To evaluate the efficacy of paclitaxel-coated balloons (SeQuent Please^®) for large de novo coronary lesions with diameters greater than 2.8 mm.

We performed a retrospective study of 527 consecutive patients with 595 de novo lesions (222 lesions) that comprised the large vessel disease (LVD) group, with a reference diameter (RD) ≥ 2.8 mm; the other 373 lesions comprised the small vessel disease (SVD) group, with a RD < 2.8 mm who received drug-coated balloon (DCB) angioplasty at the Beijing Hospital, Beijing, China. Sixty-eight patients with 91 lesions, including 45 LVD lesions, underwent coronary angiography at an average 10.7 months after DCB intervention. Clinical characteristics were recorded, and coronary angiograms were analysed with Quantitative Coronary Angiography (QCA) software.

The patients in the LVD group were much younger than those in the small vessel group (61.7 ± 11.3 vs. 63.8 ± 11.7, P = 0.003), and fewer LVD patients had diabetes (27.0 vs. 57.8%, P = 0.001), three-vessel disease (37.5 vs. 52.6%, P = 0.003) and complex lesions (37.8 vs. 48.8%, P = 0.009) than those in the SVD group. Lesion preparations for LVD were more complicated than for SVD, such as 40.1% of lesions required the additional use of a cutting or scoring balloon (P = 0.004), and 21.2% lesions required non-compliant (NC) balloons (P < 0.001). Coronary dissections occurred in 63(28.3%) lesions in the LVD group but bail-out drug-eluting stent (DES) implantation was required only in one lesion (0.5%), which were both comparable with those in the SVD group. The success rate of DCB intervention was quite high and also similar in the LVD group and SVD group (99.5 vs. 99.7%, P > 0.05). QCA analysis showed that the follow-up minimal lumen diameter (MLD) was significantly increased compared with the MLD immediately post angioplasty both in the SVD group (1.75 ± 0.48 vs. 1.58 ± 0.31 mm, P = 0.008) and the LVD group (2.26 ± 0.66 vs. 2.09 ± 0.40 mm, P = 0.067). At an average of 10.1 months of clinical follow-up, the major adverse cardiovascular event (MACE) rate was 0% in the LVD group and 1.4% in the SVD group, with target lesion revascularization (TLR) rates of 0% and 1.1%, respectively. No death was observed in either group.

DCB for de novo coronary lesions with diameters greater than 2.8 mm was as safe and effective as for small vessel lesions, suggesting that the DCB-only strategy is also feasible in large de novo lesions intervention.