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