Invest-to-treat drug-coated balloon strategy in chronic total occlusion percutaneous intervention for high-risk stent failure patients.

Abstract

Background: Long-term patency in complex chronic total occlusion percutaneous intervention (CTO-PCI) is often hindered by a high-risk of stent-failure (HR-SF), impacting prognosis. Drug-coated balloon (DCB) angioplasty may offer an alternative after successful crossing. We evaluated an invest-to-treat DCB strategy, determined by plaque modification results.

Methods: Patients with CTO wire-crossing and suboptimal lesion profile for stenting were enrolled at Campus Bio-Medico University Hospital of Rome (April-July 2024). After plaque preparation, results were classified as good, suboptimal, or poor based on residual stenosis and thrombolysis in myocardial infarction (TIMI) flow. Poor results received conventional stenting [drug-eluting stent (DES)]. Good results underwent a nine-month follow-up; suboptimal results underwent a three-month angiography. A "redo-DCB" approach was used for persistent suboptimal results within the invest-to-treat strategy.

Results: Of 32 CTO-PCIs performed, 29 completed the nine-month follow-up. 11 patients (38%) had poor outflow and required DES (DES-group). The other 18 patients (62%) were managed with DCB alone: six patients (21%) achieved good immediate results (DCB-group), and 12 (41%) were treated as "DCB-investment" due to suboptimal plaque modification (DCB-investment group). At the three-month follow-up, four patients (14%) showed improved angiographic results, while six (21%) had suboptimal outcomes and received redo-DCB after plaque modification; two (7%) of these required DES. At nine-months, 14 patients (48%) were successfully treated with a DCB-only approach.

Conclusions: This prospective study demonstrates that a DCB strategy for CTO patients with HR-SF is feasible and safe. A DCB-only approach resulted in favorable early outcomes for most patients. In the case of suboptimal initial results, the redo-DCB strategy emerged as a promising alternative to extensive stenting.