This systematic review and meta-analysis was conducted in accordance with the PRISMA 2020 guidelines. The protocol was prospectively registered in the PROSPERO database (registration number: CRD42023439041).

Initially, the protocol specified the inclusion of prospective comparative studies. However, during the screening process, we identified high-quality retrospective studies that fulfilled all other eligibility criteria. To enhance the comprehensiveness and real-world applicability of our synthesis, and prior to final data extraction or analysis, we extended the inclusion criteria to allow for retrospective comparative studies. This amendment is transparently reported and does not compromise the integrity of the review process.

All methodological decisions, including inclusion criteria, outcomes, risk of bias assessment, and analytical strategies, were conducted with strict adherence to principles of methodological rigor, transparency, and reproducibility.

We included all observational studies and randomized controlled trials (RCTs) that directly compared drug-coated balloons (DCB) with drug-eluting stents (DES) for the treatment of side branch (SB) lesions in true coronary bifurcations. We included studies that directly compared DCB and DES for the treatment of side branch (SB) lesions within true coronary bifurcations. True bifurcations were defined according to the Medina classification (1,1,1; 1,0,1; 0,1,1), consistent with contemporary European Bifurcation Club consensus standards. Eligible studies were required to report at least one prespecified clinical and/or angiographic outcome, with a minimum follow-up of 6 months.

Only studies published as full-text, peer-reviewed articles were considered. Conference abstracts, unpublished data, editorials, narrative reviews, and case series with fewer than 10 patients were excluded. Studies without branch-specific comparative outcomes between DCB and DES were also excluded. These criteria were applied to ensure methodological rigor and clinical relevance.

We carried out a comprehensive literature search across PubMed, Embase, Scopus, and the Cochrane Library from inception until May 2025. Our search combined keywords and controlled vocabulary terms (e.g., MeSH), including “drug-coated balloon,” “drug-eluting stent,” “bifurcation,” “side branch,” and “coronary artery disease.” Boolean operators and filters were tailored to each database. The full search algorithm is available in the Supplementary Material ( Table S1 ).

No language restrictions were applied during the search and full-text review.

Three reviewers independently screened all records using the Rayyan platform. After an initial title and abstract review, full texts were retrieved and assessed for eligibility. Any disagreements were resolved through discussion and, when necessary, adjudication by a third reviewer. The process followed a structured screening protocol to reduce selection bias.

In all included studies, the main vessel was treated with limus-eluting DES; the comparison concerned the management of the side branch—treated either with DCB or with DES.

Data were extracted using a predefined electronic form that was piloted prior to use. Extracted variables included: study design, sample size, year and country of publication, clinical setting (acute coronary syndrome vs stable disease), patient demographics, procedural details (e.g., DCB and DES type, use of intravascular imaging, pre/postdilation), lesion characteristics (SB diameter, lesion length), follow-up duration, and reported outcomes. We contacted corresponding authors when outcome definitions were unclear or when additional details were needed, although the response rate was limited.

Quantitative coronary angiography (QCA) was used in all included studies for the assessment of angiographic outcomes, including late lumen loss and binary restenosis.

The primary outcome, major adverse cardiac events (MACE), was defined as a composite clinical endpoint including cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). This definition reflects the most widely adopted framework in device-oriented outcomes and was consistent across the included studies. Target vessel thrombosis was also considered part of the composite when explicitly reported.

Minimum lumen diameter (MLD) and percentage diameter stenosis (%DS) at follow-up were extracted ( Table 1 ). However, due to variability in reporting formats and incomplete availability across studies, these parameters could not be consistently pooled in quantitative synthesis. Available data were directionally consistent with the late lumen loss findings.

Table 1

Main characteristics of the included studies

Author		Year			Country		Design			DCB in SB (n)				DES in SB (n)	Hypertension (%)				Diabetes (%)				Smoking (%)		Dyslipidemia (%)				True Bifurcation (%)
Ke D et al.		2022			China		RCT			30				30	65.00				33.30				70.00		58.30				49.00
Guo Q et al.		2022			China		RCT			29				32	60.70				26.20				36.10		68.90				100.00
Eraliev et al.		2022			Rusia		RCT			40				40	96.30				21.30				NA		NA				50.00
Pan et al.		2022			China		OBS			199				398	52.30				40.50				35.20		29.00				80.90
Liu et al.		2021			China		OBS			50				50	44.00				27.00				45.00		7.00				85.00

Author	Follow-up (months)				Age (mean)	Women (%)					SB diameter mm (minimum for inclusion)					SB length (mm ± DS)				DCB type				DES type				Image assessment method
Ke D et al.	12				61.10	21.30					2.25					12.85 ± 4.2				Placlitaxel				DES 2 Gen				OCT
Guo Q et al.	6				59.90	25.79					2.50					29.00 ± 3.8				Placlitaxel				DES 2 Gen				IVUS
Eraliev et al.	12				62.80	26.00					2.25					9.30 ± 4.5				Placlitaxel				DES 2 Gen				OCT
Pan et al.	24				64.24	25.79					2.00					15.20 ± 6.9				Placlitaxel				DES 2 Gen				IVUS
Liu et al.	12				63.25	26.00					2.75					N.A.				Placlitaxel				DES 2 Gen				IVUS

Author				Events TLR DCB (n)					Events TLR DES (n)			Events MACE DCB (n)					Events MACE DES (n)				Events restenosis DCB (n)					Events restenosis DES (n)
Ke D et al.				2					4			2					4				0					2
Guo Q et al.				2					2			2					0				2					0
Eraliev et al.				1					5			3					7				1					24
Pan et al.				5					34			13					53				6					9
Liu et al.				3					7			3					6				6					9

Author			MLD mm post DEB					MLD mm Follow up DEB					MLD mm post DES					MLD mm Follow up DES				Late lumen loss mm (DES)					Late lumen loss mm (DCB)
Ke D et al.			1.77 ± 0.31					1.80±0.33					2.02±0.37					1.91±0.41				0.11 ± 0.15					–0.02 ± 0.19
Guo Q et al.			2.23±0.17					2.25±0.21					2.76±0.15					2.40±0.33				0.10 ± 0.08					−0.04 ± 0.19
Eraliev et al.			1.86±0.34					1.81±0.29					1.41±0.45					1.30±0.25				1.06 ± 0.29					0.79 ± 0,.27
Pan et al.			3.12±0.22					2.34±0.71					3.14±0.21					2.04±0.70				0.42 ± 0.62					0.13 ± 0.42
Liu et al.			2.22±0.36					2.32±0.39					2.04±0.70					1.82±1.04				0.68 ± 1.02					0.14 ± 0.29

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