Clinical outcomes of drug-coated balloons vs. drug-eluting stents for coronary chronic total occlusion: a retrospective cohort study

Introduction

Chronic total occlusion (CTO) refers to an angiographically demonstrated coronary artery lesion with thrombolysis in myocardial infarction (TIMI) grade 0 blood flow, mature collateral circulation, and a duration of occlusion for over 3 months. CTO patients account for 16–20% of the total number of patients with coronary heart diseases (1-3). CTO recanalization presents considerable technical challenges, and percutaneous coronary intervention (PCI) for such lesions carries a higher risk of complications compared with non-CTO. Successful revascularization of CTO can contribute to symptom relief, improved quality of life, potentially reduced mortality and enhanced left ventricular function (4-7). Stent implantation is commonly performed after CTO recanalization. The advantage of stents is their ability to cover dissections created during lesion opening and prevent vessel recoil, thus reducing acute vascular occlusion risk. However, studies based on intravascular ultrasound (IVUS) imaging have demonstrated that successful CTO recanalization can result in positive vascular remodeling and subsequent enlargement of the lumen distal to the lesion, potentially causing undersizing of the initially selected stent (8-11). Additionally, diffuse coronary artery lesions often require significantly longer stents, resulting in prolonged dual antiplatelet therapy (DAPT) and consequently an increased bleeding risk (12,13).

Drug-coated balloons (DCBs) are emerging medical devices in PCI. They facilitate delivery of high concentrations of anti-proliferative drugs directly to target lesions, thus preventing neointimal hyperplasia (14). Initially, DCB were developed to treat in-stent restenosis (ISR) by reducing the need for implantation of an additional stent within an existing one (15). Recent studies demonstrate that DCB also produce favorable outcomes in certain de novo coronary lesions, such as small vessel disease and bifurcation lesions (16-18). Regarding the use of DCB for CTO treatment, numerous existing studies have reported its increasing use (19,20) and potential to reduce stent number and length (21,22), suggesting that it may be a safe and effective alternative to drug-eluting stents (DESs) (19-24). Supported by this evidence and the potential to avoid complications related to stent implantation, DCB have emerged as a promising option in CTO-PCI. However, most prior studies have compared clinical outcomes between hybrid groups (DCB-based PCI or DCB combined with DES) and standalone groups (DES-only or DCB-only). Data from direct comparisons specifically focused on standalone DCB versus DES remain relatively scarce. Moreover, evidence guiding device selection in CTO-PCI based on vessel anatomy (e.g., vessel diameter) remains limited. How to select devices for CTO patients with specific comorbidities (e.g., history of heart failure) remains an unresolved clinical question. Therefore, this study aimed to compare the 12-month clinical outcomes between DCB and DES in CTO patients, with particular emphasis on evaluating the impact of vessel size and a history of heart failure on treatment outcomes. We present this article in accordance with the STROBE reporting checklist (available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-478/rc).

Methods

Study population

This was a single-center, retrospective, observational cohort study. A total of 479 consecutive patients who underwent successful CTO-PCI at the First Affiliated Hospital of Dalian Medical University from March 31, 2020 to March 31, 2023 were enrolled. The exclusion criteria were: (I) acute ST-segment elevation myocardial infarction (MI); (II) prior coronary artery bypass grafting (CABG); (III) hybrid strategy using both DES and DCB after CTO recanalization; and (IV) lost to follow-up. 9 patients who underwent hybrid treatment with both DES and DCB and 25 patients lost to follow-up were excluded, and 445 patients were included in this study. Patients were assigned to either the DES group or the DCB group according to the device used during the procedure. The patient selection flowchart is shown in Figure 1. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University (approval No. PJ-KS-KY-2025-396). The requirement for informed consent was waived due to its retrospective design, the use of fully de-identified clinical data, and because the waiver did not adversely affect the rights and welfare of the participants.

Figure 1 Flowchart of patient selection. CTO, chronic total occlusion; DCB, drug-coated balloon; DES, drug-eluting stent; PCI, percutaneous coronary intervention.

Outcome measures

The primary endpoint of this study was the occurrence of major adverse cardiovascular events (MACEs) during postoperative 12-month follow-up. MACE was defined as a composite of cardiac death, MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and repeat revascularization. The secondary endpoints included all-cause mortality, heart failure recurrence, new-onset heart failure, and recurrent angina.

