Key result
Intravascular lithotripsy yields ~50% lower risk of stent underexpansion versus conventional lesion preparation.
Why the study?
Stent underexpansion in severely calcified coronary lesions increases target vessel failure risk, but OCT criteria for successful calcium modification are unclear.
Does OCT-guided lesion preparation with lithotripsy improve stent expansion and reduce underexpansion in patients with severely calcified coronary lesions compared to conventional preparation alone?
RCT (n=165)
Single-blind (blinded core laboratory)
Randomized
Yes
Does OCT-guided lesion preparation with lithotripsy improve stent expansion and reduce underexpansion in patients with severely calcified coronary lesions compared to conventional preparation alone?
Relative Risk: 0.5 (95% CI 0.27–0.91)
Absolute Event Rate: 18% vs 36%
p-value: p=0.01
In severely calcified coronary lesions, lithotripsy increases calcium fractures and improves stent expansion compared to conventional lesion preparation alone.
Supports lithotripsy for OCT-guided preparation of severely calcified lesions to optimize stent expansion; extends randomized BALI trial evidence.
BACKGROUND: Stent underexpansion in severely calcified coronary lesions increases the risk of target vessel failure. Intravascular imaging (IVI) is recommended to improve results, yet IVI criteria for successful calcium modification remain unclear. AIMS: To identify optical coherence tomography (OCT) predictors of stent underexpansion in severely calcified coronary lesions based on pre-stent OCT imaging. METHODS: In the BALI trial, patients with severely calcified lesions were randomized to OCT-guided lesion preparation with vs without lithotripsy. Pre-stent OCT pullbacks were analyzed for calcium morphology, stenosis, and fractures. These findings were correlated with stent underexpansion (stent area ≤ 80% of reference) on spatially matched post-procedure OCT pullbacks. RESULTS: (p = 0.1, p = 0.002, p = 0.01), respectively. Randomization to lithotripsy led to a higher frequency of fractures (OR 1.8, p = 0.004) and improved stent expansion at the site of maximal calcification (relative risk 0.50, p = 0.01). CONCLUSIONS: Luminal gain and multiple fractures in severely calcified lesions before stent implantation predict stent expansion. Lithotripsy increases the frequency of fractures and improves stent expansion compared to conventional preparation alone.
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Kristensen et al. (2026) conducted an RCT in Severely calcified coronary lesions (n=165). Lithotripsy vs. Conventional lesion preparation alone was evaluated on Minimal stent expansion ≤80% at the site of maximal calcification (RR 0.50, 95% CI 0.27 to 0.91, p=0.01). Lithotripsy during lesion preparation significantly increased calcium fractures and halved the risk of stent underexpansion at the site of maximal calcification compared to conventional preparation alone (RR 0.50).
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