Effect of side branch predilatation before provisional stenting in coronary bifurcation lesions

Authors

Abstract

AimPercutaneous coronary intervention (PCI) for bifurcation lesions remains technically challenging. Despite the development of single-stent provisional techniques and various dual-stent strategies, the problem of side branch (SB) occlusion and restenosis remains unresolved. In our study, we aimed to compare the side branch (SB) patency at the end of the procedure in patients with bifurcation lesions and significant SB disease, undergoing provisional stenting, with and without SB predilatation.
Materials and MethodsThis retrospective observational study included 115 patients who underwent provisional PCI for true bifurcation lesions between January 2021 and November 2024. Patients were divided into two groups: those who received SB predilatation before provisional stenting and those who did not.
ResultsThe mean age of the 115 patients in our study was 64.6 ± 10.4 years, and 31% were female. In the predilatation group, SB lesion severity, procedure duration, dissection rate, and kissing balloon requirement were significantly higher compared to the non-predilatation group (p < 0.05).
DiscussionOur study showed that routine SB predilatation during provisional stenting of true bifurcation lesions is associated with higher rates of dissection and kissing balloon requirement. Similar to the literature, routine SB predilatation does not appear to be recommended. The use of NC balloons in predilatation may be beneficial, as it may reduce dissection rates. Large-scale studies with a high number of patients will be helpful in further elucidating these findings.

Keywords

Introduction

Coronary artery disease (CAD) is a major cause of mortality and morbidity worldwide [1]. In the invasive treatment of coronary artery disease, percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) surgery are commonly utilized [2]. Although PCI has become the standard treatment for CAD, PCI for bifurcation lesions remains technically challenging [3]. Despite the development of the provisional technique using a single stent and various two-stent strategies, the issue of side branch (SB) restenosis has not been fully resolved [4]. The two-stent approach may be required as the primary option in the most complex bifurcation lesions, in rare cases of difficult SB access, or long SB lesions [5]. In patients with an SB lesion length of <10 mm and an SB diameter of <2 mm, provisional stenting is generally preferred [6]. In such lesions, direct provisional stenting of the main branch may compromise SB flow, making rewiring of the SB challenging. This has led to the consideration of performing balloon predilation of the SB before the procedure. However, according to the latest statements from the European Bifurcation Club, SB predilation is generally not recommended [6]. The primary reason for this is that if dissection occurs in the SB following ballooning, rewiring the SB after provisional stenting of the main branch may become challenging [7]. A study on this topic suggests that SB predilation is recommended, particularly in cases where there is a high risk of SB occlusion after main branch stenting, such as long ostial SB lesions or lesions with severe calcification [8]. In another study comparing the long-term mortality of patients who underwent HD predilatation with those who did not, it was found that the mortality of patients who underwent HD predilatation was higher [8]. However, the type of balloon used in these studies was not specified. As a result, there is insufficient data in the literature to establish a clear consensus on SB predilation. In our study, we aimed to compare the post- procedural SB patency in patients with bifurcation lesions and significant SB disease who underwent provisional stenting, with or without SB predilation.

