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Comparison of Limus and Paclitaxel Drug-Coated Balloons, Second-Generation or Newer Drug-Eluting Stents, and Balloon
Yuko Kiyohara1, Tadao Aikawa2, Tetsuya Saito3
1Department of Medicine, Mount Sinai Morningside and West (Y.K.), Icahn School of Medicine at Mount Sinai, New York, NY.
Insights
Drug-coated balloons (DCBs) and drug-eluting stents show comparable efficacy for coronary artery disease (CAD). Limus and paclitaxel DCBs demonstrated similar clinical outcomes in patients with CAD.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Coronary artery disease (CAD) management involves various treatment options.
- The comparative efficacy of drug-coated balloons (DCBs) and drug-eluting stents (DES) remains an area of investigation.
- Direct comparison between limus and paclitaxel DCBs is crucial for clinical decision-making.
Purpose of the Study:
- To conduct a network meta-analysis assessing the clinical efficacy of limus and paclitaxel DCBs in CAD patients.
- To compare DCBs against second-generation or newer DES and plain old balloon angioplasty.
- To evaluate outcomes in specific patient subgroups, including in-stent restenosis and small-vessel CAD.
Main Methods:
- Systematic search of multiple databases for randomized controlled trials.
- Inclusion of trials comparing limus DCB, paclitaxel DCB, newer DES, and plain old balloon angioplasty.
- Primary outcome: Major Adverse Cardiovascular Events (MACE); Secondary outcomes: MACE components and subgroup analyses.
Main Results:
- 39 randomized controlled trials with 10,219 patients were analyzed.
- No significant difference in MACE was found between limus and paclitaxel DCBs.
- Both DCBs and newer DES showed comparable MACE rates; plain old balloon angioplasty had a higher MACE risk.
Conclusions:
- Limus and paclitaxel DCBs exhibit similar clinical efficacy in CAD treatment, though statistical power was limited.
- DCBs and second-generation or newer DES provide comparable outcomes for CAD.
- Further research with increased statistical power may be beneficial for definitive conclusions, especially in specific CAD subsets.
Background:
It remains unclear whether drug-coated balloons (DCBs) and drug-eluting stents are comparable in the treatment of coronary artery disease (CAD) and whether limus versus paclitaxel DCBs yield similar clinical outcomes. We aimed to assess the clinical efficacy of limus and paclitaxel DCBs in patients with CAD through a network meta-analysis.
Methods:
We comprehensively searched multiple databases for randomized controlled trials comparing the following 4 strategies: limus DCB, paclitaxel DCB, second-generation or newer drug-eluting stent, and plain old balloon angioplasty. The primary outcome was trial-defined major adverse cardiovascular events (MACEs), typically a composite of death, myocardial infarction, or target lesion revascularization. Secondary outcomes included individual components of MACE. We performed subgroup analyses for in-stent restenosis, small-vessel (<3 mm) CAD, and other de novo CAD, such as large vessel and ST-segment-elevation myocardial infarction.
Results:
We identified 39 randomized controlled trials including 10 219 patients. There was no significant difference in MACE between limus and paclitaxel DCBs (relative risk, 1.22 [95% CI, 0.86-1.73]). There were no significant differences in MACE between limus or paclitaxel DCB and second-generation or newer drug-eluting stents. Plain old balloon angioplasty had an increased risk of MACE compared with others. These results were consistent across subgroup analyses for in-stent restenosis, small-vessel CAD, and other de novo CAD.
Conclusions:
No significant differences were observed in MACE or its components between limus and paclitaxel DCBs, albeit with limited statistical power. Furthermore, DCB and second-generation or newer drug-eluting stents yielded similar outcomes though power was limited, especially for other de novo CAD.
Registration:
URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD420250654276.
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