The observational, retrospective SIROMILANO cohort study included a total of 668 patients with coronary artery disease treated with SCB angioplasty at 2 centers in Italy (EMO-GVM Columbus, Milan, and IRCCS Humanitas Research Hospital, Rozzano) between May 1, 2021 and December 31, 2023. This study complied with the Declaration of Helsinki. All patients provided written informed consent for the procedure. Considering the retrospective nature of the study, it was exempted from a dedicated ethics committee approval. All-comer patients treated with SCB angioplasty for de novo lesions or ISR were included. Patients treated with DCB other than SLR, SCB, and MT SCB were excluded ( Figure 1 ). The investigators were responsible for all data extraction, collection, and analysis.

Study design. Flow diagram outlining patient enrollment, inclusion, and exclusion criteria. The included patients were treated with either biodegradable polymer microsphere-based SELUTION SLR SCB or phospholipid nanocarrier-based MT SCB.

Abbreviations: PCB = paclitaxel-coated balloon; PCI = percutaneous coronary intervention; SCB = sirolimus-coated balloon.

Dual antiplatelet therapy treatment was administered as per contemporary consensus. ^,, Intravenous injection of 100 U/kg unfractionated heparin to maintain an activated clotting time of >250 seconds was administered during the procedure. DCB angioplasty was performed as recommended in the Third International DCB Consensus Document. All patients received lesion preparation with plain balloons, aiming for a balloon-to-vessel ratio of 1:1, specialty balloons, atherectomy, or intravascular lithotripsy. In case of an acceptable angiographic result after lesion preparation, DCB angioplasty was performed. Bail-out stenting was mandatory in case of recoil or residual stenosis >30% of reference vessel diameter (RVD), or in the presence of advanced dissection. The decision whether to leave a dissection untreated or to proceed to bail-out stenting was followed by an algorithm previously described, based on a combined evaluation of Thrombolysis in Myocardial Infarction flow, residual minimal lumen diameter, contrast stain in the vessel wall, and resting distal coronary-to-aortic pressure ratio, when performed. An upfront hybrid PCI strategy using DES for proximal lesions in combination with distal DCB treatment could also be performed at operator’s discretion. The DCB was inflated to its nominal pressure for at least 60 seconds, ensuring extension of the DCB at least 2 mm beyond the predilation balloon length. DCBs were coated with sirolimus combined with either phospholipid nanocarriers (MT SCB) or biodegradable polymer microspheres (SLR SCB) as a carrier for the drug. After DCB use, the final assessment was performed at least 5 minutes after administering a bolus of an intracoronary vasodilator. The duration of the dual antiplatelet regimen was at least 1 to 12 months in acute coronary syndrome.

MT was the first SCB to be developed. It obtained Conformité Européenne (CE) mark in 2016 and has been widely adopted throughout Europe and Asia. Sirolimus is present at a concentration of 1.3 μg/mm ² of balloon surface, and it is encapsulated in phospholipid bilayer nanoparticles distributed on a gently inflated semicompliant balloon folded back on itself. Upon full inflation, the nanoparticles come in contact with the endothelium and are transferred into the vessel wall according to Fick’s law of diffusion. The nanoparticles (20–200 nm in diameter) act as reservoirs, providing protection against drug degradation, sustained drug release over a 2-week timeframe and prolonged drug effects within both extracellular and intracellular compartments. It incorporates the combination of 2 excipient carriers to allow penetration and release of the active agent: the first is a lipid-based component with a hydrophilic head and 2 lipophilic tails, and the second, integrated in the particle envelope (comprising ∼5% of the coating mass), is a calcium-phosphorus-based component with enhanced hemocompatibility that is readily absorbed into the vessel wall and releases the encapsulated drug on variation in pH ( Figure 1 ).

SLR SCB obtained its CE mark more recently in 2020. Its unique technology includes spherical micro‐reservoirs made of poly-lactic-coglycolic acid biodegradable polymer encapsulating the drug. The micro-reservoirs are then sprayed onto the balloon surface and adhere to the balloon surface using a proprietary three-component amphipathic phospholipid blend, allowing high retention of the drug on the balloon during preparation and delivery ( Figure 1 ). The drug coating is homogeneously distributed on the cylindrical surface of the balloon with a sirolimus concentration of 1 µg/mm² of balloon surface. As the balloon is inflated at the lesion site, the same amphipathic lipid carrier is attracted to negatively charged membranes on endothelial cells, resulting in enhanced adhesion of the micro‐reservoir coating. ^,

