Clinical safety and efficacy of a novel thin-strut cobalt-chromium coronary stent system: results of the real world Coroflex Blue Registry.

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 +/- 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.