Endeavor在中國臨床試驗的案例分析

1、1會計學Endeavor在中國臨床試驗的案例分析在中國臨床試驗的案例分析CRAs*/MonitorsRandomization SystemData Management & Statistical AnalysisCore LabsCEC*CRA: Clinical Research AssociateCEC: Clinical Event CommitteePre study preparationSite Initiation TrainingPatient EnrollmentStudy Close outSolve Data QueriesGenerate Study Rep

2、ort &PublicationPICRandomizationProcedure and Follow-upCRF Data EntryPhase I FIM 48 month resultsDouble-blind Randomized Trial36 month resultsContinued Access Safety24 month resultsConfirmatory Trial vs. Cypher24 month resultsConfirmatory Trial vs. TaxusEnrollment completedSingle Arm Trial30 day

3、s resultsReal-World Performance and Safety Evaluation Enrollment completedEndeavor vs. Cypher Safety StudyEnrollingENDEAVOR I (100 patients)ENDEAVOR II (1200 patients)ENDEAVOR II CA Registry(300 patients)ENDEAVOR III(436 patients)ENDEAVOR IV(1548 patients)ENDEAVOR Japan(99 patients)E-Five Registry(8

4、000 patients)PROTECT(8800 patients)China Endeavor Registry(2200 patients)Real-World Performance and Safety Evaluation EnrollingPhase I FIM 48 month resultsDouble-blind Randomized Trial36 month resultsContinued Access Safety24 month resultsConfirmatory Trial vs. Cypher24 month resultsConfirmatory Tri

5、al vs. Taxus12 month resultsSingle Arm Trial9 month resultsReal-World Performance and Safety Evaluation Enrollment completedEndeavor vs. Cypher Safety StudyEnrollingReal-World Performance and Safety Evaluation Enrolling30d6mo2yr*12mo*Limited number of centers and specific patient subset.CRAs/Monitor

6、sE-CRF SystemData Management & Statistical AnalysisCore LabsCEC(Recent) MI (%)Non Q-wave MIQ wave MIPrior CABG (%)Unstable Angina (%)Diabetes Mellitus (%)Prior PCI (%)Prior MI (%)Age (years)Male Gender (%)n = 8318 Patients76.763.3011.0632.112.221.425.37.532.721.834.0n=8318 patients and 10343 les

7、ionsLAD (%)46.6B2/C Lesions (%)60.3RVD (mm)2.930.47Lesion Length (mm)18.5010.60Pre-procedure MLD (mm)0.500.41Pre-procedure DS (%)82.8413.51Post-procedure DS (%)2.418.2421.2(Recent) MI (%)12.2Non Q-wave MI25.3Q wave MI7.0Prior CABG (%)31.2Unstable Angina (%)34.4Diabetes Mellitus (%)23.9Prior PCI (%)3

8、5.9Prior MI (%)62.9511.46Age (years)76.9Male Gender (%)n = 1989 patientsn=1989 patients and 2449 lesionsLAD (%)47.9B2/C Lesions (%)61.7RVD (mm)2.930.45Lesion Length (mm)18.199.90Pre-procedure MLD (mm)0.530.41Pre-procedure DS (%)81.9313.99Post-procedure DS (%)2.016.3318.199.90Lesion Length (mm)1.350.

9、53Stent: Lesion Length28.8Long lesions (20 mm) (%)5.921.016.234.718.04.2 Minimum Endeavor Stent Diameters implanted 2.25 mm (%) 2.5 mm (%) 2.75 mm (%) 3.0 mm (%) 3.5 mm (%) 4.0 mm (%)23.1711.93Total Stent Length (mm)n=1989 patients and 2449 lesions30 daysn=198912 monthsn=1989Death (all) - % (n)0.8 (

10、16)2.9 (55) Cardiac0.7 (14)2.0 (38)MI (all) - % (n)0.8 (15)1.3 (25) Q Wave0.2 (4)0.4 (8) Non Q wave0.6 (11)0.9 (17)Death (cardiac) + MI (all) - % (n)1.4 (27)3.0 (57)Stent Thrombosis (all) - % (n)0.8 (16)1.1 (20) 0-30 days 0.8 (16)0.8 (16) 31-360days 00.2 (4)TLR - % (n)0.5 (10)3.8 (71)TVR (non-TL) -

11、% (n)0.1 (1)1.1 (20)TVR - % (n)0.5 (10)4.6 (87)MACE - % (n)1.7 (33)7.0 (133)TVF - % (n)1.6 (31)6.8 (129)Clinical Outcomes out to 12 monthsComplex SubsetsSample size n=1989Diabetics - % (n) Insulin Dependent - % (n) Non Insulin Dependent % (n)34.4 (684)9.2 (182)25.2 (502)Lesions 20mm - % (n)34.4 (685

12、)RVD 20mm Clinical Outcomes out to 12 months30 daysn=91312 monthsn=866Death (all) - % (n)1.1 (10)3.5 (30) Cardiac0.9 (8)2.5 (22)MI (all) - % (n)1.1 (10)2.0 (17) Q Wave0.2 (2)0.6 (5) Non Q wave0.9 (8)1.4 (12)Death (cardiac) + MI (all) - % (n)1.8 (16)3.9 (34)Stent Thrombosis (all) - % (n)1.1 (10)1.5 (13) 0-30 days 1.1 (10)1.2 (10) 31-360days 00.3 (3)TLR - % (n)0.7 (6)