Study devices and procedure

In strict accordance with current national clinical guidelines, standardized periprocedural management and coronary intervention were provided to all enrolled patients. Prior to the procedure, a loading dose of antiplatelet therapy was provided for all patients, which was composed of 300 mg aspirin combined with a P2Y12 receptor inhibitor (300 mg clopidogrel or 180 mg ticagrelor). Heparin (70–100 IU/kg) was routinely administered during the procedure for anti-coagulation. At the discretion of the operator, glycoprotein IIb/IIIa receptor inhibitors were given based on a tailored assessment of each patient. Meanwhile, the CTO-PCI procedure was performed by experienced interventional physicians. Critically, to achieve optimal lesion preparation, the dilation of target lesions was achieved with the use of standard semi-compliant balloons, cutting balloons, or high-pressure non-compliant balloons. The optimal lesion preparation was defined by the following angiographic criteria: (I) residual stenosis <30%; (II) TIMI flow grade of 3; and (III) no flow-limiting dissection. After optimal preparation, lesions that met the International DCB Consensus Group criteria (15) were treated with DCB angioplasty. For all other lesions, DES implantation was performed. The DCB was inflated to its nominal pressure for at least 60 s, ensuring that it extended a minimum of 2 mm beyond the length of the lesion at both ends. There was a requirement for remedial stent implantation in cases where a flow-limiting dissection or significant residual stenosis occurred in the DCB-treated segment. The DES used in this study included the Resolute Integrity (Medtronic, Santa Rosa, CA, USA) and Excel (JW Medical System, China). The DCB used included the SeQuent Please (B. Braun Melsungen AG, Germany) and Bingo (Yinyi Biotech, China). The use of IVUS was determined through joint consultation by at least two senior interventional physicians and was ultimately employed in 153 patients. The analysis of corresponding IVUS images was conducted by two observers using the Boston Scientific Image Viewer software, with analysis parameters including plaque characteristics and vessel diameter. Inter-observer disagreements were resolved through discussion until consensus was reached. For patients without IVUS, the vessel diameter was determined by visual estimation on coronary angiography by operators, using the guiding catheter as a reference scale. For subsequent analysis, vessels were categorized as small (≤2.75 mm) or large (>2.75 mm) based on this diameter, consistent with established definitions in prior DCB studies and consensus recommendations (15,17).

Data collection

This study obtained data on demographics, laboratory results, medications, and procedural details from the hospital’s electronic medical record system and the catheterization laboratory database. We collected the clinical follow-up information by reviewing the electronic medical records, outpatient visits, and standardized telephone interviews of the enrolled patients.

Statistical analysis

Continuous variables were expressed as mean ± standard deviation or median (interquartile range), based on their distribution which was assessed using the Shapiro-Wilk test. Categorical variables were expressed as counts (percentages). Missing data were limited and were handled by imputation: continuous variables with the mean, categorical variables with the mode. Differences in continuous and categorical variables between groups were analyzed using Student’s t-test, and Chi-squared test or Fisher’s exact test, respectively. The Mann-Whitney U test was employed for the non-parametric data comparison. Kaplan-Meier analysis was conducted to analyze the survival-free of adverse events, with the results compared using the log-rank test. Due to subgroup imbalances and restricted sample size precluding the use of propensity score matching or inverse probability weighting, multivariate Cox proportional hazards regression analysis was applied to adjust for potential confounders. Variables that exhibited statistical significance (P<0.05) in univariate Cox regression analyses, along with clinically relevant covariates (age and vessel diameter), were included in this model to calculate adjusted hazard ratios (HR) with corresponding 95% confidence intervals (CI). Subgroup analysis was performed to investigate differences in MACE between groups, stratified by gender, hypertension grade, diabetes, IVUS utilization, and vessel size (>2.75/≤2.75 mm). All statistical analyses were conducted with SPSS (version 26.0, IBM Corporation, Armonk, NY, USA). A value of P<0.05 was deemed to indicate statistical significance.

Results

Baseline characteristics

Ultimately, 445 patients completed CTO revascularization and the 12-month follow-up. Baseline characteristics of the two groups are presented in Table 1. Compared with the DES group, patients in the DCB group were younger, had lower Killip classification, lower levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and lipoprotein(a), but higher rates of prior PCI history, non-ST-segment elevation myocardial infarction (NSTEMI) diagnosis, and higher left ventricular ejection fraction (LVEF). Regarding the use of P2Y12 receptor inhibitors, patients in the DCB group more frequently used clopidogrel than ticagrelor.

