ABSTRACT
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. CONCLUSION: 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.
Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Antibiotics, Antineoplastic/administration & dosage , Coated Materials, Biocompatible , Coronary Restenosis/prevention & control , Coronary Stenosis/therapy , Immunosuppressive Agents/administration & dosage , Sirolimus/administration & dosage , Stents , Administration, Topical , Aged , Antibiotics, Antineoplastic/adverse effects , Antibiotics, Antineoplastic/pharmacokinetics , Coronary Artery Bypass , Coronary Restenosis/blood , Coronary Stenosis/blood , Coronary Vessels/drug effects , Female , Follow-Up Studies , Germany , Graft Occlusion, Vascular/blood , Graft Occlusion, Vascular/therapy , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/pharmacokinetics , Male , Middle Aged , Multicenter Studies as Topic , Myocardial Infarction/blood , Myocardial Infarction/therapy , Outcome Assessment, Health Care/statistics & numerical data , Prospective Studies , Randomized Controlled Trials as Topic/statistics & numerical data , Registries , Shock, Cardiogenic/blood , Shock, Cardiogenic/therapy , Sirolimus/adverse effects , Sirolimus/pharmacokinetics , Treatment OutcomeABSTRACT
The aim of this prospective study was to analyze the technical feasibility, success rate and special complications of percutaneous coronary interventions (PCI) using a newly released 5 French (Fr) guiding catheter with an inner diameter of 0.058 . The study was performed in 1,200 consecutive patients subjected to coronary angioplasty. In 92% of the patients, the intervention was started with a 5 Fr catheter; in 8% of the patients, a 6 or 7 Fr catheter was used. In 5% of the 1,105 patients, the guiding catheter had to be changed during PCI from 5 Fr to a 6 or 7 Fr catheter. In 92% of the patients, the intervention was successfully performed using a 5 Fr catheter. In 3%, the overall success rate was 95% after changing the guiding catheter. Predictors of procedural failure with the 5 Fr guiding catheter were type C lesion morphology and a diameter stenosis of 99% and 100%. The success rate was 90% in acute functional occlusions and 63% in chronic total occlusions (CTO). In CTOs, predictors of procedural failure of the recanalizations using 5 Fr guiding catheters were sidebranch at the point of the total occlusion, complex lesion morphology type C and abrupt morphology of the occlusion. This study confirms that PCI was technically feasible using a 5 Fr guiding catheter in the majority of consecutive patients (success rate: 92%). There were significant differences in the success rate depending on the lesion type and the diameter stenosis.
