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Paul Teirstein MD

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<strong>Paul</strong> <strong>Teirstein</strong>, <strong>MD</strong><br />

Disclosures:<br />

Cordis, Boston, Medtronic, Abbott:<br />

Research Grants<br />

Consultant<br />

Speakers Bureau<br />

SCRIPPS CLINIC


Ahh….the benefit of hindsight<br />

<strong>Paul</strong> <strong>Teirstein</strong>, <strong>MD</strong><br />

Chief of Cardiology<br />

Director of Interventional Cardiology<br />

Scripps Clinic<br />

La Jolla, California<br />

SCRIPPS CLINIC


A Bold New Era In Cardiovascular<br />

Disease<br />

We need bold new lectures.<br />

•Lectures that go deeper, ie “Ahh….the<br />

benefit of hindsight”<br />

•Modern speakers now stress EMOTION<br />

over CONTENT<br />

•They tell us how they feel, not what they<br />

think!<br />

SCRIPPS CLINIC


“Ahh….the benefit of hindsight”<br />

Ideas for future lectures:<br />

• Phew….that data smells awfully fishy to me<br />

• Expletive deleted! My hospital administrators are killing<br />

me<br />

• Blah…another one of my papers got rejected<br />

• Wow!...that was a great case<br />

• Yuck!.....got burned by another stent thrombosis<br />

• Ahhh….the benefit of foresight<br />

• Since foresight only becomes apparent in hindsight,<br />

you cant have foresight without hindsight.<br />

SCRIPPS CLINIC


“The farther backward you can look, the farther forward you are<br />

likely to see."<br />

---Winston Churchill<br />

SCRIPPS CLINIC


“Ahh….the benefit of<br />

hindsight”<br />

“Benefit of hindsight” is really a<br />

chance to talk about mistakes<br />

Mistakes:<br />

• Inadequate response to the COURAGE trial<br />

• Our erroneous referral of too many patients to bypass<br />

surgery<br />

• Mistakes I have made in the cath lab<br />

• Mistakes I have made in my career and my life<br />

SCRIPPS CLINIC


Mistake #1<br />

COURAGE trial results<br />

should have been more<br />

forcefully refuted<br />

SCRIPPS CLINIC


Homicide: n. The killing of one person by another<br />

• Criminal Homicide:<br />

• Murder first degree: Premeditation, intent<br />

• Murder Second degree: intent, no premeditation<br />

• Manslaughter 1 st degree (voluntary manslaughter):<br />

• Intent, heat of passion, a reasonable person is provoked to kill<br />

• Manslaughter 2 nd degree (involuntary manslaughter or negligent homicide):<br />

• No intent, but did not act with the care and caution of a reasonable<br />

person (ie kicking brick off bridge that hits someone below)<br />

• Reckless homicide – aware of risk but does not care, ie driving<br />

recklessly at 90 MPH<br />

• Non-Criminal homicide<br />

• Justifiable homicide – kill to protect yourself, police officer killing in the<br />

