A prospective randomized open-label trial of sirolimus versus paclitaxel-coated balloons for the side branch of de novo coronary bifurcation lesion

Introduction

Coronary bifurcation lesions present significant challenges in modern percutaneous coronary intervention (PCI) era. Advanced techniques and appropriate strategies are essential for managing these lesions. When stenting the main branch (MB), the side branch (SB) should always try to be preserved, especially in the case of large SB. Methods to preserve the SB include wire protection, regular balloon or drug-coated balloon (DCB) angioplasty, and stenting. Before the introduction of DCB, the dual-stent strategy was commonly used. However, this strategy is technically challenging and often leads to in-stent restenosis (ISR) (1). Additionally, regular balloon angioplasty (BA) of the SB does not effectively prevent elastic recoil of the vessel. Clinical trial has demonstrated that DCB was superior to regular BA for preserving the SB, as shown by angiographic outcomes. In this trial, the drug used for coating the balloons is paclitaxel (2).

Paclitaxel is highly lipid-soluble and induces cell-cycle arrest. It is rapidly absorbed by endothelial cells, preventing their proliferation for an extended period, allowing the vessels to maintain their treated lumen area and even undergo positive remodeling long after treatment (3). Sirolimus, though also inhibiting the cell cycle, is less lipid-soluble than paclitaxel and is not easily absorbed by endothelial cells. When used with stent as a carrier, both paclitaxel and sirolimus can be continuously released, exerting anti-proliferative effects on the intima. Both sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) are widely used, whereas SES showed better outcomes compared with PES in long native coronary artery (4), small coronary vessels (5) and crush stenting in bifurcation lesions (6). However, without a carrier, sirolimus may be less effective, so most commercially available DCBs are PCBs.

DCBs have been shown to be non-inferior to drug-eluting stents (DESs) in small vessels, ISR and even in complicated lesions (7-9). Recent data suggest similar efficacy between SCBs and PCBs in coronary de novo lesions (10). Another trial reported that in cases of SB stenosis >70% after stenting MB, SCBs and PCBs treatment resulted in similar outcomes (11). However, in de novo bifurcation lesions, whether SCBs produce similar effects as PCBs in the SB remains to be investigated. We present this article in accordance with the CONSORT reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1243/rc).

Methods

Study design

This prospective, multicenter, randomized, controlled, non-inferiority clinical trial was designed to compare the efficacy and safety of SCB versus PCB in treating the SB of de novo non-left main coronary bifurcation lesions with provisional stenting (registration number: https://www.medicalresearch.org.cn/, MR-12-24-007528).

Patients

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethical Committee of The Second Affiliated Hospital of Zhejiang University School of Medicine (No. IR2021001232). All participating centers were informed and agreed to the study. Informed consent was taken from all the patients. The study enrolled patients from 10 centers in China.

Major inclusion criteria were: ≥18 years of age; stable or unstable angina, or stabilized recent myocardial infarction (MI) (occurring >7 days before enrollment, including non-ST-segment elevation and ST-segment elevation MI), or asymptomatic myocardial ischemia; de novo non-left main bifurcation lesion with ≥70% diameter stenosis of the SB ostium observed at diagnostic angiography, the MB scheduled for stenting, while the SB only proposed for balloon dilation, instead of double-stent strategy; SB diameter 2.0–4.0 mm, lesion length ≤35 mm. Major exclusion criteria included: MI within 7 days and stroke within 6 months before enrollment; renal insufficiency [estimated glomerular filtration rate (eGFR) <30 mL/min]; hypersensitivity to paclitaxel, sirolimus, or structurally similar compounds, aspirin, clopidogrel, or angiographic agents; patients unable to undergo anticoagulation due to a bleeding tendency or history of bleeding; severe congestive heart failure; life expectancy of ≤1 year or inability to complete follow-up visits within 1 year; complete occlusion of the target vessel; severely calcified SB target lesions; ISR lesions in the SB; bifurcation lesions originating from the left main coronary artery; grade C or greater dissection or ≥50% residual stenosis after pre-dilation of the SB target lesion.

