Sirolimus vs. paclitaxel DCB. A logistic regression analysis of EASTBOURNE and PEARL multicentre study
Published in congress: EuroPCR 2024

Dr. Mustafa Karanfil

Introduction:
The use of drug-coated balloons (DCBs) is expanding over time, showing successful results in in-stent restenosis (ISR) and de novo lesions, especially in small vessels.

Objectives:
A logistic regression analysis was conducted comparing sirolimus-coated balloon (SCB) and paclitaxel-coated balloon (PCB) based on the combined data from two studies: "Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry" and "Clinical Performance of a Paclitaxel Drug-Coated Balloon in Real-World Percutaneous Coronary Intervention Practice: The PEARL Registry". Both studies were prospective, single-arm, multicenter trials.

Methods:
In the PCB arm, there were 513 patients, including 382 with ISR and 131 with de novo lesions. In the SCB arm, there were 2083 patients, including 910 with ISR and 1173 with de novo lesions. The primary endpoint was major adverse cardiac events (MACE) within the first year, consisting of all-cause mortality, myocardial infarction (MI), and target lesion revascularization (TLR). Stratification was performed based on ISR and de novo lesions. Logistic regression analyses were conducted to obtain odds ratios and compare the two balloons.

Results:
In the ISR arm, compared to the PEARL study (PCB), the EASTBOURNE study (SCB) had a higher prevalence of diabetes, hypertension, hyperlipidemia, and lower incidence of prior MI (45.3% vs. 23.6%; 84.0% vs. 62.6%; 78.2% vs. 54.2%; 58.6% vs. 66.8%, respectively). The PEARL study had a higher incidence of MI at presentation, longer mean lesion length, larger mean lesion diameter, and a higher proportion of B2 and C type lesions. In the de novo lesion arm, compared to the PEARL study (PCB), the EASTBOURNE study (SCB) had a higher prevalence of diabetes, hypertension, hyperlipidemia, and lower incidence of prior MI (38.7% vs. 24.4%; 71.4% vs. 51.9%; 67.2% vs. 42.7%; 30.8% vs. 45%, respectively). The PEARL study had a higher proportion of B2 and C type lesions. At 1-year follow-up, there was no significant difference in MI, TLR, and MACE between de novo and ISR arms.

Comments:
The limitations of this comparison include the absence of a randomized comparison, significant differences between the groups in both studies that were partially mitigated by logistic regression and multivariable adjustments, and less predilatation in the PEARL study. In this real-life, large-scale comparison of the two DCBs, no difference was found in 1-year MACE between de novo and ISR lesions. There is a need for studies with longer follow-up periods and direct randomized comparisons.