Clinical safety and efficacy of a novel thin‐strut cobalt–chromium coronary stent system: Results of the real world Coroflex Blue Registry

Abstract

Objectives: The aim of this registry was to evaluate the clinical efficacy and safety of the Coroflex Blue cobalt-chromium stent in real-world practice. Background: The development of cobalt-chromium bare-metal stents (BMS) with thinner struts has lead to better deliverability and lower target-lesion revascularization rates compared with stainless steel BMS. Methods: The Coroflex Blue Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease attributable to single de novo or restenotic nonstented lesions of a single vessel amenable for percutaneous stenting. The primary end point was clinically driven target-lesion revascularisation (TLR) 6 months after enrolment, secondary endpoints were technical/procedural success, in-hospital outcome, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) after 6 months. Results: The registry included 2,315 patients (mean age 64.3 6 11.1 years, 19.8% diabetes, 37.3% acute myocardial infarction). Although a complex lesion cohort with 60.3% Typ B 2 /C-lesions, the technical success rate was 99.1% and the procedural success rate 98.5%. The incidence of TLR after 6 months was 5.5% and the cumulative 6-month acute/subacute stent thrombosis rate was 1.6%. After 6 months cumulative event-free survival was 90.8% in all patients and 87% in patients with acute PCI for acute myocardial infarction. Conclusions: This registry demonstrates the safety and efficacy of the Coroflex Blue cobalt-chromium stent platform in real-world practice. In the era of drug-eluting stents (DES), these results raise the serious question if the use of DES for primary prevention of restenosis and TLR is really justified. V C 2009 Wiley-Liss, Inc.

A Comparative Reliability and Performance Study of Different Stent Designs in Terms of Mechanical Properties: Foreshortening, Recoil, Radial Force, and Flexibility

“…Nevertheless, as efforts concentrated just on the development of drugs and coating materials in the early days of developing drug‐eluting stents, the old stent designs used in the 1990s are still applied in many cases . Recently, as it has been recognized that the platform of a coronary stent plays an important role in improvement of clinical outcomes, stent manufacturing companies have focused their efforts on development of new stent designs again .…”

Effect on Clinical Restenosis of an Ultra‐Thin‐Strut Bare Metal Cobalt‐Chromium Stent Versus a Thin‐Strut Stainless Steel Stent

“…The Coroflex Blue registry is the largest registry that has demonstrated the safety and efficacy of Coroflex Blue stent in the real world practice. In this study, exclusion criteria were cardiogenic shock, unprotected left main stenosis, arterial and venous graft lesions, and multi‐vessel or multi‐lesions PCI …”

“…Especially, in complex patients (diabetics, chronic renal failure) and in complex anatomic settings (bifurcations, unprotected left main stenosis), the risk of stent thrombosis rises to 3.3% . In the Coroflex registry, the rate of stent thrombosis was 1.6% at 6 months …”

“…Thinner strut cobalt‐chromium (Cro‐Co) BMS has advantages over stainless steel (SS) BMS in terms of significant reduction of neointimal formation, increased flexibility, and better deliverability without compromising radial strength or radio‐opacity. This has resulted in a significant reduction of neointimal formation and subsequent target‐lesion revascularization (TLR) compared with SS BMS . The aim of this study is to compare in real world practice a 65 μm Cro‐Co ultra‐thin strut stent versus an 80 μm SS thin‐strut stent in order to assess whether a reduced strut thickness is associated with less TLR.…”

Stent Coverage and Neointimal Proliferation in Bare Metal Stents Postdilated With a Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stents

“…14 After coronary angiography suitable lesions were 1:1 randomized in an alternating fashion to either the cobalt-chromium everolimus drug-eluting stent (DES) Xience V (DES; Abbott Vascular, IL) or the cobalt-chromium Coroflex Blue BMS postdilated with the DEB SeQuent Please (DEB, both BBraun Melsungen, Germany). 15,16 Angiographic Analysis and Invasive 6-Month Follow-up Quantitative coronary angiography was assessed offline by 2 independent observers (K.N. and S.O.…”