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Intravascular Lithotripsy to Treat Severely Calcified Coronary Lesions
Quick Takes
- This study reports that intravascular lithotripsy (IVL) safely and effectively facilitates stent delivery and optimizes stent expansion in patients with severely calcified coronary lesions.
- Given the reassuring results of Disrupt CAD III along with the ease of use of this technology, IVL is likely to be rapidly adopted and may become preferred first-line therapy for severely calcified lesions prior to DES implantation.
- There is a need for studies with more complex patient and angiographic lesion subsets and to delineate the relationships between calcium fracture, stent expansion, and long-term hard clinical outcomes.
Study Questions:
What is the safety and effectiveness of intravascular lithotripsy (IVL) in severely calcified de novo coronary lesions?
Methods:
The investigators conducted the Disrupt CAD III (ClinicalTrials.gov number, NCT03595176), a prospective, single-arm multicenter study designed for regulatory approval of coronary IVL. The primary safety endpoint was freedom from major adverse cardiovascular events (MACE: cardiac death, myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared to a prespecified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) substudy. Primary analysis was performed on the intent-to-treat population consisting of all enrolled patients regardless of treatment, excluding roll-in patients.
Results:
Patients (n = 431) were enrolled at 47 sites in four countries. The primary safety endpoint of the 30-day freedom from MACE was 92.2%; the lower bound of the 95% confidence interval (CI) was 89.5%, which exceeded the PG of 84.4% (p < 0.0001). The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% CI was 90.2%, which exceeded the PG of 83.4% (p < 0.0001). Mean calcified segment length was 47.9 ± 18.8 mm, calcium angle was 292.5 ± 76.5°, and calcium thickness was 0.96 ± 0.25 mm at the site of maximum calcification. OCT demonstrated multi-plane and longitudinal calcium fractures after IVL in 67.4% of lesions. Minimum stent area was 6.5 ± 2.1 mm2 and was similar regardless of demonstrable fractures on OCT.
Conclusions:
The authors concluded that coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions.
Perspective:
This study reports that intravascular lithotripsy safely and effectively facilitates stent delivery and optimizes stent expansion in patients with severely calcified coronary lesions. Longer-term clinical follow-up is required to determine the durability of clinical benefit associated with IVL optimized stent implantation. Given the reassuring results of Disrupt CAD III, along with the ease of use of this technology, IVL is likely to be rapidly adopted and may become preferred first-line therapy for severely calcified lesions prior to drug-eluting stent (DES) implantation. Finally, to increase generalizability of this technique, there is a need for studies with more complex patient and angiographic lesion subsets and to further delineate the relationships between calcium fracture, stent expansion, and long-term hard clinical outcomes.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Atherosclerotic Disease (CAD/PAD), Cardiac Surgery and Arrhythmias, Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: Calcinosis, Coronary Angiography, Coronary Artery Disease, Drug-Eluting Stents, Lithotripsy, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Secondary Prevention, Stents, Tomography, Optical Coherence, Vascular Calcification
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