plaques, stents, and clots and surgeons

8/2/2019 Plaques, Stents, And Clots and Surgeons

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CORE Conference, October 26, 2009


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Brief assessment of the physiology of CAD

Management options

Stent Controversy

Drugs or Bare What does it mean to the clinician

Future ?


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Atherosclerotic process

Thrombosis and platelets


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UnstableanginaMI

Ischemic

stroke/TIA

Critical legischemia

Intermitentclaudication

CV death

ACS

Atherosclerosis

Stable angina/Intermittent claudication

Atherothrombosis: A Generalized andProgressive Process

Thrombosis

Adapted from Libby P. Circulation. 2001;104:365-372.


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D

B

A

C

DB

A

Courtesy of Steven E. Nissen, MD, Cleveland Clinic.

C

Soft Lipid Core

Ulceration

C


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Copyright 2008 American College of Cardiology Foundation. Restrictions may apply.

Kereiakes, D. J. et al. J Am Coll Cardiol Intv 2008;1:111-121

Mechanisms of Platelet Activation and Inhibition


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Vulnerable Plaque

Vulnerable Patient

Naghavi, Circulation. 2003;108:1664-72

Vulnerable Blood

Vulnerable Myocardium


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Endothelial area stented

= 0.0002 m2

Total endothelial area= 1000 m2 1/5,000,000

Culprit lesionstented

Evidence of

multiple plaques


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Management options Medical

CABG

PTCA

Stents BMS

DES


10/51Copyright 2007 American College of Cardiology Foundation. Restrictions may apply.

Diamond, G. A. et al. J Am Coll Cardiol 2007;50:1604-1609

Imputed Effect of Drug-Eluting Stents in the COURAGE Trial



Schomig, A. et al. J Am Coll Cardiol 2008;52:894-904

Odds Ratios for Nonfatal Myocardial Infarction in Individual Trials Comparing the PCI-Based Strategy With Medical Treatment Strategy




Odds Ratios for Cardiac Death in Individual Trials Comparing the PCI-Based Strategy WithMedical Treatment Strategy




Odds Ratios for Mortality in Individual Trials Comparing the PCI-Based Strategy WithMedical Treatment Strategy


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PTCA

BMS

DES


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0

10

20

30

40

50

60

POBA BMS

High

Median

Low

SAT

1982 -1993

1992 -2003



Ribichini, F. et al. J Am Coll Cardiol 2007;50:176-185

Histologic Sections of the Iliac Arteries 42 Days After Stent Implantation and BarGraph of Percent Stenosis


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General review of trails thrombosis, death

The diabetic - comment

Acute ischemic syndromes a spectrum issue

On vs Off label ideal vs real world



Kaul, S. et al. J Am Coll Cardiol 2007;50:128-137

Pooled Analysis ofRAVEL, SIRIUS, E-SIRIUS,

and C-SIRIUS Trials



Kastrati, A. et al. J Am Coll Cardiol 2007;50:146-148

RRs for Stent Thrombosis in 17 Randomized Trials Comparing SES With BMS



Kastrati, A. et al. J Am Coll Cardiol 2007;50:146-148

RRs for Death in 17 Randomized Trials Comparing SES With BMS


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"On-label" or FDA-approved useCYPHER Sirolimus-eluting Coronary Stent (5)

For improving coronary luminal diameter in patients withsymptomatic ischemic disease due to discrete de novo lesionsin native coronary arteries

30 mm in length 2.53.5 mm in diameter 50%99% stenosis

TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System (6)

For improving luminal diameter for the treatment of de novolesions in native coronary arteries

28 mm in length 2.53.75 mm in diameter 50%99% stenosis

Indications for DES use


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"Off-label" or beyond FDA-approved use

Lesion subsets

Multivessel disease Left main disease Bifurcation lesions Chronic total occlusions (CTO) In-stent restenosis (ISR) Small vessels (3.75 mm in

diameter) Long lesions requiring multiple or overlapping stents Saphenous vein grafts (SVG) Thrombus containing lesions (acute MI)

High-risk patient subsets

Diabetics Renal dysfunction

Indications for DES use


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Mulukutla, S. R. et al. J Am Coll Cardiol Intv 2008;1:139-147

Repeat Revascularization Event Rates




Death or Myocardial Infarction Event Rates


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Relative Benefit of DES Over BMS for Safety and Efficacy


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OutcomeBMS

(n = 772)DES

(n = 1,154) p Value

Observed in-hospital

mortality rate (%)

2.46 1.39 0.12

Risk-adjusted in-hospital mortality rate(%)

2.39 1.42 0.14

Observed same-stayCABG rate (%)

1.04 0.52 0.27

Risk-adjusted same-stay CABG rate (%)

1.02 0.53 0.35

Short-Term Outcomes for STEMI Patients Undergoing Stent Placement in NewYork from October 2003 to December 2004