Trial procedures

The researchers enrolled the patients. The enrolled patients received antiplatelet therapy prior to PCI, with loading doses of aspirin (300 mg) and clopidogrel (300 mg) or ticagrelor (180 mg). Post-procedure antiplatelet therapy with aspirin and clopidogrel/ticagrelor was required for at least 12 months. The informed consent was obtained after the diagnostic angiography. The SB was protected by a guidewire. Whether or not the SB was pre-dilated before MB stenting was at operator’s discretion. The balloon diameter for SB pre-dilation was smaller than the vessel diameter to avoid dissection. A stent was implanted in the MB, and the SB was dilated with a balloon. The decision to perform kissing balloon dilation or not was based on the lesion, with the balloon diameter for branch kissing dilation being smaller than the vessel diameter of SB. After confirming that the residual stenosis of the SB after pre-dilation was less than 50% without grade C or greater dissection, the researchers initiated randomization by Central Randomization System from www.cims-medtech.com which generated the result on-site. The experimental and control groups received SCB (Drug Eluting PTCA Balloon Catheter; Revita Medical Technology Co., Ltd., Hangzhou, China) and PCB (Bingo^®; Yinyi Biotech, Dalian, China), respectively. A DCB for the SB was selected by a diameter ratio of 0.8–1:1, and the recommended dilation time for both groups was 30–60 seconds.

Quantitative coronary analysis (QCA) of baseline and follow-up images was performed by an independent core laboratory (JetMed Co., Ltd., CoreLab, Beijing, China). The QAngio XA 7.3 system (Medis Medical Imaging System Inc., Leiden, The Netherlands) was used for quantitative analysis in the core laboratory.

Follow-up and endpoint

All enrolled patients were followed up at 30 days, 6 months, 9 months, and 12 months after discharge. The primary efficacy endpoint was the percentage of target lesion stenosis (TLS) in the SB observed on angiogram 9 months after treatment. Secondary endpoints included efficacy endpoints and safety endpoints. The former included the incidence of restenosis and late lumen loss (LLL) in the SB at 9 months post-procedure, as well as the incidence of major adverse cardiac event (MACE), major adverse cardiac and cerebral event (MACCE), target lesion revascularization (TLR), target vessel revascularization (TVR), and target lesion failure (TLF) at 30 days, 6 months, 9 months, and 12 months post-procedure. The latter included adverse events (AEs) and serious adverse events (SAEs).

MACE included all-cause mortality, MI, and revascularization. MACCE included stroke, cardiac death, target vessel-related MI, and ischemia-driven TLR. TLR was defined as a new intervention (surgical or percutaneous) to treat the target lesion, due to any evidenced ischemia (anatomical or functional) related to the restenosis of target vessel. TLF included cardiac death, MI due to target vessels, and TLR.

Statistical analysis

The study employed a non-inferiority design. Based on previous studies (2), the degree of stenosis (%) of the SB target lesion in the control group treated with DCB (Bingo^®; Yinyi Biotech, Dalian, China) was 28.7%±18.73% at the 9-month follow-up. The non-inferiority cut-off was set at 7%, in consideration of the clinical situation. Assuming similar efficacy between the experimental and control groups, the sample size was calculated to be 94 subjects per group with α=0.025 (one-sided test) and statistical power (1-β) =80%. After accounting for a 20% dropout rate, a total of 236 subjects were included in the study, with 118 subjects in each group.

Efficacy analyses were conducted in both the full analysis set (FAS) and the per protocol set (PPS). Baseline demographic analyses were performed in the FAS. Safety endpoints were analyzed using the safety set (SS). The FAS consists of all subjects who were randomized and received the study treatment, in line with the intention to treat (ITT) principle. The PPS includes only those subjects who completed the trial and excludes those with significant protocol violations. The SS includes all subjects who used the study device post-randomization and had at least one safety evaluation.

