Barcelona, June 19, 2024 — iVascular is pleased to announce the publication of positive results from a prospective single-center study, demonstrating that the company’s essential pro paclitaxel drug-coated balloon (DCB) offers low target lesion revascularization (TLR) and minimal adverse event rates in the treatment of coronary in-stent restenosis (ISR).
According to ESC guidelines, DCBs provide innovative, non-implant options for treating coronary ISR, with strong evidence supporting their safety and efficacy. The study, conducted at the Instituto Cardiovascular de Buenos Aires (ICBA) and led by Principal Investigator Dr. Lucio Padilla, has been published in the journal REC: Interventional Cardiology.
The study included 160 consecutive patients with a total of 206 lesions treated via coronary angioplasty using the essential pro DCB. The population had an average age of 71.4 years, with 15.5% being women and 35.5% having diabetes. Additionally, 53.3% presented with acute coronary syndrome at the time of treatment.
Key Findings:
- Device Delivery and Procedure Outcomes: essential pro DCB was successfully delivered in 100% of cases. The final angiographic assessment showed a Thrombolysis in Myocardial Infarction (TIMI) 3 flow in 98.5%, and residual stenosis <30% in 96.6%. Bail-out stenting was required in only 4.8% of cases.
- 1-Year Follow-Up: At the 1-year follow-up, the mortality rate was 0%, myocardial infarction occurred in 3.4%, TLR was 2.5% and target vessel revascularization (TVR) was 6.3%.
- 18-Month Follow-Up: At 18 months, the mortality rate was 0%, the TLR rate was 4.3%, with none of the patients requiring surgical revascularization during the follow-up period.
Dr. Lucio Padilla, the study’s principal investigator, commented, “I am highly satisfied using this new DCB technology, which enables me to treat all types of lesions, including those in tortuous and calcified arteries, as well as in unstable patients (UA 53%). Its excellent pushability and drug delivery result in impressive medium- and long-term outcomes. Key to these results is meticulous lesion preparation (residual stenosis <30%, no more than type B dissection, and TIMI III flow) before drug delivery. This preparation underpins the remarkable results observed at 12-18 months follow-up.
I strongly recommend DCB technology as a therapeutic alternative to DES in various scenarios, including ISR, HBR, de novo lesions, small vessels, distal LAD, and provisional ULM PCI”.
This real-world evidence highlights the safety and efficacy of iVascular essential pro drug-coated balloon in treating coronary in-stent restenosis. The findings demonstrated that essential pro had a high delivery success rate and a low incidence of adverse clinical outcomes and target vessel revascularization during follow-up, significantly enhancing clinical outcomes and patient quality of life.
