Mid-term outcomes of using drug-coated balloon angioplasty for the treatment of large vessel de novo coronary lesions: comparison of large and small vessels
Highlight box
Key findings
• A 34.2-month mid-term follow-up of 1,514 patients receiving paclitaxel drug-coated balloon (DCB) monotherapy for de novo coronary lesions showed no significant differences in all-cause death, myocardial infarction, stroke and target vessel revascularization between the large-vessel disease (LVD; ≥3.0 mm) and small-vessel disease (SVD; ≤2.75 mm) groups.
What is known and what is new?
• DCB is a well-established non-inferior alternative to drug-eluting stent for SVD de novo lesions, but mid-term clinical evidence for DCB monotherapy in LVD (≥3.0 mm) de novo lesions is scarce and inconsistent.
• This large-sample real-world study confirms that standalone paclitaxel DCB achieves equivalent mid-term safety and efficacy for LVD and SVD de novo lesions, and validates the feasibility of DCB monotherapy for LVD in clinical practice.
What is the implication, and what should change now?
• DCB monotherapy can be a viable treatment option for de novo LVD (≥3.0 mm) coronary lesions, expanding DCB’s clinical application beyond SVD in percutaneous coronary intervention.
Introduction
Percutaneous coronary intervention (PCI) supplemented by drug-eluting stent (DES) implantation remains the principal non-pharmacological intervention for symptomatic coronary heart disease. A primary disadvantage of metallic stents stems from the insertion of an exogenous material into the native coronary artery, which may precipitate vascular inflammation, hypersensitivity, neoatherosclerosis, and subsequent stent thrombosis (1,2). Drug-coated balloons (DCBs) offer an innovative treatment for coronary artery disease (CAD), involve the combination of balloon dilation with drug delivery to widen narrowed coronary lesions and can lower restenosis rates by avoiding residual metal (3,4). In patients with small-vessel CAD, DCB may reduce long-term stent-related complications and better mitigate the bleeding risk associated with dual antiplatelet therapy (DAPT) as compared with DES (5-8). In non-small-vessel disease (SVD), sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) exhibited comparable angiographic efficacy.
At 6 months post-procedure, the in-segment late lumen loss (LLL) was similar between the two groups, and both trials met the criteria for noninferiority (9).
A study by Nishiyama et al. demonstrated that in large vessels [reference vessel diameter (RVD) 2.5–4 mm], there was no significant difference in the incidence of major adverse cardiovascular events (MACEs) at short-term follow-up. However, in long-term clinical follow-up, the MACE rate was slightly higher in the DCB group than in the DES group (10,11). However, the findings across different lesion scenarios are inconsistent. The BABILON trial randomly assigned 108 patients with coronary bifurcation lesions into two groups. The experimental group received a sequential strategy of two-branch DCB angioplasty with pre-dilation combined with provisional bare metal stent (BMS) implantation in the main branch, while the control group was treated with the standard protocol of main branch pre-dilation plus provisional everolimus-eluting stent implantation. At the 9-month follow-up, the strategy of DCB combined with BMS was noninferior to the DES-alone strategy in terms of in-segment LLL. Additionally, there was no statistically significant difference in the LLL for the side-branch vessels between the two groups (12). In another prospective observational study focusing on patients with long coronary lesions (mean length of 44 mm), it was found that patients treated with DCB alone and those receiving DCB combined with DES had comparable 3-year target lesion revascularization (TLR) rates and incidence of MACEs (13). This finding suggests that DCB holds potential advantages in the treatment of such lesions, supporting its clinical application in managing this lesion phenotype. Recent studies have also found that in small vessels [reference vessel diameter (RD) <2.75 mm], diffuse lesions, and bifurcation lesions, DCB alone or in combination with DES can reduce stent burden, with the 3-year clinical being outcomes comparable to those of DES (11). Although DCB has been widely applied in coronary interventions, its efficacy and safety in de novo large-vessel CAD are still poorly defined. We thus performed a real-world study to evaluate midterm clinical outcomes following DCB treatment in patients with de novo coronary lesions >3.0 mm. We present this article in accordance with the STROBE reporting checklist (available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-1-634/rc).
