Tactics of Endovascular Treatment of Patients with Coronary Heart Disease with Recurrent Coronary In-Stent Restenosis Using Second- and Third-Generation Stent Systems and Paclitaxel-Coated Balloon Catheters

Abstract

INTRODUCTION: The binary in-stent restenosis (ISR) still remains the main factor limiting the effectiveness of percutaneous coronary intervention in the long-term period. Histologically, ISR is defined as neointimal hyperplasia leading to hemodynamically significant narrowing of the arterial lumen. Patients with coronary artery (CA) restenosis represent a particularly challenging group for endovascular treatment.
 AIM: To compare effectiveness and safety of the endovascular correction of coronary in-stent restenosis using second- and third-generation stent systems and balloon angioplasty with a drug-coated balloon catheter.
 MATERIALS AND METHODS: The study retrospectively included 62 patients with recurrent ISR after the previous endovascular correction. The patients underwent treatment with re-stenting in Saint George Clinic of Thoracic and Cardiovascular Surgery of the National Pirogov Medical Surgical Center in 2016–2023 with use of second- and third-generation drug-eluting stents — cobalt (cobalt alloy) systems with zotarolimus, cobalt-chromium stent systems with sirolimus and zotarolimus, platinum-chromium stent systems with everolimus with biodegradable drug coating. Balloon angioplasty was performed using paclitaxel-coated balloon catheters. The primary endpoint of the study was the target lesion failure (TLF) of CA. The secondary endpoint was major adverse cardiovascular events (MACE).
 RESULTS: The TLF rate was 15.6% vs. 13.3% and 28.1% vs. 46.7% in the groups with use of a drug-eluting stent and balloon angioplasty at 1- and 2-year follow-up, respectively (p = 0.30). MACE was recorded in 18.8% vs. 16.7% and 37.5% vs. 56.7% of cases in the groups with use of a drug-eluting stent and balloon angioplasty at 1- and 2-year follow-up, respectively (p = 0.25). The dispersion analysis of predictors of TFL risks identified three factors showing a reliable correlation with the probability for TFL by the second follow-up year in both groups: (1) recurrence of binary ISR (hazard ratio (HR) 2.21; 95% confidence interval (CI) 0.95–4.01; p = 0.03)) in 365 days after the third stage of the percutaneous coronary intervention; (2) length of coronary restenotic lesion (per every 10 mm) (HR 1.25; 95% CI 0.99–1.40; p = 0.002); (3) occlusive restenosis (HR 4.16; 95% CI 0.43–26.96; p = 0.04).
 CONCLUSIONS: The implantation of a second- and third-generation drug-eluting stent and balloon angioplasty with use of a drug-coated catheter are comparable in the effectiveness and safety in correcting the recurrent ISR, however, restenting is associated with a lower probability for developing TFL and adverse events.