line of duty,<br />

• Accidental homicide: A lawful act done under a reasonable belief that no<br />

harm is possible


Harmonizing Outcomes with Revascularization and Stents in AMI<br />

≥3400* pts with STEMI with symptom onset ≤12 hours<br />

Aspirin, thienopyridine<br />

UFH + GP IIb/IIIa inhibitor<br />

(abciximab or eptifibatide)<br />

R<br />

1:1<br />

Bivalirudin monotherapy<br />

(± provisional GP IIb/IIIa)<br />

Emergent angiography, followed by triage to…<br />

CABG –<br />

Primary PCI<br />

–<br />

Medical Rx<br />

3000 pts eligible for stent randomization<br />

R<br />

1:3<br />

Bare metal stent<br />

TAXUS paclitaxel-eluting stent<br />

*To rand 3000 stent pts<br />

Clinical FU at 30 days, 6 months,<br />

1 year, and then yearly through 5 years


Mortality (%)<br />

1-Year Mortality: Cardiac and Non Cardiac<br />

Excess deaths 3 =<br />

2.9%<br />

30<br />

Number at risk<br />

Bivalirudin alone<br />

Heparin+GPIIb/IIIa<br />

5<br />

Mortality =<br />

4<br />

68 vs 38 pts<br />

2<br />

1<br />

0<br />

Bivalirudin alone (n=1800)<br />

Heparin + GPIIb/IIIa (n=1802)<br />

1.8%<br />

Time in Months<br />

HR [95%CI] =<br />

0.57 [0.38, 0.84]<br />

P=0.005<br />

Cardiac<br />

Δ = 1.1%<br />

P=0.03<br />

Non Cardiac<br />

1.3%<br />

1.1%<br />

0 1 2 3 4 5 6 7 8 9 10 11 12<br />

1800 1705 1684 1669 1520<br />

1802 1678 1663 1646 1486<br />

3.8%<br />

Δ = 1.7%<br />

2.1%


Homicide: n. The killing of one person by another<br />

• Criminal Homicide:<br />

• Murder first degree: Premeditation, intent<br />

• Murder Second degree: intent, no premeditation<br />

• Manslaughter 1 st degree (voluntary manslaughter):<br />

• Intent, heat of passion, ie provoked to kill<br />

• Manslaughter 2 nd degree (involuntary manslaughter or negligent<br />

homicide):<br />

• No intent, but did not act with the care and caution of a reasonable<br />

person (ie kick brick off bridge)<br />

• Reckless homicide – aware of risk but doesn‟t care,ie driving<br />

recklessly at 90 MPH<br />

• Non-Criminal homicide<br />

• Justifiable homicide – kill to protect yourself, police officer killing<br />

in the line of duty,<br />

• Accidental homicide: A lawful act done under a reasonable belief<br />

that no harm is possible


Hypothetical trial<br />

The HOLIE CHUTE trial<br />

Group A<br />

Group B<br />

Primary endpoint = Mortality<br />

Inexpensive trial<br />

Expected 90% relative risk; 40 pts provides power 0.90, alpha < 0.05<br />

DSMB halts trial early because of excess deaths in treatment group B


Homicide: n. The killing of one person by another<br />

• Criminal Homicide:<br />

• Murder first degree: Premeditation, intent<br />

• Murder Second degree: intent, no premeditation<br />

• Manslaughter 1 st degree (voluntary manslaughter):<br />

• Intent, heat of passion, ie provoked to kill<br />

• Manslaughter 2 nd degree (involuntary manslaughter or negligent<br />

homicide):<br />

• No intent, but did not act with the care and caution of a reasonable<br />

person (ie kick brick off bridge)<br />

• Reckless homicide – aware of risk but doesn‟t care,ie driving<br />

recklessly at 90 MPH<br />

• Non-Criminal homicide<br />

• Justifiable homicide – kill to protect yourself, police officer killing<br />

in the line of duty,<br />

• Accidental homicide: A lawful act done under a reasonable belief<br />

that no harm is possible


COURAGE: Clinical Outcomes Utilizing<br />

Revascularization and Aggressive<br />

Guideline-Driven Drug Evaluation<br />

Boden W et al. NEJM 2007;356:1503-16.


