Individual patient data meta-analysis of paclitaxel-coated balloons vs. drug-eluting stents for small-vessel coronary artery disease: the ANDROMEDA study
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,384 participants or records.
Read the paper
Related studies
- Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials
- Tocilizumab in patients with severe COVID-19: a retrospective cohort study
- A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study
- Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study
- Are noise and air pollution related to the incidence of dementia? A cohort study in London, England
- Long COVID symptoms and duration in SARS-CoV-2 positive children — a nationwide cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.