Aim: The aim of this study was to compare the safety and efficacy of paclitaxel-coated balloons (PCB) and sirolimus-coated balloons (SCB) in patients with in-stent restenosis (ISR).
Methods: This prospective, observational, single-centre pilot study enrolled 85 patients diagnosed with drug-eluting stent ISR. For all the eligible patients, various clinical baseline characteristics were collected, and angiography was performed to evaluate the lesion characteristics. After assessment, patients were treated with either PCB or SCB based on our center's time-based approach. Intravascular ultrasound (IVUS) imagining was used to assess the pre- and post-procedural minimal stent area (MSA). All the patients were followed up and major adverse cardiovascular events were documented for patients in both the groups.
Results: Of total 85 patients with ISR, 32 underwent treatment with PCB and 53 with SCB. A significant difference was noted in the post procedural MSA in both the groups (p = 0.005) and the values were 7.01 ± 1.11 mm and 8.01 ± 1.70 mm for PCB and SCB group, respectively. At median follow-up of 3.8 years, no cardiac death was noted in PCB group and one death was reported in SCB group (p = 0.459). In PCB group, target lesion revascularization (TLR) was noted in one (12.5 %) patient, while in SCB group TLR was noted in four (16.5 %) patients (p = 0.920).
Conclusion: Both PCB and SCB are found to be effective and safe in treating in patients with drug-eluting stents-ISR. Also, the use of DCB with imaging techniques like IVUS enhances treatment outcomes and optimizes patient care in ISR treatment.
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http://dx.doi.org/10.1016/j.ihj.2025.03.003 | DOI Listing |
Catheter Cardiovasc Interv
March 2025
CVPath Institute, Gaithersburg, MD, USA.
Background: Paclitaxel (PCB) and sirolimus-coated balloons (SCB) are major therapeutic options for coronary artery disease, but there is no direct head-to-head histological comparison of their effects during the percutaneous coronary intervention (PCI).
Aims: We aimed to investigate the vascular and downstream effects and drug pharmacokinetics in a porcine coronary model treated with MagicTouch-SCB (MT-SCB), Selution-SRL-SCB (SEL-SCB), Agent PCB, and plain old balloon angioplasty (POBA).
Methods: Twenty-eight coronary arteries from 10 pigs were treated with one of three drug-coated balloons (DCBs) (n = 7 for each) or POBA (n = 7) with 28 days follow-up.
Indian Heart J
March 2025
Fortis Hospital, Anandapur, West Bengal, 700107, India.
Aim: The aim of this study was to compare the safety and efficacy of paclitaxel-coated balloons (PCB) and sirolimus-coated balloons (SCB) in patients with in-stent restenosis (ISR).
Methods: This prospective, observational, single-centre pilot study enrolled 85 patients diagnosed with drug-eluting stent ISR. For all the eligible patients, various clinical baseline characteristics were collected, and angiography was performed to evaluate the lesion characteristics.
J Pers Med
February 2025
Heart and Vascular Centre, Semmelweis University, 1122 Budapest, Hungary.
Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a cornerstone of the management of ischemic heart disease. However, in-stent restenosis (ISR) remains a significant clinical challenge, occurring in approximately 5-10% of patients undergoing PCI. This study is designed to compare the efficacy and safety of the primary therapeutic approaches for DES-ISR, specifically drug-coated balloons (DCBs)-paclitaxel-coated balloons (PCBs) and sirolimus-coated balloons (SCBs)-with a new-generation everolimus-eluting stent (EES), contributing to the evolving field of personalized medicine.
View Article and Find Full Text PDFJACC Cardiovasc Interv
February 2025
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, People's Republic of China. Electronic address:
Background: The use of drug-coated balloons is a well-established strategy for the management of coronary vessels. However, head-to-head comparisons of sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) for treating in-stent restenosis (ISR) are currently limited.
Objectives: The aim of this randomized, controlled trial (SIBLINT-ISR [Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis]) was to compare a novel SCB with a PCB for the treatment of ISR.
EuroIntervention
November 2024
Protestant Hospital Paul Gerhardt Stift, Lutherstadt Wittenberg, Germany.
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