Drug-Coated Balloons: A Safe and Effective Alternative to Drug-Eluting Stents in Small Vessel Coronary Artery Disease.

BACKGROUND: Drug-coated balloons (DCB) have been used to treat de novo small vessel coronary disease (SVD), with promising results and shorter dual antiplatelet therapy (DAPT) duration compared to drug-eluting stents (DES). We compared safety and effectiveness of the two treatments at 1 year. METHODS: We reviewed 3,613 angioplasty cases retrospectively from 2011 to 2013 and identified 335 patients with SVD treated with device diameter of ≤2.5 mm. DCB-only angioplasty was performed in 172 patients, whereas 163 patients were treated with second-generation DES. RESULTS: DCB patients had smaller reference vessel diameter (2.22 ± 0.30 vs. 2.44 ± 0.19 mm, P < 0.001) and received smaller devices (median diameter 2.25 vs. 2.50 mm, P < 0.001) compared to the DES group. DES-treated vessels had larger acute lumen gain (1.71 ± 0.48 mm) than DCB (1.00 ± 0.53 mm, P < 0.001). Half the patients had diabetes mellitus. While there were more patients presenting with acute coronary syndrome (ACS) in the DCB group (77.9% vs. 62.2%, P = 0.013), they received shorter DAPT (7.4 ± 4.7 vs. 11.8 ± 1.4 months, P < 0.001) than the DES group. The 1-year composite major adverse cardiac event rate was 11.6% in the DCB arm and 11.7% in the DES arm (P = 1.000), with target lesion revascularization rate of 5.2% and 3.7%, respectively, (P = 0.601). CONCLUSIONS: In this high-risk cohort of patients, DCB-only angioplasty delivered good clinical outcome at 1 year. The results were comparable with DES-treated patients, but had the added benefit of a shorter DAPT regime.

Drug coated balloon angioplasty in elderly patients with small vessel coronary disease.

BACKGROUND: Coronary angioplasty in advanced age is associated with higher rate of comorbidities and complications. Drug coated balloon only angioplasty (DCBA) has emerged as an alternative to treat small vessel coronary disease (SVCD), of reference vessel diameters <2.8 mm, with shorter duration of dual antiplatelet (DAPT). This is the first study to assess the DCBA efficacy in an elderly population with SVCD. METHODS AND RESULTS: We performed a prospective study of 447 patients (334 patients aged <75 and 113 patients aged ⩾75 years old) acquired from the SeQuent Please Small Vessel 'Paclitaxel-Coated Balloon Only' registry. In the older age group, more patients have hypertension (89% versus 77%; p = 0.006), renal insufficiency (21% versus 6%; p < 0.001), atrial fibrillation (17% versus 7%; p = 0.001), and calcified lesions (33% versus 20%; p = 0.006). At 30 days, there was one myocardial infarction requiring target lesion revascularization (TLR) in the younger group. No major adverse cardiac event (MACE) was observed in the older group. At 9 months, the MACE rate in the younger group was 4.2% and 6.1% in the older group (p = 0.453), with TLR rates at 3.9% and 3.0% (p = 0.704) respectively. There was no cardiac death observed. CONCLUSION: DBCA in the elderly with SVCD is as safe and effective compared with younger patients despite more complex anatomy and comorbidities.