Procedural characteristics

Table 2 summarizes coronary angiography and PCI characteristics of the study participants. Specifically, single-vessel CTO accounted for 80.0%, with CTO located the most commonly in the right coronary artery (42.5%). There was no difference in the proportion of large vessel disease (diameter >2.75 mm) and small vessel disease (diameter ≤2.75 mm) (50.6% vs. 49.4%). The overall Japanese-chronic total occlusion (J-CTO) score was 1.18±1.01, without statistically significant inter-group difference. However, the DES group had a higher proportion of lesions with bending >45°, a feature that increases the technical challenge of stent delivery. Furthermore, compared to the DES group, the DCB group had a higher proportion of CTO in the left circumflex artery, a smaller target vessel diameter, and less contrast volume used during the procedure. Meanwhile, the DCB group exhibited significantly fewer devices, shorter total deployed length, and smaller mean nominal device diameter compared to the DES group. In addition, no statistically significant inter-group differences was found in terms of artery approach, CTO wire number, proportion of bilateral angiography, IVUS utilization rate, as well as the proportions of fibrous, calcified, and lipid plaques assessed by IVUS.

Clinical outcomes during follow-up

The 12-month clinical outcomes for both groups are presented in Table 3. The results of univariate Cox regression analysis for MACE are presented in Table 4. The results of multivariate Cox regression analysis are summarized in Table 5. No statistically significant differences were observed between groups regarding the incidence of MACE, all-cause mortality, incident heart failure, or recurrent angina during follow-up. However, the DCB group showed significantly higher incidence of heart failure recurrence than that in the DES group (HR 0.08; 95% CI: 0.01–0.52; P=0.007). The Kaplan-Meier survival curves for MACE and heart failure recurrence events are presented in Figure 2.

Figure 2 Kaplan-Meier survival curves for MACE (A) and heart failure recurrence (B) events during follow-up. DCB, drug-coated balloon; DES, drug-eluting stent; MACE, major adverse cardiovascular event.

Subgroup analysis

A significant interaction existed between treatment strategy (DCB/DES) and vessel size, as presented in Figure 3. Patients who underwent large-vessel CTO-PCI (>2.75 mm) with DCB demonstrated a significantly lower incidence of MACE compared to those treated with DES. However, this difference was not observed in small-vessel CTO-PCI (≤2.75 mm). Besides, there were no significant interactions between treatment strategy and other subgroup variables (gender, hypertension grade, diabetes, or IVUS utilization). Kaplan-Meier survival curve for MACE in large-vessel group is presented in Figure 4, and the forest plot is shown in Figure 3.

Figure 3 The forest plot. CI, confidence interval; DCB, drug-coated balloon; DES, drug-eluting stent; HR, hazard ratio; IVUS, intravascular ultrasound.

Figure 4 Kaplan-Meier survival curve for MACE in large-vessel group. DCB, drug-coated balloon; DES, drug-eluting stent; MACE, major adverse cardiovascular event

Discussion

In this real-world, single-center cohort of 445 patients who underwent successful CTO-PCI, we compared standalone DCB angioplasty with drug-eluting stent DES implantation and report three principal findings. First, the DCB strategy was associated with comparable rates of MACE at 12 months to DES. Second, vessel size critically modified treatment outcomes: in large vessel CTO (>2.75 mm), DCB was associated with a significantly lower risk of MACE, whereas outcomes were comparable in small vessel CTO (≤2.75 mm). Third, a history of heart failure identified a subgroup that derived greater benefit from DES, as evidenced by a significantly reduced risk of heart failure recurrence. These findings suggest that a one-size-fits-all approach is suboptimal for CTO revascularization, and that device selection should be guided by vessel anatomy and patient comorbidities.

Our study supports the high efficacy of DCB in CTO-PCI, aligning with its proven effectiveness in managing other complex coronary artery lesions. For instance, DCB angioplasty is currently endorsed in myocardial revascularization guidelines for ISR lesions with a Class I recommendation and Level of Evidence A (15). For small vessel disease, randomized controlled trials, including BASKET-SMALL 2 (16) and RESTORE SVD China (17), established DCB as a safe therapeutic option, provided optimal lesion preparation is achieved. In addition, for bifurcation lesions, current observational study has documented favorable clinical outcomes in patients receiving main branch DES implantation combined with branch DCB dilation (18). While preliminary studies suggest the potential feasibility of DCB in large vessel coronary disease, evidence remains limited and predominantly derived from exploratory trials without randomised controlled trials (25,26).

