LEONARDO - Clinical Evaluation of a Last Generation Coronary Stent in a Real World Typical Non-DES Population - A Prospective, Single-centre Registry

LEONARDO - Clinical Evaluation of a Last Generation Coronary Stent in a Real World Typical Non-DES Population - A Prospective, Single-centre Registry

Maria Rosaria De Vita
Internventional Cardiology 2007
Published: October 2007
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While rates of restenosis and major adverse cardiac events (MACEs) have both been demonstrated to be significantly reduced with the use of drugeluting stents (DES) compared with bare-metal stents (BMS) in a broad variety of trials,1-6 the same trials could not demonstrate any difference in mortality or acute myocardial infarction (AMI) rates. Therefore, the reported clinical benefit of DES is entirely due to the highly significant reduction in the need for repeated interventions; however, concerns about late events associated with DES have recently come to light, suggesting that the indiscriminate use of DES is actually not advisable.7-9 Moreover, subgroup analysis of such large randomised trials revealed no substantial advantage of using DES over BMS in terms of clinical outcome for short lesions and relatively large vessels (≥3.0mm).10

Finally, in the majority of the randomised DES trials the BMS used were not the most up-to-date in terms of stent design and technology; in other studies involving last-generation BMS, lower revascularisation rates were found - approximately 7-10%.11 From the above-mentioned concepts, we hypothesised that selective use of last-generation BMS may provide satisfactory clinical results. To test this hypothesis, we designed the LEONARDO registry - clinical evaluation of a last generation coronary stent in a Real world typical non-drug-eluting stent population - using the new Skylor™ stent (Invatec, Roncadelle, Italy; see Figure 1) in patients considered at low risk of target vessel revascularisation (TVR).


Figure 1: Skylor™ 3.0x16mm Stent
skylor stent



Methods
The aim of this prospective, non-randomised, single-centre study was to evaluate the safety and efficacy of the Skylor stent in patients with stable and unstable coronary artery disease (CAD). The Skylor is a balloonexpandable cobalt-chromium (Co-Cr) stent characterised by a closed cell and thin struts pre-mounted on a rapid-exchange-type balloon catheter. Skylor’s closed-cell platform is based on a uniform interconnection of monotype cells, differentiated into three families based on vessel diameters: SV (small vessels, 2.0-2.5mm), MV (medium vessels, 2.75-3.5mm) and LV (large vessels, 4.0-5.0mm). Each family features a distinct number of circumferential cells (three, four and five for SV, MV and LV, respectively) and strut thickness (70, 80 and 95μm for SV, MV and LV, respectively); this allows the stents to adapt to different vessel-size-dependent requirements. The metal-to-artery ratio has been deliberately kept on the low side for SV (12.5%) compared with MV and LV (14-15%) in order to limit metal concentration in the highly sensitive small vessels. In particular, it was the closed-cell design of the Skylor stent with its thin struts, flexibility and low profile that led us to select this stent for this non-DES clinical evaluation.

The decision to use the Skylor stent was based mainly on the clinical and angiographic baseline characteristics and risk factors of patients: the Skylor was implanted in all patients in whom DES was either contraindicated or judged not to match the requirements for optimal DES patient benefit according to commonly known and widespread criteria - i.e. large vessels, no long lesions and no complex lesions. This decision-making process is well-established in our clinical routine, and the final decision is left at the discretion of our operators.

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