Recent Clinical Trials in CCTA Implica3ons for Prac3ce

Transcription

1 Recent Clinical Trials in CCTA Implica3ons for Prac3ce Tej Sheth Associate Professor of Medicine McMaster University Interven3onal Cardiologist Hamilton Health Sciences and Niagara Health System

2 65 F, Hypertension, Diabetes Retrosternal chest pain occurs with ac3vity for 5 to 10 minutes per episode, once or twice per day, no effect of NTG Normal ECG, Able to Exercise What inves3ga3on for CAD would you choose? A. Stress ECG B. Stress ECG with Echocardiography C. Stress ECG with Nuclear Imaging D. Coronary CTA

3 Audience Response

4 New CCTA Studies Stable Chest Pain PROMISE SCOT Heart Pre- opera3ve Risk Predic3on CTA VISION

5 Stable Chest Pain 50% of non- invasive imaging is done for cardiac indica3ons Mul3ple modali3es func3onal and anatomic Can CCTA add to or replace func3onal modali3es?

6 NEJM, 2015

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9 Study Power: 10,000 pa3ents 90% power to detect 20% RRR in the primary end point in the CTA group, assuming an event rate of 8% in the func3onal- tes3ng group Actual Event Rate: 3.0% at median follow- up of 25 months in func3onal group

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12 Lancet, 2015

13 Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Trial Population Randomiza7on$1:1$ n=4,146$ Standard$of$Care$ $ n=2,073$ Standard$of$Care$+$ CT$Coronary$Angiogram$ n=2,073$ Computed$Tomography$$ Coronary$Angiogram$ n=3$ 100%$Data$for$the$$ Primary$End4point$ Inten7on4to4Treat$ Analysis$ CT$Coronary$Angiogram$ n=1,778$ $ Non$comple*on Ill$health/death Pa*ent+default Technical Other Data$for$Primary$ Endpoint$ n=2,073$ Data$for$Primary$ Endpoint$ n=2,073$

14 !!!! All!Par'cipants! Standard!Care!+! Standard!Care! CTCA!! Anginal!Symptoms! Typical! 1462!(35%)! 737!(36%)! 725!(35%)!!! Atypical! 988!(24%)! 502!(24%)! 486!(23%)!!! Non9anginal! 1692!(41%)! 833!(40%)! 859!(41%)! Electrocardiogram! Normal! 3492!(84%)! 1757!(85%)! 1735!(84%)!!! Abnormal! 608!(15%)! 292!(14%)! 316!(15%)! Stress!Electrocardiogram!!!!!!!! Performed! 3517!(85%)! 1764!(85%)! 1753!(85%)!!! Normal! 2188!(62%)! 1103!(63%)! 1085!(62%)!!! Inconclusive! 566!(16%)! 284!(16%)! 282!(16%)!!! Abnormal! 529!(15%)! 264!(15%)! 265!(15%)! Further!Inves'ga'on!!! 1315!(32%)! 633!(31%)! 682!(33%)! Stress!Imaging! Radionuclide! 389!(9%)! 176!(9%)! 213!(10%)!!! Other! 30!(1%)! 16!(1%)! 14!(1%)! Invasive!Coronary!Angiography!!! 515!(12%)! 255!(12%)! 260!(13%)! Baseline!Diagnosis!! Coronary!Heart!Disease! 1938!(47%)! 982!(47%)! 956!(46%)!!! Angina!due!to!CHD! 1485!(36%)! 742!(36%)! 743!(36%)! Predicted!109year!Coronary!Heart!Disease!Risk! 17±12%!! 18±11%! 17±12%!

