Title:Intravascularultrasound(IVUS)July2001

Title:IntravascularUltrasound(IVUS)July2001

Agency:MedicalServicesAdvisoryCommittee(MSAC) CommonwealthDepartmentofHealthandAgeing GPOBox9848CanberraACT2601Australia

Reference:MSAC application1032Assessment report ISSN 1443-7120

Aim

ToassessthesafetyandeffectivenessofIntravascularUltrasoundandthecircumstancesunder whichpublicfundingshouldbesupportedfortheservice.

Conclusions and results

Safety

Overall,IVUSappearstobearelativelysafeprocedure.Adverseeventsappeartorelate primarilytovasospasmwhichcanbereadilytreatedwithintravenousnitratetherapy.Therate ofmajoracuteproceduralcomplicationsassociatedwithIVUS,suchasdissectionorvesselclosure,hasbeenreportedtobeapproximately<0.5%,withmajorcomplicationsmorelikelytooccurinpatientsundergoingtherapeuticIVUSratherthandiagnosticIVUSimaging.

Effectiveness

DiagnosticapplicationsIVUSappearstoofferadditionalandcomplementaryinformation overthatprovidedbycoronaryangiography.Itisableto moreaccuratelydemonstratethelikely extentofcoronaryandperipheralvessellesions;appearstohavegoodsensitivityand

specificityfordetectionofplaquedissectionsandmediarupturebutlowersensitivityforthe detectionofplaqueruptureandthrombusformation;hasquitehighaccuracyinpredictingthe likelyfunctionalseverityoflesions;andcanalsoprovideinformationonthecompositionof plaques.Thereissomeevidencetosuggestthatit maybeabletopredictclinicalevents,and altermanagementofpatientswithangiographicallyindeterminateorambiguouslesions.

TherapeuticapplicationsBasedonRCTevidence,stentplacementusingIVUSguidance results inastatisticallysignificantreductionintheoddsofpatientsrequiringtargetlesion revascularisation(TLR)proceduresat9–12monthsintheIVUSguidedcomparedtonon-IVUS guidedtreatmentgroups(OddsRatio(OR)0.73,95%confidenceinterval0.54–0.99,p=0.04)

ItisunclearatthisstagewhetherthereductioninTLRissustainedoveralongerfollow-up periodorwillresultinimprovementsineitherQ-wavemyocardialinfarctionorsurvival,asthe trialswerenotpoweredtodetectsignificantdifferencesintheseparameters.

Cost-effectiveness

UsingpublishedRCTevidence,thebaselinecostperclinically-driventargetlesion revascularisation(TLR)preventedfromIVUSguidedstentdeploymentisestimatedtobe approximately$26,000.Thisestimatevariesfromapproximately$12,000to$800,000perTLRpreventedovertheevidencebasedrangesexaminedinsensitivityanalyses.

Recommendations

MSACrecommendedagainstpublicfundingasthereiscurrentlyinsufficientevidenceofthe effectivenessandcost-effectivenessofIVUSaseitheradiagnosticortherapeutictool.

Method

Asystematicliteraturereviewaddressing(a)thediagnosticaccuracyofIVUSand(b)itsroleas anadjuncttocoronaryinterventionswasconductedbytheNHMRCClinicalTrialsCentreusingbiomedical electronic databases, existing reviews, the Internet and internationalhealthtechnologyassessment organisation websites.

For(a)theliteraturewassearched from1990toAugust2001and,for(b),from1999-2000,withpre-1999papersidentified from a recent comprehensive HTA by Berry et al. 20001

ProducedbyKirstenHoward(epidemiologist)andSallyWortley,NHMRCCTC,Australia.

1Berry,E. et al(2000)"Intravascular ultrasound-guidedinterventions in coronary arterydisease: a systematic literaturereview,with decision-analyticmodelling,of outcomes andcost-effectiveness", Health Technology Assessment (South Hampton,NY),vol.4,no.35,pp.1-117.