Objective: The aim of this study was to evaluate the efficacy of scoring balloon angioplasty for drug-coated balloon (DCB) treatment in percutaneous coronary intervention. Background: The scoring balloon angioplasty may play a pivotal role in enhancing the outcomes of DCB treatment. Methods: A total of 259 patients (278 lesions) with coronary artery disease successfully treated with DCB were retrospectively enrolled. The mean age of the patients was 62.2 ± 11.1 years, and the majority of patients were men (68.7%). The study's endpoint was defined as achieving an optimal angiographic result, which consisted of Thrombolysis in Myocardial Infarction (TIMI) flow grade 3, residual diameter stenosis ≤ 30%, and dissection less than type C after the procedure. Results: Angioplasty was performed for 61 lesions with a scoring balloon and 217 lesions with a non-scoring balloon. All lesions were TIMI flow grade 3 except two lesions in the non-scoring balloon group. The scoring balloon group had a higher prevalence of residual diameter stenosis ≤ 30% (68.9% vs. 39.6%, p < 0.001), while severe dissection, defined as type C or greater, was observed less frequently (9.8% vs. 31.8%, p = 0.001). Moreover, the scoring balloon group achieved a superior rate of optimal angiographic results (60.7% vs. 28.6%, p < 0.001). In multivariable analysis, scoring balloon (OR: 3.08 [95% confidence interval, 1.47–6.58], p = 0.003) and DCB balloon-to-artery ratios (OR: 5.46 [95% confidence interval, 1.43–21.93], p = 0.014) were independent factors in the increasing rate of optimal angiographic result. Conclusions: The application of a scoring balloon catheter for lesion preparation, aiming to make them suitable for DCB treatment, was associated with a decreased risk of severe dissection and a greater occurrence of optimal angiographic outcomes compared with non-scoring balloon angioplasty.
Keywords: scoring balloon; drug-coated balloon; balloon angioplasty; dissection; coronary artery disease
For successful drug-coated balloon (DCB) treatment, optimal lesion preparation is an essential factor for percutaneous coronary intervention (PCI) in coronary artery disease (CAD). The importance of lesion preparation is emphasized by both the International DCB Consensus Group and the Asia-Pacific DCB Consensus Group [[
In the process of preparing the lesion, balloon angioplasty is the basic technique, and currently, semi-compliant plain balloons are commonly used as the standard choice. However, several studies have indicated that using scoring balloon angioplasty enhances lumen gain [[
A total of 259 patients (278 lesions) who underwent successful PCI for CAD using DCB alone were retrospectively included in this study. The data were collected from October 2018 to November 2020 at two teaching hospitals in South Korea (Ulsan University Hospital, Ulsan Medical Center), both of which had prior experience in treating patients with CAD using DCB ("Impact of Drug-Coated Balloon Treatment in de Novo Coronary Lesion"; NCT04619277). The mean age of the patients was 62.2 ± 11.1 years, and the majority of patients were men. Exclusion criteria were previously undergone coronary artery bypass surgery, severe left ventricular dysfunction (ejection fraction < 35%), chronic kidney disease, ST-segment elevation myocardial infarction requiring primary PCI, heavily calcified or thrombotic lesion, failed PCI for target lesions, and a life expectancy of <1 year. The study protocol was approved by the institutional review board of each participating center, and all patients provided written informed consent at the time of enrollment.
All patients were pretreated with aspirin 200 mg and clopidogrel 300 or 600 mg as loading doses, followed by intravenous injection of 100 U/kg unfractionated heparin to maintain an activated clotting time of ≥250 s during the procedure. Intracoronary nitroglycerin (200 µg) was administered before diagnostic coronary angiography was performed. For the DCB treatment, the intervention was performed according to international and Asia-Pacific consensus recommendations [[
Angiography was performed after the administration of 200 µg of intracoronary nitroglycerine in at least two orthogonal projections before and after the procedure. Quantitative analysis of angiographic data was performed offline by a single independent expert in blinded core lab (Cardiovascular Research Foundation in Dong-A University Hospital) using the validated software (CAAS II, Pie Medical Imaging). The following parameters were analyzed: reference vessel diameter, minimal lumen diameter (MLD), percent diameter stenosis, lumen gain (defined as the value obtained by subtracting MLD after procedure from MLD before procedure), and lesion length. Measurements included the whole segment treated plus 5 mm proximally and distally. In the post-lesion preparation angiography, coronary dissection was assessed and graded from A to F (with A being the lowest grade and F the highest grade) according to the National Heart, Lung, and Blood Institute (NHLBI) classification [[
The study endpoint was defined as achieving an optimal angiographic result, which consisted of Thrombolysis in Myocardial Infarction (TIMI) flow grade 3, residual diameter stenosis ≤ 30%, and dissection less than type C after the procedure.
