[Safety and current indications during "real life" use of sirolimus-eluting coronary stents in Germany. Results from the prospective multicenter German Cypher Registry].
BACKGROUND
Although randomized, controlled clinical trials (RCTs) showed a reduced target vessel revascularization rate and a good safety profile for the sirolimus-eluting coronary Cypher stent, at least the safety data need to be confirmed by larger data in clinical practice. Under the circumstances of frozen medical budgets in Germany, there may also be a shift toward implantation of a drug-eluting stent (DES) for indications not yet evaluated by RCTs.


METHODS
The authors analyzed the data of the German Cypher Registry a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher stent, in April 2002.


RESULTS
From April 2002 until December 2003, 3,579 interventions using a Cypher stent at 102 centers were included in the German Cypher Registry. This reflects a proportion of this DES compared to all stents implanted at the participating centers of < 10%. Patients' median age was 63.4 years (quartiles: 55-70 years) with 75% men. Renal insufficiency was seen in 10.1%, previous myocardial infarction in 37%, prior percutaneous coronary intervention (PCI) in 54.6%, and prior coronary artery bypass grafting (CABG) in 18.7%. In a large proportion of interventions, Cypher stents were implanted in lesions or in clinical situations not yet evaluated by RCTs: 10.1% ST elevation myocardial infarction, 1.8% cardiogenic shock, 2.1% left main stenoses, 5.5% CABG lesions, 23.2% in-stent stenosis, and 6% chronic total occlusions. PCI before DES implantation was performed in 65.5% of cases, a mean of 1.02 +/- 0.43 Cypher stents per lesion were implanted with a median sum length of all Cypher stents per lesion of 18 mm (quartiles: 13-21 mm). Maximum median balloon diameter during stent implantation was 3.00 mm (quartiles: 2.75-3.00 mm). Acute complication rate was low, with 0.2% deaths, 0.3% subacute stent thromboses, 1.3% myocardial infarctions, 2.1% urgent PCIs, and 0.2% CABGs.


CONCLUSIONS
In about one half of the patients included into the German Cypher Registry, the DES were implanted in lesions that were excluded from RCTs. The use of this sirolimus-eluting coronary stent in "real life" conditions was found to be safe concerning acute complications.
Zahn
Ralf
R
Herzzentrum, Kardiologie, Ludwigshafen, erzahn@aol.com
Hamm
Christian W
CW
Zeymer
Uwe
U
Schneider
Steffen
S
Nienaber
Christoph A
CA
Richardt
Gert
G
Kelm
Malte
M
Levenson
Benny
B
Bonzel
Tassilo
T
Tebbe
Ulrich
U
Schöbel
Wolfgang A
WA
Sabin
Georg
G
Senges
Jochen
J
D000287:Administration, Topical; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D020099:Coated Materials, Biocompatible; D001026:Coronary Artery Bypass; D023903:Coronary Restenosis / Q000097:blood / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000097:blood / Q000628:therapy*; D003331:Coronary Vessels / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006083:Graft Occlusion, Vascular / Q000097:blood / Q000628:therapy; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000097:blood / Q000628:therapy; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012042:Registries; D012770:Shock, Cardiogenic / Q000097:blood / Q000628:therapy; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D015607:Stents; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D020123:Sirolimus