COURAGE: Inclusion Criteria<br />

• Pts must have angiographically confirmed single<br />

or multivessel CAD (>70%) and objective<br />

evidence of ischemia<br />

• - LAD: prox or mid<br />

• - RCA: prox to PDA<br />

• - LCx: prox to PDA/PL<br />

• Pts with classic angina, >80% lesion, without<br />

documented objective ischemia


COURAGE: Exclusion Criteria<br />

The very highest CLINICAL risk patients were excluded<br />

• Unstable angina<br />

• CCS class IV angina refractory to medical therapy<br />

• Markedly abnormal stress test<br />

• Substantial STD or hypotensive response during Bruce I<br />

• Revascularization within the last 6 months<br />

• Unprotected LM stenosis (>50%)<br />

• Refractory heart failure or cardiogenic shock<br />

• Severe LV dysfunction (EF


52 year old<br />

business<br />

executive,<br />

diabetic with<br />

class II angina.<br />

Adenosine<br />

perfusion scan<br />

shows lateral<br />

wall ischemia.<br />

© Cordis Corporation 2007 19


55 yo male<br />

with class II<br />

angina and<br />

anterior<br />

ischemia


65 yo male<br />

with two<br />

episodes of<br />

angina;<br />

TMT found<br />

ST<br />

depression<br />

laterally


70 yo male<br />

with Class II<br />

angina,<br />

stress test:<br />

mild anterior<br />

ischemia<br />

and LAD<br />

lesions 60-<br />

70%; By IVUS<br />

they are both<br />

< 4.0 mm;<br />

© Cordis Corporation 2007 22


77 yo male with<br />

class 3 angina,<br />

abnormal nuclear<br />

study<br />

© Cordis Corporation 2007 23


Where high risk angiographic lesions included in<br />

COURAGE?<br />

Local Heart team (surgeon &<br />

interventional cardiologist) assessed<br />

each patient in regards to:<br />

Patient’s operative risk (EuroSCORE & Parsonnet<br />

score)<br />

Coronary lesion complexity (newly developed<br />

SYNTAX score)<br />

– The goal of the SYNTAX score is to provide a<br />

tool to assist physicians in their<br />

revascularization strategies for patients with<br />

high risk lesions<br />

Calcification<br />

Thrombus<br />

Dominance<br />

Bifurcation<br />

Tortuosity<br />

Number &<br />

location of<br />

lesions<br />

SYNTAX<br />

score<br />

Left Main<br />

3 Vessel<br />

Total<br />

Occlusion<br />

Sianos et al, EuroIntervention 2005;1:219-227<br />

Valgimigli et al, Am J Cardiol 2007;99:1072-1081<br />

Serruys et al, EuroIntervention 2007;3:450-459<br />

Coronary tree segments based on the classification proposed by the AHA<br />

and modified for the ARTS study Circulation 1975; 51:31-3 & Semin Interv<br />

Cardiol 1999; 4:209-19<br />

Leaman score, Circ 1981;63:285-299<br />

Lesions classification ACC/AHA , Circ 2001;103:3019-3041<br />

Bifurcation classification, CCI 2000;49:274-283<br />

CTO classification, J Am Coll Cardiol 1997;30:649-656


COURAGE: Enrollment<br />

35,539 pts screened<br />

3071 pts eligible<br />

784 (26%) consent not given by <strong>MD</strong> or patient<br />

2287 pts consented<br />

All patients had angiography.<br />

32,468 Were excluded<br />

8677 Did not meet inclusion criteria<br />

5155 Had undocumented ischemia<br />

3961 Did not meet protocol for vessels<br />

6554 Were excluded for logistic reasons<br />

18,360 Had one or more exclusions<br />

4513 Had recent (50%<br />

722 Had only restenosis (no new lesions)<br />

528 Had complications after MI<br />

A lot of patients were excluded.<br />

PCI (n=1149)<br />

Medical (n=1138)<br />

Were the patients who were at high risk for death<br />

and MI Mean excluded? follow-up 4.6 yrs


% of Patients<br />

Hard Endpoints at 4.6 Years<br />

40%<br />

P


COURAGE Myths<br />

Peterson and Rumsfeld, NEJM 359;7, 751-752 accompanying<br />

COURAGE QOL manuscript in NEJM<br />

• „COURAGE trial patients were not low risk.‟<br />

•Diabetics 34%<br />

•Heart failure 5%<br />

•Multivessel disease 70%<br />

• No, no, no…….this is high risk<br />

....yada, yada, yada<br />

SCRIPPS CLINIC


Courage Myths<br />

Peterson and Rumsfeld, NEJM 359;7, 751-752 accompanying<br />

COURAGE QOL manuscript in NEJM<br />

• “Although the majority of patients who received<br />

optimal medical therapy alone had improved<br />

symptoms within 3 months, 21% crossed over and<br />

received PCI.”<br />

•Actually, 32.6% of OMT patients crossed over to PCI<br />

• “Thus, a very reasonable „take-home‟ message from<br />

the COURAGE trial is to pursue optimal medical<br />

therapy initially and if this is ineffective, turn to PCI”<br />

• No mention of importance of angiography to risk stratify<br />

• 1/3 patients will get an extra procedure<br />

SCRIPPS CLINIC


Courage Myths<br />

Cost-Effectiveness of Percutatneous Coronary Intervention in Optimally<br />

Treated Stable Coronary Patients<br />

---Weintraub et al Circ Cardiovasc Qual Outcomes. 2008;1:12-30<br />

Item PCI + medical Medical only PCI - Medical<br />

Initial Cost $12,162 $752 $11,410<br />

Lifetime Cost $99,820 $90,370 $9,451<br />

But…the cost of diagnostic angiography was not included in the<br />

medical only arm.<br />

If the cost of the qualifying angiogram where included in the medical<br />

arm, the cost differences would be mitigated.<br />

