ORIGINAL ARTICLE   

Panminerva Medica 2023 September;65(3):327-34

DOI: 10.23736/S0031-0808.21.04573-0

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: English

Paclitexel versus sirolimus-coated balloon in the treatment of coronary instent restenosis

Carlo BRIGUORI ¹ ✉, Gabriella VISCONTI ¹, Marco GOLINO ¹, Amelia FOCACCIO ¹, Mario SCARPELLI ¹, Silvia NUZZO ², Giuseppe BIONDI-ZOCCAI ^{1, 3}

¹ Unit of Interventional Cardiology, Mediterranea Cardiocentro, Naples, Italy; ² IRCCS SDN, Naples, Italy; ³ Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University, Latina, Italy

BACKGROUND: Few studies compared paclitaxel-coated balloon (PCB) versus sirolimus-coated balloon (SCB) in the treatment of drug-eluting stent (DES) instent restenosis (ISR).
METHODS: Between November 5, 2009, and October 14, 2020, in our center 212 patients with first DES-ISR were treated with PCB (Restore^®; Cardionovum GmbH, Bonn, Germany), whereas 230 patients were treated with SCB (Devoir^®; MINVASYS SAS, Gennevilliers, France). Following a propensity matching, 186 patients were included into PCB group (PCB group), and in the SCB group (SCB group). The primary purpose of the study was the 1-year target lesion failure (TLF) rate, including cardiac death, target vessel-related myocardial infarction, and repeated target lesion or target vessel revascularization.
RESULTS: Procedural success occurred in all cases. Fully optimal predilation (that is, balloon-to-stent ratio >0.91, time of DCB inflation >60 sec, and residual percent diameter stenosis after lesion preparation <20%) was observed more often in the SCB group (126 [68%] patients versus 106 [57%] patients; P=0.042). One-year TLF occurred in 29 (15.5%) patients in the SCB group and in 32 (17%) patients in the PCB group (OR=1.12 [0.65-1.95]; P=0.78). By logistic Cox regression analysis fully optimal predilation (OR=0.06; 95% CI: 0.01-0.21; P<0.001) but not DCB type (OR=0.74; 95% CI: 0.41-1.31; P=0.29) was independent predictor of 1-year TLF.
CONCLUSIONS: The current study suggests that 1-year TLF is not statistically and clinically different in patients with DES ISR treated with a PCB and a SCB.

KEY WORDS: Angioplasty, balloon; Drug-eluting stents; Coronary restenosis