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The Svelte Integrated Delivery System (IDS) is a novel drug-eluting stent-on-a-wire consisting of a low-compliant balloon affixed to a 0.014” integrated steerable wire with shapeable tip. The Svelte IDS is low-profile and specifically designed for use with the transradial approach, ‘slender’ PCI and direct stenting. It is indicated for use with small-calibre diagnostic and guiding catheters (ID > 0.047”). The DIRECT I First-In-Man study reports 2.7% stent volume obstruction (IVUS) at 6 months and 0% clinically-driven MACE through 4 years.
159 patients with symptomatic ischemic heart disease, coronary arteries with RVD 2.5mm – 3.5mm and lesion length < 20 mm were prospectively randomized (2:1 Svelte IDS:Medtronic Resolute Integrity). Clinical and angiographic follow-up was scheduled at 6-months, with clinical follow-up continuing through 5 years. All events and imaging were reviewed and adjudicated by an independent core lab, CEC and DSMB.
Patients with RVD 2.68 ± 0.47 mm and 2.74 ± 0.53 mm and lesion length of 13.4 ± 5.7 mm and 13.7 ± 6.4 mm were treated in the Svelte IDS and Resolute Integrity arms, respectively. Direct stenting was performed > 90% in each arm, with the transradial approach employed in 67% of patients. At 6 months, in-stent LL was 0.09 ± 0.31 mm with the Svelte IDS compared to 0.13 ± 0.27 with Resolute Integrity (p<0.001 for non-inferiority). 6-month and 2-year TVF rates were similar (4.6% vs. 7.8%; p=0.469 at 6 months and 6.5% vs. 9.8%; p=0.524 at 2 years) in the Svelte IDS and Resolute Integrity arms, respectively, with no increase in either arm observed between 1 and 2 years. No patients experienced stent thrombosis through 2 years. Subset analysis deomonstrated reduced procedure times with the Svelte IDS, with 22 minutes (n=23) and 31 minutes (n=26) reported in the Svelte IDS and Resolute Integrity arms, respectively (p=0.039). In addition, device times were 4 minutes in the Svelte IDS group vs. 11 minutes in the Resolute Integrity group (p=.005).
DIRECT II demonstrated non-inferiority of the Svelte IDS to the Resolute Integrity DES with respect to in-stent late loss at 6 months and target vessel failure at 2-year follow-up. No clinical evidence of catch-up presented betwen 1 and 2 years. Procedure and device times were reduced, with trends toward reduction in fluoroscopy time and contrast use. A larger, randomized, controlled study in the US and Japan is planned to further validate these angiographic, clinical and procedural efficiency findings.
CORONARY: Stents: Drug-Eluting