The percentage of TLS in SB at 9 months post-procedure was statistically described, and intergroup comparisons were made using either the two-sample independent t-test or the Wilcoxon rank-sum test. Covariance analysis was used to estimate the least-squares mean (LS mean) for the degree of stenosis in each group. The LS mean difference and the 95% confidence interval (CI) between groups were calculated. The model adjusted for treatment, baseline characteristics, and center. The study hypothesis was considered valid if the upper limit of the 95% CI for the difference in the percentage of TLS in SB between the two groups was below the non-inferiority cutoff. To assess consistency between centers, the interaction between centers and subgroups was tested within the covariance analysis model. The significance of the interaction term was evaluated at the 0.10 level.

The incidence of target lesion restenosis at 9 months post-procedure, as well as the occurrence of MACE and MACCE, was described using categorical data. Comparisons between groups were made using the Chi-squared test or Fisher’s exact test. LLL in the SB target lesion at 9 months post-procedure was described using continuous measures, with group comparisons made using either the two-sample independent t-test or the Wilcoxon rank-sum test. The incidence of TLR, TVR, and TLF was described using Kaplan-Meier survival curves, with group differences tested using the log-rank test and analyzed with Cox proportional hazards regression models. Centers and groups included in Cox proportional hazard analysis.

Continuous data are presented as mean ± standard deviation, median, and quartiles, and the normality test is conducted by Shapiro-Wilk test, and comparisons between groups were made by the two-sample independent t-test or the Wilcoxon rank-sum test. Categorical data are presented as frequencies and percentages, and the Chi-squared test was used. If Chi-squared test assumptions are violated, Fisher’s exact test was used. All statistical tests were two-sided, and a P value of ≤0.05 was considered statistically significant. Statistical analyses were performed using SAS version 9.4 (SAS Institute Inc., NC, USA).

Results

The trial started in June 2021 and ended in October 2023. Ten centers in China participated in this trial, enrolling a total of 241 cases (121 in the SCB group and 120 in the PCB group). Ultimately, 236 cases were included in the FAS, 198 cases in the PPS, and 236 cases in the SS (Figure S1).

The two groups were generally well balanced in terms of demographic characteristics and medical history (Table 1), procedural features (Tables 2,3, Table S1), except for a higher history of prior PCI in the PCB group.

In the FAS, the percentage of TLS in SB was 26.78%±14.40% in the SCB group and 30.60%±17.07% in the PCB group at 9 months post-procedure. The 95% CI for the difference between the two groups was −7.87%, 0.23%, meeting the non-inferiority. In the PPS, the percentage of TLS in SB was 28.38%±14.66% in the SCB group and 30.57%±16.70% in the PCB group at 9 months post-procedure. The 95% CI for the difference was −6.60%, 2.23%, within the non-inferiority range. Analysis of covariance considering baseline and center effects revealed no interaction between center and grouping in both the FAS and PPS. In the FAS, the LS mean difference in the percentage of TLS in SB at 9 months post-procedure was −3.27%, with a 95% CI of −7.26%, 0.71%. In the PPS, the LS mean difference was −1.85%, with a 95% CI of −6.24%, 2.53% (Figure 1). Sensitivity analysis based on worst-value replacement and predictive mean matching confirmed consistent results (Figure S2).

Figure 1 Assessment of primary efficacy endpoint. Covariance analysis included TLS of the SB in the preoperative period as a covariate. No interaction between centers and groups in FAS (P=0.12) and PPS (P=0.50). Analysis according to covariance without interaction term. CI, confidence interval; FAS, full analysis set; LS mean, least-squares mean; PCB, paclitaxel-coated balloon; PPS, per protocol set; SB, side branch; SCB, sirolimus-coated balloon; TLS, target lesion stenosis.

