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Scientific Paper under Submission, May 2007
 Exciting Results with Skylor Co-Cr Stent Clinical Evaluation
Pricipal Investigator: Dr. J.J. Koolen
Catharina Hospital, Eindhoven, The Netherlands
LEONARDO Registry
Background: Drug Eluting Stent (DES) decreases angiographic and clinical restenosis compared to Bare Metal Stents (BMS) but don't reduce the rate of myocardial infarction and cardiac death. The benefit of DES has been demonstrated mainly in comparison to old fashioned BMS and in selected subsets of patients. Accordingly, a remarkable portion of patients with coronary artery disease may nowadays benefit from new generation BMS.
Methods: A new closed cell, thin strut Cobalt Chromium stent* was used in a prospective single center registry. Between August 2005 and June 2006, consecutive patients with stable or unstable coronary artery disease candidate for Percutaneous Coronary Interventions (PCI) with BMS were enrolled. Patients were considered eligible for non-DES stenting if they had and Acute Myocardial Infarction (AMI) or if they had coronary lesions at low-medium risk of restenosis (large vessels, no long lesions, no complex lesions). Pre-PCI and Post-PCI quantitative coronary angiography (QCA) was performed off line. Clinical outcome up to 6-month was prospectively assessed.
Results: 150 patients were successfully treated with the investigational BMS during the study period. Mean reference vessel diameter was 3.05 mm (±0.31 SD). Mean lesion length was 15.19 mm(± 6.49 SD). The rate of diabetic patients was 5.33% and the rate of patients with AMI was 22.00%. All patients underwent 6-month clinical follow up. Hierarchial count showed MACE (Major Adverse Cardiac Events) rate at 6 months of 4.00%: there were 2 (1.33%) cardiac deaths, 1 (0.67%) AMI and 3 (2.00%) clinically driven target lesion revascularization (TLR).
Conclusions: Selective adoption of latest generation bare metal Co-Cr stents in fairly un-complex angiographic setting results in very low MACE and TLR rate. The benefit of DES in such real world daily cases may not be cost effective neither beneficial.
Further studies are needed to support this statement.
*SKYLOR™ (Invatec, Roncadelle – Italy)
From Invatec.com |
