This is a pooled analysis of seven multicenter, observational, investigator-initiated cohort studies. Three were single-arm, all-comers registries of patients treated with DCB: the EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry, Unique identifier: NCT03085823), which employed the Magic Touch sirolimus-coated balloon (SCB) (Concept Medical, USA); the DCB-RISE (Results of the Italian Elutax SV Registry), which used the Elutax paclitaxel-coated balloon (PCB) (Aachen Resonance, Germany) ; and the Milan-DCB registry, which included different DCB platforms.

Three single-arm, all-comers registries included patients undergoing PCI with DES: the ULISSE (ULtimaster Italian multicenter all-comers Stent rEgistry), the ASTUTE (Amphilimus Italian Multicentre Registry), and the RUDI-FREE (Polymer-Free Biolimus-Eluting Stent Implantation in an All-Comers Population) registry. Finally, the DRAGON registry (DEB vs Thin-DES in DES-ISR: Long-Term Outcomes; NCT04415216) enrolled patients with DES-ISR treated either with PCB or DES.

For the present analysis, only patients with CKD were included, defined as structural or functional renal abnormalities persisting for more than 3 months with a sustained reduction in estimated glomerular filtration rate <60 ml/min/1.73 m² (CKD stages G3 to G5).

All patients provided written informed consent for the procedure and data collection, in accordance with local Institutional Review Board requirements. Additional details regarding study design and included populations are provided in Supplementary Table 1 .

In the DCB treatment group, PCI was performed according to the recommendations of the DCB Academic Research Consortium. ^, Lesion predilatation was carried out using a balloon-to-vessel ratio of 0.8 to 1.0:1.0. The DCB length exceeded the target lesion by at least 3 mm proximally and distally, and balloon inflation was maintained at nominal pressure for at least 30 seconds. In cases of suboptimal angiographic results, defined as type C or more severe dissections, TIMI flow grade <3, or residual stenosis >30%, bailout DES implantation was performed.

In the DES group, PCI was conducted according to current clinical practice and guideline recommendations. The choice and duration of antithrombotic therapy at discharge were left to the discretion of the treating physician.

Details regarding the specific DCB and DES devices used are reported in Supplementary Figure 1 .

Clinical follow-up was conducted through outpatient visits or structured telephone interviews.

The primary endpoint was major adverse cardiovascular events (MACE), defined as the composite of cardiac death, nonfatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR).

Secondary endpoints included target lesion failure, defined as the composite of cardiac death, target-vessel MI (TVMI), and TLR, as well as all-cause mortality, the individual components of the composite endpoints, and Bleeding Academic Research Consortium type 3 to 5 bleeding events. All study endpoints were defined in accordance with the Academic Research Consortium-2 criteria.

Continuous variables are reported as mean ± standard deviation or median with interquartile range, as appropriate, based on data distribution. Normality was assessed using the Shapiro–Wilk test. Categorical variables are expressed as counts and percentages. Baseline clinical and procedural characteristics were compared using the chi-square test or Fisher’s exact test for categorical variables, and the Student’s t test or Mann–Whitney U test for continuous variables, as appropriate. Patients lost to follow-up were censored at the time of last contact.

To minimize confounding between the DCB and DES groups, propensity scores (PSs) were estimated using logistic regression, including baseline clinical and angiographic variables that differed significantly between groups: age, sex, diabetes, clinical presentation (acute coronary syndrome vs chronic coronary syndrome), lesion type (ISR vs de novo), lesion length, reference vessel diameter, number of lesions, and lesion complexity according to the American Heart Association/American College of Cardiology classification.

PS matching was performed using 1:1 nearest-neighbor matching without replacement, with a caliper width of 0.1 standard deviations of the logit of the PS. Matching quality was high, with all covariates achieving standardized mean differences <0.10 ( Supplementary Figure 2 ) and a median bias of 1.2% across covariates. The PS model demonstrated good discrimination, with a C -statistic of 0.80.