In the FAS (Table 4), for secondary efficacy endpoints, there was one MI in PCB group at 30-day follow-up. There were no clinical events of TLR, TVR, or TLF in either group at 6-month follow-up. At 9-month follow-up, the incidence of restenosis of target lesion, LLL, TLR, TVR, TLF, MACE and MACCE were not statistically significant different between the SCB and PCB groups. A significant difference was observed in the incidence of MACCE at 12-month follow-up (SCB: 0.84% vs. PCB: 5.98%, P=0.04). In the SCB group, there was 1 MI (0.84%) without revascularization; and in the PCB group, there was 1 noncardiac death (0.85%) which occurred in 9 months after procedure, 3 MI (2.56%) including 1 occurred in 2 days after procedure without revascularization, 2 occurred in 12 months with revascularization, and 2 stroke (1.67%) including one in 9 months and another in 12 months. Consistent results were also observed in the PPS (Table 4).

Cox regression analysis of TLR, TVR and TLF and cumulative incidence of events showed no statistically significant differences between the two groups (Table 5, Figure S3).

The incidences of post-PCI AE (67.8% vs. 70.3%, P=0.78) and SAE (17.0% vs. 23.7%, P=0.26) were not significantly different between the SCB and PCB groups (Table S2).

Discussion

This study is a prospective, multicenter, randomized controlled, non-inferiority clinical trial designed to compare the efficacy and safety of SCB and PCB for treating the SB of de novo non-left main coronary bifurcation lesions. The primary results showed that SCB was noninferior to PCB in terms of the percentage of TLS in SB at 9 months of follow-up. SCB was also noninferior to PCB in the incidence of MACE, MACCE, LLL, TLR, TVR, and TLF. Additionally, SCB demonstrated a favorable clinical safety profile.

Due to the complex anatomy of bifurcation lesions, the interventional treatment is challenging, with a low success rate and high rates of both restenosis and complications. In previous clinical practice, the management strategy for coronary bifurcation lesions typically involved dual-stent strategy. While this approach can provide better immediate imaging results, it is technically complex, associated with a higher incidence of in-stent thrombosis and restenosis over the long term, and requires a prolonged period of dual antiplatelet therapy (DAPT) (12-14). Several studies have highlighted that a dual-stent strategy can be technically demanding, increasing procedure time and cost. The single-stent technique offers advantages over the dual-stent approach, including better clinical efficacy, shorter procedure time, simpler procedure, fewer complications, and lower clinical costs. Therefore, bifurcation lesions should be managed as less stents as possible, following the “simple and safe” principle (12,14). However, whether a single-stent or dual-stent strategy is used, restenosis of SB remains common. The use of DCB in bifurcation lesions reduces the need for a dual-stent approach, lowers the restenotic rate of the MB and SB, and reduces the risk of in-stent thrombosis (15-17).

DCB for bifurcation lesions simplifies interventional procedures while reducing restenosis. Observational studies have shown that treating patients with bifurcation lesions using DES for the MB and DCB for the SB is both safe and effective (18-20). Furthermore, other studies have provided support for using the DCB-only strategy in bifurcation lesions (15,21-23). Paclitaxel-coated balloon treatment of de novo non-left main coronary bifurcation lesions has been shown to increase the SB lumen area after 9 months (24). The BEYOND study was a prospective, multicenter, randomized controlled superiority trial comparing the safety and efficacy of paclitaxel-eluting balloon (PEB) versus regular BA alone in treating coronary bifurcation lesions (2). The study included 222 patients (113 PEB vs. 109 BA) from 10 centers. The primary endpoint, the percentage of TLS at 9 months, was significantly different between the groups (PEB: 22.3% vs. BA: 34.6%, P<0.0001; 95% CI: −16.59% to −8.01%), confirming the superiority of PEB. The DCB-BIF study is a randomized controlled trial designed to compare the efficacy of DCB versus noncompliant balloon for treating the SB in patients with true and simple coronary bifurcation lesions using a provisional stenting approach (25). The study found that DCB treatment of the SB reduced the risk of MACEs within 1 year compared to noncompliant balloons. According to the Chinese expert consensus on the clinical application of DCB, for pseudo-bifurcation lesions, simple DCB in the SB is recommended; for true bifurcation lesions, DES in the MB and DCB in the SB are recommended (26).