All 259 patients underwent a clinical follow-up following the index procedure via telephone interviews and outpatient clinic visits. We conducted an analysis of cumulative major adverse cardiac events (MACE), which is a composite outcome comprising cardiac death, myocardial infarction, target lesion thrombosis, and target vessel revascularization at 1 year. Cardiac death was defined as any death that was not clearly of extracardiac origin, including myocardial infarction, according to previously published guidelines [[
Clinical characteristics are reported as percentages for categorical variables and means with standard deviations for continuous variables. Comparisons between groups were made using either the Pearson's chi-squared test or the Fisher's exact test for categorical variables and the Student's t-test for continuous variables, as appropriate. Logistic regression model was used to calculate odds ratio (OR) and 95% CIs; logistic regression was used to examine associations between scoring balloon and optimal angiographic results. All p-values were two-sided, and a value of <0.05 was considered statistically significant. R version 4.1.2 (R Foundation for Statistical Computing, Vienna, Austria) was used for all statistical analyses in this study.
The baseline clinical and procedural characteristics of the patients are summarized in Table 1. The left anterior descending artery lesion was more frequently observed in the scoring balloon group, while the left circumflex artery lesion was more prevalent in the non-scoring balloon group. The SYNTAX score and total number of treated vessels were comparable in both groups. In the scoring balloon group, the DCB diameter was larger, and the inflation time was longer. However, there was no difference in the DCB balloon-to-artery ratios between the groups. Notably, severe dissections of type C or higher were significantly less frequent in the scoring balloon group compared with the non-scoring balloon group (9.8% vs. 31.8%, p = 0.001).
The quantitative angiographic data of the lesions are summarized in Table 2. The baseline characteristics of the lesion were different between the two groups. The reference vessel diameter and MLD were larger in the scoring balloon group, while the lesion length and diameter stenosis were greater in the non-scoring balloon group. After the procedure, the scoring balloon group still had a larger MLD and a smaller diameter stenosis compared with the other group. Furthermore, the scoring balloon achieved a greater increase in lumen gain (1.10 ± 0.38 mm vs. 0.94 ± 0.42 mm, p = 0.009). They also had more optimal angiographic results, consisting of TIMI flow grade 3, residual stenosis of 30% or less, and dissection less than type C, compared with the non-scoring balloon group (60.7% vs. 28.6%, p < 0.001) (Figure 1). All lesions were TIMI flow grade 3 except two lesions in the non-scoring balloon group. The scoring balloon group had a higher prevalence of residual diameter stenosis ≤ 30% (68.9% vs. 39.6%, p < 0.001), while severe dissection, defined as type C or greater, was observed less frequently (9.8% vs. 31.8%, p = 0.001). When assessing lumen gain based on dissection severity, the scoring balloon group exhibited significantly greater lumen gain compared with the non-scoring balloon group in cases without dissection.
The MACE consisting of cardiac death, myocardial infarction, target lesion thrombosis, and target vessel revascularization at 1 year occurred comparably in both groups (5.4% in the scoring balloon group vs. 5.9% in the non-scoring balloon group) (Table 3). Nevertheless, the presence of suboptimal angiographic results showed a tendency towards an increased occurrence of adverse events, particularly in cases where the non-scoring balloon group exhibited suboptimal angiographic outcomes (Figure 2). However, the limited number of events resulted in insufficient statistical power, precluding any definitive conclusions.
In the multivariable analysis, the scoring balloon was identified as an independent predictor of severe dissection (odds ratio: 0.18 [95% confidence interval, 0.05–0.49], p = 0.002) (Table 4). Additionally, two independent factors associated with an increased rate of optimal angiographic results were the scoring balloon (odds ratio: 3.08 [95% confidence interval, 1.47–6.58], p = 0.003) and the DCB balloon-to-artery ratio (odds ratio: 5.46 [95% confidence interval, 1.43–21.93], p = 0.014).