Thus, the myth of COURAGE is perpetuated , i.e: “Angiography is not<br />

required for patients with stable angina”<br />

SCRIPPS CLINIC


How Has the COURAGE Trial Changed<br />

My Practice?<br />

LESSONS I HAVE LEARNED:<br />

• You don‟t have to stent every little blockage in every<br />

little vessel<br />

• Fix the major, ischemia producing lesions<br />

• Leave the small, distal, sidebranch vessels alone<br />

unless the patient has recalcitraint angina<br />

SCRIPPS CLINIC


Why such controversy? Are there two<br />

different cardiologist phenotypes?<br />

• We all agree medical therapy should be used in<br />

most patients to reduce death and MI<br />

• Anti-thrombotics, lipid lowering, beta blockers and ACE<br />

inhibitors<br />

• We disagree about how to control angina. Here,<br />

cardiologists have emotionally charged differences<br />

of opinion:<br />

•Aggressive anti-anginal medications versus<br />

revascularization<br />

SCRIPPS CLINIC


an oxygen molecule: O 2


Revascularization Therapy For Angina:<br />

Open the artery<br />

Stents increase oxygen supply<br />

YOUR HEART VESSELS EXPAND!<br />

The Liberated Heart


Medical Therapy For Angina:<br />

Beta-blockers, Nitrates,<br />

Decrease Oxygen Demand<br />

YOUR HEART IS<br />

IN 4 POINT<br />

RESTRAINTS!<br />

The Repressed Heart<br />

42


Think About It! Are you…<br />

• Are you a demand cutting cardiologist who wants<br />

to repress the heart?<br />

• Or<br />

• Are you a supply expanding cardiologist who wants<br />

to liberate the heart?<br />

SCRIPPS CLINIC


What‟s Your Phenotype?<br />

THE HEART<br />

REPRESSOR?<br />

•THE HEART<br />

LIBERATOR?<br />

SCRIPPS CLINIC


Mistake #2<br />

We should be more<br />

aggressively against CABG,<br />

especially when it involves<br />

SVGs<br />

SCRIPPS CLINIC


PCI Vs CABG: New Vs Old Technology<br />

1,100,000<br />

800,000<br />

500,000<br />

920,000<br />

770,000 810,000 850,000<br />

542,000<br />

514,000<br />

485,000<br />

1,092,000<br />

1,030,000 1,037,000<br />

980,000<br />

Angioplasty<br />

Bypass Surgery<br />

200,000<br />

395,000<br />

305,000 299,500 296,000 289,000<br />

2000 2001 2002 2003 2004 2005 2006 2007<br />

© Cordis Corporation 2007 46<br />

Sources: Cordis Database, Morgan Stanley


POD #1 after multi vessel revascularization:<br />

OLD technology<br />

POD #1 after multi vessel revascularization:<br />

NEW technology<br />

47


The Interventionalist‟s View of Bypass Surgery<br />

What do I like about bypass surgery?<br />

• Left internal mammary<br />

What do I dislike about bypass surgery?<br />

• Morbidity of the procedure<br />

• Saphenous vein grafts<br />

• Acceleration of underlying native coronary disease<br />

SCRIPPS CLINIC


Impact of increased sheer<br />

stress on native disease<br />

progression<br />

52


Percent of Native Arteries with Progression<br />

----- Cosgrove et al. Cleveland Clinic; J Thorac and Cardiovasc Surg 82:520-530, 1981<br />

100<br />

80<br />

60<br />

Less than 1 year<br />

1 to 2 years<br />

Greater than 2 years<br />

40<br />

20<br />

0<br />

20% decrease in MLD) of atherosclerosis in native vessels was<br />

accelerated by vein grafts and occurred in over 50% of native vessels within 2 years 53<br />

of surgery


Effect of Coronary Artery Bypass Grafting on Native<br />

Coronary Artery Stenosis<br />

----Hamada, Y. et al. Journal of Cardiovascular Surgery 2001; 42: 159-164<br />

40%<br />

30%<br />

20%<br />

p = 0.016<br />

35%<br />

10%<br />

0%<br />

8%<br />

IMA<br />

SVG<br />

35% of native coronaries bypassed with a vein graft<br />

progressed to total occlusion by 5 month angiography


Risk Factors for<br />

Acceleration of Coronary Disease<br />

• Smoking<br />

• Hypertension<br />

• LDL cholesterol<br />

• Obesity<br />

• Sedentery life style<br />

• Bypass surgery<br />

•especially saphenous vein graft implantation<br />

SCRIPPS CLINIC


The most frequently implanted<br />

surgical graft in the U.S. is still a<br />

saphenous vein…<br />

and after a few years, it‟s not a pretty<br />

site!


2006 Isolated CABG Data:<br />

Society of Thoracic Surgeons STS<br />

• 156,128 patients with isolated CABG<br />

•LIMA = 88.2%<br />

•Bilateral IMA = 4.4%<br />

•Radial artery = 7.7%<br />

---- 2006 STS database<br />

Bilateral IMA = 27.6%<br />

---- SYNTAX<br />

SCRIPPS CLINIC


By 5 years, vein graft patency was less than 40%. It was even worse for radial<br />

artery conduits and not much better for RIMAs!<br />

----Khot UN et al. Cleveland Clinic, Circulation. 2004;109:2086-91.<br />

Cumulative patency (


A contemporary study (2002-2003), 73%<br />

received statins, 90% received aspirin!


1,820 (81%) patients underwent 12 month angiography


By 12 months ¼ of SVG‟s are occluded; 40% of<br />

patients had at least one occluded SVG<br />

At 1 year ITA failure was less frequent than SVG failure 8% Vs 29%


Vein graft failure profoundly increased death, MI<br />

and revascularization<br />

Saphenous vein graft failure<br />

+ Native disease acceleration<br />

= A very difficult day for the<br />

Interventional cardiologist!