This collective evidence provides a plausible clinical rationale for the potential utility of DCB in CTO management. This rationale is reflected in the treatment preferences observed in our real-world cohort, where operators consistently selected DCB for patients and lesion profiles that aligned with its advantages, such as smaller vessel diameters, consistent with established evidence.

There is still undefined conclusion regarding the efficacy of DCB and DES for CTO. Currently, DCB have potential clinical value in treating CTO with optimal pre-dilation according to several single-center small-sample studies (27-29). Specifically, bare-metal stents combined with DCB has demonstrated efficacy non-inferior to that of DES (29). Jun et al. observed favorable 2-year clinical outcomes in patients with de novo CTO managed with DCB following initial balloon angioplasty (30). In another study, Basavarajaiah et al. (31) analyzed 403 patients with intra-stent chronic total occlusion (IS-CTO) undergoing PCI between 2011 and 2017 at two high-volume centers. Their findings indicated comparable rates of cardiac death and target vessel MI among the three groups: plain old balloon angioplasty (POBA), DCB, and DES. However, patients receiving DCB or DES exhibited lower incidences of TLR and overall MACE compared to the POBA group. Moreover, Zhang et al. (32) corroborated no significant differences in MACE between paclitaxel-coated balloons (PCBs) and DES in patients with IS-CTO within DES, thereby reinforcing PCB as a viable therapeutic alternative to DES in such cases. Recent studies over the past three years have gradually expanded patient inclusion criteria to encompass de novo CTO. However, most studies have compared clinical outcomes between hybrid groups (DCB-based PCI or DCB combined with DES) and standalone groups (DES-only or DCB-only). For instance, Qin et al. (33) indicated comparable recanalization results and long-term outcomes between hybrid group (DCB combined with DES) and DCB-only group despite more complicated lesions in hybrid group. Shin et al. (21) and Madanchian et al. (22) both demonstrated fewer stents, shorter stent lengths, and lower rate of MACE in DCB-based PCI group than those in the DES-only PCI group. Additionally, a prospective, multicenter observational study demonstrated significantly reduced late lumen loss (LLL) at 1-year angiographic follow-up in patients treated with less DES strategy (DCB alone or combined with DES) relative to the DES-only strategy, despite similar restenosis rates and 3-year MACE incidences between groups (34). Therefore, according to both the preliminary evidence and routine clinical practices, DCB combined with DES is feasible and can be advantageous for minimizing the overall length of the stent while preserving the scaffolding characteristics of stents when necessary (35). This has also enhanced our confidence in the standalone DCB treatment.

Our analysis indicated that standalone DCB had a similar incidence of MACE to DES. Concurrently, the DCB strategy was associated with a significantly lower risk of MACE in large-vessel CTOs (>2.75 mm). This finding is likely attributable to the phenomenon of positive vascular remodeling after recanalization, a process that can lead to late lumen enlargement (8-11). Such enlargement may result in malapposition of previously appropriately sized stents, thereby increasing the long-term risk of in-stent thrombosis, a risk uniquely mitigated by the implant-free DCB approach. Therefore, with optimal lesion preparation, standalone DCB constitutes a clinically justified strategy for CTO intervention. The potential efficacy of DCB may stem from its inherent advantages, including adequate pre-dilation to control acute vascular occlusion and an implant-free characteristic that prevents stent thrombosis caused by malapposition following positive remodeling. Additionally, the DCB strategy permits a shortened and reduced antiplatelet regimen, ensuring safety for high-bleeding-risk patients or those requiring imminent surgery.

The rationale for short DAPT after DCB angioplasty is the absence of a permanent implant, thereby avoiding the need for the 6–12 months of DAPT required after DES implantation to mitigate the risks of stent thrombosis and restenosis (36). This principle is supported by current consensus, with some guidelines even proposing a course of ≥4 weeks as a viable alternative (37). A multicenter randomized trial has also demonstrated the feasibility and safety of a stepwise DAPT de-escalation approach following DCB angioplasty (38). Additionally, two single-center studies found that a DCB-only strategy combined with single antiplatelet treatment did not elevate thrombotic risk while significantly reducing bleeding in high-bleeding-risk patients (39,40). Scheller et al. (41) reported that DCB had comparable safety and efficacy to DES for treating coronary arteries <3 mm, irrespective of patient bleeding risk. Therefore, the DCB strategy not only provides comparable efficacy but also possesses a superior safety profile by fundamentally reducing the requirement for prolonged and intensive antithrombotic management.

