Preliminary experience with the V-Flex Plus coronary stent: Immediate and one-month clinical outcome

Abstract

Procedural and 1‐month outcome data following implantation of the V‐Flex Plus stent in our first 54 consecutive patients (35 male; mean age, 62 years) are described. Sixty‐four stents were implanted for 60 mainly complex lesions; 48% were left anterior descending; 20%, circumflex; 27%, right coronary artery; and 5%, saphenous vein graft. The indication for stenting was elective in half of the patients and for a suboptimal result or as a bailout procedure in the other half. The stents were deployed at a mean of 12 atm (range, 6–18) and postdilated to a mean of 15 atm (range, 8–20). Pre‐ and postdilatation balloon sizes were 2.96 ± 0.57 mm and 3.16 ± 0.34 mm, respectively. The procedural success rate was 98%. There were no deaths or Q‐wave myocardial infarctions. One patient suffered a non–Q‐wave myocardial infarction and another developed a femoral false aneurysm. At 1‐month follow‐up, there were no additional events, in particular no revascularization procedures. Eighty‐nine percent of patients were free of angina. Implantation of the V‐Flex Plus stent is safe and effective with an excellent early success rate comparable to that of published randomized trials and registries of carefully selected patients. Cathet. Cardiovasc. Intervent. 47:504–508, 1999. © 1999 Wiley‐Liss, Inc.

Polymer-Free Drug-Eluting Stents: An Overview of Coating Strategies and Comparison with Polymer-Coated Drug-Eluting Stents

“…It is a polished polymer-free metal stent with paclitaxel (2.7 μg/mm 2 ) coated on the adluminal exterior. , The V-Flex plus stent showed initial clinical success in a pilot trial. However, late studies showed it to be inferior to polymer-based stents in preventing restenosis and cardiac events, which may be due to significant drug loss during the stent delivery and rapid release of the remaining drug, thus leading to attenuated effectiveness of the stent in suppression of neointimal formation. ,, The Supra-G and Achieve stents are similar to the V-Flex design and were also developed by Cook Inc. The Supra-G stent was shown to be safe and effective in a clinical trial addressing de novo coronary lesions, but the Achieve stent did not sufficiently decrease restenosis and revascularization compared to a bare metal stent. , …”

“…However, late studies showed it to be inferior to polymer-based stents in preventing restenosis and cardiac events, which may be due to significant drug loss during the stent delivery and rapid release of the remaining drug, thus leading to attenuated effectiveness of the stent in suppression of neointimal formation. 18,55,65 The Supra-G and Achieve stents are similar to the V-Flex design and were also developed by Cook Inc. The Supra-G stent was shown to be safe and effective in a clinical trial addressing de novo coronary lesions, but the Achieve stent did not sufficiently decrease restenosis and revascularization compared to a bare metal stent.…”