Example: The Graft Dependent Patient<br />

• The graft dependent patient was not graft<br />

dependent before surgery.<br />

• He is graft dependent because of surgery


Three Great Myths of Cardiac Surgery<br />

• Myth # 1: “Cardiologists do not obtain informed consent<br />

from patients prior to multivessel PCI.”<br />

•No surgical consultation obtained<br />

•Risk of restenosis not disclosed<br />

• How many cardiac surgeons do you know who inform<br />

patients that their saphenous vein graft only have about a<br />

50% chance of patency within 5 years?<br />

• How many cardiac surgeons do you know who inform<br />

patients that their underlying native vessel disease will<br />

accelerate due to SVG bypass, making their overall<br />

coronary diseased burden much worse when the SVG<br />

occludes?<br />

SCRIPPS CLINIC


AWESOME 454 5<br />

MASS-II* 408 1<br />

SOS 988 2<br />

ARTS 1,205 1<br />

ERACI-II* 450 2.5<br />

BARI* 1,829 10<br />

EAST 392 8<br />

CABRI 1,054 4<br />

GABI 359 1<br />

ERACI* 127 3<br />

RITA* 1,011 6.5<br />

Total 8,258<br />

PCI vs CABG<br />

Mortality<br />

Pt F-U Odds ratio<br />

(no.) (yr) 95% Cl<br />

.1 1 10<br />

PCI<br />

CABG<br />

better<br />

Hazard*/risk ratios<br />

better<br />

Holmes DR Jr., Berger PB: Complex Intervention. Textbook of Interventional Cardiology, 4th<br />

Edition, Topol EJ, editor. 2003:201-22.


