Coronary Artery By-pass Graft (CABG)

Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)

Total of all reporting groups

number of particpiants with stable, unstable, or no angina at baseline

Number of participants with at least one bifurcation lesion as determined by the angiographic core laboratory on the baseline angiogram

number of participants with blood pressure equal or higher than 130/85mmHg

number of particpants with diagnosed carotid artery disease at baseline

number of particpants with congestive heart failure at baseline

Number of participants that were smoking at baseline

All participants with diagnosed diabetes at baseline

number of male participants with a high-density lipoprotein (HDL)<40 and female particpants with a HDL<50 determined by the central chemistry laboratory

participants with hyperlipidemia at baseline

Number of participants with diabetes treated with insulin

Number of participants with medically treated diabetes.Excludes participants with diabetes treated with diet only.

number of participants that met the criteria of metabolic syndrome defined by the American Heart Association

number of participants with left ventricular ejection fraction <30% at baseline

Number of participants who had a myocardial infarction before baseline

number of participants who had a stroke before baseline

number of partipants who had a Transient Ischemic Attack before baseline

Number of participants with at least one total occlusion as determined by the angiografic core laboratory on the baseline angiogram

participants with Triglyceride levels ≥150 mg/dL as determined by a central chemistry laboratorium at baseline

Additive EuroSCORE is a prognostic scoring system calculating predicted operative mortality for patients undergoing cardiac surgery; it has been the most rigorously evaluated scoring system in cardiac surgery. A predetermined weighted score is assigned for specified patient-, cardiac-, and operation-related factors; for example, pulmonary hypertension is assigned a score of 2. The sum of scores is the additive EuroSCORE. EuroSCORE is calculated from site reported baseline data. A score of greater than 6 is considered as being predictive of an increased mortality risk. (www.euroscore.org)

Body Mass Index calculated from participants heigth and weight.

Average number of lesions per participant as determined by the investigator

The first scoring system in cardiac surgery to calculate mortality risk and to become popular was the Parsonnet risk stratification system, which was developed in the United States in the 1980s. A predetermined weighted score is assigned for several specified patient-, cardiac-, and operation-related factors; for example, dialysis is assigned a score of 10. A score of greater than 15 is considered as being predictive of an increased mortality risk. Parsonette score is calculated from baseline information.

The SYNTAX score characterizes the coronary vasculature. It combines the importance of a diseased coronary artery segment (Leaman score), adverse characteristics of a lesion (ACC/AHA lesion classification) and the modified Duke/ICPS classification for bifurcation lesions. Higher SYNTAX scores are indicative of more complex lesions and disease; thus higher scores would predict worse short-term outcomes. Calculated from angiographic corelab analysis of baseline angiogram. (www.syntaxscore.com)

Coronary Artery By-pass Graft (CABG)

Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)

Total of all abnormal blood tests (increased or decreased) and abnormal diagnostic procedures. Occurrence of each individual event term is less than 1%.

Total of events related to immune system disorder like anaphylactic reaction or shock and drug hypersensitivity. Occurrence of each individual event term is less than 1%.

Rare cardiac disorders like ventricular arrhytmias, atrioventricular blocks, cardiomyopathy, valve disease, coronary artery dissection and occlusion. Occurrence of each individual event term is less than 1%.

Total of hepatobiliary disorders like bile duct stone, cholecystitis, hepatic failure and hepatic function abnormal.Occurrence of each individual event term is less than 1%.

Total of any other infection or abcess. Occurrence of each individual event term is less than 1%.

Total of all other procedural complications and injuries. Occurrence of each individual event term is less than 1%.

Total of all metabolism and nutrition disorders like hyper- and hypoglycaemie, hypokalaemia, hyponatraemia, dehydration, etc. Occurrence of each individual event term is less than 1%.

Total of musculoskeletal and connective tissue disorders. Occurrence of each individual event term is less than 1%.

Total of neoplasms, benign, malignant and unspecified. Occurrence of each individual event term is less than 1%.

Total of all other nervous system disorders. Occurrence of each individual event term is less than 1%.

Sum of all other gastrointestinal disorders like ulcers, pain, hernia, obstructions, vomiting, nausea, etc. Occurrence of each individual event term is less than 1%.

Other general disorders mainly related to catheter site events like pain, haemorrhage and pyrexia, multi-organ failure, wound healing problems. Occurrence of each individual event term is less than 1%.

Total of all reproductive system and breast disorders. All events in this system were related to prostatic disorders. Occurrence of each individual event term is less than 1%.

Total of all psychiatric disorders. Occurrence of each individual event term is less than 1%.

Total of all other renal and urinary disorders. Occurrence of each individual event term is less than 1%.

Total of all other respiratory, thoracic and mediastinal disorders. Occurrence of each individual event term is less than 1%.

Total of surgical and medical procedures. Occurrence of each individual event term is less than 1%.

Total of vascular disorders. Occurrence of each individual event term is less than 1%.

Total of other events and subjects affected with these events in this organ system. Event terms are coagulopathy, iron deficiency anaemia, leukocytosis and thrombocyopenia. Occurrence of each individual event term is less than 1%.

Total of skin and subcutaneous tissue disorders. Occurrence of each individual event term is less than 1%.

Total of all other adverse events with an occurrence below the 5% treshold.