Drug-Coated Balloon (DCB) Use After Intravascular Lithotripsy (IVL) Evaluated in Multicenter Registry: Findings from Latest JACC Advances Study

In calcified coronary lesions, using drug-coated balloons (DCBs) after intravascular lithotripsy (IVL) demonstrated excellent efficacy and safety, achieving high technical success with low device-dependent adverse event rates, concluded a recent multicenter analysis. DCB demonstrated comparable procedural success to drug-eluting stents (DES).

The findings, published in JACC Advances, were drawn from the prospective BENELUX-IVL registry, offer strong real-world evidence to date that the “crack and drug” strategy may be a viable alternative to traditional stent implantation in carefully selected cases.

IVL has rapidly become a preferred method for modifying heavily calcified plaque by creating controlled fractures that enhance vessel compliance. However, what clinicians should use after plaque fracture—DES or a stent-free approach using DCB, has remained uncertain, especially in calcified territories where recoil, poor drug absorption, and complex anatomy pose challenges. The new analysis provides clarity by comparing 45 patients treated with DCB after IVL with 534 treated with DES, all within the same registry framework.

Baseline characteristics were broadly similar, though the DCB group had more complex lesions, including a higher prevalence of chronic total occlusions (17.8% vs 6.8%) and in-stent restenosis (60% vs 29.6%). Despite the greater complexity, procedural performance was nearly identical. IVL balloon crossing success was 100% in the DCB group and 98.3% in the DES group. Procedural success, defined as residual stenosis <30%, TIMI 3 flow, and no in-hospital major adverse cardiac events—was similarly high (89.4% vs 89.8%). No bailout stenting was required in the DCB arm, and intra procedural complications were low and comparable.

Imaging insights support these findings. Intravascular ultrasound and OCT—used in roughly half of patients in both groups—showed comparable pre-IVL stenosis severity and calcium morphology. Notably, persistent calcium fractures after treatment were more frequently seen in the DCB group (64% vs 42%), reinforcing the mechanical advantage provided by IVL that may facilitate more effective drug penetration from the DCB. Minimum lumen area post-procedure, although slightly smaller in the DCB cohort, did not differ significantly.

Clinical outcomes over 12 months were equally reassuring. Rates of major adverse cardiac events—including cardiac death, myocardial infarction, and target vessel revascularization (TVR)—were statistically similar between DCB and DES (11.1% vs 7.5%, P=0.38). Cardiac death (2.2% vs 2.4%) and MI (2.2% vs 1.9%) remained low in both groups, and no early safety concerns emerged during hospitalization. Kaplan-Meier survival curves in the study showed no significant difference in event-free survival between strategies.

The results are particularly relevant for lesions where stenting is undesirable or may interfere with future vessel remodeling. DCB therapy avoids leaving a permanent metallic scaffold and may be advantageous in lesions such as bifurcations, ostial lesions, and chronic total occlusions—settings where the study indeed saw higher DCB adoption. IVL’s calcium-fracturing effect appears to mitigate the traditional limitations of DCBs, namely lack of radial force and reduced drug uptake in calcified segments.

While the study offers encouraging evidence, the authors note key limitations, including the small size of the DCB cohort, observational design, and sub-optimal use of intracoronary imaging. Larger randomized trials will be needed to confirm long-term equivalence.

Still, the registry findings render potentially important real-world learnings. In balloon-crossable, calcified coronary lesions, a stent-free approach after IVL, “crack and drug”—is not only possible but performs on par with DES for technical success and 1-year safety. As calcium-modifying technologies and DCB platforms continue to evolve, this strategy may play a growing role in contemporary percutaneous coronary intervention.

Reference: Oliveri F, van Oort MJH, Phagu AAS, Al Amri I, Bingen BO, Paradies V, Mincione G, Claessen BEPM, Dimitriu-Leen AC, Kefer J, Girgis H, Vossenberg T, Mandurino-Mirizzi A, Van der Kley F, Jukema JW, Montero-Cabezas J. Drug-Coated Balloon After Intravascular Lithotripsy: Procedural and Clinical Outcome of the "Crack and Drug" Strategy. JACC Adv. 2025 Oct 23;4(11 Pt 1):102250. doi: 10.1016/j.jacadv.2025.102250. Epub ahead of print. PMID: 41135381; PMCID: PMC12593658.