All study endpoints met in DIRECT II


Svelte Medical Systems has reported that its drug-eluting coronary stent integrated delivery system (IDS), which is a new approach to percutaneous coronary intervention (PCI), met all DIRECT II study six-month angiographic and clinical endpoints. The system also exhibited reduced procedure and device times, with trends toward reduced fluoroscopy time and contrast use.

A press release reports that DIRECT II is a prospective, randomised, multicentre clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent IDS and the Medtronic Resolute Integrity drug-eluting coronary stent in 159 patients undertaken in support of CE-mark certification of the Svelte system. Non-inferiority to Resolute Integrity in the primary efficacy endpoint of in-stent late lumen loss at six-months was established (0.09±0.31mm with Svelte IDS vs. 0.13±0.27mm with Resolute Integrity, p-value for non-inferiority <0.0001). Clinical outcomes were similarly positive, with six-month target lesion revascularisation, target lesion failure, target vessel failure, myocardial infarction and major adverse cardiac event (MACE) rates in the Svelte IDS arm half those observed in the Resolute Integrity arm. Six-month target lesion revascularisation with the Svelte IDS was 0.9%, affirming results seen in the DIRECT First-In-Man study in which 0% target lesion revascularisation and MACE are now sustained through 28-months.

“The results of the DIRECT II study confirm the safety and effectiveness of this interesting new concept for coronary artery stenting,” said Stefan Verheye, and co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp. “The Svelte IDS can be delivered through smaller catheters and facilitates radial artery access, two increasingly important approaches to PCI demonstrating improved procedural outcomes and greater patient comfort.”

The press release states that the Svelte IDS represents the first change in coronary stent delivery since the advent of the rapid-exchange catheter. Using an integrated wire design which provides the lowest crimped stent profile on the market, the IDS is designed to optimise transradial interventions and a “slender” approach to PCI by downsizing catheter sizes used during intervention.