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EBM PresentationGroup No. 3
蔡依達1 陳冠良2 張弘正3
1. Department of surgery, VGHTC2. Department of internal medicine, TAFGH3. Department of family medicine, LSH
Scenario
Scenario
80 y/o male with diabetes for 20 years
Scenario
80 y/o male with diabetes for 20 years
s/p right BK amputation 3 years ago
Scenario
80 y/o male with diabetes for 20 years
s/p right BK amputation 3 years ago
Left foot chronic ulcer, ABI: 0.6, angio: femoral a. stenosis
Scenario
80 y/o male with diabetes for 20 years
s/p right BK amputation 3 years ago
Left foot chronic ulcer, ABI: 0.6, angio: femoral a. stenosis
Afraid of amputation !!!
Scenario
80 y/o male with diabetes for 20 years
s/p right BK amputation 3 years ago
Left foot chronic ulcer, ABI: 0.6, angio: femoral a. stenosis
Afraid of amputation !!!
Femoral popliteal a. bypass VS stents
Question
Question
In patients with critical limb ischemia, is the amputation rate of endovascular stent less than of bypass surgery?
PICO
PICO
P Patients with limb ischemiaI StentsC Bypass surgeryO Amputation rate
Background Knowledge
Background Knowledge
Treatment of chronic critical limb ischemia
Percutaneous transluminal angioplasty
Bypass surgery
Thrombolytic therapy
Background Knowledge
Treatment of chronic critical limb ischemia
Percutaneous transluminal angioplasty
Bypass surgery
Thrombolytic therapy
Aortoiliac vs infrainguinal disease
Refined PICO
Refined PICOP Patients with limb ischemiaI AngioplastyC Bypass surgeryO Amputation rate
Refined PICO
Type: Therapy
P Patients with limb ischemiaI AngioplastyC Bypass surgeryO Amputation rate
Refined PICO
Type: Therapy
Level of evidence
P Patients with limb ischemiaI AngioplastyC Bypass surgeryO Amputation rate
Level 1 Level 2 Level 3 Level 4
RCT Cohort Case-control Case series
Database: PubMed
Keywords(limb ischemia) AND bypass AND angioplasty AND amputation
Database: PubMed
Keywords(limb ischemia) AND bypass AND angioplasty AND amputation
Results: 175
Database: PubMed
Database: PubMed
Keywords(limb ischemia) AND bypass AND angioplasty AND amputation*[MeSH]
Database: PubMed
Keywords(limb ischemia) AND bypass AND angioplasty AND amputation*[MeSH]
LimitsHumans, Clinical Trial, Meta-analysis, Randomized Controlled Trial
Database: PubMed
Keywords(limb ischemia) AND bypass AND angioplasty AND amputation*[MeSH]
LimitsHumans, Clinical Trial, Meta-analysis, Randomized Controlled Trial
Results: 8
Database: PubMed
Database: PubMed
Database: PubMed
Paper
Why?
Why?
Multicentric randomized trialsurgery-first (n=228) or angioplasty-first (n=224) strategy
Why?
Multicentric randomized trialsurgery-first (n=228) or angioplasty-first (n=224) strategy
Infrainguinal disease
Why?
Multicentric randomized trialsurgery-first (n=228) or angioplasty-first (n=224) strategy
Infrainguinal disease
Primary Endpoint: Amputation-free survival
Critical Appraisal
Critical AppraisalTrial duration: 5.5 years
Critical AppraisalTrial duration: 5.5 years
Eight individuals (1.7%) were lost to follow-up
Critical AppraisalTrial duration: 5.5 years
Eight individuals (1.7%) were lost to follow-up
Baseline data
Critical Appraisal
Critical AppraisalAfter 6 months, no significant difference in amputation-free survival (48 vs 60 p’t; hazard ratio: 0.73; 95% CI: 0.49-1.07)
Critical AppraisalAfter 6 months, no significant difference in amputation-free survival (48 vs 60 p’t; hazard ratio: 0.73; 95% CI: 0.49-1.07)
No difference in health-related quality of life
Critical AppraisalAfter 6 months, no significant difference in amputation-free survival (48 vs 60 p’t; hazard ratio: 0.73; 95% CI: 0.49-1.07)
No difference in health-related quality of life
One third higher hospital costs in surgery-first strategy for the first year
Validity of Critical Appraisal
Validity of Critical Appraisal
病人的分組是隨機分派的嗎？ Yes
Validity of Critical Appraisal
病人的分組是隨機分派的嗎？ Yes
分派的方法是否保密？ Yes
Validity of Critical Appraisal
病人的分組是隨機分派的嗎？ Yes
分派的方法是否保密？ Yes
追蹤是否完整？ Yes
Validity of Critical Appraisal
病人的分組是隨機分派的嗎？ Yes
分派的方法是否保密？ Yes
追蹤是否完整？ Yes
治療方法對病患、醫護人員、是否 blinded？No
Validity of Critical Appraisal
病人的分組是隨機分派的嗎？ Yes
分派的方法是否保密？ Yes
追蹤是否完整？ Yes
治療方法對病患、醫護人員、是否 blinded？No
除了研究治療項目以外，其他的治療是否相同？Yes
Validity of Critical Appraisal
病人的分組是隨機分派的嗎？ Yes
分派的方法是否保密？ Yes
追蹤是否完整？ Yes
治療方法對病患、醫護人員、是否 blinded？No
除了研究治療項目以外，其他的治療是否相同？Yes
兩組在治療開始時的 baseline 是否相似？Yes
Level of Evidence
Level of Evidence
Application to our case
Application to our case
Angioplasty = Stents ?
Application to our case
Angioplasty = Stents ?
根據文獻看法: outcome 相似、較低 costs
Application to our case
Angioplasty = Stents ?
根據文獻看法: outcome 相似、較低 costs
文獻證據中的治療我們能不能執行: Yes
!anks!a
