TASC Process & Documents: Needed or a Waste of Time? Mahmood Razavi, MD, FSIR Director Center for Clinical Trials St Joseph Heart & Vascular Institute
TASC Process & Documents:Needed or a Waste of Time?
Mahmood Razavi, MD, FSIRDirectorCenter for Clinical TrialsSt 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
Anatomic Classification Generated
Does TASC Classification Predict Outcome?
TASC-ATASC-A
TASC-BTASC-B
TASC-DTASC-D
TASC-CTASC-C
pate
ncy
pate
ncy
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 guidelines Common 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 byvascular 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 professional TASC process is subject to political infighting between professional Societies and recommendations are based as much on political Societies 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 Societies After 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 threatened including 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 needs Unmet needs
in practicein practiceHypothesisHypothesisand R&Dand R&D
Clinical trialsClinical trials& evidence& evidence
SocietalSocietalGuidelineGuideline
Practice Practice patternspatterns
Practice is ahead of dataPractice is ahead of dataData 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