Abstract
This study aimed to evaluate the efficacy and safety of excimer laser coronary atherectomy (ELCA) prior to paclitaxel-coated balloon angioplasty for de novo coronary artery lesions. This retrospective observational study analyzed 118 eligible patients with de novo coronary artery disease whose only percutaneous coronary intervention was a drug-coated balloon angioplasty (i.e., no subsequent stent placement). Data related to our primary outcomes of interest—incidence of major adverse cardiovascular and cerebral events (MACCE), and incidence of procedural complications (bailout stenting and minor complications)—were collected and retrospectively analyzed. ELCA was used significantly more often in the cases of main branch and ostial lesions (i.e., of the circumflex, right coronary, or left anterior descending arteries, or high lateral branch), normally associated with poor treatment outcomes (55.6% vs. 14.3%, p < 0.0005). However, the two groups were not different in terms of cumulative incidence as estimated by the Kaplan–Meier method (log-rank test, p = 0.603) and a causal relationship between ELCA and MACCE was not identified (OR, 2.223; 95% CI, 0.614–8.047; p = 0.223). This study confirms the safety of ELCA prior to paclitaxel DCB angioplasty to treat de novo coronary artery lesions. While difficult-to-treat lesions were significantly more prevalent in the group treated by ELCA, the study revealed similar efficiency as conventional pre-dilation methods. Our findings provide grounds for a prospective randomized trial with consistent lesion and procedural characteristics to evaluate the potential benefits of combining paclitaxel DCB angioplasty following ELCA for de novo coronary artery lesions.
Highlights
Drug-coated balloons (DCB) are semi-compliant angioplasty balloons covered with an anti-restenotic drug that is rapidly released locally into the vessel wall during the balloon contact [1]
While the efficacy for de novo coronary artery disease (CAD) has not been studied, we hypothesized that adjuvant excimer laser coronary atherectomy (ELCA) prior to DCB insertion may reduce the risk of Lasers Med Sci (2021) 36:111–117 lesion recurrence and adverse events
To address the lack of studies on this topic and based on the promising preliminary results obtained by combining paclitaxel DCB angioplasty following excimer laser irradiation for de novo coronary artery lesions, we decided to evaluate the efficacy and safety of this strategy performed in the Department of Cardiology of Tokyo Metropolitan Hiroo Hospital
Summary
Drug-coated balloons (DCB) are semi-compliant angioplasty balloons covered with an anti-restenotic drug that is rapidly released locally into the vessel wall during the balloon contact [1]. Combining ELCA with vessel scoring is theorized to achieve even greater luminal expansion [6] This combined strategy has been evaluated in several pathological situations, including femoropopliteal in-stent restenosis (ISR) [7, 8], coronary ISR [9, 10], coronary aneurism [11], acute coronary syndrome (ACS) [12], and peripheral arterial diseases [13], with variable effects. While the efficacy for de novo CAD has not been studied, we hypothesized that adjuvant ELCA prior to DCB insertion may reduce the risk of Lasers Med Sci (2021) 36:111–117 lesion recurrence and adverse events. We conducted a pilot study, where we analyzed 5 patients that underwent ELCA prior to DCB angioplasty for de novo coronary artery lesions in our department from 2013 to 2017, to treat deviceuncrossable and other difficult-to-treat lesions. Follow-up coronary angiography, performed in four of these patients, found no evidence of lesion recurrence or adverse events
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