iVascular Essential Pro DCB Studied in Treatment of Coronary ISR

July 18, 2024—iVascular, headquartered in Barcelona, Spain, announced the publication of results from a prospective, single-center study of the company’s Essential Pro paclitaxel drug-coated balloon (DCB). The study was led by Principal Investigator Lucio Padilla, MD, and conducted at the Instituto Cardiovascular de Buenos Aires in Buenos Aires, Argentina.

In its press release, iVascular stated that this real-world evidence highlighted the safety and efficacy of the Essential Pro DCB in treating coronary in-stent restenosis (ISR).

The findings demonstrated a high delivery success rate and low incidence of target lesion revascularization (TLR), adverse clinical outcomes, and target vessel revascularization (TVR) during follow-up, significantly enhancing clinical outcomes and patient quality of life, noted the company.

The findings were published by Dr. Padilla et al in REC: Interventional Cardiology.

According to iVascular, the study included 160 consecutive patients with a total of 206 lesions treated via coronary angioplasty using the Essential Pro DCB. Average patient age was 71.4 years, 15.5% were women, and 35.5% had diabetes. Additionally, 53.3% presented with acute coronary syndrome at the time of treatment.

As outlined in the company’s press release, the investigators reported the following key findings:

• Device delivery and procedure outcomes: The Essential Pro DCB was successfully delivered in 100% of patients. The final angiographic assessment showed thrombolysis in myocardial infarction (TIMI) 3 flow in 98.5% of patients and residual stenosis < 30% in 96.6% of patients. Bail-out stenting was required in only 4.8% of procedures.
• At 1-year follow-up: The mortality rate was 0%, myocardial infarction occurred in 3.4% of patients, the rate of TLR was 2.5%, and the rate of TVR was 6.3%.
• At 18-month follow-up: The mortality rate was 0%, the TLR rate was 4.3%, and one of the patients required surgical revascularization during the follow-up period.

“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 (unstable angina, 53%),” commented Dr. Padilla in the iVascular press release. “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, TIMI 3 flow) before drug delivery. This preparation underpins the remarkable results observed at 12- to 18-month follow-up.”

Dr. Padillo added, “I strongly recommend DCB technology as a therapeutic alternative to drug-eluting stents in various scenarios, including ISR, high bleeding risk, de novo lesions, small vessels, distal left anterior descending, and provisional unprotected left main percutaneous coronary intervention.”

Additionally, the company noted that the European Society of Cardiology guidelines have stated that DCBs provide innovative, nonimplant options for treating coronary ISR, with strong evidence supporting their safety and efficacy.