Serial quantitative optical coherence tomography for luminal volume changes following either paclitaxel or sirolimus coated balloon in de novo small coronary artery lesions

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: de novo small coronary artery lesions. Intervention: Sirolimus coated balloon (SCB) vs. Paclitaxel coated balloon (PCB). Primary outcome: Late lumen volume loss (post-procedural lumen volume - lumen volume at 6 months) (p=0.06).

Q: What does this research mean for the field?

In de novo lesions of small coronary arteries, sirolimus-coated balloons lead to a significant reduction in luminal volume at 6 months compared to post-procedure, whereas paclitaxel-coated balloons maintain luminal volume without significant change. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Akihiro Tobe; Patrick Serruys; Kotaro Miyashita; Asahi Oshima; Pruthvi Chenniganahosahalli Revaiah; Tsung-Ying Tsai; Jouke Dijkstra; Scot Garg; Angela McInerney; Yoshinobu Onuma; Faisal Sharif

doi:10.1016/j.carrev.2025.03.025

April 8, 2025Cardiovascular revascularization medicineOpen Access

Serial quantitative optical coherence tomography for luminal volume changes following either paclitaxel or sirolimus coated balloon in de novo small coronary artery lesions

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Key result

Sirolimus-coated balloons show no significant difference in 6-month lumen volume loss vs paclitaxel-coated balloons.

P=0.06

Why the study?

Does sirolimus coated balloon compared to paclitaxel coated balloon improve late lumen volume loss at 6 months in patients with de novo small coronary artery lesions?

Key Points

To compare 6-month luminal volume changes using serial optical coherence tomography after treating de novo small coronary artery lesions with paclitaxel-coated balloons versus sirolimus-coated balloons.
Evaluated patients undergoing intervention for de novo small coronary artery lesions using either paclitaxel-coated balloons (PCB) or sirolimus-coated balloons (SCB).
Performed serial quantitative optical coherence tomography (OCT) post-procedure and at 6 months to measure late lumen volume loss (post-procedural lumen volume minus 6-month lumen volume).
Treatment with SCB led to a significant decrease in lumen volume at 6 months compared to post-procedure, whereas PCB treatment showed no significant change (SCB vs PCB, p = 0.06).
A trend for interaction emerged between balloon type and dissection volume on late lumen volume loss (SCB: LLVL = 1.28 ∗ dissection volume + 7.42, p = 0.37; PCB: LLVL = -2.84 ∗ dissection volume + 4.51, p = 0.12; p for interaction = 0.07).

Study Design

Type

Cohort

Structured PICO

Does sirolimus coated balloon compared to paclitaxel coated balloon improve late lumen volume loss at 6 months in patients with de novo small coronary artery lesions?

P

Population

Patients with de novo lesions of small coronary arteries treated with either a sirolimus or paclitaxel coated balloon, evaluated at 6 months.

E

Exposure

Sirolimus coated balloon (SCB)

C

Comparator

Paclitaxel coated balloon (PCB)

O

Outcome

Late lumen volume loss (LLVL) at 6 months (defined as post-procedural lumen volume - lumen volume at 6 months)surrogate

Main Result

p-value: p=0.06

Implication

In de novo small coronary artery lesions, paclitaxel-coated balloons may be superior to sirolimus-coated balloons in preserving lumen volume at 6 months.

Abstract

BACKGROUND: Drug coated balloons (DCB) are a treatment option for lesions in small coronary arteries, with treatment using paclitaxel coated balloons (PCB) associated with less angiographic late lumen loss than sirolimus coated balloons (SCB). METHODS: ) was defined as the post-procedural lumen volume - lumen volume at 6 months. RESULTS: in the SCB and PCB group, respectively (SCB vs PCB, p = 0.06). A trend for interaction between SCB and PCB was observed in the relationship between dissection volume and LLVL (SCB: LLVL = 1.28 ∗ dissection volume + 7.42, p = 0.37; PCB: LLVL = -2.84 ∗ dissection volume + 4.51, p = 0.12; p for interaction = 0.07). CONCLUSION: In de novo lesions of small coronary arteries, treatment with an SCB lead to a significant decrease in lumen volume at 6-months compared to post-procedure, with no significant change observed after treatment with a PCB.

Discussion

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Cite This Study

Tobe et al. (2025) conducted a cohort in de novo small coronary artery lesions. Sirolimus coated balloon (SCB) vs. Paclitaxel coated balloon (PCB) was evaluated on Late lumen volume loss (post-procedural lumen volume - lumen volume at 6 months) (p=0.06). Sirolimus coated balloons led to a significant decrease in lumen volume at 6 months in small coronary artery lesions, with no significant change observed with paclitaxel coated balloons (p=0.06).

synapsesocial.com/papers/6a1a77b0837f1a2c63b8a4ee https://doi.org/10.1016/j.carrev.2025.03.025

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Serial quantitative optical coherence tomography for luminal volume changes following either paclitaxel or sirolimus coated balloon in de novo small coronary artery lesions

Key Points

Study Design

Structured PICO

Main Result

Implication

Abstract

Discussion

Cite This Study

Serial quantitative optical coherence tomography for luminal volume changes following either paclitaxel or sirolimus coated balloon in de novo small coronary artery lesions

Key Points

Study Design

Structured PICO

Main Result

Implication

Abstract

Discussion

Cite This Study

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