Materials and Methods

This retrospective observational study reviewed patients who underwent coronary angiography (CAG) between January 2021 and November 2024. Among these patients, those with true bifurcation lesions who underwent provisional stenting were included in the study. Patients who underwent direct two- stent bifurcation stenting, those with an SB diameter <2mm, those with an SB lesion length >10mm, those with isolated SB ostial lesions, patients with a life expectancy of less than one year, those with left main coronary artery stenosis, those with total occlusion in the relevant vessel, those with a left ventricular ejection fraction (LVEF) <30%, those with moderate or severe valvular heart disease, and patients with primary cardiomyopathy, as well as those with active cancer, active autoimmune diseases, active infections, end-stage liver failure, and chronic kidney disease requiring hemodialysis or peritoneal dialysis, were excluded from the study. The remaining 115 patients were selected as the final study cohort (Figure 1). This study was conducted in accordance with the Declaration of Helsinki.
The data to be evaluated will be obtained from the catheter laboratory archives of our hospital’s cardiology department, patient files, and the hospital’s computer record system. Blood samples were collected after an overnight fasting period following the procedure. Complete blood count (CBC) will be performed using the Coulter Counter LH Series by Beckman Coulter Inc., Hialeah, Florida, USA. Biochemical analyses were carried out by Roche Diagnostics, Mannheim, Germany, using a molecular analyzer.
The CAG images were reviewed, and the patients’ SB diameters and the percentage of stenosis in the lesions were examined by two experienced interventional cardiologists. The patients with true bifurcation lesions who underwent provisional stenting were divided into two groups: those who underwent SB predilation before the main branch stenting and those who did not. Semi-compliant (SC) and non-compliant (NC) balloons were used for SB predilation. The study will evaluate whether there is a difference between the two groups in terms of procedural outcomes, including a decrease in flow velocity in the SB after main branch stenting, the development of dissection at the SB ostium, chest pain, electrocardiogram (ECG) changes during the procedure, the need for kissing balloon inflation, the need for SB stenting, and the procedural complications rate, considering all of these factors together. Additionally, demographic and blood parameter differences between the two groups will be assessed. Subgroups based on the type of balloon used will also be evaluated for similar procedural outcomes.
Statistical AnalysisWindows SPSS 21.0 (SPSS Inc., Chicago, Illinois, USA) was used for statistical analysis. Continuous variables were described as means ± standard deviation or median (minimum, maximum), and categorical variables were expressed as number (percentage). Evaluations, including the Kolmogorov- Smirnov test, were performed to determine the normality of the distribution. Categorical variables were compared with the Chi-square or Fisher’s exact test, and continuous variables were compared with the Mann-Whitney U test or Student t-test. Two- sided p < 0.05 was considered statistically significant.
Ethical ApprovalOur study was approved by the Ethics Committee of Sivas Cumhuriyet University (Date:2025-01-16, No: 2025-01/36).

Results

The mean age of the 115 patients in our study was 64.6 ± 10.4 years, and 31% were female. The demographic and clinical data of the patients are listed in Table 1, with a comparison between the predilation (+) and predilation (-) groups. No significant difference was found between the two groups in terms of demographic and clinical characteristics. When examining angiographic characteristics, the predilation group showed significantly higher lesion severity, procedure duration, dissection rate, and kissing balloon requirement compared to the non-predilation group (p < 0.05) (Table 1). In contrast, the non- predilation group exhibited a significantly higher incidence of ECG changes during the procedure compared to the predilation group (p < 0.05) (Table 1). No significant differences were found between the two groups in terms of procedural complications. Laboratory data are presented in Table 1, with no significant differences between the two groups. When comparing patients who underwent predilation with only an NC balloon to the non- predilation group in terms of angiographic parameters and procedural complications, no significant differences were found between the two groups (Table 2). When comparing patients who underwent predilation with only an SC balloon to those who underwent predilation with only an NC balloon, the rate of contrast-induced nephropathy was found to be significantly higher in the SC balloon group (38.1% vs. 0%; p = 0.011). No significant differences were observed between the two groups in terms of other angiographic outcomes and procedural complications (Table 3).

