Cardiology SymposiumCardiology Symposium

James T. DeVries, MDJames T. DeVries, MDAssistant Professor of MedicineAssistant Professor of Medicine

Dartmouth Medical SchoolDartmouth Medical SchoolDartmouth-Hitchcock Medical Dartmouth-Hitchcock Medical

CenterCenter

No disclosure or conflictsNo disclosure or conflicts

OutlineOutline

• What is new with revascularization?What is new with revascularization?• Bypass surgery (CABG) versus coronary stents Bypass surgery (CABG) versus coronary stents

(PCI)(PCI)

• New technologies in the pipeline- ready New technologies in the pipeline- ready for primetime?for primetime?

• Aortic valve replacement without opening the Aortic valve replacement without opening the chestchest

• Stroke therapyStroke therapy

Coronary Artery DiseaseCoronary Artery Disease

• Heart disease is the #1 killer in the USHeart disease is the #1 killer in the US• We are diagnosing heart disease more We are diagnosing heart disease more

frequently due to better testing, improved frequently due to better testing, improved sensitivity and increased awarenesssensitivity and increased awareness

• As a nation, we have too much obesity As a nation, we have too much obesity and lack of physical activity, risk factors and lack of physical activity, risk factors for the development of coronary artery for the development of coronary artery diseasedisease

How do we best treat heart How do we best treat heart disease?disease?

• Medical therapy?Medical therapy?• Coronary stents (PCI)?Coronary stents (PCI)?• Bypass surgery (CABG)?Bypass surgery (CABG)?

+Angina reliefAngina relief+ReducedReduced

re-interventionre-intervention+CompleteComplete

revascularizatirevascularizationon

­ High costsHigh costs­ InvasiveInvasive

+Cost effective Cost effective +Fast recoveryFast recovery+Reduced acute Reduced acute

complicationscomplications

- Increased Increased restenosisrestenosis

- Repeat Repeat revascularizatirevascularizationon

P C I C A B G

The pros and cons of CABG historically outweighed those of PCI

CABG & PCI: Historical Pro CABG & PCI: Historical Pro & Cons& Cons

Evolution of Evolution of RevascularizationRevascularization

+Off pump Off pump techniquetechnique

+Less invasive Less invasive approachapproach

+Increased Increased arterialarterialrevascularizatirevascularizationon

+Optimal Optimal perioperative perioperative monitoringmonitoring

+Improved Improved techniquetechnique

+Improved Improved stent designstent design

+DESDES P C IC A B G

­ High costsHigh costs­ InvasiveInvasive­ Recovery Recovery

timetime

- Increased Increased restenosisrestenosis

- Repeat Repeat revascularizationrevascularization

?

Over the last decade, the standard of care for both CABG and PCI has continuously improved, leveling the playing field.

CABG vs PCI TrialsCABG vs PCI TrialsResults SummaryResults Summary

• TrialTrial

• Clinical ParametersClinical Parameters

AngiograpAngiographic hic

EndpoinEndpointsts

Cost Cost AssessmeAssessme

ntntMortality & Mortality &

MIMIAngina Angina

ReliefRelief

Repeat Repeat RevasculariRevasculari

zationzation

GABIGABIPCIPCI PCIPCI CABGCABG No No

differencdifferencee

n/an/a

EASTEAST No differenceNo difference CABGCABG CABGCABG CABGCABG PCIPCI

RITARITA No differenceNo difference CABGCABG CABGCABG n/an/a n/an/a

ERACIERACI No differenceNo difference CABGCABG CABGCABG n/an/a PCIPCI

CABRICABRI No differenceNo difference CABGCABG CABGCABG n/an/a n/an/a

BARIBARI No differenceNo difference n/an/a CABGCABG n/an/a n/an/a

MASS-2MASS-2CABG (MI)CABG (MI) n/an/a CABGCABG n/an/a No No

differendifferencece

AWESOMAWESOMEE

No differenceNo difference No No differencedifference

CABGCABG n/an/a n/an/a

ERACI-2ERACI-2PCIPCI n/an/a CABGCABG CABGCABG No No

differendifferencece

SoSSoS CABG CABG (Mortality)(Mortality)