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Hannan, E. L. et al. J Am Coll Cardiol Intv 2008;1:129-135

Adjusted Rates of Subsequent PCI in Target Vessel


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Adjusted Rates of Subsequent CABG


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Risk-Adjusted Mortality


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Outcome

Unadjusted HR forPrimary Angioplasty

Cases BMS/DES (95% CI)

Adjusted* HR for PrimaryAngioplasty CasesBMS/DES (95% CI)

Mortality 1.53 (1.022.29) 2.01 (1.213.34)

CABG revascularization 1.74 (1.122.71) 2.33 (1.314.16)

Target vesselrevascularization

1.25 (0.841.88) 1.15 (0.741.78)

Adjusted for individual hospital, IV GPIIb/IIIa platelet inhibitors given prior to theoperation, number of vessels diseased, region of disease (LAD involvement or

proximal LAD involvement), age, female gender, ejection fraction, peripheralvascular disease, cerebrovascular disease, hemodynamic instability, shock, diabetes,and renal failure.HR = hazard ratio.

Hazard Ratios (BMS/DES) for STEMI PatientsUndergoing Stent Placement in New York


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Definition

Perspective


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"Academic Research Consortium" definitions (4)

Definite ST cute coronary syndrome with angiographic orautopsy evidence of thrombus or occlusion

Probable ST 1 Unexplained deaths within 30 days following PCI2 Acute myocardial infarction involving the target-vessel territory without angiographic confirmation

Possible stent thrombosis ll unexplained deaths occurring at least 30 daysfollowing PCI

Temporal classification

Acute ST During PCI or within the following 24 h

Subacute ST Between 1 and 30 days following PCI

Late ST Between 1 month and 1 yr following PCI

Very late ST More than 1 yr following PCI

Stent Thrombosis Definitions and Classification

PCI = percutaneous coronary intervention; ST = stent thrombosis.


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Patient characteristics Diabetes, acute coronary syndrome,

renal failure, advanced age, reducedejection fraction, major adverse cardiacevent within 30 days of the originalprocedure, previous myocardial infarct

Coronary anatomy Type C lesion, bifurcation, in-stentrestenosis, multivessel disease,

calcification, total occlusion, stentlength, bypass graft

Procedural characteristics Reduced coronary flow after stenting,stent underexpansion, residualdissection, "crush" technique, sidebranch occlusion, need for glycoproteinIIb/IIIa inhibitor

Discontinuation of dual antiplatelettherapyClopidogrel resistanceHypersensitivity reactionDelayed arterial healing

Suggested Risk Factors For Late and Very Late Stent Thrombosis


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How long to treat with clopidogrel

What else and how much

When can I have surgery

How should the stent be treated in prep for surgery Oops !


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Wenaweser, P. et al. J Am Coll Cardiol 2008;52:1134-1140

Cumulative Incidence of Definite ST in 8,146 Patients During a 4-Year Follow-Up Period


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Wenaweser, P. et al. J Am Coll Cardiol 2008;52:1134-1140

Cumulative Incidence of Ischemic Adverse Events in 8,146 Patients During 4 Years ofFollow-Up


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Overall Population

(n = 8,146)

ST

(n = 192)

No ST

(n = 7,954) p Value

Age (yrs), mean SD 62.8 11.5 59.4 12.1 62.9 11.5


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Angiolillo, D. J. et al. J Am Coll Cardiol 2007;49:1505-1516

Interindividual Variability in Platelet Aggregation


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Guideline Recommendations

12 months dual antiplatelet therapy post DES1 month dual antiplatelet therapy post BMS

This is a guideline which is neither absolutenor binding. It is best to place theserecommendations in light of the clinicalcircumstances and the particulars of the history.Given the current rate of change of the clinicaldata and assumptions made to date they

probably reflect a minimum standard of care.


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ACC / AHA recommendations due to theextended risk of SAT advise continuationof the Plavix for a minimum of 1 year inpatients managed with DES

Many interventionalists are advocatingcontinuation for up to 2 years dependingon the complexity of the anatomy


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Brilakis, E. S. et al. J Am Coll Cardiol 2007;49:2145-2150

Perioperative Stent Thrombosis Prevention Strategies


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What about emergencies

You can wait 5 days for the plavix effect to dissipate

You really can t wait 5 days for the plavix effect to dissipate

Then you can contact your attorney..

You can be aware of the effects of the drug and treat accordinglyintraoperatively and post operatively.


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Kaul, S. et al. J Am Coll Cardiol 2007;50:128-137

Schematic of a Kinetic Model of Restenosis, Thrombosis,and Adverse Events Post-Stenting


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Remember, the next time you wish to commentupon the size of boots a cardiologists mother

wears

As we ply our trade and experience success,

You then have opportunity to experience yours

plaques, stents, and clots and surgeons

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