The main findings of this study are as follows. (
Despite the crucial significance of appropriate lesion preparation for the successful treatment of DCB in coronary lesions, there is a scarcity of available data on this matter. In particular, the data are limited on the impact of scoring balloon angioplasty on coronary lesions. The attainment of adequate luminal gain before performing DCB treatment assumes significant importance in cases where stent or scaffold implantations are not performed. In the follow-up angiogram after plain balloon angioplasty, late lumen loss occurs three times more and restenosis occurs in about one-third of lesions compared with after DCB treatment [[
Balloon angioplasty serves as a fundamental technique, with semi-compliant plain balloons commonly used as the standard option in current practice. However, in an effort to streamline the procedure and improve stent expansion, specialized scoring balloons were developed for predilating complex lesions. A previous study demonstrated that pretreatment with the AngioSculpt balloon improved stent expansion and reduced the disparity between predicted and achieved stent dimensions [[
First, this study had a fundamental limitation because it was observational in nature and relied on registry data. Additionally, allowing physicians to choose the treatment strategy, including the selection of predilation balloon devices, introduces the potential for selection bias. While scoring balloons are typically designed for treating complex coronary artery diseases, especially for angioplasty of calcified plaques, lesion preparation was consistently employed prior to DCB treatment, making it a routine practice. Consequently, the selection of the scoring balloon depended more on the operator's preference than on the characteristics of the lesion. Upon examining the SYNTAX score, no significant differences were observed between the two groups. Second, the study population came from an expert center in DCB treatment for CAD. Thus, these results may not be reproducible without an adequate learning curve. To determine whether scoring balloon angioplasty is effective for treating CAD with DCB, it is crucial to conduct well-planned and large-scale randomized trials involving multiple specialized centers experienced in DCB treatment.
In this research, the utilization of a scoring balloon catheter aimed at preparing lesions for DCB treatment was found to be associated with a reduced risk of severe dissection and a higher rate of achieving optimal angiographic outcomes when compared with non-scoring balloon angioplasty. To further confirm the safety and effectiveness of the scoring balloon in DCB treatment, conducting larger randomized controlled trials in the future will be crucial.
Graph: Figure 1 Incidences of optimal angiographic result in scoring balloon and non-scoring balloon groups.
Graph: Figure 2 The major adverse cardiovascular events in scoring balloon and non-scoring balloon groups according to the presence of optimal angiographic result at 1-year follow-up.
Table 1 Baseline clinical and procedure characteristics.
Scoring Balloon Non-Scoring Balloon Age, years 60.8 ± 9.1 62.7 ± 11.3 0.202 Men 40 (71.4) 138 (68.0) 0.741 Cardiovascular risk factors Hypertension 37 (66.1) 143 (70.4) 0.642 Diabetes 14 (25.0) 72 (35.5) 0.284 Dyslipidemia 47 (83.9) 156 (76.8) 0.461 Current smoking 13 (23.2) 50 (26.5) 0.352 Previous PCI 7 (12.5) 44 (21.7) 0.205 Clinical manifestations 0.573 Stable angina 21 (37.5) 67 (33.0) Unstable angina 22 (39.3) 90 (44.3) Non-ST-segment elevation myocardial infarction 11 (19.6) 33 (16.3) ST-segment elevation myocardial infarction 2 (3.6) 13 (6.4) Treated vessel N = 61 vessels N = 217 vessels <0.001 Left main 2 (3.3) 1 (0.5) Left anterior descending 33 (54.1) 68 (31.3) Left circumflex 12 (19.7) 105 (48.4) Right coronary 14 (23.0) 43 (19.8) SYNTAX score 9.8 ± 5.5 10.3 ± 7.0 0.504 Total number of treated vessels 1.0 ± 0.2 1.0 ± 0.1 0.234 DCB treatment DCB diameter, mm 2.8 ± 0.4 2.5 ± 0.3 <0.001 DCB length, mm 23.6 ± 5.0 22.0 ± 5.2 0.041 Maximal inflation pressure, atm 9.6 ± 2.1 9.2 ± 2.3 0.259 Inflation time 67.7 ± 21.0 52.4 ± 18.3 <0.001 DCB balloon-to-artery ratio 1.0 ± 0.1 1.1 ± 0.2 0.337 Dissection type after procedure None 17 (27.9) 37 (17.1) 0.088 A 19 (31.1) 46 (21.2) 0.147 B 19 (31.1) 65 (30.0) 0.983 C 6 (9.8) 69 (31.8) 0.001
Table 2 Quantitative coronary angiography data.
