# Paclitaxel- and Sirolimus-Coated Balloons Versus Drug-Eluting Stents in Coronary Artery Disease: A Comprehensive Narrative Review

**Authors:** Flavius-Alexandru Gherasie, Al Hassan Ali, Ana Maria Corzanu, Eva Catalina Costescu, Sonia-Gabriela Cornea

PMC · DOI: 10.3390/life16010063 · Life · 2025-12-31

## TL;DR

This review compares drug-coated balloons and drug-eluting stents for treating coronary artery disease, highlighting their effectiveness and potential benefits in specific patient scenarios.

## Contribution

The paper provides a comprehensive comparative analysis of sirolimus- and paclitaxel-coated balloons versus drug-eluting stents in various coronary conditions.

## Key findings

- DCB-P achieves non-inferior outcomes to DES in stable de novo lesions, especially in small vessels and high bleeding-risk patients.
- DCB-S may match DES outcomes in broader populations, with early data showing promise in acute coronary syndromes and in-stent restenosis.
- Sirolimus and paclitaxel differ in mechanisms and pharmacokinetics, with technological advances improving drug delivery and outcomes.

## Abstract

Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DESs) in percutaneous coronary intervention, delivering antiproliferative drugs without leaving a permanent implant. This review provides a comparative analysis of sirolimus-coated DCBs (DCB-S), paclitaxel-coated DCBs (DCB-P), and DESs across key scenarios: de novo coronary lesions in chronic coronary syndrome (CCS), acute coronary syndromes (ACS), and in-stent restenosis (ISR). We discuss late lumen loss (LLL), target lesion/vessel revascularization (TLR/TVR), vessel patency, and major adverse cardiac events (MACE) outcomes, along with current guidelines and emerging indications for DCB-S. We also examine pharmacological differences between sirolimus and paclitaxel (mechanisms of action, tissue uptake, and healing profiles), trial methodologies, and recent innovations in DCB technology. Across stable de novo lesions (especially small vessels and high bleeding-risk patients), multiple trials show DCB-P can achieve non-inferior clinical outcomes to DES. Early data suggest newer DCB-S may likewise match DES outcomes in broader populations. In ACS, DCB-only strategies have demonstrated feasibility and safety in carefully selected lesions without heavy thrombus, with randomized studies like REVELATION (STEMI) showing non-inferior fractional flow reserve and low revascularization rates compared to DES. For ISR, DCB-P is an established Class I treatment in both BMS-ISR and DES-ISR, yielding similar or lower TLR rates than repeat stenting. DCB-S are now being evaluated as an alternative in ISR, aiming to avoid additional stent layers. Contemporary guidelines endorse DCB use in ISR and small vessels, and experts anticipate expanding indications as evidence grows. Sirolimus and paclitaxel differ in antiproliferative mechanisms and pharmacokinetics—sirolimus (cytostatic, mTOR inhibition) may offer faster endothelial recovery, whereas paclitaxel’s high lipophilicity ensures sustained arterial wall retention. Technological advances (e.g., phospholipid micro-reservoirs for sirolimus) are enhancing drug transfer and addressing prior limitations. In summary, DCB-P and DCB-S now represent viable alternatives to DES in specific scenarios, especially where “leaving nothing behind” could reduce long-term complications. Ongoing large randomized trials, such as SELUTION DeNovo, currently available as conference-presented data, together with longer-term follow-up will further clarify the optimal niches for DCB-S versus DCB-P and DES.

## Linked entities

- **Chemicals:** paclitaxel (PubChem CID 36314), sirolimus (PubChem CID 5284616)
- **Diseases:** coronary artery disease (MONDO:0005010), acute coronary syndromes (MONDO:0005542)

## Full-text entities

- **Genes:** MTOR (mechanistic target of rapamycin kinase) [NCBI Gene 2475] {aka FRAP, FRAP1, FRAP2, RAFT1, RAPT1, SKS}
- **Diseases:** bleeding (MESH:D006470), thrombus (MESH:D013927), ACS (MESH:D054058), STEMI (MESH:D000072657), cardiac (MESH:D006331), Coronary Artery Disease (MESH:D003324), coronary lesions (MESH:D003327), ISR (MESH:D023903)
- **Chemicals:** Paclitaxel (MESH:D017239), DCB (-), Sirolimus (MESH:D020123), BMS (MESH:C095300)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

_Full body text omitted from this summary view._ Fetch the complete paper as Markdown: https://tomesphere.com/paper/PMC12842739/full.md

## Figures

3 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12842739/full.md

## References

51 references — full list in the complete paper: https://tomesphere.com/paper/PMC12842739/full.md

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Source: https://tomesphere.com/paper/PMC12842739