Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5 |
||
Intravascular Lithotripsy improves angiographic results in patients with calcified coronary artery stenoses compared to debulking balloon angioplasty –an observational registry | ||
J. Leick1, T. Rheude2, M. Denne1, S. Cassese2, A. Kastrati2, A. Berkowitsch1, F. Hauptmann1, T. Gehrig1, M. Lauterbach1, N. Werner1 | ||
1Innere Medizin III, Krankenhaus der Barmherzigen Brüder Trier, Trier; 2Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München; | ||
Backround: Coronary calcification complicates stent deployment and is associated with unfavorable outcomes. Debulking angioplasty (DBA) using a cutting or scoring balloon is commonly used for plaque modification. Intravascular lithotripsy (IVL) is a new technology for lesion preparation. This is the first study to compare debulking angioplasty with IVL.
Methods: In this prospective two-center registry study, all patients with moderate to severe calcified coronary lesions, which were treated by DBA or IVL were consecutively included between November 2019 and September 2021 (n=178). Primary endpoint was strategy success (<20% residual stenosis after stent implantation or drug eluting balloon application). Secondary endpoint was in-hospital, 30-day, and 6 months safety outcomes (MACE: myocardial infarction, target vessel revascularization (TVR), cardiac death). Quantitative coronary angiography was performed to determine the degree of residual stenosis.
Results: A total of n=94 patients were treated by DBA and n=84 patients by IVL. Patients in the IVL group had significantly higher-grade stenoses compared to the DBA group (IVL 90% (interquartile range (IQR) 90-95%) vs. DBA 80% (IQR 80-90%); P=0.042). Severe calcification was more frequently seen in the IVL group compared to the DBA group (IVL 76.60% vs. DBA 31.91%; P=0.001). Procedural time was longer in the IVL group compared to the DBA group (IVL 70 min (IQR 59-88min) vs. 57 min (IQR 41-72 min); P=0.024). The primary endpoint was reached in 153 patients (85.96%). Patients in the DBA group had significantly more residual stenosis compared to the IVL group (DBA 22.34%, IVL 4.76%; P=0.001). In the in-stent restenosis subgroup (ISR; n=116), 83 (71.55%) patients were treated with DBA (ISR-DBA) and 33 (28.45%) patients with IVL (ISR-IVL). The primary endpoint was reached in 99 patients (85.34%) in the ISR subgroup. Failure of strategy success was seen exclusively in patients treated with DBA (ISR-DBA 20.48% vs. ISR-IVL 0.0%; P=0.003). Secondary endpoint analyses revealed no differences in in-hospital and 30 days MACE rate between the groups (0% DBA vs. 1.19% IVL, P=0.289; 3.19% DBA vs. 4.76% IVL, P=0.590, respectively). Analysis for 6 months MACE rate is available in 03/2022.
Conclusion: Lesion preparation with intravascular lithotripsy results in a significant lower rate of residual stenosis in patients with calcified coronary stenoses compared to debulking balloon angioplasty. |
||
https://dgk.org/kongress_programme/jt2022/aV138.html |