Scoring Balloon Non-Scoring Balloon Before procedure Lesion length, mm 14.61± 6.36 17.41 ± 5.58 0.001 Reference vessel diameter, mm 2.74 ± 0.49 2.46 ± 0.48 <0.001 Minimum lumen diameter, mm 0.99 ± 0.35 0.71 ± 0.39 <0.001 Diameter stenosis, % 61.33 ± 11.47 70.79 ± 13.70 <0.001 After procedure Minimum lumen diameter, mm 2.08 ± 0.42 1.64 ± 0.43 <0.001 Diameter stenosis, % 26.29 ± 9.84 34.50 ± 11.93 <0.001 Lumen gain, mm 1.10 ± 0.38 0.94 ± 0.42 0.009 TIMI flow grade 3 61 (100) 215 (99.1) >0.999 Residual stenosis ≤ 30% 42 (68.9) 86 (39.6) <0.001 Dissection < type C 55 (90.2) 148 (68.2) 0.001 Optimal angiographic result 37 (60.7) 62 (28.6) <0.001 Lumen gain according to dissection severity, mm None 1.31 ± 0.47 0.89 ± 0.42 0.002 A 0.96 ± 0.28 0.95 ± 0.43 0.969 B 1.05 ± 0.35 0.99 ± 0.42 0.601 C 1.10 ± 0.24 0.91 ± 0.43 0.273
Table 3 Clinical events at 12-month follow-up according to the presence of an optimal angiographic result.
Scoring Balloon (N = 56) Non-Scoring Balloon (N = 203) Optimal Suboptimal Angiographic Result Optimal Suboptimal Angiographic Result Major adverse cardiovascular events 1 (1.8) 2 (3.6) 3 (1.5) 9 (4.4) Cardiac death 0 0 0 2 (1.0) Myocardial infarction 0 0 0 0 Target lesion thrombosis 0 0 0 0 Target vessel revascularization 1 (1.8) 2 (3.6) 5 (1.5) 8 (3.9)
Table 4 Multivariable analysis of factors associated with severe dissection and optimal angiographic result.
Variable Severe Dissection Optimal Angiographic Result Odds Ratio (95% CI) Odds Ratio (95% CI) Age 0.99 (0.96–1.02) 0.359 1.00 (0.97–1.03) 0.995 Women 1.62 (0.82–3.20) 0.162 0.70 (0.35–1.35) 0.291 Hypertension 0.65 (0.33–1.30) 0.220 1.07 (0.55–2.13) 0.845 Diabetes 1.25 (0.64–2.44) 0.508 0.77 (0.39–1.50) 0.454 Dyslipidemia 1.03 (0.52–2.04) 0.936 1.00 (0.51–1.96) 0.996 Current smoking 0.73 (0.32–1.58) 0.433 1.14 (0.52–2.46) 0.731 Acute coronary syndrome 0.96 (0.50–1.91) 0.917 1.01 (0.53–1.96) 0.968 Left anterior descending artery 0.59 (0.29–1.15) 0.130 1.52 (0.82–2.81) 0.181 DCB balloon-to-artery ratio 0.69 (0.12–3.87) 0.679 5.46 (1.43–21.93) 0.014 DCB inflation time 1.01 (0.99–1.03) 0.380 1.00 (0.99–1.02) 0.574 Baseline diameter stenosis 0.99 (0.97–1.02) 0.566 0.99 (0.96–1.01) 0.310 Scoring balloon 0.18 (0.05–0.49) 0.002 3.08 (1.47–6.58) 0.003
Data curation, E.-S.S., S.H.A. and B.K.; formal analysis, B.K.; investigation, E.-S.S.; resources, E.-S.S., T.-H.K., C.-B.S. and B.J.C.; writing—original draft preparation, E.-S.S. and B.K.; writing—review and editing, E.-S.S., S.H.A. and M.H.J. All authors have read and agreed to the published version of the manuscript.
The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Ulsan University Hospital.
Informed consent was waived as this study was a deidentified retrospective review.
The data presented in this study are available on request from the corresponding author.
The authors declare no conflict of interest.
By Eun-Seok Shin; Soe Hee Ann; Mi Hee Jang; Bitna Kim; Tae-Hyun Kim; Chang-Bae Sohn and Byung Joo Choi
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