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Sciahbasi et al. Vessel Plus 2023;7:19 https://dx.doi.org/10.20517/2574-1209.2023.22 Page 5 of 12

Table 1. Characteristics of the DISRUPT CAD studies
Disrupt I Disrupt II Disrupt III Disrupt IV
Year of publishing 2019 2019 2020 2021
N sites 7 15 47 8
Patients 60 120 384 64
Age (years) 72 (66-79)* 72 ± 10 71 ± 9 75 ± 8
Male sex 80 (48) 78 (94) 77 (294) 75 (48)
Hyperlipidaemia 80 (48) 72 (86) 89 (342) 86 (55)
Hypertension 80 (48) 80 (96) 89 (342) 83 (53)
Diabetes mellitus 30 (18) 32 (38) 40 (154) 48 (31)
Renal insufficiency 10 (6) 8 (10) 26 (101) 23 (15)
Lesion length 18 (14-25)* 20 ± 10 26 ± 12 28 ± 10
Diameter stenosis 73 (59-77)* 60 ± 12 65 ± 11 66 ± 11
Procedural success 95 (57) 113 (94) 92 (354) 94 (60)
Follow-up duration (days) 180 30 30 30
MACE at follow-up 2 (5) 8 (4) 8 (30) 6 (4)
TVR 0 1 (1) 2 (6) 0
Angiographic complications 0 2 (2) 1 (2) 0

Results are expressed as mean ± standard deviation or percentage with absolute numbers in brackets. *Median with interquartile range; MACE:
Major adverse cardiac event; TVR: target vessel revascularization; NA: not available.

Many exclusion criteria (acute myocardial infarction within 30 days, renal failure, left ventricular ejection
fraction < 40%, unprotected left main, and chronic total occlusion) limit the applicability of the results of
DISRUPT-CAD studies.

Data from real-world populations came from different studies, most of which were multicentre, both
prospective [28-32] and retrospective [33-36] , enrolling all consecutive IVL PCI, often without clinical or
angiographic exclusion criteria [Table 2]. Other minor studies have analysed the efficacy and safety of IVL
in special populations, reported later in the text. The retrospective design of some studies and the small
number of patients enrolled in the prospective ones with a single-arm protocol sometimes limit their value.
Globally, the reported procedural success and major adverse cardiovascular events (MACE) are similar
compared to the DISRUPT CAD studies, confirming the feasibility of the IVL even in the context of more
complex patients and procedures.

Additional randomized clinical trials (Clinical Trials.gov ID NCT04960319, NCT04253171, NCT04428177)
and multicentre observational registries (NCT05016726, NCT05828186, NCT04698902) are currently
underway that may provide more robust data on the efficacy of IVL PCI in the real world and its advantages
compared with other debulking methods.

It is surprising that a cost-effectiveness analysis is lacking in most of the trials conducted by now. A good
cost-effectiveness analysis should not include just the cost of the device but also the cost of any eventual re-
intervention necessary for target lesion failure after S-IVL or the cost of other complementary techniques
for treating severe calcification. Furthermore, the cost of any complications, duration of hospitalization, and
impact on mortality should be taken into account. Comparing the costs of single devices, the cheapest are
NC balloons, followed by cutting and scoring balloons, which cost 20 times more. The cost of atherectomy
devices is higher than balloons but cheaper than IVL devices. Anyway, evaluating the cost of the whole IVL-
PCI, we agree with Kassimis et al. that lithotripsy device may be more cost-effective than other treatments
of severe calcified stenosis as the need for additional devices is reduced, the rate of complications is lower,