Methods
Patients and examination procedures
This single-center, retrospective study included 1,514 consecutive patients with de novo coronary lesions who received paclitaxel DCB angioplasty at Beijing Anzhen Hospital (a tertiary cardiac center in China) between June 2019 and November 2021.
Patients were divided according to whether they had large-vessel disease (LVD; RD ≥3.0 mm) or SVD (RD ≤2.75 mm) with 462 and 1,052 patients ultimately being allocated to LVD and SVD cohorts, respectively (11,14). Patients with vessel diameters of 2.76–3.0 mm, in-stent restenosis lesions, or those receiving combined DCB and stent treatment were excluded, and all enrolled participants received DCB monotherapy only.
Adequate pre-dilation was implemented prior to the use of a PCB catheter with a balloon-to-vessel diameter ratio ranging from 0.8 to 1.0. Noncompliant (NC), scoring, cutting or non-slip element (NSE) balloons were used as appropriate. Satisfactory pre-dilation—characterized by residual stenosis ≤30%, thrombolysis in myocardial infarction (TIMI) grade 3 flow, and no lesion dissection or type A/B dissection—was a prerequisite for DCB therapy eligibility. The PCB was inflated at 8–10 atm for at least 30 seconds, with 2–3 mm of balloon overlap beyond each lesion margin. Successful DCB intervention was defined as residual stenosis ≤30% and TIMI grade 3 flow. Failure was indicated by apparent dissection [National Heart, Lung, and Blood Institute (NHLBI) type C or above] or TIMI flow < grade 3, If bailout stenting with DES was performed in a patient, this patient was not enrolled in the analysis. The SeQuent Please DCB was used, which utilizes a butyl methacrylate copolymer matrix and delivers paclitaxel at a dose of 3 µg/mm2. Only patients who received successful DCB intervention procedure were enrolled.
All patients provided written informed consent for the procedure prior to its initiation and for the collection and analysis of data for subsequent research purposes. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University (No. 2026028x), which also sanctioned the utilization of data for this work.
Clinical definitions and follow up
Patients were clinically followed up at 1 month, 6 months, and 1 year postprocedure, with subsequent annual follow-up visits thereafter. Follow-up data were gathered through outpatient consultations, telephone interviews, and optional angiographic evaluations—with angiography recommended only for those exhibiting ischemic symptoms or signs. The final determination of all clinical events was verified against source materials and centrally adjudicated by the Local Events Committee of Beijing Anzhen Hospital, Capital Medical University.
The end points of the study were all-cause death; myocardial infarction (MI); stroke, and target vessel revascularization (TVR). MI was identified based on evidence of myocardial necrosis that aligned with Third International Definition of Myocardial Infarction (8). Stroke was defined as the occurrence of neurologic deficits as confirmed by a neurologist based on imaging results. All events were clinically diagnosed by attending physicians and subjected to central adjudication by an independent panel of clinicians from Beijing Anzhen Hospital. For cumulative endpoint analysis, only the first occurrence of the event was included in the statistical count.
Statistical analysis
Continuous variables are presented as the mean ± standard deviation (SD) or median with interquartile range (IQR). Between-group comparisons were conducted using the independent samples t-test for normally distributed data and the Mann-Whitney U test for non-normally distributed data. Categorical variables are summarized as frequencies and percentages, and between-group differences were evaluated using the Chi-squared test. The Kaplan-Meier method was employed to analyze the time to the primary endpoint, while the log-rank test was used to compare endpoint occurrence rates between the LVD and SVD cohorts. Cox proportional hazards regression analyses were performed to adjust for confounding factors, including age, sex, diabetes mellitus, smoking, hypertension, dyslipidemia, prior stroke, prior MI, prior coronary artery bypass grafting (CABG), and prior PCI. All statistical analyses were completed with SPSS 22.0 (IBM Corp., Armonk, NY, USA) for Windows, with P<0.05 being considered statistically significant.
Results
A total of 1,514 patients who underwent paclitaxel DCB angioplasty for de novo coronary lesions were ultimately enrolled in the analysis, with the study period spanning from June 2019 to November 2021. The LVD group comprised 462 patients with 515 lesions, whereas the SVD group comprised 1,052 patients with 1,149 lesions.
