What does this research mean for the field?

In patients with de novo, non-small coronary lesions (≥ 2.5 mm), drug-coated balloon-only angioplasty is associated with higher rates of device-oriented composite endpoints and target lesion revascularization compared to drug-eluting stents. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

October 31, 2025BMC Medicine1 citationsOpen Access

Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: De novo non-small coronary lesions (n=4621). Intervention: Paclitaxel-coated balloon (DCB) vs. Drug-eluting stent (DES). Primary outcome: Device-oriented composite endpoint (DoCE), including cardiovascular death, non-fatal target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR) (HR 1.87, 95% CI 1.04-3.36, p=0.039).

XHXingqiang HeChengdu Medical College YLYi LiuGansu University of Traditional Chinese Medicine ZYZhiyong YinChinese PLA General Hospital

Key Result

Paclitaxel-coated balloon angioplasty was associated with a significantly higher rate of the device-oriented composite endpoint (HR 1.87) compared to drug-eluting stents at 3 years in patients with de novo non-small coronary lesions.

Study Design

Type

Cohort (n=4,621)

Multicenter

Yes

Structured PICO

Does paclitaxel-coated balloon angioplasty reduce the device-oriented composite endpoint compared to sirolimus-eluting stents in patients with de novo non-small coronary lesions (≥ 2.5 mm)?

Population

4,621 patients with de novo non-small coronary lesions (≥ 2.5 mm) treated with either paclitaxel-coated balloons or drug-eluting stents, followed for 3 years.

Intervention

Paclitaxel-coated balloon (DCB) angioplasty only, with recommended pre-dilatation and inflation time of at least 45 seconds.

Comparator

Second-generation sirolimus-eluting stents (DES) only.

Outcome

Device-oriented composite endpoint (DoCE), including cardiovascular death, non-fatal target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 3 years.composite

Main Result

Hazard Ratio: 1.87 (95% CI 1.04–3.36)

Absolute Event Rate: 6.1% vs 3.8%

p-value: p=0.039

Limitations

Rate of non-fatal MI was relatively low and might be underestimated as CK-MB and cTn levels were not routinely tested post-PCI
Lesion preparation and treatment decisions were based primarily on angiographic visual assessment without routine intravascular imaging
Imbalances in baseline characteristics existed between DES and DCB groups, leaving potential for unmeasured confounding despite IPTW and PSM adjustments
The REC-CAGEFREE registry was a single-center study
The NANO plus and HELIOS stents used are commonly used only in China, potentially limiting generalizability
Device thrombosis events were not prespecified for collection in the REC-CAGEFREE registry
Median follow-up duration was less than 3 years
Detailed longitudinal data on DAPT regimens and LDL-C profiles were not available

Abstract

The efficacy of drug-coated balloons (DCB) for the treatment of de novo, non-small coronary lesions remains uncertain. This study aimed to evaluate the real-world performance of DCB-only angioplasty in this setting. Patients with de novo, non-small coronary lesions (≥ 2.5 mm) treated exclusively with either drug-eluting stents (DES) or DCB were included from the DCB registry and two DES registries. The primary endpoint was the device-oriented composite endpoint (DoCE), including cardiovascular death, non-fatal target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR). Differences between cohorts were compared and adjusted by inverse probability of treatment weighting (IPTW). The study included 4621 patients, with 3780 in the DES group and 841 in the DCB group. At 3 years, the primary endpoint occurred in 51 (6.1%) patients receiving DCB and 143 (3.8%) patients with DES (HRIPTW: 1.87, 95% CI: 1.04–3.36, P = 0.039). Cardiovascular death occurred in 12 (1.4%) patients in the DCB group and 88 (2.3%) patients in the DES group (HRIPTW: 1.24, 95% CI: 0.34–4.48), non-fatal TV-MI occurred in 5 (0.6%) patients in the DCB group and 18 (0.5%) patients in the DES group (HRIPTW: 1.21, 95% CI: 0.33–4.38), and TLR occurred in 34 (4.0%) patients in the DCB group and 45 (1.2%) in the DES group (HRIPTW: 2.94, 95% CI: 1.72–5.01). DCB-only angioplasty is associated with a higher rate of DoCE and TLR compared with DES group in patients with de novo coronary lesions which were ≥ 2.5 mm in diameter. Registered on clinicaltrials.gov (NCT02929030, NCT03916432, and NCT05133921).

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Cite This Study

He et al. (Fri,) conducted a cohort in De novo non-small coronary lesions (n=4,621). Paclitaxel-coated balloon (DCB) vs. Drug-eluting stent (DES) was evaluated on Device-oriented composite endpoint (DoCE), including cardiovascular death, non-fatal target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR) (HR 1.87, 95% CI 1.04-3.36, p=0.039). Paclitaxel-coated balloon angioplasty was associated with a significantly higher rate of the device-oriented composite endpoint (HR 1.87) compared to drug-eluting stents at 3 years in patients with de novo non-small coronary lesions.

synapsesocial.com/papers/6a63c2e99ccc90a7df926cac https://doi.org/https://doi.org/10.1186/s12916-025-04429-9

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