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

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

This single-center sub-study of the TRANSFORM-I study compared quantitative optical coherence tomography (OCT) data in patients with de novo lesions in small coronary arteries treated with the MagicTouch (SCB) or SeQuent Please Neo (PCB). The relationship between the lumen volume of the treated segment immediately post procedure and at 6-month follow-up was evaluated. Late lumen volume loss (LLVL, mm3) was defined as the post-procedural lumen volume - lumen volume at 6 months.

RESULTS

Serial OCT analysis was performed in 19 patients with 21 lesions (SCB: 9 patients/11 lesions; PCB: 10 patients/10 lesions). There was a significant decrease in lumen volume between post-procedure and 6 months in the SCB group (97.35 ± 71.09 mm3 vs 87.96 ± 61.48 mm3, p = 0.03), but not in the PCB group (69.67 ± 38.24 mm3 vs 71.64 ± 42.22 mm3, p = 0.64). The LLVL was 9.39 ± 12.76 mm3 and - 1.97 ± 12.90 mm3 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.