Drug-coated balloon–only strategy versus drug-eluting stents in large-vessel complex PCI: a propensity-matched 3-year outcome analysis
R Bando, K Yamaguchi, Y Kawabata, R Zheng, Y Okushi, Y Saijo, R Ueno, T Hara, M Kadota, T Matsuura, T Ise, S Yagi, H Yamada, T Soeki, M SataAbstract
Background
Accumulating evidence suggests that DCB may achieve clinical outcomes comparable to DES, even in large coronary arteries and selected complex lesion subsets. However, the definition of “complex PCI” remains heterogeneous, and direct long-term comparisons between DCB-only strategies and newer-generation DES in anatomically complex large-vessel lesions are limited.
Purpose
To compare 3-year clinical outcomes between a DCB-only strategy and newer-generation DES in patients with large (≥3.0 mm) coronary arteries and complex lesions defined as ACC/AHA type B2/C.
Methods
We retrospectively analyzed consecutive patients undergoing PCI between January 2018 and December 2023. Inclusion criteria were: large coronary vessels (≥3.0 mm), and complex lesions (ACC/AHA type B2 or C). Patients with in-stent restenosis or acute coronary syndrome were excluded. After propensity score matching, 113 patients treated with DCB were compared with 113 patients treated with newer-generation DES. The primary endpoint was target lesion failure (TLF), defined as cardiac death, target vessel myocardial infarction, or target lesion revascularization at 3 years. Secondary endpoints included all-cause death, cardiac death, target vessel revascularization (TVR), and target lesion revascularization (TLR). Procedural characteristics were also assessed.
Results
Median follow-up duration was 1223 ± 690 days. At 3 years, cumulative TLF was numerically lower in the DCB group compared with the DES group (6.0% vs. 11.3%), but the difference did not reach statistical significance (log-rank p=0.159). The cumulative incidences of all-cause death, cardiac death, TVR, and TLR were comparable between groups. Procedural parameters, including contrast volume, procedure time, and fluoroscopy time, were similar between strategies, suggesting no procedural simplification advantage with DCB-only treatment.
Conclusions
In patients with large coronary vessels and ACC/AHA type B2/C complex lesions, a DCB-only strategy demonstrated comparable but not superior 3-year outcomes compared with newer-generation DES. Lesion complexity alone may not be sufficient to guide device selection. Instead, patient-specific factors—such as bleeding risk or the desire to avoid permanent metallic implantation—may play a more decisive role when considering a DCB-only strategy. A more patient-centered approach, rather than lesion morphology alone, may better inform optimal device selection in complex PCI.