Discussion

In our study, patients with true bifurcation lesions who underwent provisional PCI were compared between those who received SB ostium predilation and those who did not. In the analysis, including all procedural complications, no significant difference was found between the two groups. However, the procedure duration, dissection rate, and the need for kissing balloon inflation were significantly higher in the predilation group compared to the non-predilation group (p < 0.05). No cardiovascular deaths were observed in either group. In the predilation group, the severity of the SB ostium was found to be significantly higher (%80 vs. 50%, p < 0.001). This suggests that operators tend to perform more predilation as the severity of SB ostial lesions increases. In the recent study published by Carvalho et al., 143 out of 428 patients with true bifurcation lesions underwent SB predilation, and their in-hospital and procedural outcomes were compared. Consistent with our findings, the proportion of SB lesions was significantly higher in patients who underwent predilation compared to the other group. Additionally, in this study, the rate of conversion to a dual- stent strategy was higher in the predilation group. Procedural complications and in-hospital events were similar between the two groups. ( available at: DOI: 10.1002/ccd.31465)
In the treatment of bifurcation lesions, the proximal optimized (POT) provisional stenting technique forms the cornerstone of our current approach to coronary bifurcation interventions [9, 10]. In this technique, the potential loss of the SB and the subsequent challenges in rewiring the SB compel operators to seek solutions [6, 7, 10]. The main reason for this is thought to be the possibility of problems in YD rewiring due to possible dissections [11]. In the studies conducted, a higher rate of SB crossover stenting was observed in patients who underwent SB predilation [12, 13]. In line with the results of our study, patients who underwent SB predilation exhibited a higher incidence of dissection, consistent with the literature. As a consequence, flow loss and the need for kissing balloon inflation were significantly higher in the predilation group. In the first study conducted on this topic, the COBIS registry, 837 patients were included, with 175 patients undergoing predilation. In the predilation group, a significantly higher number of patients underwent rescue two-stent placement and kissing balloon inflation. Additionally, in this study, after 21 months of follow-up, the target vessel revascularization (TVR) rate was higher in the predilation group [14]. In our study, similar to the aforementioned study, a higher incidence of SB ostium dissection and the need for kissing balloon inflation was observed. However, when comparing the group that underwent predilation with only an NC balloon to the non-predilation group, no significant difference was found in terms of dissection, kissing balloon need, or overall procedural complications. Additionally, when comparing patients who underwent predilation with an NC balloon to those who received an SC balloon, although the dissection rate was numerically lower in the NC group, no significant difference was found between the two groups. Contrast-induced nephropathy was found to be significantly less common in the NC predilation group compared to the SC predilation group (p < 0.05). A likely reason for this could be that, due to fewer complications in the NC balloon group, the procedures were completed more quickly with less contrast use. Based on these results, it suggests that NC balloon predilation may be associated with improved procedural success and a reduction in SB flow loss. We believe that further studies with larger patient populations could be beneficial. In the study by Vassilev et al., 324 out of 831 patients who underwent bifurcation PCI received predilation, and long-term mortality was followed. While angiographic outcomes were significantly better in the predilation group, the 8-year follow-up revealed a worse patient survival rate [15]. The association of these studies with long-term SB restenosis and TVR suggests that balloon dilation alone does not prevent lesion recoil over an extended period. Therefore, studies involving drug-coated balloons for SB predilation could provide clearer data on this matter. Although our study does not include long-term mortality data, no in-hospital mortality was observed in any of the patients.

Limitations

The study is designed retrospectively. It is not blinded to the operator or the patient. Whether the operators perform balloon predilation or not, and the type of balloon they use, depends on the operator, which makes the study subjective and susceptible to some degree of bias. Additionally, the inclusion of both elective and emergency PCI patients in the study population is an important limitation, as this may affect the results, and it is difficult to correlate these outcomes separately with clinical conditions. The sample size of the study is limited, and it was conducted at a single center. This may restrict the generalizability of the results. In the future, multicenter studies with larger sample sizes would be beneficial to validate the applicability of the results to a broader patient population.

Conclusion

In conclusion, in our study of provisional stenting for true bifurcation lesions, routine YD predilatation was associated with a higher incidence of dissection and the need for kissing balloon. Similar to the literature, it seems more reasonable not to apply routine predilatation. In patients who require predilatation, the use of NC balloons may be beneficial as it could reduce the incidence of dissection. Further studies with a larger patient sample would be valuable in this regard.

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