CABGCABG CABGCABG n/an/a n/an/a

ARTSARTS No differenceNo difference n/an/a CABGCABG n/an/a PCIPCI

Superior Treatment ModalityNo stents used

Stents used CABG No differencePCI

­

­

Significant decrease of

revascularization expected with DES

RepeatRevascularization

TAXUS

I

TAXUS

II

Mean stent length [mm]

E-SI

RIUS

SIRIU

S

TAXUS

IV

C-SIR

IUS

Lesi

on

Com

ple

xit

y [

% C

Typ

e]

RAVEL

Complex Lesions

LongStented lengths

TAXUS

VI

TAXUS

V

QCA long lesion breakdown pending

Drug Eluting Stent TrialsDrug Eluting Stent Trials

… expanding lesion & procedural complexity with randomized trials

Arterial Revascularization Therapies Arterial Revascularization Therapies Part II: a non-randomized comparison Part II: a non-randomized comparison

of contemporary PCI and coronary of contemporary PCI and coronary artery bypass grafting (CABG) in artery bypass grafting (CABG) in

patients with multi-vessel coronary patients with multi-vessel coronary artery lesionsartery lesions

ARTS-II TrialARTS-II TrialARTS-II TrialARTS-II Trial

Sirolimus-eluting stent3.7­stents­per­patient

Avg­total­length:­73­mmn­=­607

Sirolimus-eluting stent3.7­stents­per­patient

Avg­total­length:­73­mmn­=­607

ARTS-II TrialARTS-II TrialHistorical Controls from ARTS I: 1202

patients with multivessel coronary lesions 18.2%­diabetic

28%­3­vessel­disease7.5%­type­C­lesions

Historical Controls from ARTS I: 1202 patients with multivessel coronary lesions

18.2%­diabetic28%­3­vessel­disease7.5%­type­C­lesions

607 patients with multivessel coronary lesions

26.2%­diabetic54%­3­vessel­disease13.9%­type­C­lesions

607 patients with multivessel coronary lesions

26.2%­diabetic54%­3­vessel­disease13.9%­type­C­lesions

CABG

n­=­602

CABG

n­=­602

Bare Metal Stent2.8­stents­per­patient

Avg­total­length:­48­mmn­=­600

Bare Metal Stent2.8­stents­per­patient

Avg­total­length:­48­mmn­=­600

Endpoints: Primary –­Major­adverse­cardiac­and­cerebrovascular­events­(MACCE),­including­

death,­cerebrovascular­event,­myocardial­infarction,­and­revascularization,­ at­1­year­for­the­comparison­of­CABG­treated­patients­in­the­ARTS­I­trial­ with­sirolimus-eluting­stent­patients­in­the­ARTS­II­trial

Secondary­ –­MACCE­at­30­days,­6­months,­3­and­5­years.

­­­ –­Total­cost­at­30­days

–­Cost,­cost­effectiveness,­quality­of­life­at­six­mo,­and­1,­3,­and­5­years

Endpoints: Primary –­Major­adverse­cardiac­and­cerebrovascular­events­(MACCE),­including­

death,­cerebrovascular­event,­myocardial­infarction,­and­revascularization,­ at­1­year­for­the­comparison­of­CABG­treated­patients­in­the­ARTS­I­trial­ with­sirolimus-eluting­stent­patients­in­the­ARTS­II­trial

Secondary­ –­MACCE­at­30­days,­6­months,­3­and­5­years.

­­­ –­Total­cost­at­30­days

–­Cost,­cost­effectiveness,­quality­of­life­at­six­mo,­and­1,­3,­and­5­years

ARTS II: Event free ARTS II: Event free survival survival

96.9%91.5% 89.5%90.7%

78.1%73.7%

92.0%95.9%

88.5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

110%

Survival free fromdeath/CVE/MI

Survival free fromreintervention

Survival free from MACE

ARTS II: DES ARTS I: BMS ARTS I: CABG

96.9%91.5% 89.5%90.7%

78.1%73.7%

92.0%95.9%

88.5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

110%

Survival free fromdeath/CVE/MI

Survival free fromreintervention

Survival free from MACE

ARTS II: DES ARTS I: BMS ARTS I: CABG

p­=­<0.001p­=­0.003 p­=­0.46

ARTS II: MACCE at ARTS II: MACCE at one year one year

10.4%

26.5%

11.6%

0%

5%

10%

15%

20%

25%

ARTS II ARTS I: BMS ARTS I: CABG

10.4%

26.5%

11.6%

0%

5%

10%

15%

20%

25%

ARTS II ARTS I: BMS ARTS I: CABG

Overall MACCE at 1 year

•­At­1­year,­there­was­no­difference­in­the­incidence­of­MACCE­between­the­ARTS­II­SES­group­and­the­ARTS­I­CABG­group.­­

