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