One-year Rates of Repeat Revascularization in 4<br />

CABG vs. Stent Assisted PCI Trials<br />

Mercado et al, J thoracic Cardiovasc Surg, 2005


Rate (%)<br />

SYNTAX<br />

One Year Clinical Outcomes<br />

20<br />

15<br />

10<br />

5<br />

0<br />

P=0.0015*<br />

12.1<br />

17.8<br />

P=0.98<br />

7.7<br />

CABG (N=897)<br />

7.6<br />

P=0.11<br />

P=0.37<br />

4.3 4.8<br />

3.5 3.2<br />

TAXUS (N=903)<br />

P=0.003<br />

2.2<br />

0.6<br />

P


Three Great Myths of Cardiac Surgery<br />

• Myth # 2: Target vessel revascularization rates are much<br />

higher following PCI compared to CABG<br />

SCRIPPS CLINIC


Repeat Revascularization Following CABG:<br />

Interpreting Clinical Trial Results<br />

• Several years post CABG, both the native vessel and SVG often<br />

progress to a total occlusion or diffuse disease resulting in limited<br />

options for PCI.<br />

• Given the high threshold for repeat bypass surgery (particularly in<br />

the presence of a patent LIMA graft), many post CABG patients are<br />

not offered repeat revascularization; not because they wouldn‟t<br />

benefit from re-intervention, but because the risks are prohibitive<br />

and the likelihood of success is low.<br />

• Thus, much of the relative increase in repeat revascularization<br />

following PCI observed in clinical trials is because the post PCI<br />

patient, in contradistinction to the post CABG patient, remains a<br />

good candidate for further revascularization.<br />

SCRIPPS CLINIC


What‟s missing from the PCI vs<br />

CABG trial data discussion?<br />

• Why does the debate seem to always focus on mortality<br />

and repeat revascularization?<br />

• Shouldn‟t we include morbidity endpoints?<br />

SCRIPPS CLINIC


Any above complication 53% 1%<br />

53% of CABG patients had a morbid complication compared to only 1%<br />

of DES patients


PREVENT 4<br />

JAMA 2005<br />

CABG + CABG +


Risk of Procedural Stroke<br />

PCI Vs CABG = 0.6% vs 1.2%, p = 0.002<br />

73


Rate (%)<br />

SYNTAX<br />

One Year Clinical Outcomes<br />

20<br />

15<br />

10<br />

5<br />

0<br />

P=0.0015*<br />

12.1<br />

17.8<br />

P=0.98<br />

7.7<br />

CABG (N=897)<br />

7.6<br />

P=0.11<br />

P=0.37<br />

4.3 4.8<br />

3.5 3.2<br />

TAXUS (N=903)<br />

P=0.003<br />

2.2<br />

0.6<br />

P


Three Great Myths of Cardiac Surgery<br />

• Myth # 3: Given differences in morbidity, bypass<br />

surgery can even be compared to PCI.<br />

• If my PCI patient has a pseudo aneurysm requiring<br />

surgical repair of the femoral artery, it is considered a<br />

major complication that I have to defend at M&M and QA<br />

committee. The untoward event is a small surgical<br />

incision in the groin.<br />

•All CABG patients have a major surgical incision in the<br />

chest. Therefore 100% of all CABG patients, by this<br />

definition, suffer a major complication as a result of<br />

their care plan.<br />

SCRIPPS CLINIC


Survival (%)<br />

3 VD with Disease of the Proximal LAD Artery<br />

100<br />

A thought experiment!<br />

95<br />

90<br />

85<br />

94.3<br />

92.0<br />

Number needed to treat = 20 pts<br />

91.5<br />

Start with 20 pts<br />

3 yrs post CABG = 18 pts left<br />

3 yrs post stenting = 17 pts left<br />

88.1<br />

CABG<br />

Stenting<br />

89.3<br />

84.4<br />

80<br />

0 1 2 3<br />

Hannan EL: NEJM, 2005<br />

Years<br />

CP1190491-7


Original Article<br />

Drug-Eluting Stents vs. Coronary-Artery Bypass Grafting<br />

in Multivessel Coronary Disease<br />

Edward L. Hannan, et al N Engl J Med, Volume 358(4):331-341 Jan 24, 2008<br />

Mortality (after adjustment) 7.3% for DES Vs. 6.0% for CABG<br />

This 1.3% absolute difference (p=0.03) yields a NNT of 77<br />

If we need to do 77 bypasses to save one life, I believe the<br />

mortality benefit is clinically meaningless!<br />

This point was completely missed by the lay press<br />

78


The TVR Trade-off:<br />

Good data – Bad interpretation<br />

• The clinician‟s perspective<br />

•Most of my patients tell me they would rather go through 3, 4 or<br />

even 5 PCI procedures rather than go through one bypass surgery<br />

• Yet some are using SYNTAX data to say exactly the<br />

opposite<br />

SCRIPPS CLINIC


Rate (%)<br />

SYNTAX<br />

One Year Clinical Outcomes<br />

20<br />

15<br />

10<br />

5<br />

0<br />

P=0.0015*<br />

12.1<br />

17.8<br />

P=0.98<br />

CABG (N=897)<br />

P=0.11<br />

P=0.37<br />

4.3 4.8<br />

3.5 3.2<br />

TAXUS (N=903)<br />

Number needed to prevent analysis<br />

Number of CABGs needed to<br />

prevent one re-PCI = 13<br />

At the cost 7.7of 7.6almost 4 times as<br />

many strokes<br />

P=0.003<br />

2.2<br />

0.6<br />

P


Adverse Events to 12 Months<br />

Stent (N=357)<br />

Left Main Subset<br />

CABG (N=348)<br />

All-Death<br />

P=0.88*<br />

CVA (Stroke)<br />

P=0.009*<br />

Number Needed to Prevent<br />

Number of CABGs needed to<br />

prevent one re-PCI = 19<br />

Myocardial Infarction<br />

This means 18 P=0.97* of every 19<br />

CABGs were unnecessary!<br />

At the cost of 9 times as many<br />

strokes<br />

4.4%<br />

4.2%<br />

4,1%<br />

4.3%<br />

Revascularization<br />

P=0.02*<br />

2.7%<br />

0.3%<br />

12.0%<br />

6.7%


54 yo business man<br />

with angina,<br />

dyspnea on exertion<br />

and ischemic<br />

dilatation on nuclear<br />

study<br />

82


After long<br />

discussion, patient<br />

requests stents<br />

85


Three stents to RCA two weeks later<br />

89


Single DES “crossover”<br />

circumflex with<br />

final kissing balloon<br />

inflation.<br />

Will stage RCA chronic<br />

occlusion.<br />

69 yo male with class III angina, anterolateral<br />

ischemia on cardiolyte scan, new<br />

decrease in EF on stress echo. Angio finds<br />

CTO of RCA with bridging collaterals and<br />

high grade distal LM and ostial LAD.<br />

Patient requests stents.<br />

90


Patients (%)<br />

USVC.TBD.October 2007.Page 91 of 157<br />

Safety at 12 Months (Death/CVA/MI)<br />

Left Main Subset<br />

CABG TAXUS ® Express ® Stent<br />

18<br />

16<br />

14<br />

12<br />

10<br />

8<br />

6<br />

4<br />

2<br />

0<br />

9.2<br />

ITT population<br />

Presented by Dr. Serruys; TCT 2008<br />

P>0.99 P=0.29 P=0.72 P=0.57 P=0.11<br />

7.0<br />

2.1<br />

0<br />

7.4 7.7<br />

4.5<br />

9.9<br />

14.5<br />

8.1<br />

LM all LM only LM+1VD LM+2VD LM+3VD<br />

(n=705) (n=91) (n=138) (n=218) (n=258)<br />

The safety and effectiveness of the TAXUS® Express® Stent System have not been established in the following patient populations: lesions located in the unprotected left main coronary artery<br />

or patients with multi-vessel disease.


Patients (%)<br />

USVC.TBD.October 2007.Page 92 of 157<br />

Revascularizations * at 12 Months<br />

Left Main Subset<br />

CABG TAXUS ® Express ® Stent<br />

ITT population<br />

18<br />

16<br />

14<br />

12<br />

10<br />

8<br />

6<br />

4<br />

2<br />

0<br />

*Any revascularization (PCI or CABG)<br />

P=0.02 P=1.0 P=0.68 P=0.08 P=0.02<br />

11.8<br />

15.3<br />

7.7<br />

6.5<br />

7.1<br />

6.4 5.9<br />

6.0<br />

3.0<br />

Number Needed to Prevent<br />

LM + 3VD Patients<br />

Number of CABGs needed to<br />

prevent one re-PCI = 11<br />

14.8<br />

LM all LM only LM+1VD LM+2VD LM+3VD<br />

(n=705) (n=91) (n=138) (n=218) (n=258)<br />

Presented by Dr. Serruys; TCT 2008<br />

The safety and effectiveness of the TAXUS® Express® Stent System have not been established in the following patient populations: lesions located in the unprotected left main coronary artery<br />

or patients with multi-vessel disease.


