Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis

• Published in: REC, Interventional cardiology (Internet. English ed.) Interventional cardiology (Internet. English ed.), 2024-08, Vol.6 (3), p.166-171
• Main Authors: Padilla, Lucio, Liberman, Federico, Tello, Jorge, Rosas, Pablo, Spaletra, Pablo, Pedernera, Gustavo, Mascolo, Pablo, Ordoñez, Santiago, Santilli, Pablo, Candiello, Alfonsina, Cura, Fernando, Belardi, and, Jorge, Lamelas, Pablo
• Format: Article
• Language: English
• Subjects: Drug-eluting balloon; In-stent restenosis; Paclitaxel
• ISSN: 2604-7322; 2604-7322
• DOI: 10.24875/RECICE.M24000462

ABSTRACT Introduction and objectives: Drug-eluting balloons (DEB) are an established treatment option for in-stent restenosis (ISR). This study aimed to assess the safety and efficacy of a novel DEB in patients with ISR. Methods: This prospective, single-center study enrolled a consecutive cohort of patients diagnosed with ISR who underwent coronary angioplasty with a new second-generation paclitaxel-eluting balloon. The 3 main endpoints were myocardial infarction, target lesion revascularization, and target vessel revascularization. Baseline variables were collected, including patient and procedure characteristics. Follow-up data were collected through medical records or telephone contact. Results: The study included 160 consecutive patients with 206 treated lesions (mean age, 71.4 ± 14.9 years, 15.5% women) undergoing percutaneous coronary intervention with DEB for ISR. A total of 53.3% of patients had acute coronary syndrome. The average diameter of the treated vessel was 3.10 ± 0.7 mm. The DEB used had a mean diameter of 3.1 ± 0.6 mm and a mean length of 23.1 ± 6.8 mm. Predilatation was performed in 98% of the lesions, and a noncompliant balloon was used in 80%. Intracoronary imaging was used in 24% of cases. At the end of the procedure, 98.5% of patients had Thrombolysis in Myocardial Infarction flow grade 3, residual stenosis was > 30% in 3.4%, and dissection occurred in 1.4%. Bail-out stenting was required in 4.8% of patients. Mortality was nil during follow-up (maximum 768 days). The incidence of myocardial infarction, target lesion revascularization, and target vessel revascularization were 5.4% (95%CI, 0.69-10.1), 8.4% (95%CI, 0-17.8), and 14.2% (95%CI, 3.61-24.78), respectively. Conclusions: In this cohort of patients with ISR treated with DEB, we observed a low rate of adverse events in both the short- and mid-term. These results support the safety and efficacy of this new generation of DEB for treating ISR.