Abstract
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.
Highlights
Coronary angioplasty with drug-coated balloons (DCB) has been found to have a low rate of target lesion revascularization comparative to those of drug-eluting stents (DES) [1, 2] and the complexity of the lesions treated with DCB has gradually increased, the major limitation of a DCB only strategy is the occurrence of severe dissections and subsequent stenting after inflation of DCB [3]
Inflation of oversized compliant balloons at low pressure prevents subsequent severe dissections after rotational atherectomy for complex lesions [10, 11]. erefore, if the application of an oversized DCB at low pressure is effective for reducing dissections and late restenosis, DCB could safely be applied to complex lesions following successful lesion preparation
Debulking with rotational atherectomy was considered for lesions which met one of the following criteria: (1) the lesion was not crossable by the smallest balloon or by intravascular ultrasound (IVUS) or optical frequency domain imaging (OFDI); (2) the lesion could not be dilated with a high-pressure balloon or a scoring balloon; or (3) the lesions had extensive intimal deposition of calcium assessed by an imaging catheter
Summary
Coronary angioplasty with drug-coated balloons (DCB) has been found to have a low rate of target lesion revascularization comparative to those of drug-eluting stents (DES) [1, 2] and the complexity of the lesions treated with DCB has gradually increased, the major limitation of a DCB only strategy is the occurrence of severe dissections and subsequent stenting after inflation of DCB [3]. Inflation of oversized compliant balloons at low pressure prevents subsequent severe dissections after rotational atherectomy for complex lesions [10, 11]. Erefore, if the application of an oversized DCB at low pressure is effective for reducing dissections and late restenosis, DCB could safely be applied to complex lesions following successful lesion preparation. Us, in this study, a retrospective comparison of the acute and long-term results of low-pressure application of an Journal of Interventional Cardiology oversized DCB against those of the standard technique of DCB after successful lesion preparation of ischemic de novo native coronary lesions was undertaken to assess the efficacy of a low-pressure inflation of an oversized DCB
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