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TASC Process & Documents:
Needed or a Waste of Time?
Mahmood Razavi, MD, FSIR
Director
Center for Clinical Trials
St Joseph Heart & Vascular Institute
Disclosures
♦ Scientific Advisory Board
• 480 Biomedical, Abbott Vascular, Bard, Boston
Scientific, Covidien, EmboMedix, Javlin, Mercator,
Neuravi, Reflow Medical, Trivascular, Veneti, Walk
Vascular
♦ Consultant
• Cordis
♦ Grants
• NIH, WL Gore
TASC Disclosure
♦ TASC Writing Group & Steering
Committee
TASC Classification
&Recommendations
♦ Does TASC matter?
♦ Does anyone care?
♦ Why is it important to have such a
process and document?
Background
♦ There are multiple treatment options
for pts with PAD
♦ Approaches are sometimes
complementary but often competitive
and occasionally mutually exclusive
♦ Robust comparative data often not
available
So how should a patient be best
treated?
Expert panelsExpert panels
AHA & TASCAHA & TASC
Determinants of Therapy
♦ Patients’ condition
♦ Anatomic severity of disease
♦ Comorbid conditions
♦ Patients’ wishes
Disease classification is neededDisease classification is needed
Basis of TASC Classification
♦ Clinical presentation (considering all
relevant clinical variables)
♦ Lesion characteristics:
• Location
• Length
• Morphology
TASC-I & II Process
♦ Representatives from 16 international
Societies & health economics experts
participated
♦ After extensive review of existing
literature a draft document prepared
♦ All participating Societies reviewed
and commented
Grading of Recommendations
ecommendations and selected statements are rated according to guidance issued
rmer US Agency for Health Care Policy and Research (6), now renamed the Age
ealthcare Research and Quality:
Grade Recommendation
A Based on the criterion of at least one randomized, controlled
clinical trial as part of the body of literature of overall good quality
and consistency addressing the specific recommendation
B Based on well-conducted clinical studies but no good quality
randomized clinical trials on the topic of recommendation
C Based on evidence obtained from expert committee reports or
opinions and/or clinical experiences of respected authorities (i.e.
applicable studies of good quality)
Anatomic Classification Generated
Does TASC Classification Predict Outcome?
TASC-ATASC-A
TASC-BTASC-B
TASC-DTASC-D
TASC-CTASC-C
patencypatency
TASC classificationTASC classification
Who Needs TASC?
♦ The TASC documents are the second
highest referenced papers in the history
of surgical literature
♦ TASC documents are clearly important
♦ Is it the classification or the
recommendations?
TASC Recommendations for
Treatment of PAD
♦ Risk factor modification
• Optimal management of DM & HTN,
smoking cessation, wt. reduction,
exercise, etc
♦ Anti-lipids, antiplatelets
♦ Cilostezol & exercise for IC
♦ Revascularization when needed
Common to all international guidelinesCommon to all international guidelines
TASC Controversy
♦ Method of revascularization
TASC-II Recommendations for
Aortoiliac & Fempop Lesions
♦ TASC A: Endovascular approach is the tx
of choice
♦ TASC B: Endo preferred
♦ TASC C: Surgery preferred
♦ TASC D: Surgery is the tx of choice
TASC-II classification is useful but the
revascularization recommendations are
mostly irrelevant today
In the real world endo first is the majority
practice in all morphologies
Recommendations commonly ignored byRecommendations commonly ignored by
vascular surgeons who are endo-trainedvascular surgeons who are endo-trained
Recommendations commonly ignored byRecommendations commonly ignored by
vascular surgeons who are endo-trainedvascular surgeons who are endo-trained
TASC-IIb Recommendations
♦ TASC A & B: Endovascular approach is the
tx of choice
♦ TASC C: Endo preferred if local expertise
exist
♦ TASC D: Surgery is tx of choice, endo if
local expertise exist & patient’s anatomy
allows
TASC-IIb illuminated the
weaknesses of TASC process
TASC process is subject to political infighting between professionalTASC process is subject to political infighting between professional
Societies and recommendations are based as much on politicalSocieties and recommendations are based as much on political
considerations as on clinical evidence and practice patternsconsiderations as on clinical evidence and practice patterns
After an exhaustive 3 year review process by all SocietiesAfter an exhaustive 3 year review process by all Societies
and initial acceptance of TASC IIb recommendations,and initial acceptance of TASC IIb recommendations,
including by the SVS & ESVS, SVS threatenedincluding by the SVS & ESVS, SVS threatened
to pull out of TASC if TASC-IIb was publishedto pull out of TASC if TASC-IIb was published
The TASC IIb document was
hence withdrawn from
publication !!
TASC III
♦ SVS & ESVS were active participants
initially but withdrew when they could
not get their way
♦ Among their demands:
• >50% surgical representation on all
aspects of TASC because …
“Setting standards across the
world for optimal care of this
group of patients resides
principally with vascular
surgeons.”
