Purpose: To evaluate the safety and efficacy of the Svelte Acrobat integrated delivery system (IDS) via radial approach with 5 Fr catheters. The direct stenting (DS) system enables easy delivery, deployment, and postdilatation of a cobalt-chromium stent.
Methods: Patients with coronary artery disease (CAD) were prospectively enrolled at three centers to undergo percutaneous coronary intervention with DS via radial approach using 5 Fr catheters. The primary endpoint was IDS success, which was defined as DS without postdilatation and final stenosis <20% with Thrombolysis in Myocardial Infarction (TIMI)-3 flow.
Results: Fifty consecutive patients with 55 lesions were included. The procedure success rate was 98%. The device could not cross the lesion in 2 cases, so DS success was 96%. Fifty lesions met the primary study objective; thus, IDS success rate was 91%. The procedure duration was 21 ± 9 minutes, fluoroscopy time was 7.3 ± 4.7 minutes, and contrast volume per vessel was 103 ± 33 cm3. The final residual stenosis, by quantitative coronary angiography, was 3.4 ± 4%. The reduced need for additional catheters resulted in a 20% procedural cost reduction. There were no bleeding or vascular complications. At 8 months, the event-free survival rate was 84%.
Conclusions: DS using the Svelte Acrobat IDS via radial approach with low-profile catheters is safe and efficacious in select coronary artery disease patients, and its use is associated with potential procedural cost savings.