OBJECTIVE -  To evaluate the efficacy of paclitaxel-coated balloon for de novo coronary lesions with diameters ≥ 2.8 mm.

METHODS - This prospective study included 215 consecutive patients with 238 de novo lesions, who received paclitaxel-coated balloon angioplasty in Beijing Hospital from May 2014 to June 2016. According to the reference vessel diameter, the patients were divided into large vessel disease (LVD) group (reference vessel diameter≥2.8 mm, 85 patients and 90 lesions) and small vessel disease (SVD) group (reference vessel diameter<2.8 mm, 130 patients and 148 lesions). Clinical characteristics, interventional procedures and major adverse cardiovascular events (including all-cause mortality, non-fatal myocardial infarction and target lesion revascularization) after procedure were compared between the 2 groups.

RESULTS - (1)Patients in LVD group were younger than SVD group ((60.1±11.1) years old vs. (65.0±10.6) years old, P<0.01), and less patients had diabetes (24.7% (21/85) vs. 43.1%(56/130), P<0.01).(2)Prevalence of three-vessel disease (35.5%(30/85) vs. 53.6%(67/130), P<0.05) and complex lesions (type B2/C,34.4% (31/90) vs. 50.0%(74/148), P<0.05) were significantly lower in LVD group than in SVD group.(3) During pre-dilation, the rate with plain balloons use was significantly higher in SVD group than in LVD group(76.4%(113/148) vs. 58.9%(53/90), P<0.01), while the proportion of additional use of non-compliant balloons was significantly higher in LVD groupthan in SVD group(20.0% (18/90) vs. 3.4% (5/148) , P<0.01). The ratio of paclitaxel-coated balloon diameter/RVD was significantly lower (0.87±0.12 vs. 0.96±0.15, P<0.01) and the duration of dilationwas significantly shorter ((41.5±9.5) seconds vs. (45.1±9.1) seconds, P<0.01) in LVD group than those in SVD group. Each group had 1 failure case that was bailout stented with drug-eluting stents. The success rate of paclitaxel-coated balloon treatment was similar in LVD group and SVD group (98.9% (89/90) vs. 99.3%(147/148), P>0.05).(4) At the fourth day of procedure, there was 1 acute myocardial infarction requiring emergent target lesion revascularization in SVD group. No major adverse cardiovascular event was observed in LVD group during hospitalization. Forty-two patients with 53 lesions, including 27 LVD lesions and 26 SVD lesions,underwent coronary angiography at (9.4±4.6) months after paclitaxel-coated balloon intervention. The quantitative coronary angiography analysis showed that minimal lumen diameter significantlyincreased during follow-up than that of post-procedurein SVD group ((1.71±0.36)mm vs. (1.52±0.30)mm, P<0.05) , while in LVD group the minimal lumen diameter was similar between during follow-up and post-procedure ((2.35±0.48)mm vs. (2.19±0.34)mm, P>0.05). Major adverse cardiovascular event rate was 0 in LVD group and 2.3%(3/130) in SVD group (P>0.05) during follow up. No death was observed in this patient cohort.

CONCLUSIONS - Treatment with paclitaxel-coated balloon for de novo coronary lesions with diameters ≥2.8 mm is safe and effective.