Serial quantitative angiographic study of target lumen enlargement after drug-coated balloon angioplasty for native coronary artery disease.

BACKGROUND: Target lumen enlargement (TLE) or "late lumen enlargement" is often encountered after percutaneous coronary intervention (PCI) with drug-coated balloons (DCB). To date, the prognosis of coronary arterial lesions with or without TLE has not been clearly elucidated. AIMS: This study aimed to assess the long-term prognosis of coronary arterial lesions with or without TLE observed within 1 year (early TLE) after DCB angioplasty using serial quantitative angiographic follow-up. METHODS: One hundred and ninety-three consecutive patients (de novo coronary arterial lesions, 251) who underwent follow-up angiography within 1 year after DCB angioplasty (early follow-up, median: 6 months) were retrospectively evaluated. Of these, 97 patients (125 lesions) also underwent angiography more than 1 year after DCB angioplasty (late follow-up, median: 37 months). TLE was defined as an increase in minimal lumen diameter (MLD) after PCI at each follow-up. RESULTS: Early TLE was detected in 142 lesions (56.6%). Of these, 76 lesions were also evaluated at late follow-up. TLE persisted even at late follow-up in 67 of the 76 lesions (88.2%). An increase in MLD in early TLE (+) lesions was observed in the period between post-PCI and early follow-up (1.84 ± 0.06 vs. 2.12 ± 0.07 mm, p < 0.001) but not between early and late follow-up (2.12 ± 0.07 vs. 2.16 ± 0.07 mm, p = 0.74). In contrast, 49 of 109 lesions without early TLE were evaluated at late follow-up, of which 28 lesions (57.1%) showed TLE at late follow-up. The MLD of early TLE (-) lesions (n = 49) significantly increased from early (1.63 ± 0.061 mm) to late follow-up (1.84 ± 0.06 mm) (p < 0.001). No aneurysms were found in any of these cases. CONCLUSION: Early TLE was observed in more than half of the lesions, with the majority remaining at late follow-up. Alternatively, half of the lesions without early TLE showed late TLE, occurring biphasically after DCB angioplasty.

Efficacy of Low-Pressure Inflation of Oversized Drug-Coated Balloon for Coronary Artery Disease.

OBJECTIVES: This study sought to assess the efficacy of oversized drug-coated balloon (DCB) inflation at low pressure for the prevention of acute dissections and late restenosis. BACKGROUND: The major limitation of DCB coronary angioplasty is the occurrence of severe dissection after inflation of DCB. METHODS: Between 2014 and 2018, 273 consecutive patients were retrospectively studied. 191 lesions (154 patients) treated by oversized DCB inflation at low pressure (<4 atm, 2.4 ± 1.2 atm, DCB/artery ratio 1.14 ± 0.22; LP group) were compared with 135 lesions (119 patients) treated by the standard DCB technique (7.1 ± 2.2 atm, DCB/artery ratio 1.03 ± 0.16; SP group). RESULTS: Although the lesions in the LP group were more complex than those in the SP group (smaller reference diameter (2.38 mm vs. 2.57 mm, P=0.011), longer lesions (11.7 mm vs. 10.5 mm, P=0.10), and more frequent use of rotational atherectomy (45.0% vs. 28.1%, P=0.003), there was no significant difference in the NHLBI type of dissections between the two groups (11.5%, 12.0%, 5.2% vs. 12.6%, 12.6%, 2.2% in type A, B, and C, P=0.61), and no bailout stenting was required. In 125 well-matched lesion pairs after propensity score analysis, the cumulative incidence of target lesion revascularization at 3 years was 4.5% vs. 7.0%, respectively (P=0.60). Late lumen loss (-0.00 mm vs. -0.01 mm, P=0.94) and restenosis rates (7.4% vs. 7.1%, P=1.0) were similar in both of the groups. CONCLUSION: The application of oversized DCB at low pressure is effective and feasible for preventing late restenosis comparative to the standard technique of DCB.

Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents.

OBJECTIVES: This study sought to assess the safety and long-term efficacy of drug-coated balloons (DCB) following aggressive intracoronary image-guided rotational atherectomy (iRA) for severe coronary artery calcification (CAC), and to compare this strategy with new generation drug-eluting stents (nDES) following iRA. BACKGROUND: Ischemic events following the treatment of CAC is still relatively high. Thus, more innovative strategies are required. METHODS: We evaluated 123 consecutive patients (166 lesions) with de novo CAC undergoing an iRA (burr size; 0.7 of the mean reference diameter by intracoronary imaging) followed by DCB (DCB-iRA; 54 patients, 68 lesions) or nDES (nDES-iRA; 69 patients, 98 lesions). Follow-up angiography was obtained at > 6 months. RESULTS: The target vessels (right coronary and circumflex), bifurcation (67.6% versus 47.9%), reference diameter (2.28mm versus 2.49mm), and lesion length (11.89mm versus 18.78mm) were significantly different between the two groups. The median follow-up was 732 days. TLR and TVR in DCB-iRA and nDES-iRA at 3 years were similar: 15.6% versus 16.3% (P=0.99) and 15.6% versus 23.3% (P=0.38). In 41 well-matched lesion pairs after propensity score analysis, the cumulative incidence of TLR and TVR in DCB-iRA and nDES-iRA at 3 years was 12.9% versus 16.3% (P=0.70) and 12.9% versus 26.1% (P=0.17), respectively. On QCA analysis, although the acute gain was smaller in DCB-iRA (0.85 mm versus 1.53 mm, P<0.001), the minimum lumen diameter at follow-up was similar (1.69 mm versus 1.87 mm, P=0.29). The late lumen loss was lower (0.09 mm versus 0.52 mm, P=0.009) in DCB-iRA. CONCLUSIONS: DCB-iRA is feasible for CAC.

Outcomes after drug-coated balloon treatment for patients with calcified coronary lesions.

OBJECTIVES: To investigate the efficacy of drug-coated balloon (DCB) for calcified coronary lesions. BACKGROUND: Calcified coronary lesions is associated with poor clinical outcomes after revascularization. Recently, DCB is emerging as an alternative strategy for de novo coronary lesions. However, reports describing the efficacy of DCB for calcified coronary lesions are limited. METHODS: A total of 81 patients (96 lesions) who electively underwent DCB treatment for de novo coronary lesions were enrolled: 46 patients (55 lesions) in the calcified group and 35 patients (41 lesions) in the non-calcified group. Angiographic follow-up data and clinical outcomes after the procedure were evaluated. RESULTS: The diameter of the DCB used was 2.5 ± 0.5 mm. No bail-out stenting was observed after DCB treatment. Rotational atherectomy was used in 82% of lesions in the calcified group. Follow-up angiography (median, 6.5 months after intervention) was performed for 59 patients (30 in the calcified group and 29 in the non-calcified group). Late lumen loss and rates of restenosis were comparable between the groups (0.03 mm in the calcified group vs -0.18 mm in the non-calcified group, P = 0.093 and 13.9% vs 3.03%, P = 0.095, respectively). The survival rates for target lesion revascularization free survival and major adverse cardiac events at 2 years were comparable between the groups (85.3% vs 93.4%, P = 0.64 and 81.4% vs 88.5%, P = 0.57, respectively). CONCLUSION: Calcified coronary lesions might dilute the effect of DCB. However, clinical outcomes in the calcified group were similar to those in the non-calcified group.