov: NCT04561739.</p>

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

  • 期刊论文

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  • 发表日期：

    2026年3月30日

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  • Yali Yang,
  • Likun Ma,
  • Feng Yang,
  • Zheng Ji,
  • Hua Wang,
  • Yanqing Wu,
  • Zhenfei Fang,
  • Dongdong Sun,
  • Qiong Wang,
  • Hong Jiang,
  • Zhiyong Yin,
  • Shangyu Wen,
  • Wenjun Yan,
  • Fuyang Zhang,
  • Wangwei Yang,
  • Jielai Xia,
  • Jianzheng Liu,
  • Xingqiang He,
  • Chao Gao,
  • Ling Tao

摘要

Background

We investigate the impact of pulse pressure on long-term outcomes for patients treated with drug-coated balloons (DCBs) or drug-eluting stents (DESs).

Methods

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.

Results

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).

Conclusions

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.

Trial registration

Registered on clinicaltrial.gov: NCT04561739.