The baseline clinical characteristics are summarized in Table 1. The LVD group had a higher percentage of males than did the SVD group; meanwhile, the SVD group had a significantly higher prevalence of hypertension, dyslipidemia, and three-vessel disease but a lower mean estimated glomerular filtration rate.
Table 1
| Variables | LVD group (n=462) | SVD group (n=1,052) | P value |
|---|---|---|---|
| Age, years | 58 [50–66] | 60 [52–66] | 0.06 |
| Male | 384 (83.1) | 795 (75.6) | 0.001 |
| Diabetes mellitus | 162 (35.1) | 408 (38.8) | 0.17 |
| Smoking history | 286 (61.9) | 684 (65.0) | 0.44 |
| Hypertension | 267 (57.8) | 692 (65.8) | 0.003 |
| Dyslipidemia | 91 (19.7) | 251 (23.9) | <0.001 |
| Prior stroke | 30 (6.5) | 86 (8.2) | 0.52 |
| Prior MI | 101 (21.9) | 228 (21.7) | 0.87 |
| Prior CABG | 13 (2.8) | 14 (1.3) | 0.045 |
| Prior PCI | 91 (19.7) | 251 (23.9) | 0.13 |
| eGFR, mL/min/1.73 m2 | 96.4 [88.4–103.8] | 93.3 [82.3–101.7] | <0.001 |
| LVEF, % | 64 [60–66] | 63 [60–66] | 0.71 |
| sCr (μmol/L) | 73.7 [64.8–82.5] | 73.4 [64.7–84.1] | 0.63 |
| Clinical presentation | 0.02 | ||
| NSTEMI | 21 (4.5) | 78 (7.4) | |
| STEMI | 18 (3.9) | 22 (2.1) | |
| Stable angina | 52 (11.2) | 80 (17.5) | |
| Unstable angina | 406 (87.8) | 930 (88.4) | |
| Extent of diseased vessel | <0.001 | ||
| LM | 21 (4.5) | 24 (2.3) | |
| Single-vessel disease | 219 (47.4) | 389 (37.0) | |
| Double-vessel disease | 136 (29.4) | 352 (33.5) | |
| Triple-vessel disease | 86 (18.6) | 287 (27.3) |
Data are presented as median [IQR] or n (%). CABG, coronary artery bypass grafting; eGFR, epidermal growth factor receptor; IQR, interquartile range; LM, left main; LVD, large-vessel disease; LVEF, left ventricular ejection fraction; MI, myocardial infarction; NSTEMI, non-ST-elevation myocardial infarction; PCI, percutaneous coronary intervention; sCr, serum creatinine; STEMI, ST-elevation myocardial infarction; SVD, small-vessel disease.
The baseline lesion characteristics are presented in Table 2. The LVD group had a significantly higher percentage of left anterior descending artery and right coronary artery lesions, while the SVD group had a higher percentage of left circumflex artery, chronic total occlusion and B2/C lesions.
Table 2
| Variables | LVD group (n=515) | SVD group (n=1,149) | P value |
|---|---|---|---|
| Lesion location | <0.001 | ||
| LAD/D | 248 (48.2) | 348 (30.3) | |
| LCX/OM | 80 (15.5) | 466 (40.6) | |
| RCA/PDA/PL | 176 (34.2) | 300 (26.1) | |
| LM | 9 (1.7) | 2 (0.2) | |
| Ramus intermedius | 2 (0.4) | 33 (2.9) | |
| CTO | 19 (3.7) | 76 (6.6) | 0.02 |
| Calcified lesions | 22 (4.3) | 33 (2.9) | 0.14 |
| Bifurcation | 131 (25.4) | 243 (21.1) | 0.053 |
| B2/C lesions | 333 (64.7) | 885 (77.0) | <0.001 |
| Reference diameter (mm) | 3.0 [3.0–3.5] | 2.5 [2.0–2.5] | <0.001 |
| Lesion length (mm) | 22.5±7.2 | 22.9±7.8 | 0.46 |
Data are presented as median [IQR] or n (%). CTO, chronic total occlusion; IQR, interquartile range; LAD/D, left anterior descending artery/diagonal branch; LCX, left circumflex artery; LM, left main coronary artery; LVD, large-vessel disease; OM, obtuse marginal artery; PDA, posterior descending artery; PL, posterolateral branch; RCA, right coronary artery; SVD, small-vessel disease.
