Abstract
BACKGROUND: Severe coronary calcification complicates percutaneous coronary intervention by limiting lesion compliance and impairing stent expansion.
OBJECTIVES: To evaluate the safety and effectiveness of the SonicForce Coronary Intravascular Lithotripsy System (Abbott Vascular) in severely calcified de novo coronary lesions.
METHODS: TECTONIC CAD intravascular lithotripsy investigational device exemption (NCT06885177) was a prospective, multicenter, single-arm study of 335 patients at 40 U.S.
CENTERS: The primary safety endpoint was 30-day target lesion failure, defined as cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization. The primary effectiveness endpoint was procedural success. Each endpoint was tested against a prespecified performance goal. A prespecified optical coherence tomography (OCT) substudy evaluated calcium modification and stent expansion.
RESULTS: A total of 335 patients were included in the full analysis set, with 330 and 334 as the evaluable populations for the primary safety and primary effectiveness endpoints, respectively, and a median follow-up duration of 36 days (Q1-Q3: 28-37 days). Thirty-day target lesion failure was 0.3% (1 of 330; exact 2-sided 95% CI: 0.0%-1.7%); the upper 1-sided 97.5% confidence bound was 1.7%, below the 12.9% performance goal (P < 0.0001). Procedural success was 97.0% (324 of 334; exact 2-sided 95% CI: 94.6%-98.6%); the lower 1-sided 97.5% confidence bound was 94.6%, above the 87.1% performance goal (P < 0.0001). In the OCT substudy, mean calcium length was 22.2 ± 10.3 mm, and the maximum contiguous calcium site had a calcium arc of 247.3 ± 99.0° and a thickness of 0.90 ± 0.25 mm at baseline. At this site, final stent area was 7.1 ± 1.9 mm2, with stent expansion of 95.9% ± 18.6%. Calcium fracture was identified in 62.5% (50 of 80) of lesions after intravascular lithotripsy and 66.3% (53 of 80) after stenting.
CONCLUSIONS: TECTONIC CAD met both prespecified coprimary safety and effectiveness endpoints, demonstrating low 30-day target lesion failure and high procedural success. OCT demonstrated calcium fracture and favorable stent expansion at maximum contiguous calcium.