SVS & ESVSSVS & ESVS
Ideal Situation
Unmet needsUnmet needs
in practicein practice
HypothesisHypothesis
and R&Dand R&D
Clinical trialsClinical trials
& evidence& evidence
SocietalSocietal
GuidelineGuideline
PracticePractice
patternspatterns
Practice is ahead of dataPractice is ahead of data
Data is ahead of GuidelinesData is ahead of Guidelines
Practice politics is ahead of everythingPractice politics is ahead of everything
Conclusions
♦ Classification of disease is needed to be
able to compare outcomes across studies
and judge best therapies
♦ Standardization of reporting and treatment
critical in advancing tx of PAD
♦ TASC process critically needed but
disabled by politics of $$ and power

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TASC RECOMMENDATIONS

  • 1. TASC Process & Documents: Needed or a Waste of Time? Mahmood Razavi, MD, FSIR Director Center for Clinical Trials St Joseph Heart & Vascular Institute
  • 2. Disclosures ♦ Scientific Advisory Board • 480 Biomedical, Abbott Vascular, Bard, Boston Scientific, Covidien, EmboMedix, Javlin, Mercator, Neuravi, Reflow Medical, Trivascular, Veneti, Walk Vascular ♦ Consultant • Cordis ♦ Grants • NIH, WL Gore
  • 3. TASC Disclosure ♦ TASC Writing Group & Steering Committee
  • 4. TASC Classification &Recommendations ♦ Does TASC matter? ♦ Does anyone care? ♦ Why is it important to have such a process and document?
  • 5. Background ♦ There are multiple treatment options for pts with PAD ♦ Approaches are sometimes complementary but often competitive and occasionally mutually exclusive ♦ Robust comparative data often not available
  • 6. So how should a patient be best treated? Expert panelsExpert panels AHA & TASCAHA & TASC
  • 7. Determinants of Therapy ♦ Patients’ condition ♦ Anatomic severity of disease ♦ Comorbid conditions ♦ Patients’ wishes Disease classification is neededDisease classification is needed
  • 8. Basis of TASC Classification ♦ Clinical presentation (considering all relevant clinical variables) ♦ Lesion characteristics: • Location • Length • Morphology
  • 9. TASC-I & II Process ♦ Representatives from 16 international Societies & health economics experts participated ♦ After extensive review of existing literature a draft document prepared ♦ All participating Societies reviewed and commented
  • 10. Grading of Recommendations ecommendations and selected statements are rated according to guidance issued rmer US Agency for Health Care Policy and Research (6), now renamed the Age ealthcare Research and Quality: Grade Recommendation A Based on the criterion of at least one randomized, controlled clinical trial as part of the body of literature of overall good quality and consistency addressing the specific recommendation B Based on well-conducted clinical studies but no good quality randomized clinical trials on the topic of recommendation C Based on evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities (i.e. applicable studies of good quality)
  • 12. Does TASC Classification Predict Outcome? TASC-ATASC-A TASC-BTASC-B TASC-DTASC-D TASC-CTASC-C patencypatency TASC classificationTASC classification
  • 13. Who Needs TASC? ♦ The TASC documents are the second highest referenced papers in the history of surgical literature ♦ TASC documents are clearly important ♦ Is it the classification or the recommendations?
  • 14. TASC Recommendations for Treatment of PAD ♦ Risk factor modification • Optimal management of DM & HTN, smoking cessation, wt. reduction, exercise, etc ♦ Anti-lipids, antiplatelets ♦ Cilostezol & exercise for IC ♦ Revascularization when needed Common to all international guidelinesCommon to all international guidelines
  • 15. TASC Controversy ♦ Method of revascularization
  • 16. TASC-II Recommendations for Aortoiliac & Fempop Lesions ♦ TASC A: Endovascular approach is the tx of choice ♦ TASC B: Endo preferred ♦ TASC C: Surgery preferred ♦ TASC D: Surgery is the tx of choice
  • 17. TASC-II classification is useful but the revascularization recommendations are mostly irrelevant today In the real world endo first is the majority practice in all morphologies Recommendations commonly ignored byRecommendations commonly ignored by vascular surgeons who are endo-trainedvascular surgeons who are endo-trained Recommendations commonly ignored byRecommendations commonly ignored by vascular surgeons who are endo-trainedvascular surgeons who are endo-trained
  • 18. TASC-IIb Recommendations ♦ TASC A & B: Endovascular approach is the tx of choice ♦ TASC C: Endo preferred if local expertise exist ♦ TASC D: Surgery is tx of choice, endo if local expertise exist & patient’s anatomy allows
  • 19. TASC-IIb illuminated the weaknesses of TASC process TASC process is subject to political infighting between professionalTASC process is subject to political infighting between professional Societies and recommendations are based as much on politicalSocieties and recommendations are based as much on political considerations as on clinical evidence and practice patternsconsiderations as on clinical evidence and practice patterns After an exhaustive 3 year review process by all SocietiesAfter an exhaustive 3 year review process by all Societies and initial acceptance of TASC IIb recommendations,and initial acceptance of TASC IIb recommendations, including by the SVS & ESVS, SVS threatenedincluding by the SVS & ESVS, SVS threatened to pull out of TASC if TASC-IIb was publishedto pull out of TASC if TASC-IIb was published
  • 20. The TASC IIb document was hence withdrawn from publication !!
  • 21. TASC III ♦ SVS & ESVS were active participants initially but withdrew when they could not get their way ♦ Among their demands: • >50% surgical representation on all aspects of TASC because …
  • 22. “Setting standards across the world for optimal care of this group of patients resides principally with vascular surgeons.” SVS & ESVSSVS & ESVS
  • 23. Ideal Situation Unmet needsUnmet needs in practicein practice HypothesisHypothesis and R&Dand R&D Clinical trialsClinical trials & evidence& evidence SocietalSocietal GuidelineGuideline PracticePractice patternspatterns Practice is ahead of dataPractice is ahead of data Data is ahead of GuidelinesData is ahead of Guidelines Practice politics is ahead of everythingPractice politics is ahead of everything
  • 24. Conclusions ♦ Classification of disease is needed to be able to compare outcomes across studies and judge best therapies ♦ Standardization of reporting and treatment critical in advancing tx of PAD ♦ TASC process critically needed but disabled by politics of $$ and power