15 of'the'heart'(scot;heart)'trial' Diagnosis:)Primary)Endpoint'! ' Diagnosis'of'Angina'due'to'Coronary'Heart'Disease' ' Yes' Probable' Unlikely' No' Certainty:'' Yes/No'versus'Probable/Unlikely' ' Frequency:'' Yes/Probable'versus'Unlikely/No' Certainty Frequency 1.79 [ ] 0.93 [ ] Relative Risk [95% Confidence Intervals] Yes/No Diagnosis: 20% in standard care vs 34% in CTA+standard care

16 CTCA and Medical Therapy Baseline Compared to 6 Weeks Overall"Changes"in"Treatments:"23%"versus"5%,"P<0.001" Cancella4ons" New"Treatments" 400" 400" 350" 350" 300" 300" Frequency" 250" 200" 150" 100" Frequency" 250" 200" 150" 100" 50" 50" 0" 0" Preventa4ve" Therapy" An49" Anginal" Therapy" All" Therapies" Preventa4ve" Therapy" An49" Anginal" Therapy" All" Therapies" CTCA"+"Standard"Care" Standard"Care"

17 CTCA and Clinical Outcome Coronary Angiography & Revascularisation Proportion of patients with an event (%) CTCA Standard Care Coronary#Angiography# HR#1.06#[0.92*1.21],#P=0.451! CTCA Standard Care Proportion of patients with an event (%) CTCA Standard Care Coronary#RevascularisaCon# Cumulative incidence, % % 10% 5% 0% HR#1.20#[0.99*1.45],#P=0.061! CTCA Standard Care Time, days strata AllocatedTreat AllocatedTreat Follow Up (years) Follow Up (years)

18 CTCA and Clinical Outcome 1.7 Years of Follow-up Proportion of patients with an event (%) CTCA CHD$Death$and$Non-Fatal$MI$ Cumulative incidence, % Standard Care 5% 4% 3% 2% 1% 0% HR$0.62$[ ],$P=0.053! Standard Care CTCA Time, days Proportion of patients with an event (%) strata CTCA Cumulative incidence, % AllocatedTreatment=2 2 AllocatedTreatment=1 1 0 Standard Care CHD$Death,$Non-Fatal$MI$ and$non-fatal$stroke$ 5% 4% 3% 2% 1% 0% HR$0.64$[ ],$P=0.056! Standard Care CTCA Time, days strata Allocate Allocate Follow Up (years) Follow Up (years)

19 In Stable Chest Pain, CTA Improved diagnos3c confidence for angina and increased detec3on of coronary disease compared to stress tes3ng alone Led to changes in medical therapy and increased revasculariza3on rates Ini3al CTA strategy compared to func3onal imaging had similar and low clinical outcomes but was associated with a lower rate of invasive catheteriza3on without obstruc3ve CAD Radia3on is lower than nuclear imaging and falling rapidly with newer genera3on scanners

20 Pre- opera3ve Risk Evalua3on FUNCTIONAL( ( Persan'ne(Sestamibi/ Thallium( ( Dobutamine( Echocardiography( ( ANATOMIC( ( Coronary(CT( Angiography( ( To adequately inform the risk of noncardiac surgery Clinical risk predic3on: Revised cardiac risk index) simple and widely used By detecting ischemic myocardium or the extent of coronary stenoses, imaging modalities may improve peri-op risk prediction Few rigourously conducted studies Non- invasive cardiac imaging performed prior to 8% of all intermediate to high risk surgeries in Ontario ( ) Wijesundera BMJ 2010;340:b5526

21 First large peri- op imaging study to blind imaging findings to avoid change in pre- op or peri- opera3ve management rou3nely measure of troponins to detect asymptoma3c MI observe enough clinical events to determine the incremental value of imaging variables over clinical risk es3ma3on Enrolled 955 pa3ents who had CTA and noncardiac surgery BMJ, 2015

22 Clinical Risk Predic3on The Revised Cardiac Risk Index simple, validated, and accepted tool to assess periopera3ve risk of major cardiac complica3ons high- risk type of surgery (suprainguinal vascular, intraperitoneal, or intrathoracic surgery history of ischemic heart disease, history of conges3ve heart failure, history of cerebrovascular disease, preopera3ve treatment with insulin preopera3ve serum crea3nine >170mmol/L

23 CTA provided independent predic3on beyond clinical variables

24 Risk Reclassifica3on 16 Pa3ents Had Risk Increased 94 Pa3ents Had Risk Increased Net effect of CTA is to overes3mate risk Nega3ve consequences: cancella3on/delay of surgery, unnecessary pre- op inves3ga3ons

25 Conclusion Pre- op imaging with CCTA is not recommended Whether similar risk overes3ma3on occurs with pre- opera3ve func3onal imaging is unclear Requires prospec3ve well conducted trials