Incidence and Predictors of Outcome in the Treatment of In-Stent Restenosis with Drug-Eluting Balloons

Abstract

In-stent restenosis (ISR) continues to pose a significant clinical challange after percutaneous coronary intervention (PCI), despite the use of drug-eluting stents (DES). Drug-eluting balloons (DEBs) have surfaced as a promising therapeutic solution for ISR, offering a non-stent-based approach to administer antiproliferative drugs directly to the vessel wall. This study aims to evaluate the incidence of major adverse cardiac events (MACE) and identify clinical and procedural predictors of outcomes in patients undergoing DEB treatment for ISR.

Methods: This was a retrospective cohort study conducted at Pakistan Institute of Medical science, Islamabad, during study period from July 2022 to July 2023. All patinets with age ?18 years, angiographically confirmed restensosis were included.

Results: A total of 264 patients were included in the study majority male (73.86%), with a mean age of 61.42± 9.74 years. Procedural success of 99.24%  was achieved, and    of patients within the 12-month. The cumulative incidence of MACE was 8%  at 12 months with diabetes mellitus (HR: 1.9, 95% CI: 1.1-3.2, p<0.01), stent length >20 mm (HR: 1.7, 95% CI: 1.0-2.8, p<0.05), and suboptimal stent expansion (HR: 2.6, 95% CI: 1.7-4.8, p<0.01). Moreover, age more than 65 years and multiple vessel disease were significant predictors of MACE. KM analysis revealed significantly higher ISR and lower MACE-free survival in patients with DM and longer stent (p<0.01 and p<0.05, respectively).

Conclusion

In conclusion, the use of DEBs in the treatment of ISR shows a good procedural success rate along with a controllable restenosis recurrence rate. Significant predictors of unfavorable outcomes, such as diabetes mellitus, stent length, and poor stent expansion, were identified

Keywords: coronary artery disease, In-stent restenosis drug-eluting balloons, percutaneous coronary intervention.