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EBM Presentation
     Group No. 3
     1       2     3




                       1. Department of surgery, VGHTC
                       2. Department of internal medicine, TAFGH
                       3. 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 ischemia
I   Stents
C   Bypass surgery
O   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 PICO
P   Patients with limb ischemia
I   Angioplasty
C   Bypass surgery
O   Amputation rate
Refined PICO
P     Patients with limb ischemia
I     Angioplasty
C     Bypass surgery
O     Amputation rate

Type: Therapy
Refined PICO
P             Patients with limb ischemia
I             Angioplasty
C             Bypass surgery
O             Amputation rate

Type: Therapy

Level of evidence
    Level 1        Level 2      Level 3      Level 4
     RCT           Cohort    Case-control   Case series
Database: PubMed
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]

Limits
Humans, Clinical Trial, Meta-analysis,
Randomized Controlled Trial
Database: PubMed
Keywords
(limb ischemia) AND bypass AND angioplasty
AND amputation*[MeSH]

Limits
Humans, Clinical Trial, Meta-analysis,
Randomized Controlled Trial

Results: 8
Database: PubMed
Database: PubMed
Paper
Why?
Why?

Multicentric randomized trial
surgery-first (n=228) or angioplasty-first (n=224) strategy
Why?

Multicentric randomized trial
surgery-first (n=228) or angioplasty-first (n=224) strategy


Infrainguinal disease
Why?

Multicentric randomized trial
surgery-first (n=228) or angioplasty-first (n=224) strategy


Infrainguinal disease

Primary Endpoint:
Amputation-free survival
Critical Appraisal
Critical Appraisal
Trial duration:
5.5 years
Critical Appraisal
Trial duration:
5.5 years

Eight individuals
(1.7%) were lost to
follow-up
Critical Appraisal
Trial duration:
5.5 years

Eight individuals
(1.7%) were lost to
follow-up

Baseline data
Critical Appraisal
Critical Appraisal
After 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 Appraisal
After 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 Appraisal
After 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



                      Yes
Validity   of Critical Appraisal



                      Yes

            Yes
Validity   of Critical Appraisal



                      Yes

            Yes

     Yes
Validity   of Critical Appraisal



                      Yes

            Yes

     Yes

                              blinded No
Validity   of Critical Appraisal



                        Yes

              Yes

       Yes

                                blinded No


Yes
Validity    of Critical Appraisal



                         Yes

               Yes

       Yes

                                 blinded No


Yes

             baseline                 Yes
Level of Evidence
Level of Evidence
Application   to our case
Application         to our case




Angioplasty = Stents ?
Application         to our case




Angioplasty = Stents ?

            : outcome              costs
Application         to our case




Angioplasty = Stents ?

            : outcome              costs

                               : Yes
!anks!

  a

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