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Background: Much has changed in the world of drug eluting stents (DES) with anti-platelet medication have both been incorporated into clinical practice, but the impact of this more cautious approach has not been as the current incidence of stent thrombosis (ST) and of bleeding following successful procedures, the impact of co-morbid conditions, and the causes and consequences of unplanned interruption in anti-platelet medication. Methods: Between 2006 and 2008, we prospectively enrolled 15,266 patients from 321 hospitals in 56 countries after implantation of one or several Cypher Select stents. Monitoring of 20% randomly selected enrolled patients is ongoing. All adverse events are adjudicated by an independent CEC. The main outcome measure of the e-Select registry is the incidence of ST at 3 08 the 30 days results for the entire cohort of: 1) The patient demographics, lesion characteristics and procedure parameters, analysed both for on and off-label indications. These will be comparedto the data of the previous e-Cypher registry (2002-2004); 2) The incidence of death, myocardial infarction, repeat revascularization, ST and bleeding; 3) The incidence of co-morbid conditions, analysed using the Charlson index. The impact of this score on the incidence of adverse events will be evaluated; 4) The compliance with the prescribed anti-platelet regimen and its relationship with bleeding and ST events. Conclusion: The early results from this contemporary registry will shed light on the current use of DES world-wide and will help identify possible changes in practice since the early years and understand their consequences. They will also allow for the first time to analyse the impact of several elements that are specific to routine clinical use, as opposed to those that occur in randomized trials. |
