DRUG-COATED BALLOONS (DCB) FOR THE TREATMENT OF IN-STENT RESTENOSIS (ISR) IN POST-PCI PATIENTS: A SHORT-TERM CLINICAL OUTCOMES STUDY

Abstract

Objective: To assess the short-term clinical outcomes of treating in-stent restenosis (ISR) in patients who have had PCI at monthly and three-month follow-ups using drug-coated balloons (DCB).

Methodology: This prospective observational study, conducted at Department of Interventional Cardiology AFIC/ NIHD Rawalpindi, Pakistan from January, 2023 to January, 2024 involved 121 patients. Participants were selected using consecutive sampling, including adults treated with a paclitaxel-coated balloon, presenting with acute coronary syndrome (ACS) or worsening angina, and showing angiographic luminal narrowing of 50% or more in the diameter of a pre-deployed stent or within 4-5 mm of the stent. Ethical approval and informed consent were obtained. Data collection involved a structured questionnaire covering baseline clinical variables, procedural information (ISR type, target vessel, therapies, complications, outcomes), and angiographic data (lesion diameter, TIMI flow grade). SPSS version 20.0 was used for data analysis. The Chi-square test (p < 0.05) was used to determine significance. Continuous variables were summarized as mean ± SD, while categorical variables were expressed as numbers and percentages.

Results: The study included 121 patients (mean age 56± 8.45years, 62% male) with a mean BMI of 27.5±4.2 kg/m². Comorbidities included diabetes (25%), hypertension (45%), dyslipidemia (41%), chronic kidney disease (12%), and heart failure (8%). Smoking was reported in 33% of patients. Indications for the procedure were unstable angina (37%), NSTEMI (41%), and STEMI (22%). The mean ISR luminal diameter was 75±10%, with 81% involving DES and 19% BMS. Target vessels were the left anterior descending artery (41%), right coronary artery (33%), and left circumflex artery (26%). Tirofiban was administered peri-procedurally to 53% of patients, and post-procedural DAPT with clopidogrel to 75% and ticagrelor to 24%. At the one-month follow-up, MACE included target vessel revascularization (4.1%), myocardial infarction (2.5%), stroke (1.6%), and death (0.8%). At three months, target vessel revascularization was 2.5%, myocardial infarction 1.6%, stroke 0.8%, and death 0.8%. There were no discernible variations in the clinical results across the one-month and three-month follow-ups (p > 0.05). Angiographic analysis showed improvement in TIMI flow grade from 1.5±0.5 to 3.0±0.2 post-intervention.

Conclusion: At the 1-month and 3-month follow-ups, the overall mortality rate stayed low at 0.8%, while the risk of major adverse cardiac events (MACE) dropped from 8.2% at the 1-month mark to 4.9% at the 3-month mark. Based on these findings, DCBs appear to be a safe and effective therapeutic option for ISR.