# Paclitaxel-gecoate ballonnen versus DES bij kleine vaten: IPD meta-analyse

*geplaatst 2025-05-02 · Algemeen · European heart journal · doi 10.1093/eurheartj/ehaf002 · https://hartvaat.nl/2025/05/02/paclitaxel-gecoate-ballonnen-versus-des-bij-kleine-vaten-ipd-meta-analyse/*

IPD meta-analyse vergeleek paclitaxel-gecoate ballonnen met DES bij kleine coronaire vaten. DCB was non-inferieur aan DES, wat een stentvrij alternatief biedt voor deze lastige anatomie.

## English: Individual patient data meta-analysis of paclitaxel-coated balloons vs. drug-eluting stents for small-vessel coronary artery disease: the ANDROMEDA study.

This individual patient data meta-analysis compared paclitaxel-coated balloons with drug-eluting stents for small coronary artery disease, confirming DCB noninferiority and supporting the leave-nothing-behind approach in small vessels.

## Abstract (original, from the publication)

BACKGROUND AND AIMS: In randomized clinical trials of patients undergoing percutaneous coronary intervention (PCI) for de novo small-vessel coronary artery disease (SV-CAD), paclitaxel-coated balloon (PCB) angioplasty showed mid-term angiographic or clinical non-inferiority to drug-eluting stent (DES) implantation. Nevertheless, these trials have sample size limitations, and the relative safety and efficacy beyond the first year remain uncertain. METHODS: The ANDROMEDA study was a collaborative, investigator-initiated, individual patient data meta-analysis comparing 3 year clinical outcomes between PCB angioplasty and DES implantation for the treatment of de novo SV-CAD. Multiple electronic databases (PubMed, Scopus, ScienceDirect, and Web of Science) were searched from May 2010 to June 2024 to identify eligible trials. All the following eligibility criteria were required: (i) random allocations of treatments; (ii) patients with SV-CAD; (iii) treatment with PCB or DES; and (iv) clinical follow-up of at least 36 months. The primary and co-primary endpoints were major adverse cardiac events (MACE) and target lesion failure (TLF), respectively. The protocol was registered with PROSPERO (CRD42023479035). RESULTS: Individual patient data from three randomized trials, including a total of 1154 patients and 1360 lesions, were combined. At 3 years, PCB was associated with a lower risk of MACE compared with DES [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.47-0.96], due to a lower risk of myocardial infarction and target vessel revascularization. This benefit persisted after multivariable adjustment (HR 0.75, 95% CI 0.58-0.96), but did not reach statistical significance in the two-stage analysis (HR 0.67, 95% CI 0.43-1.04). At the landmark analysis, the risk of MACE between groups was consistent over time. At 3 years, TLF was not significantly different between PCB and DES groups. Reconstructed time-to-event information from a fourth trial was included in a sensitivity analysis (1384 patients and 1590 lesions), showing consistent results in terms of TLF (HR 0.87, 95% CI 0.63-1.20). The comparison between PCB and second-generation DES did not reveal significant differences in 3 year TLF (HR 1.03, 95% CI 0.70-1.50). CONCLUSIONS: In patients undergoing PCI for de novo SV-CAD, PCB angioplasty is associated with a reduction in MACE and a non-significant difference in TLF at 3 year follow-up compared with DES implantation. The restriction of the comparator group to second-generation DES does not alter the main conclusions. Larger trials comparing contemporary devices at a more prolonged follow-up are warranted to confirm these findings.

Auteurs: Simone Fezzi, Daniele Giacoppo, Gregor Fahrni, Azeem Latib, Fernando Alfonso, Antonio Colombo, Felix Mahfoud, Bruno Scheller, Raban Jeger, Bernardo Cortese

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Bron: European heart journal, https://doi.org/10.1093/eurheartj/ehaf002. Bijgewerkt 2026-07-03T13:30:37Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.