Who would I send CABG Surgery?<br />

•Several restenoses, large territory at risk<br />

•Diabetics with diffuse disease, particularly if small vessels but<br />

usually these are poor targets for CABG<br />

•Total occlusions with large and important territory at risk, not<br />

amenable to PCI or failed PCI<br />

•Excessive proximal tortuosity, particularly if calcified with good<br />

distal targets<br />

SCRIPPS CLINIC


You Can Call Me Now…<br />

…Or You Can Call Me Later<br />

But Remember:<br />

• Bypass surgery is very hard to go through more than<br />

once<br />

– Your saphenous vein grafts will likely close down<br />

– Your native vessels will likely shrivel up<br />

– Your subsequent PCI will likely be more difficult<br />

• But, PCI can be repeated as often as you like<br />

– And you can always have a bypass<br />

– Sometime in the future<br />

– Or, maybe never<br />

95


Bypass the Bypass!<br />

96


Mistake #3<br />

Mistakes I have made in the<br />

cath lab<br />

SCRIPPS CLINIC


Top Ten Things Not to Say<br />

in the Cath Lab<br />

6) Can I get a nurse in here who knows what she's<br />

doing.<br />

7) I just can't understand this anatomy.<br />

It’s really weird. Where's the LAD?<br />

8) This room is horrible...I can’t see anything I’m<br />

doing! Can you see anything?<br />

9) Stop that!...your killing my patient.<br />

10) Wow! I've never done that before... lets give it a<br />

try!


Top Ten Things Not to Say<br />

in the Cath Lab<br />

1) Ugh! This is the worst case I've ever had in my<br />

entire life!<br />

2) You smell really nice. What are you wearing?<br />

3) I’ve got to get out of here, lets hurry up!<br />

4) Huh? Where’d the stent go. Can anyone find the<br />

stent?<br />

5) No, I have no idea what vessel that is! Our job is<br />

to fix vessels, not name them.


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


The Cardiovascular<br />

Research Foundation<br />

Lenox Hill Heart and Vascular<br />

Institute of New York


"A smart person learns from his own mistakes,<br />

a brilliant person learns from the mistakes of<br />

others"<br />

--- Bill Collins (Mike's father)


Beep…Beep…Beep…Beep…Beep…Be<br />

4-4701 911


113


114


115


116


“Success is going from failure to<br />

failure with no loss of<br />

enthusiasm”<br />

--Winston Churchill<br />

SCRIPPS CLINIC<br />

1 800 Fix A Stent<br />

117


Stranger Then Fiction<br />

69 yo female, fell in bathtub and hit her head.<br />

Went to ER, CT was obtained and something<br />

“unusual” observed.<br />

Due to stent procedure 8 years previously at<br />

another hospital, patient referred to cardiology<br />

for evaluation<br />

Cine images of chest obtained<br />

118


119


Lesson<br />

Learned:<br />

Always do a<br />

“wire out”<br />

shot<br />

120


80 yo female, no<br />

grafts, s/p double<br />

barrel DES with<br />

LAD in-stent<br />

restensosis and<br />

angina<br />

136


Mid LAD Cypher ISR<br />

Simple re-stent with<br />

Taxus for Cypher<br />

ISR<br />

A humbling<br />

experience<br />

137


Re-stent with TAXUS<br />

2.5 mm followed by<br />

non-compliant 2.5<br />

mm balloon @ 20 atm<br />

138


Some “plaque shift”<br />

into proximal LAD.<br />

After “discussion”<br />

decision to deploy<br />

second stent<br />

….hmmmm<br />

139


Position second<br />

2.5 mm stent<br />

140


Deploy second<br />

stent at 18 atm<br />

141


!!!!!!!!!!!!!!!!!!!!!!!!!!!!<br />

142


Tamponade with<br />

stent delivery<br />

balloon at 4 atm.<br />

But….patient is<br />

receiving AngioMax<br />

Patient tolorates<br />

inflation well, insert<br />

IABP.<br />

Need to wait 45 min<br />

for AngioMax to<br />

wear off<br />

How to pass the<br />

time?<br />

143


144


Question 30<br />

Which one of the following statements is true regarding echocardiography with<br />

dobutamine administration in comparison with exercise echocardiography?<br />

End of text<br />

(A) Sensitivity and specificity are lower<br />

(B) Oxygen demand is greater<br />

(C) The incidence of procedural complications is lower<br />

(D) It provides superior assessment of myocardial viability<br />

(E) It is less desirable for assessment of risk prior to noncardiac surgery<br />

