Key result
Stent-less PCI using IVL plus DCB yields an 8.9% target lesion failure rate at one year.
Why the study?
Does stent-less PCI with intravascular lithotripsy followed by drug-coated balloon provide safe and effective outcomes in patients with severely calcified de novo coronary lesions?
Observational (n=45)
No
Does stent-less PCI with intravascular lithotripsy followed by drug-coated balloon provide safe and effective outcomes in patients with severely calcified de novo coronary lesions?
Stent-less PCI using intravascular lithotripsy followed by a drug-coated balloon is a feasible strategy for severely calcified de novo coronary lesions, with low rates of target lesion failure.
Abstract [Background] Intravascular lithotripsy (IVL) followed by drug-eluting stent (DES) implantation has been proven to be a safe and effective strategy for severely calcified lesions. However, achieving optimal lesion preparation with IVL in stent-less percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) for severely calcified lesions may be challenging because IVL can not remove calcified plaque. [Purpose] The purpose of this study was to evaluate the safety and the efficacy of DCB after IVL for the treatment of severely calcified lesions. [Methods] This retrospective, single-center study included 45 patients who underwent stent-less PCI with IVL and DCB for severely calcified de novo coronary lesions between July 2022 and May 2024. All lesions were treated with DCB as the final device. Target lesion failure (TLF) was defined as a composite of culprit lesion-related cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR), and its incidence and associated factors were assessed. [Results] In a total 45 patients, the median age was 74 (interquartile range [IQR], 65–81) years, and 73.3% were male. Most patients (N=37, 82.2%) presented with chronic coronary syndrome and 15.6% of patients had end-stage renal failure requiring hemodialysis. All PCI procedures were performed under intravascular imaging guidance (optical coherence tomography [OCT]; 40, intravascular ultrasound [IVUS]; 5). Despite a calcium score of ≥3 on OCT or IVUS in all lesions, calcium fractures were observed in 84.4% of patients. No periprocedural complications or bail-out stent deployments were observed in this study. At the median follow-up period of 392 (IQR, 206−503) days, TLF events occurred in 4 patients (8.9%); non-fatal myocardial infarction in 1 patient, and TLR in 3 patients. Compared with non-TLF, TLF was associated with hemodialysis (50.0% vs. 12.2%, P=0.11) and more severely calcified lesions (calcium angle: 326 [IQR, 321−332] degrees vs. 268 [IQR, 198−309] degrees, P=0.07, calcium length: 18.2 [IQR, 13.0−24.0] mm vs. 8.2 [IQR, 5.2−13.6] mm, P=0.02). Additionally, more calcified nodules were observed in patients with TLF than those without TLF (50.0% vs. 19.5%, P=0.21). On univariable Cox proportional hazards regression analysis, hemodialysis (hazard ratio [HR], 6.06; 95% confidence interval [CI], 0.85−43.28, P=0.07), larger calcium angle (HR, 1.02; 95% CI, 0.99−1.04, P=0.10), and longer calcium length (HR, 1.15; 95% CI, 1.00−1.33, P=0.05) were associated with TLF. [Conclusions] DCB following IVL strategy was feasible for severely calcified de novo coronary lesions.
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Misawa et al. (2025) conducted an observational in Severely calcified de novo coronary lesions (n=45). Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) was evaluated on Target lesion failure (composite of culprit lesion-related cardiac death, non-fatal myocardial infarction, and target lesion revascularization). Stent-less percutaneous coronary intervention using intravascular lithotripsy followed by a drug-coated balloon resulted in an 8.9% rate of target lesion failure at a median follow-up of 392 days.
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