Paclitaxel-coated balloon angioplasty was associated with a reduction in MACE and a non-significant difference in TLF at 3 years compared with drug-eluting stents for de novo SV-CAD.
Meta-Analysis
Does paclitaxel-coated balloon angioplasty reduce MACE compared to drug-eluting stents in patients undergoing PCI for de novo small-vessel coronary artery disease?
In patients with de novo small-vessel coronary artery disease, paclitaxel-coated balloons reduce MACE compared to drug-eluting stents at 3 years, with no significant difference in target lesion failure.
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.
“El estudio ANDROMEDA respalda el uso de balones recubiertos como estrategia alternativa en la revascularización de lesiones en vasos pequeños, aunque se requieren estudios de mayor seguimiento”
Fezzi et al. (Fri,) conducted a meta-analysis in de novo small-vessel coronary artery disease. Paclitaxel-coated balloons vs. Drug-eluting stents was evaluated on MACE and TLF. Paclitaxel-coated balloon angioplasty was associated with a reduction in MACE and a non-significant difference in TLF at 3 years compared with drug-eluting stents for de novo SV-CAD.