TECTONIC CAD: Pivotal IDE Evaluation of Coronary Intravascular Lithotripsy for Severely Calcified Lesions
Authors' conclusion
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.
Study context
- Population
- Patients with severely calcified de novo coronary lesionsfull analysis set · evaluable population, primary safety endpoint 330 · evaluable population, primary effectiveness endpoint 334
- Participants
- 335 patients
- Exposure
- Each endpoint was tested against a prespecified performance goal
- SonicForce Coronary Intravascular Lithotripsy Systemn = 335
- Outcome
- Coprimary endpoints: 30-day target lesion failure (primary safety; cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization) and procedural success (primary effectiveness)
Methodological detailsinvestigational device exemption, 40 U.S. centers, prespecified optical coherence tomography (OCT) substudy
- Investigational device exemption
- 40 U.S. centers
- Prespecified optical coherence tomography (OCT) substudy
Main finding
As reported in the abstract
Upper 1-sided 97.5% confidence bound
1.7%
P < 0.0001
30-day target lesion failure vs 12.9% performance goal · below the 12.9% performance goal
Lower 1-sided 97.5% confidence bound
94.6%
P < 0.0001
Procedural success vs 87.1% performance goal · above the 87.1% performance goal
- Thirty-day target lesion failure
- 0.3% (1 of 330; exact 2-sided 95% CI: 0.0%-1.7%)
- Procedural success
- 97.0% (324 of 334; exact 2-sided 95% CI: 94.6%-98.6%)
Observational data: associations, not effects.
Further findings
Follow-up
- Median follow-up duration
- 36 days (Q1-Q3: 28-37 days)
Baseline calcium (OCT substudy)
- Mean calcium length
- 22.2 ± 10.3 mm
- Calcium arc at the maximum contiguous calcium site
- 247.3 ± 99.0°
- Thickness at the maximum contiguous calcium site
- 0.90 ± 0.25 mm
Stent results at the maximum contiguous calcium site (OCT substudy)
- Final stent area
- 7.1 ± 1.9 mm²
- Stent expansion
- 95.9% ± 18.6%
Calcium fracture (OCT substudy)
- Lesions after intravascular lithotripsy
- 62.5% (50 of 80)
- Lesions after stenting
- 66.3% (53 of 80)
Original publication
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