Patients underwent clinical follow-up following the index procedure via telephone interviews, outpatient, or inpatient clinic visits. Primary end point was rate of target lesion failure (TLF), defined as a composite of cardiac death, target vessel MI, and TLR, at 12-month follow-up. Primary time-to-event analyses were conducted at the patient level, with the outcome defined as the time to the first adjudicated component of TLF. Secondary end points included the single components of the composite primary end point. Overall, end points were defined according to the DCB Academic Research Consortium criteria. Target vessel failure was defined as a composite of cardiac death, target vessel MI, and target vessel revascularization, while major adverse cardiovascular events (MACE) were defined as a composite of all-cause death, MI, and any revascularization. Clinical events were identified through clinical records and follow-up contacts and were adjudicated by the investigators at each participating center. No independent clinical event adjudication committee was involved.

Continuous variables are reported as mean ± standard deviation or median ± interquartile range, and were compared using Student’s t test or the Mann–Whitney U in case of 2-group comparisons, according to normality of data distribution, verified using the Shapiro–Wilk test. Categorical variables are reported as numbers (percentages) and were compared using the chi-square test without Yates’ correction for continuity or the Fisher exact test, as appropriate. Unadjusted survival curves were constructed with the use of Kaplan–Meier estimates, and groups compared according to the log-rank test and the Cox proportional hazards model. Hazard ratio and 95% CI are reported.

To account for selection and confounding bias between patients treated with SLR SCB and MT SCB, a propensity score methodology with inverse probability of treatment weighting (IPTW) was applied. ^, Propensity scores predicting each patient’s probability of undergoing SLR SCB or MT SCB PCI were estimated with multivariable logistic regression, including variables with a difference in their distribution between the 2 treatment groups or deemed to be clinical relevant. The following clinically relevant variables were included in the model used to estimate the propensity scores: age, sex, previous MI, chronic kidney disease, diabetes mellitus, clinical presentation, in-stent restenosis (ISR) versus de novo lesion, intravascular imaging, total lesion length, and hybrid PCI. Stabilized weights were computed from propensity scores by means of IPTW. The weight for SLR SCB treatment was the inverse of the respective propensity score, whereas the weight for MT SCB treatment was the inverse of 1−propensity score. Post-IPTW adjustment, the balance of covariates between the treatment groups was assessed by means of standardized mean differences (SMD), and variables were considered balanced if the SMD was ≤10%.

Cox regression models evaluating the impact of SLR SCB versus MT SCB on clinical end points were weighted using IPTW. AHR and 95% CI are reported. Adjusted Kaplan–Meier survival curves were generated by weighting the survival function with the IPTW in the 2 comparisons. In addition, doubly robust IPTW adjustment was also performed, augmenting the Cox regression models with covariates that were considered clinically relevant for the outcome of interest (TLF), including bifurcation lesion, RVD ≥3 mm, ACC/AHA Class B2/C, moderate-severe lesion calcification, Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score, angiographically evident dissection, predilation balloon inflation pressure, center and dual antiplatelet regimen duration. Considering the relatively low number of events, the variables of interest were added separately to the IPTW-adjusted models in order to avoid overfitting. Also, the interaction between SCB type and the following variables was assessed for TLF: age ≥70 years, diabetes mellitus, ISR versus de novo lesion, bifurcation lesion, adoption of intravascular imaging, moderate-severe lesion calcification, lesion length ≥40 mm, reference vessel diameter ≥3.0 mm, angiographically evident dissection, and hybrid PCI. The Schoenfeld residuals test was adopted for assessment of the proportional hazards assumption.

Clinical follow-up was censored at the date of death or the latest available follow-up. Data for patients lost to follow-up were censored at the time of the last contact. A two-sided p value <0.05 was considered statistically significant. Statistical analyses were performed using Stata version 14.0 (StataCorp, College Station, Texas).

A total of 668 patients undergoing SCB angioplasty were included ( Figure 1 ); of these, 204 patients were treated with SLR SCB and 464 patients with MT SCB.

Baseline characteristics of patients according to SCB type are reported in Table 1 , and data stratified for lesion type (de novo vs ISR lesion) are available in Supplemental Table 1 . The included patients had a mean age of 68 ± 10 years, and the minority were female (10%, n = 70). In particular, the proportion of female patients was lower in the SLR group (7% vs 12% in MT, p = 0.043). Diabetes mellitus was present in one-third of patients in the overall cohort, with no differences between groups, while hyperlipidemia, history of previous MI, and previous PCI were less common in SLR ( Table 1 ). The most common clinical presentation was chronic coronary disease, accounting for 84% of the patients.