The median follow-up time was 34.2 months (IQR, 31.3–39.7 months). Among the 1,514 patients in the overall cohort, 43 (2.8%) died, 21 (1.4%) experienced MI, and 21 (1.4%) experienced stroke; 167 (11.0%) underwent TVR.
The crude relative risks are presented in Figure 1 and Table 3. No significant differences were observed in the mortality rate (LVD: 2.4%; SVD: 3.0%; P=0.32), MI (LVD: 1.1%; SVD: 1.5%; P=0.37), stroke (LVD: 0.9%; SVD: 1.6%; P=0.19), or TVR (LVD: 11.9%; SVD: 10.6%; P=0.92). After multivariate adjustment, there were no significant differences in any of all endpoints between the two groups (Table 3).
Table 3
| Outcomes | LVD | SVD | P value | HR (95% CI) |
|---|---|---|---|---|
| Unadjusted | ||||
| Death | 11 (2.4%) | 31 (3.0%) | 0.32 | 1.418 (0.713–2.819) |
| MI | 5 (1.1%) | 16 (1.5%) | 0.37 | 1.580 (0.577–4.329) |
| Stroke | 4 (0.9%) | 17 (1.6%) | 0.19 | 2.052 (0.689–6.114) |
| TVR | 55 (11.9%) | 111 (10.6%) | 0.92 | 0.984 (0.712–1.361) |
| Adjusted | ||||
| Death | 2.3% | 2.5% | 0.85 | 1.092 (0.447–2.670) |
| MI | 1.3% | 1.9% | 0.54 | 1.424 (0.464–4.369) |
| Stroke | 1.1% | 1.8% | 0.40 | 1.604 (0.529–4.864) |
| TVR | 16.0% | 15.9% | 0.98 | 0.995 (0.719–1.378) |
CI, confidence interval; HR, hazard ratio; LVD, large vessel disease; MI, myocardial infarction; SVD, small-vessel disease; TVR, target vessel revascularization.
Discussion
This study evaluated the safety and efficacy of standalone DCB angioplasty in patients with de novo lesions in vessels ≥3.0 mm in diameter over a median follow-up duration of 34.2 months. The LVD and SVD groups group showed similar mortality, MI, stroke, and TVR.
DCB has been established as a viable alternative to DES for treating patients with SVD—a condition commonly defined by an RD <3.0 mm. In the randomized BASKET-SMALL 2 study, paclitaxel-coated DCB was non-inferiority to second-generation DES for the composite outcome of cardiac death, non-fatal MI, or TVR at 12-month follow-up (7). Furthermore, the randomized RESTORE SVD China trial showed that DCB was non-inferior to Resolute Integrity® DES with respect to diameter stenosis percentage at 9 months, and the 1-year target lesion failure (TLF) rates were similar between the two groups (8). DCBs may be a valuable option for treating de novo large coronary artery lesions (≥3.0 mm), as they can circumvent stent strut malapposition, particularly in vessels with irregular walls, aneurysmal dilatation, or bifurcations. However, evidence regarding the use of DCB in de novo lesions with a large RD (≥3.0 mm) remains scarce.
Large coronary arteries contain a greater number of smooth muscle fibers than do small arteries, rendering them more prone to recoil and dissection—with subsequent risks of acute vessel occlusion or restenosis. Thus, many interventional cardiologists have questioned the safety of DCB used alone for large-vessel lesions. The feasibility of standalone DCB treatment for LVD was initially established from the inclusion of this anatomical subgroup in retrospective observational and prospective studies (15-18). The 3-year follow-up data of the BASKET-SMALL 2 trial, indicated no significant difference in the rates of acute or subacute occlusion between the DCB and DES groups (19). In a subsequent analysis of their patient cohort, Rosenberg et al. compared outcomes of small and large vessel disease after propensity matching. The results showed comparable bailout stenting rates (7.6% for large vessel disease and 7.1% for small vessels) and 9-month MACE rates (6.1% for large vessel disease and 5.7% for small vessels) (20). Their study included only 134 patients with vessel sizes ≥2.75 mm. In contrast, our study included 462 patients with LVD and 1,052 patients with SVD both treated only with paclitaxel DCB angioplasty. Compared to previous research on this subject, our study had a larger sample size and a longer follow-up period. According to our data, the treatment of large native coronaries with the DCB-only strategy was safe, and the rates of all-cause death and MI in the LVD group were particularly low (2.4% and 1.1%, respectively). The low TVR rate at nearly 3 years in the LVD group (11.9%) and SVD group (10.6%) observed in this study is in line with previous work (21).
