Long term clinical outcomes following drug coated balloons in coronary artery disease

Objective: The aim of this study was to evaluate the long-term efficacy of drug coated balloons (DCB) in percutaneous coronary intervention (PCI) in two different pathophysiologic scenarios.

Background: There are different underlying pathological processes in coronary artery disease. Long-term safety and efficacy of DCB approach is still limited.

Methods: Medical records of all consecutive patients undergoing DCB were evaluated. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 24 months.

Results: Between January 2011 to December 2017, 442 patients were included, representing 4.4% of all PCIs in our institution. A total of 460 DCB lesions were treated, 328 (71.3%) of them were de-novo and 132 (28.7%) were combined bare metal or drug eluting stents in-stent restenosis (ISR). The patients’ mean age was 66.2±11.7 years with a diabetes prevalence of 45.3%. The TLR rate was lower in the de-novo group (5.3%) when compared to the ISR group (9.4%) (P = 0.04). No differences were observed in major adverse cardiovascular events (MACE) between the de-novo group (7.5%) and ISR group (15.7%) (P = 0.93). No significant differences were detected in TLR occurrence in the subgroup analysis.

Conclusion: Our extended experience demonstrates that the long-term DCB approach in these two pathophysiologic settings represent a reasonable option, with low TLR rate and clinical MACE.