Details on treated lesions and procedural features are shown in Table 2 , and results are stratified according to ISR versus de novo lesion in Supplemental Table 2 . A total of 769 lesions were included: 253 lesions were treated with SLR (70% [n = 178] de novo), and 516 with MT (65% [n = 338] de novo). The left anterior descending artery was the most common target vessel (42%), followed by the left circumflex (27%) and right coronary arteries (23%). Lesion length did not differ significantly in SLR versus MT (40 [30–60] mm vs 40 [30–68] mm, p = 0.977), although ISR lesions were longer in SLR (40 [30–60] mm vs 31 [20–55] mm, p = 0.013). Two-thirds of lesions (67%) were in vessels with RVD 3.0 mm or larger, and RVD was similar in SLR and MT (3.0 ± 0.6 vs 3.1 ± 0.6, p = 0.556). When stratifying lesions by type and vessel size ( Figure 2 ), most were de novo in large vessels (38%), followed by de novo in small vessels (29%) and ISR in large vessels (28%). A similar distribution of treated lesion type was present in SLR and MT SCB ( Supplemental Figure 1 ). Synergy Between PCI With Taxus and Cardiac Surgery score was 18 ± 8, and 95% of treated lesions were ACC/AHA class B2/C (98% vs 93%, p = 0.016), 23% at bifurcations (p = 0.020), and 30% presented moderate-severe calcification (39% vs 26%, p < 0.001).

Table 2

Lesion and procedural characteristics according to sirolimus-coated balloon type

Variable	Overall (n = 769)	SELUTION SLR SCB (n = 253)	Magic Touch SCB (n = 516)	p Value
Target vessel				0.394
LAD	327 (42.5)	104 (41.1)	223 (43.2)
LCx	206 (26.8)	75 (29.6)	131 (25.4)
RCA	179 (23.3)	53 (20.9)	126 (24.4)
Left main	28 (3.6)	13 (5.1)	15 (2.9)
Ramus	26 (3.4)	7 (2.8)	19 (3.7)
Other	3 (0.4)	1 (0.4)	2 (0.4)
Lesion length, mm	40 [30-64]	40 [30-60]	40 [30-68]	0.977
Lesion length ≥40 mm	422 (54.9)	138 (54.5)	285 (55.0)	0.897
RVD, mm	3.0 ± 0.6	3.1 ± 0.6	3.0 ± 0.6	0.556
RVD ≥3 mm	512 (66.6)	171 (67.6)	341 (66.1)	0.678
ACC/AHA class B2/C	722 (94.9)	246 (97.6)	476 (93.5)	0.016
Bifurcation	176 (23.2)	45 (18.1)	131 (25.7)	0.020
Moderate-severe calcification	228 (30.0)	97 (38.6)	131 (25.7)	<0.001
In-stent restenosis	253 (32.79)	75 (29.6)	178 (34.5)	0.178
SYNTAX score	18 ± 8	20 ± 9	17 ± 7	<0.001
IV imaging	229 (29.8)	87 (34.4)	142 (27.5)	0.059
IVUS	227 (29.5)	87 (34.4)	140 (27.1)
OCT	2 (0.3)	0 (0)	2 (0.4)
RA	35 (4.5)	13 (5.1)	22 (4.3)	0.584
IVL	27 (3.5)	10 (3.9)	17 (3.3)	0.641
Cutting balloon	138 (17.9)	75 (29.6)	63 (12.2)	<0.001
Predilation balloon	702 (97.5)	225 (96.6)	477 (97.9)	0.267
Diameter, mm	3.0 ± 0.6	2.9 ± 0.6	3.0 ± 0.6	0.812
Pressure, atm	18 ± 5	19 ± 4	17 ± 5	<0.001
SCB diameter, mm	2.8 ± 0.5	2.9 ± 0.5	2.8 ± 0.5	0.045
SCB length, mm	30 [20-40]	30 [30-40]	30 [20-40]	0.003
SCB pressure, atm	11 ± 3	11 ± 2	11 ± 3	0.528
Angiographic dissection	237 (31.1)	79 (31.2)	158 (31.0)	0.945
Coronary perforation	10 (1.3)	3 (1.3)	7 (1.4)	1.000
Acute target vessel occlusion	5 (0.7)	1 (0.4)	4 (0.8)	1.000
Any side branch occlusion	5 (0.7)	2 (0.9)	3 (0.6)	0.650
Any hybrid PCI *	301 (39.1)	75 (29.6)	226 (43.8)	<0.001
Bail-out stenting	76 (9.9)	19 (7.5)	57 (11.0)	0.123

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