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German Cypher Registry - German Cypher Registry
Description:
The goal of the study was: 1) to disclose unexpected events associated with sirolimus-eluting stent use, 2) to monitor indications for use of sirolimus-eluting stents, and 3) to collect cost-effectiveness data on use of sirolimus-eluting stents.
Study Design
Patients Enrolled: 5,878
Mean Follow Up: Six months
Mean Patient Age: Mean age 63.8 years
Female: 25
Drug/Procedures Used:
The registry was designed to collect information on use, costs, and outcomes of drug-eluting stents in Germany. Participation included 115 sites in Germany that were using drug-eluting stents, but not all sites in Germany participated in the registry. Registry data included baseline and procedural characteristics, costs, and outcomes through six months.
Principal Findings:
Data included information on 5,878 patients with 6,589 lesions and 7,382 stents placed. Indication for stent placement was stable angina in 44.3%, unstable angina in 19.6%, ST elevation myocardial infarction (MI) in 9.1%, non-ST elevation MI in 9.4%, and cardiogenic shock in 1.8%. The majority of patients had hypertension (80.0%) and hyperlipidemia (87.0%), while 28.8% had diabetes and 38.8% had a prior MI. Additionally, 56.1% of patients had had a prior PCI and 19.9% a prior coronary artery bypass graft (CABG). Stents were placed in native vessels in a large majority of patients (95.3%), with 75.9% in de novo lesions and 20.6% in lesions with in-stent restenosis. One-third of patients had a diameter ≤2.5 mm and length ≥30 mm.
At hospital discharge, subacute thrombosis had occurred in 11 patients (0.2%). By six months, the rate of mortality was 0.8%, MI 1.3%, repeat percutaneous coronary intervention (PCI) 12.1%, and CABG 1.5%. Minor bleeds were reported in 22.3% of patients, but only 0.5% had major bleeds.
Outcomes at six months were compared in the subgroup of diabetics versus nondiabetics and de novo lesions versus in-stent restenosis lesions. There was no difference between diabetics and nondiabetics in death (1.1% vs. 0.7%), MI (1.8% vs. 1.0%), repeat PCI (11.6% vs. 12.3%), or CABG (1.8% vs. 1.4%), but angina class at six months was slightly worse in the diabetic cohort versus the nondiabetic cohort (class I, 70.1% vs. 74.6%, p<0.001). Likewise, there was no difference between de novo and in-stent restenosis in death (0.8% vs. 0.9%), MI (1.2% vs. 1.6%), repeat PCI (12.4% vs. 11.3%), or CABG (1.5% vs. 1.5%), but angina class at six months was slightly worse in the in-stent restenosis cohort versus the de novo lesion cohort (class I, 68.6% vs .75.4%, p<0.001).
Death or MI at six months occurred in 3.4% of patients with an acute coronary syndrome, 2.9% with diabetes, 2.5% with in-stent restenosis, and 5.3% in patients with vein-graft treated lesions. In the 1,345 patients with angiography performed at six months, 11% had evidence of restenosis >50% while 89% had restenosis <50%.
Interpretation:
Among patients receiving sirolimus-eluting stents and enrolled in the Germany Registry, event rates of death or MI were similar to those reported in randomized trials, but rates of repeat revascularization appeared somewhat higher. However, data from the registry included patients with multiple presenting syndromes, including ST and non-ST elevation MI, and patients with in-stent restenosis, unlike the prior randomized trials that only included stable patients with de novo coronary artery disease.
Additionally, while registry data provide important descriptive information on characteristics and safety events of drug-eluting stents in a real-world setting, limited conclusions on efficacy can be drawn, given the nonrandomized nature of the data. There was also no monitoring of the data reporting, and not all sites in Germany that used sirolimus-eluting stents participated in the registry.
References:
Hamm CW. The German Cypher Registry. Paper presented at the European Society for Cardiology Congress 2004, 29 August-1 September, Munich, Germany.
Zahn R, Hamm CW, Zeymer U, et al. Coronary stenting with the sirolimus-eluting stent in patients with restenosis after intracoronary brachytherapy: results from the prospective multicentre German Cypher Stent Registry. Clin Res Cardiol. 2010 Feb;99(2):99-106.
Keywords: Hyperlipidemias, Angina, Stable, Coronary Restenosis, Drug-Eluting Stents, Sirolimus, Germany, Angioplasty, Balloon, Coronary, Shock, Cardiogenic, Thrombosis, Coronary Artery Bypass, Hypertension, Diabetes Mellitus
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