Among patients treated with DCB, an additional PS was estimated using sex, clinical presentation, prior PCI, treated vessel, lesion type, lesion length, and lesion complexity as covariates ( Supplementary Figure 3 ).

Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for the association between treatment strategy and outcomes in the matched cohort. The proportional hazards assumption was assessed using scaled Schoenfeld residuals. Kaplan–Meier survival curves were generated and compared using the log-rank test.

All analyses were performed using R software (RStudio v.2022.07.2), with the MatchIt, survival, survminer, and cobalt packages. A two-sided p value <0.05 was considered statistically significant.

The final study cohort comprised 1.732 patients, of whom 765 were treated with DCB and 967 with DES. The matched cohort included 920 patients, of whom 38% presented with ACS and 25% with ISR. Each treatment arm comprised 460 patients. Patients treated with DCB had a slightly higher left ventricular ejection fraction compared to those treated with DES (51 ± 10% vs 49 ± 10%, p < 0.001). No other significant differences in baseline clinical characteristics were observed between groups ( Table 1 ). Baseline characteristics of the unmatched population are summarized in Supplementary Table 2 .

In the DES group, the left anterior descending artery was the most frequently treated vessel (72%), whereas in the DCB group, procedures more commonly involved the left circumflex (34%) and right coronary arteries (20%) (p < 0.001). Both predilatation (95% vs 65%, p < 0.001) and the use of intracoronary imaging (9.1% vs 5.7%, p < 0.001) were significantly more frequent in the DCB group than in the DES group. In addition, in the DES group, the devices used were significantly longer (30 ± 23 mm vs 27 ± 16 mm, p = 0.008) and had a larger average diameter (2.94 ± 0.45 mm vs 2.75 ± 0.55 mm, p < 0.001) ( Table 2 ). Procedural characteristics in the unmatched population are detailed in Supplementary Table 3 .

The cumulative incidence of MACE was 10.6% at a mean follow-up of 564 ± 455 days ( Table 3 ). Compared with DES, DCB treatment was associated with a similar risk of MACE (HR 1.09; 95% CI 0.71 to 1.66; p = 0.703), with no significant differences in the rates of cardiac death (4.3% vs 6.1%; HR 0.86; 95% CI 0.46 to 1.61; p = 0.644), nonfatal MI (2.6% vs 4.8%; HR 0.56; 95% CI 0.26 to 1.22; p = 0.146), or TLR (5.4% vs 5.4%; HR 1.06; 95% CI 0.59 to 1.92; p = 0.836) and a trend toward reduced TVMI (0.7% vs 2.8%; HR: 0.27, 95% CI: 0.06; 1.26, p = 0.097. Notably, DCB-only PCI was associated with a significantly lower incidence of major bleeding events (1.2% vs 3.3%; HR 0.13; 95% CI 0.03 to 0.48; p < 0.001) ( Figures 1 and 2 ).

Table 3

Cox regression analysis for the occurrence of adverse events in the matched cohort

Clinical outcomes	DCB group ( n = 460)	DES group ( n = 460)	HR (95% CI)	p Value
MACE	49 (10.6%)	49 (10.6%)	1.09 (0.71; 1.66)	0.703
TLF	42 (9.1%)	42 (9.1%)	1.13 (0.72–1.76)	0.595
CV death	20 (4.3%)	28 (6.1%)	0.86 (0.46–1.61)	0.644
All-cause mortality	44 (9.6%)	54 (11.7%)	0.99 (0.66–1.50)	0.977
TVMI	3 (0.7%)	13 (2.8%)	0.27 (0.06–1.26)	0.097
Non-fatal MI	12 (2.6%)	22 (4.8%)	0.56 (0.26–1.22)	0.146
TLR	25 (5.4%)	25 (5.4%)	1.06 (0.59–1.92)	0.836
TVR	34 (7.4%)	28 (6.1%)	1.27 (0.74–2.20)	0.390
BARC Major bleedings	6 (1.2%)	15 (3.3%)	0.13 (0.03–0.48)	< 0.001

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