Another interesting finding was a significantly higher incidence of heart failure recurrence at 12 months in the DCB group compared to the DES group. We speculate that DES implantation might be a preferable strategy for CTO patients with heart failure. Although successful CTO-PCI is known to improve cardiac function and outcomes in patients who have heart failure with reduced ejection fraction (HFrEF) (42-44), the impact of the specific device (DCB vs. DES) remains unclear. A plausible explanation for our finding might be that the permanent scaffold of a DES provides more stable vascular support, reducing elastic recoil and hemodynamic disturbances, thereby potentially decreasing cardiac load. We acknowledge that this hypothesis requires further validation, as our study lacked serial cardiac function measurements [e.g., LVEF, brain natriuretic peptide (BNP)] to directly corroborate it.

Currently, there is still a lack of large-scale randomized controlled trials to offer evidence-based medical guidance in determining suitable devices (DCB/DES) for CTO-PCI. DCB have demonstrated potential in certain lesions, but DES remain the mainstream choice for current PCI, a view supported by the latest clinical trials. In the REC-CAGEFREE I trial, an open-label, randomized, non-inferiority study conducted in China, the strategy of DCB angioplasty with rescue stenting failed to achieve non-inferiority against DES implantation regarding the device-oriented composite endpoint (DoCE), comprising cardiovascular death, target vessel MI, and clinically or physiologically indicated TLR at 2 years among patients presenting with de novo, non-complex coronary artery disease (45). Therefore, DES remains the recommended treatment for this group of patients. The ongoing multi-center randomized PICCOLETO III trial aims to further evaluate long-term clinical outcomes over 5 years, comparing paclitaxel and sirolimus DCB with DES in patients with CTO (35).

Our study has several limitations. First, it was designed as a single-center retrospective study with a relatively limited sample size, introducing inherent selection bias and potential confounding factors. Second, data regarding whether CTO lesions were de novo or in-stent were incomplete, preventing meaningful subgroup analyses. Moreover, as a retrospective study involving successfully revascularized patients, detailed periprocedural complications were not systematically recorded, precluding their analysis. Consequently, despite our cohort including 445 patients, the sample size might still be insufficient for reliably assessing rare procedural complications, and thus, the procedural safety profile should be interpreted cautiously. Additionally, IVUS use at operator discretion in approximately one-third of cases might have introduced variability in vessel sizing and lesion complexity assessments. Furthermore, the relatively low incidence of MACE could have reduced the statistical power for between-group comparisons. Finally, the 12-month follow-up period may be insufficient to fully evaluate the long-term risk for CTO-PCI patients, such as late lumen loss, stent thrombosis, or vessel remodeling, which may occur beyond one year. These limitations should be addressed in future studies.

Conclusions

In summary, DCB angioplasty is safe and effective for treating CTO, demonstrating comparable clinical outcomes at 12 months to DES implantation. For large-vessel CTOs (>2.75 mm), patients undergoing DCB angioplasty with optimal lesion preparation might experience improved clinical outcomes over those receiving DES implantation. For CTO patients with concurrent heart failure, DES implantation might be preferable following successful recanalization.

Acknowledgments

The authors thank all study participants and Yidu Cloud Technology Co., Ltd for their assistance in data searching, extraction, and processing.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-478/rc

Data Sharing Statement: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-478/dss

Peer Review File: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-478/prf

Funding: This study was funded by the National Natural Science Foundation of China (No. 82170252); Liaoning Revitalization Talents Program (No. XLYC2203054); Innovation Team Project of Higher Education Institutions in Liaoning Province (No. LJ222410161084); Outstanding Youth Scientific Talent Project of Dalian (No. 2024RJ013); and Dalian Science and Technology Innovation Foundation (No. 2023JJ13SN039).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-478/coif). All authors acknowledge that data support was provided by Yidu Cloud Technology Co., Ltd. The authors have no other 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. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University (approval No. PJ-KS-KY-2025-396). The requirement for informed consent was waived due to its retrospective design, the use of fully de-identified clinical data, and because the waiver did not adversely affect the rights and welfare of the participants.

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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