Immediate and Midterm Efficacy and Safety of Intravascular Lithotripsy for Calcified In-Stent Restenosis: A Systematic Review and Meta-Analysis.

BACKGROUND

In-stent restenosis (ISR) remains a major challenge in coronary revascularization, especially in lesions with heavy calcification, where recurrence rates are high. The lack of data on newer treatment options often creates dilemmas for both physicians and patients. Intravascular lithotripsy (IVL) is a relatively new technique that has shown promise in managing calcified ISR. This meta-analysis aims to evaluate the procedural success and clinical outcomes of IVL in this setting.

METHODS

Following PRISMA 2020 guidelines, a systematic search was conducted on PubMed, ScienceDirect, and SCOPUS. Studies reporting procedural success and major adverse cardiovascular events (MACE) of IVL for calcified ISR during follow-up were included. The Newcastle-Ottawa Scale was used to assess study quality. Data analysis was performed using RevMan 5.4.0 and SPSS v25.

RESULTS

Five studies with a total of 207 patients and 212 lesions treated were analyzed. Acute procedural success was 85% (95% CI 0.76-0.91, I² = 42.0%). At 1-year follow-up, major adverse cardiac events (MACE) included myocardial infarction (MI) in 6% of patients (95% CI 0.02-0.16, I² = 52.5%), target lesion revascularization in 13% (95% CI 0.08-0.20, I² = 45.8%), and cardiac death in 4% (95% CI 0.02-0.08, I² = 0.0%). The rate of periprocedural MI was 1.5% (95% CI 0.01-0.05, I2 = 0.0%), while no reflow phenomenon was 0.5% (95% CI 0.01-0.06, I2 = 0.0%), with no other procedural complication occured. The overall incidence of MACE was 16% (95% CI 0.07-0.33, I² = 69.8%).

CONCLUSION

IVL shows potential as a treatment option for for calcified-ISR, demonstrating high acute procedural success and acceptable 1-year clinical outcomes. The 1-year TLR (13%) and MACE (16%) rates compare favorably with historical data for non-IVL strategies. Further large-scale, controlled studies with longer follow-up are needed to further validate its long-term safety and effectiveness.