The results of the EASTBOURNE study, a large-scale sirolimus DCB trial, confirmed that SCB is safe and effective in treating de novo lesions and in-stent restenotic lesions (27,28). However, the superiority of PCB over SCB has been widely discussed. A randomized, prospective, multicenter controlled trial found that SCB was noninferior to PCB in terms of LLL, and the incidence of MACEs was similar between the two groups at 12-month follow-up (10). A recent trial showed that in ostial stenosis of SB resulted from MB stenting, treating the SB with SCB was noninferior to PCB (11). In contrast, another prospective, multicenter, noninferiority trial found that SCB did not show non-inferiority in angiographic net lumen gain at 6 months compared to PCB (29). Researchers suggest that drug delivery and tissue residence time are key factors influencing these outcomes (30,31). Compared to PCB, SCB delivers weaker and more differential drug release over time. However, SCB still requires more evidence from higher-quality studies with refined interventional techniques to explore its clinical value.

This study is the first to evaluate the role of SCB in treating SB with de novo bifurcation lesions. The management of bifurcation lesions in this study was similar to that in the BEYOND study. At the operator’s discretion, DES was implanted in the MB after pre-dilation or without pre-dilation, provided that there was no significant dissection in the SB and the residual stenosis of the SB was <50% before randomization. A total of 10 centers and 241 patients (121 in the trial group and 120 in the control group) were enrolled in this trial, which is comparable to the BEYOND study. However, 198 patients (82.16%) completed the 9-month follow-up for the primary endpoint, a higher completion rate than in the BEYOND study. In addition to the primary endpoint, secondary endpoints at multiple time points were also assessed, and SCB performed noninferiorly to PCB across these endpoints. Notably, the 12-month post-procedure MACCE incidence rate in the SCB group was lower than that in the PCB group. These findings suggest that SCB offers comparable therapeutic efficacy to PCB for treating bifurcation lesion in the SB.

However, there are some limitations in this study. First, the follow-up period did not exceed one year, so the long-term prognosis of SCB for bifurcation lesions requires further follow-up. Second, due to the non-inferiority design, additional research is needed to evaluate the relative effectiveness of SCB compared to PCB. Furthermore, although the study included patients from multiple centers, the population was limited to Chinese patients, and the generalizability and stability of these findings need to be confirmed in other ethnic groups.

Conclusions

For patients with de novo non-left main bifurcation lesions undergoing provisional stenting of the SB, the efficacy and safety of SCB for treating the SB is noninferior to that of PCB.

Acknowledgments

We would like to thank the study participants, their families, and caregivers, as well as colleagues from the following 10 centers for their valuable contributions: The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; Suzhou Municipal Hospital, Suzhou, China; The First Affiliated Hospital of Nanchang University, Nanchang, China; The First Affiliated Hospital of Ningbo University, Ningbo, China; Beijing Anzhen Hospital Capital Medical University, Beijing, China; Teda International Cardiovascular Hospital, Tianjin, China; The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; Renmin Hospital of Wuhan University, Wuhan, China; The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China; Affiliated Hospital of Zunyi Medical University, Zunyi, China.

Footnote

Reporting Checklist: The authors have completed the CONSORT reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1243/rc

Trial Protocol: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1243/tp

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1243/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1243/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1243/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethical Committee of The Second Affiliated Hospital of Zhejiang University School of Medicine (No. IR2021001232). All participating centers were informed and agreed to the study. Informed consent was taken from all the patients.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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