DCB-guided PCI provides several advantages. First, it avoids the risk of undersized stenting, and the absence of a metallic structure allows for positive remodeling of the treated vessel. Second, without polymers or metallic materials, there is chronic inflammation in the vessel wall. Third, PCI with DCB allows for a shorter period of DAPT than does DES, contributing to a lower bleeding occurrence. Achieving adequate predilation is critical for the success of DCB treatment in patients with de novo coronary lesions. The majority of consensus statements recommend a predilation balloon diameter-to-RD ratio of 0.8–1.0:1 (22). As stated in the recently published Third Report of the International DCB Consensus, the recommended balloon-to-vessel ratio is 1:1 (3). Aggressive predilation, aimed at achieving sufficient initial lumen gain, may cause severe dissection that invalidates stent-less DCB treatment. On the other hand, conservative lesion preparation leads to smaller minimal luminal areas and excessive residual plaque—predictors of subsequent restenosis. This dilemma has led to greater concerns regarding the treatment of LVD, as a larger balloon size is strongly correlated with technical failure (odds ratio 1.94) (23).
Although DCBs have yielded promising results as a standalone therapy for de novo small coronary lesions, a key drawback is that the optimal approach for bailout stenting in the presence of vessel dissection remains undefined. Severe dissection can lead to acute vessel occlusion and subsequent MI, which represents a particularly devastating complication in the setting of large-vessel coronary disease. However, several studies have confirmed that conservative management of non-flow-limiting dissections following DCB angioplasty is safe and not associated with an increased risk of TLR (24,25). Furthermore, in a study that used, 6-month follow-up repeat angiography, 93.8% of patients with type A-C dissection achieved complete vascular healing (24).
Over 40,000 PCI procedures were performed in Beijing Anzhen Hospital from June 1, 2019 to November 30, 2021, but only 462 patients with LVD received DCB-only treatment. In the event of dissections following the application of DCB, operators tend to perceive stenting large vessel diseases as safer and more comfortable than stenting small vessels. Notably, the notion that the incidence of significant predilation-induced recoil or flow-limiting dissection renders DCB therapy infeasible (leading to stenting) has not been substantiated. Moreover, the number of cases in which bailout stenting was performed due to severe dissection is not clear. As we aimed to evaluate the efficacy and safety of the DCB-only strategy, the bailout stenting cases were excluded. The rate of TVR in our study was approximately 11%. In contrast, a study in The Lancet reported a TVR rate of 9.6% among 26,616 patients followed up for a mean of 3.2 years (26). However, the higher TVR rate in our center may be attributable to the higher proportion of complex lesions included in our cohort.
Several limitations to this study should be addressed. First, we employed a retrospective, single-center design. Despite data being collected from a large-volume cardiac center, the inclusion of a greater volume of data from multiple clinical sites could undoubtedly strengthen our findings. Second, the low event rate may reduce the statistical power, increasing the risk of a type II error. Given the relatively short follow-up duration after DCB treatment, future studies with longer-term follow-up are needed to confirm these findings. Third, patients requiring bailout stenting after DCB angioplasty were excluded from this study, which may restrict the generalizability of the results.
Conclusions
Over a midterm follow-up, DCB was found to be safe and effective for the treatment of patients with de novo lesions in vessels with diameters exceeding 3.0 mm as it was for the treatment of patients with SVD.
Acknowledgments
We would like to thank J. Gray for his help in polishing our paper.
Footnote
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-1-634/rc
Data Sharing Statement: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-1-634/dss
Peer Review File: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-1-634/prf
Funding: This work was supported by
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-1-634/coif). Z.S. serves as an unpaid editorial board member of Cardiovascular Diagnosis and Therapy from September 2025 to August 2027. The other 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. This study was approved by the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University (No. 2026028x). All patients provided written informed consent for the procedure prior to its initiation and for the collection and analysis of data for subsequent research purposes. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments.
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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