•­­The­ARTS­I­bare­metal­stent­group­was­associated­with­a­significantly­higher­rate­of­1­year­MACCE­compared­to­the­other­groups

ARTS II: ARTS II: components of components of

MACCE MACCE

1.0% 0.8% 1.2%2.0%

5.4%

2.7%1.8%

5.0% 4.7%

12.3%

2.7%1.8%

3.5%

7.0%

3.0%

0%1%2%3%4%5%6%7%8%9%

10%11%12%13%14%

death CVE MI CABG PCI

ARTS II ARTS I: BMS ARTS I: CABG

1.0% 0.8% 1.2%2.0%

5.4%

2.7%1.8%

5.0% 4.7%

12.3%

2.7%1.8%

3.5%

7.0%

3.0%

0%1%2%3%4%5%6%7%8%9%

10%11%12%13%14%

death CVE MI CABG PCI

ARTS II ARTS I: BMS ARTS I: CABG

%

ACC 2005ACC 2005

p=NSp=NS

p=NS p=NS

ARTS II: SummaryARTS II: Summary• Among patients with multivessel coronary lesions, patients Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG.equivalent to patients from the same registry treated with CABG.

• The majority of the difference in MACCE between the ARTS II The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of CABG group, despite having increased length and complexity of lesions. lesions.

• Among patients with multivessel coronary lesions, patients Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG.equivalent to patients from the same registry treated with CABG.

• The majority of the difference in MACCE between the ARTS II The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of CABG group, despite having increased length and complexity of lesions. lesions.

Syntax Overall Study GoalSyntax Overall Study Goal• To provide real-world answers to these To provide real-world answers to these

questions in order to develop new guidelines questions in order to develop new guidelines for the beginning of the 21for the beginning of the 21stst century. This century. This goal requires a novel study approach:goal requires a novel study approach:

allcomer study instead of highly selected patient population

consensus physician decision (surgeon & cardiologist) instead of inclusion & exclusion criteria

nested registry for CABG only and PCI only patients to capture patient characteristics and outcomes

Eligible Study PopulationEligible Study Population

left­main­+1-vessel­disease

left­main­+­2-vessel­disease­

3-vessel­disease

left­main­+3-vessel­disease

Question of optimal treatment approach? new disease

Isolatedleft­main

•­Previous­interventions­(PCI­or­CABG)­excluded­•­Acute­MI­with­CK>2x•­Concomitant­valve­surgery

Revascularization­inall­3­vascular­territories

Patient FlowPatient Flow

• define CABG only population (2750 pts)

• define PCI only population (50 pts)• Establish profiles of non

randomizable patients and their outcomes

amenable for ≤1 interventional treatment

TAXUS CABGvs

Patients with de novo 3-vessel-disease and/or left main disease

screening

Local Heart Team (surgeon and interventionalist)

registration

Randomize 1500 pts

Registries

amenable for both treatments options

Multi-center randomized controlled trial

• TAXUS DES non inferior to CABG for 12 months binary MACCE rate

MACCEPost-allocation/procedure to 5 years

Follow Up and Data Follow Up and Data CollectionCollection

Multi-center randomized controlled trial

Registries CABG only

750 ptsRandomly

selected out of approx.>2750 pts

PCI only<50 pts

Baseline data

QOL & Costs Baseline to 5 years

PCI750 pts

CABG750 pts

SYNTAX Results- 1 Year SYNTAX Results- 1 Year

End PointEnd Point CABGCABG StentStent p valuep value

RevascularizatioRevascularizationn

5.9%5.9% 13.7%13.7% 0.0010.001

Death/MI/StrokeDeath/MI/Stroke 7.6%7.6% 7.7%7.7% NSNS

StrokeStroke 2.2%2.2% 0.6%0.6% 0.0010.001

MIMI 3.2%3.2% 4.8%4.8% NSNS

The Bottom LineThe Bottom Line

• Choice between CABG and PCI is complex, Choice between CABG and PCI is complex, and depends on patient factors as well as and depends on patient factors as well as technical considerationstechnical considerations

• CABG tends to have less revascularizationCABG tends to have less revascularization• There is no “one size fits all” approachThere is no “one size fits all” approach• Discussion regarding the pro’s and cons of Discussion regarding the pro’s and cons of

each approach is importanteach approach is important

Communication is Communication is Important!Important!

