19 83 7 18 628 1
19 8 3 7 18 6 28 30 MI 31 360 21700BZY00247000 5mm CEA 59 mm 2
50% 80 1. 2. 3
19 8 3 [ ] 7 [ ] [ ] [ ] [ ] 18 6 28 [ ] CEA 49mm 50 80 2 4
carotid endarterectomy CEA 1,2 CEA ECST 3 NASCET 4 ACAS 5 5
CEA CEA carotid artery stenting CAS CAS SMART 1998 SMART 1999 XP Angioguard XP 2002 2006 9 2007 7 ****** MDR Medical Device Reporting 0.122%**** 0.016%** 0.012%** 0.010%** 0.44% 0.071% 6
0.061%:2002 8 1 2003 8 31 2002 2 28 2007 7 15 0.057% 0.007%2004 12 31 CAS 2 1 1 2 MRI 2 2 2 3 ***** 10 ************** 7
************************* 41 3 MRI 2 1 1 2 21700BZY00247000 BX 21300BZY00444000 8
21600BZY00076000 5.5 Fr 6 Fr SMART 30 30 6 1 5.5Fr 6Fr 26 SMART 52 1 SMART 26 9
EN1441 Risk Analysis of Medical Devices EN-ISO 14971 Medical Devices- Risk Management 13 4 2 43 63 2 1 FDA MRI SAPPHIRE Angioguard 2 CASCADE Study 121 31 Angioguard 30 Angioguard 10%(9/90) 3.1%(1/32) Feasibility Study 60% 80% 261 10
30 Major Adverse EventMAE: 6.9%(18/261) MAE(30 31 1 ) 10.7%(28/261) 1 MAE Angioguard 12.5%(22/176) 7.1%(6/85) Angioguard MAE SAPPHIRE 29 334 29 413 CEA 50 80 CAS (167 )CEA (167 ) CEA 406 CEA CAS 7 CEA SMART SMART CEA CAS CEA MAE 30 MI 31 360 30 MAE 360 MAE 360 MAE CAS CEA 30 MAE 4.8 8/167 CEA 9.6 16/167P=0.14 - - 360 MAE 12.020/167 CEA 19.232/167P=0.10 - - CEA 360 MAE 11
(Objective Performance Criteria OPC) 30 360 MAE 6.9 28/406 15.8 64/406 OPC 30% MAE ) 88.1 140/159 87.9 355/404 360 ( 50% ) 19.7 24/122 CEA 31.3 30/96 P=0.06-360 0.6 CEA 4.3 P=0.04 - - 360 27.7% (78/282) 0.8% 1 SAPPHIRE CEA P N=167N=167 N=406 88.1%(140/159) N/A N/A 87.9%(355/404) 91.2%(145/159) N/A N/A 89.6%(363/405) 95.6%(152/159) N/A N/A 91.6%(372/406) 19.7%(24/122) 31.3%(30/96) 0.06 27.7%(78/282) 15.6%(19/122) 13.5%(13/96) 0.70 18.4%(52/282) TLR 0.60% 4.30% 0.04 0.80% MAE 12.20% 20.10% 0.05 16.00% 30 MAE 4.8%(8/167) 9.6%(16/167) 0.14 6.9%(28/406) 1.2%(2/167) 2.4%(4/167) 0.68 2.2%(9/406) MI 2.4%(4/167) 6.0%(10/167) 0.17 1.7%(7/406) 3.6%(6/167) 3.0%(5/167) 1.00 4.9%(20/406) 360 MAE 12.0%(20/167) 19.2%(32/167) 0.10 15.8%(64/406) 7.2%(12/167) 12.6%(21/167) 0.14 10.1%(41/406) 6.0%(10/167) 7.2%(12/167) 0.83 9.1%(37/406) 0.6%(1/167) 3.0%(5/167) 0.21 3.2%(13/406) 3.6%(6/167) 1.8%(3/167) 0.50 3.9%(16/406) 9.0%(15/167) 10.2%(17/167) 0.85 13.3%(54/406) 30 17.4%29/167 CEA 12
3.0%5/167 CEA P<0.01 - - 8.4%14/167 CEA 3.0%5/167 p=0.06 - - 15.5% 63/406 3.4%14/406 CEA p=0.01 - - 2 CEA P N=167N=167 N=406 30 9.0%(15/167) 10.2(17/167) 0.85 12.8%(52/406) 17.4%(29/167) 3.0%(5/167) 0.00 15.0%(61/406) 8.4%(14/167) 3.0%(5/167) 0.06 3.2%(13/406) 0.0%(0/167) 4.2%(7/167) 0.01 0.0%(0/406) 360 9.0%(15/167) 10.2%(17/167) 0.85 13.3%(54/406) 17.4%(29/167) 3.0%(5/167) 0.00 15.5%(63/406) 8.4%(14/167) 3.0%(5/167) 0.06 3.4%(14/406) 0.0%(0/167) 4.8%(8/167) 0.01 0.0%(0/406) SAPPHIRE 1. 2. 3. 4. 5. OPC 13
6. 3 CAS CEA 1. ( ) 2. (TCD; Transcranial doppler sonography) 3. 4. SAPPHIRE 600900 2400 100 CEA FDA 334 167 334 14
360 MAE CEA 5. CEA OPC CEA MAE CEA CEA CEA CEA CCS III IV 6. SAPPHIRE 3 MAE 26.2 CEA 30.3 P=0.27 - - 33.3 CEA CEA CEA SAPPHIRE SAPPHIRE CEA CEA 360 MAE CEA OPC CEA OPC CEA OPC CEA propensity score analysis CEA 15
SAPPHIRE CEA CAS CEA CEA CAS CEA CAS CEA CEA CEA CASCEA CAS CEA CEA ******* (10 76 ) 60 SMART 81.8%63/77 30 1.3 2/76 2.6 2/76 2.6 2/76 31 6 2.6 2/76 1.3 2/76 SAPPHIRE 16
SAPPHIRE CEA 60% CAS CEA SAPPHIRE CEA CEA CEA SAPPHIRE CEA 50% 60% CEA 80% 2% 80% 5% 80% CEA 50% 80% CEA CEA SAPPHIRE CAS CEACAS 17
510mm 5mm 5mm 5mm 5mm 3 5mm 5mm 14 5 GCP 14 5 GCP GCP GCP QMS 14 6 18
CEA CEA CAS 1. CEA CAS CEA CAS CEA CAS CEA CEA CEA CAS CEA CEA 2. / CEA CAS 19
CEA 59 mm 50% 80 1. 2. 3 20
1. 2004 2. Philip A, et al. Preventing Ischemic Stroke in Patients With Prior Stroke and Transient Ischemic Attack. A Statement for Healthcare Professionals From the Stroke Council of the American Heart Association. Stroke 30: 1991-1994, 1999. 3. European Carotid Surgery Trialist s Collaborative Group : MRC European Carotid Surgery Trial : Interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. Lancet 337 : 1235-1243, 1991 4. North American Symptomatic Carotid Endarterectomy Trial Collaborators : Beneficial effect of carotid endarterectomy in symptomatic patients with high grade carotid stenosis. N Engl J Med 325 : 445-453, 1991 5. Endarterectomy for asymptomatic carotid artery stenosis. Exective Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA 273 : 1421-1428, 1995 21