145


Much improved.<br />

Lets wait another 15<br />

minutes.<br />

146


Re-inflate balloon<br />

for another 15<br />

minutes<br />

How should we<br />

pass the time?<br />

147


Question 31<br />

In patients over age 60, which of the following characterizes cardiovascular risk for those<br />

who have elevated systolic blood pressure, in comparison with those who have elevated<br />

diastolic blood pressure?<br />

End of text<br />

(A) Lower<br />

(B) Equivalent<br />

(C) Higher<br />

148


Question 36<br />

A 60-year-old man is admitted to the hospital for treatment of atrial fibrillation,<br />

associated with dyspnea and orthopnea, of two weeks' duration. He has had a heart<br />

murmur for many years. Physical examination reveals pulse rate of 108 per minute<br />

with irregularly irregular rhythm. Vital signs are otherwise normal. Cardiac examination<br />

reveals a grade 3/6 holosystolic murmur at the apex and an S 3<br />

followed by a short<br />

low-frequency murmur at the apex.<br />

Electrocardiogram reveals atrial fibrillation. Chest radiograph shows moderate cardiac<br />

enlargement and prominent vascular markings.<br />

Therapy with digoxin, atenolol, furosemide, and potassium chloride results in marked<br />

improvement of the patient's symptoms and slowing of the ventricular rate to 76 beats<br />

per minute at rest. Doppler echocardiogram reveals nearly normal left ventricular<br />

function, severe mitral regurgitation without evidence of mitral stenosis, and left atrial<br />

dimension of 5.5 cm. Estimated left ventricular ejection fraction is 55%.<br />

End of text<br />

149


Which of the following is most appropriate at this time?<br />

(A) Start warfarin therapy, and schedule semiannual evaluations including Doppler<br />

echocardiography<br />

(B) Start warfarin therapy, and perform direct-current cardioversion in three to four<br />

weeks; then schedule semiannual evaluations including Doppler echocardiography<br />

(C) Start heparin therapy, and schedule coronary angiography and mitral valve surgery<br />

(D) Start heparin and warfarin therapy, and order transesophageal echocardiography; if<br />

no clot is present, perform direct-current cardioversion; then schedule semiannual<br />

evaluations including Doppler echocardiography<br />

(E) Start warfarin and angiotensin-converting enzyme inhibitor therapy, and schedule<br />

semiannual evaluations including Doppler echocardiography<br />

150


After another 15<br />

minutes of balloon<br />

tamponade, (total<br />

inflation time 1<br />

hour) perforation<br />

is a bit worse.<br />

151


Remove IABP,<br />

exchange for<br />

second guide<br />

catheter.<br />

152


Deflate balloon for a<br />

few seconds to allow<br />

passage of second<br />

guidewire<br />

Then, reinflate<br />

balloon!<br />

153


Bring Jo-stent<br />

through proximal<br />

double barrel<br />

stents down LAD<br />

right up to inflated<br />

balloon<br />

154


Position 3.0 x 12 mm<br />

Jo-stent across<br />

perforation<br />

155


Deploy Jo-stent @ 16<br />

atm<br />

156


Final result<br />

Echo: minimal<br />

pericardial effusion<br />

ReoPro bolus plus<br />

infusion<br />

Discharge next<br />

morning: no CPK<br />

rise, no pericardial<br />

effusion.<br />

157


Emergency Angiogram for a 83 y.o Man Admitted<br />

with Episodic Angina and Hypotension<br />

The left main<br />

coronary artery<br />

has a 99%<br />

stenosis, and is<br />

intermittently<br />

obstructing!<br />

Patient requests<br />

stents<br />

158


Sudden Cardiac Arrest Due to Complete<br />

Closure of Left Main Artery – CPR!<br />

159


Emergency Balloon Inflation in Left Main Artery<br />

160


A Little More Flow but CPR Continues<br />

161


More Balloon Inflations<br />

162


Better Flow but CPR Continues!<br />

163


Now the Flow is Increasing and Cardiac<br />

Contraction is Improving<br />

164


More Balloon Inflations<br />

165


Position Stent in Left Main Artery<br />

166


Deploy Stent in Left Main Artery<br />

167


Final Result – Normal Flow!<br />

168


3 Months Later: Asymptomatic<br />

169


“Good judgement comes<br />

from experience . . .<br />

and experience comes from<br />

bad judgement”<br />

Lillehei<br />

SCRIPPS CLINIC<br />

1 800 Fix A Stent<br />

170


Mistake #4<br />

Mistakes I have made in my<br />

career and in my life<br />

SCRIPPS CLINIC


Top 10 mistakes I have made in my career<br />

and in my life<br />

10) I did not invent the coronary stent<br />

9) My first automobile was a Renault...sorry<br />

8) I took singing lessons in medical school…pointless!<br />

7) I recently drilled a small hole in the trunk of my<br />

Mercedes…right into the fuel tank…it‟s a long<br />

story…I‟ll tell you at the break<br />

6) Sending emails when upset<br />

5) Sending emails when intoxicated<br />

4) Thinking I could think of 10 mistakes, when all I<br />

could come up with is 8 mistakes<br />

1)…Not marrying my wife about 10 years sooner<br />

SCRIPPS CLINIC

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