Future Tech-Future Tech-Coming to a cath lab near you!Coming to a cath lab near you!

Aortic Valve Replacement-Aortic Valve Replacement-Without Surgery!Without Surgery!

Aortic StenosisAortic Stenosis• Common cause of Common cause of

cardiovascular cardiovascular morbidity and mortality, morbidity and mortality, particularly in the particularly in the elderlyelderly

• Narrowing of aortic Narrowing of aortic valve results in valve results in increased work load on increased work load on the heartthe heart

• Symptoms include Symptoms include shortness of breath, shortness of breath, chest pain, and passing chest pain, and passing out (syncope)out (syncope)

• Currently, only open Currently, only open heart surgery with valve heart surgery with valve replacement can correct replacement can correct this problemthis problem

Aortic Valve ReplacementAortic Valve Replacement

Percutaneous Aortic ValvePercutaneous Aortic Valve

Percutaneous Aortic ValvePercutaneous Aortic Valve

Technique for InsertionTechnique for Insertion

Aortic ValvuloplastyAortic Valvuloplasty

Stroke TherapyStroke Therapy

Stroke StatisticsStroke Statistics• There are over 700,000 strokes per year in the There are over 700,000 strokes per year in the

USUS

• Stroke is the leading cause of adult disability Stroke is the leading cause of adult disability and the third most common cause of deathand the third most common cause of death

• The vast majority of strokes result from The vast majority of strokes result from blockage in the arteries of the brainblockage in the arteries of the brain

• The risk factors for stroke are the same as the The risk factors for stroke are the same as the risk factors for coronary heart diseaserisk factors for coronary heart disease

• Treatment of strokes is limited, consisting Treatment of strokes is limited, consisting mostly of supportive caremostly of supportive care

Stroke TherapyStroke Therapy

• Intravenous thrombolytic (“clot buster”) is the Intravenous thrombolytic (“clot buster”) is the only currently approved therapy for strokeonly currently approved therapy for stroke

• Must be given within 3 hours of onset of Must be given within 3 hours of onset of symptomssymptoms

• Less effective in large strokes, risk of bleeding Less effective in large strokes, risk of bleeding into the braininto the brain

• Nationwide, it is used in less than 3% of strokesNationwide, it is used in less than 3% of strokes

Stroke TherapyStroke Therapy

• Increasing interest in catheter-based Increasing interest in catheter-based therapies for acute stroketherapies for acute stroke

• Mechanically “open” the artery with Mechanically “open” the artery with devices, pull out the clotdevices, pull out the clot

• Stroke teams are integral part of this Stroke teams are integral part of this therapy, available 24/7 for rapid therapy, available 24/7 for rapid activationactivation

• Many similarities to treating heart attackMany similarities to treating heart attack

Case ExampleCase Example• 49 yo mother of three presents with ride 49 yo mother of three presents with ride

sided paralysis, inability to speak, onset 1 sided paralysis, inability to speak, onset 1 hour priorhour prior

• Given thrombolytic drugs and transferredGiven thrombolytic drugs and transferred

• Remained with dense paralysis, inability to Remained with dense paralysis, inability to speak 2 hours laterspeak 2 hours later

• Brought to angiographyBrought to angiography

Case Case

• Immediately recovered partial use of Immediately recovered partial use of right hand and footright hand and foot

• Talking the following dayTalking the following day

• Was discharged to home 3 days later Was discharged to home 3 days later with mild right sided weakness, but with mild right sided weakness, but speech intactspeech intact

Technology is not always Technology is not always easy…..easy…..

SummarySummary

• What we can do through catheters is What we can do through catheters is increasing every dayincreasing every day

• Many trials ongoing to determine the Many trials ongoing to determine the best therapy for stroke and heart best therapy for stroke and heart diseasedisease

• Stay tuned!Stay tuned!