AUTHOR=Leick Jürgen , Rheude Tobias , Denne Michael , Cassese Salvatore , Kastrati Adnan , Hauptmann Felix , Gehrig Thomas , Kuna Constantin , Lindner Michael , Lauterbach Michael , Werner Nikos 

TITLE=Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=10

YEAR=2023

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1185422

DOI=10.3389/fcvm.2023.1185422

ISSN=2297-055X

ABSTRACT=<sec><title>Background</title><p>The aim of this two-center, all-comers registry was to compare the effectiveness and safety of intravascular lithotripsy (IVL) to that of modified balloon angioplasty (MB). MB angioplasty using a cutting or scoring balloon is commonly used in patients with calcified coronary arteries. IVL is a new technology for lesion preparation. This is the first study to compare MB with IVL.</p></sec><sec><title>Methods</title><p>The cohort included all patients treated by MB angioplasty or IVL between 2019 and 2021. The primary endpoint was strategy success (&lt;20% residual stenosis). The secondary endpoint was long-term safety outcomes [cardiac death, acute myocardial infarction (AMI), target lesion failure/revascularization (TVR)]. Quantitative coronary angiography (QCA) was performed in all patients. Primary and secondary endpoints were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation.</p></sec><sec><title>Results</title><p>A total of <italic>n</italic> = 86 patients were treated by IVL and <italic>n</italic> = 92 patients by MB angioplasty. The primary endpoint was reached in 152 patients (85.4%). Patients in the IVL group had less residual stenosis (5.8% vs. 22.8%; <italic>p</italic> = 0.001) in QCA. Weighted multivariable regression analysis revealed that IVL had a significant positive effect on reaching the primary endpoint of strategy success [odds ratio (OR) 24.58; 95% confidence interval (95% CI) 7.40–101.86; <italic>p</italic> = 0.001]. In addition, severe calcification was shown to result in a lower probability of achieving the primary endpoint (OR 0.08; 95% CI 0.02–0.24; <italic>p</italic> = 0.001). During the follow-up period (450 days) there was no difference in cardiovascular mortality rate [IVL (<italic>n</italic> = 5) 2.8% vs. MB (<italic>n</italic> = 3) 1.7%; <italic>p</italic> = 0.129]. Patients with unstable angina at the time of the index procedure had the highest probability of cardiovascular death [hazard ratio (HR) 7.136; 95% CI 1.248–40.802; <italic>p</italic> = 0.027]. No differences were found in long-term rates of AMI (IVL 1.7% vs. MB 2.8%; <italic>p</italic> = 0.399; IVL HR 2.73; 95% CI 0.4–17.0; <italic>p</italic> = 0.281) or TVR (IVL 5.6% vs. MB 9%; <italic>p</italic> = 0.186; IVL HR 0.78; 95% CI 0.277–2.166; <italic>p</italic> = 0.626).</p></sec><sec><title>Conclusion</title><p>IVL leads to a significantly better angiographic intervention outcome compared to MB angioplasty in our cohort. During long-term follow-up, no differences in cardiovascular mortality, rate of acute myocardial infarction, or target lesion failure/revascularization were observed.</p></sec>