Medical Management and Risk Factor Modification SVS clinical research priorities meeting 2011 Peter Henke, MD University of Michigan.
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Medical Management and Risk Factor Modification
SVS clinical research priorities meeting 2011
Peter Henke, MDUniversity of Michigan
Overview• Epidemiology of atherosclerotic/-
atherothrombotic manifestations in vascular surgical patients
• Current medical management of arterial vascular disease patients– Evidence for major therapies
• Preoperative risk assessment pathways• Current and potential study areas/questions
Background Issues
• Goals of medical management and risk factor modification for the vascular surgeon– Clinic setting and peri-operative setting
• Local practice patterns often dictate the vascular medicine interest– Do it all yourself to consult specialists for everything
• Costs saved for preventative care by vascular surgeons
• Costs incurred due to multiple consultants and elaborate workups with no discernable patient benefit
Epidemiology
Steg PG, etal. JAMA 2007;297:1197
REACH RegistryN = 64,977 with CAD, CVOD, PAD or >3 risk factors
Epidemiology
Baumgartner I, etal. J Vasc Surg 2008;48:808
REACH RegistryN = 68,236 with CAD, CVOD, PADFocus on AAA patients comorbidities
Epidemiology
Bhatt, D, etal. JAMA 2010;304:1350
REACH RegistryN = 45,227 patients with CAD, CVOD, PAD or > 3 risks4 yr outcomeSig increased risk with DM (OR = 1.44); prior event (1.71); polyvasc Dz (1.99)
Strong Evidence exists for Treating our Patients
• Anti-platelet therapy (ASA, IA)• Lipid mngt (LDL<100 mg/dL, IB) • HTN control (BP < 140/90 or 130/80, IB)
– RAAS (IA) and B-blockers (IA)• Smoking cessation (IB)• Fitness and weight mngt (IB)Smith SC, etal. Circulation 2006;113:2363
Medications: ASA
Meta-analysis of ASA for primary preventionN = 95,000
12% reduction in serious vascular events
ATT collaboration. Lancet 2009;373:1849
Medications: ASA
Biondi-Zoccai GL, etal. Eur Heart J 2006;27:2667
Metaanalysis of 50,279 patients with CAD for risk of events with DC
Medications: B-blockers
Adjusted Odds Ratio of In-hospital Mortality Associated with Beta Blocker Therapy in Major Noncardiac Surgery Stratified by Revised Cardiac Index (RCRI) Score
Lindenaeur PK, et al. N Engl J Med 2005;353:349-61
N= ~ 663,000Propensity matched cohort from 329 US hospitalsMajor non cardiac surgery
Medications: B-blockers
P<0.001
0 7 14 21 28Days after Surgery
Per
cen
tag
e o
f P
atie
nts
0
10
20
30
40
Standard care
Bisoprolol
N = 112High risk vasc surgeryBisoprolol 7-89 days pre-op (mean 37)
D(%) MI(%) p
CONT 17 17 0.02BIS 3.4 0<0.001
Poldermans D et al. NEJM 1999;341:1789
Medications: Statins
Schauten O, etal. NEJM 2009;361:10
N = 497 RCT, mean duration of use 37d
MI, Trop T was primary composite outcome
Decreased CRP, IL-6
All on b-blocker
Medications: Statins
Kapoor AS, etal. BMJ doi:10.1136
Metaanalysis of ~800,000 pts for perioperative risk reduction effects
How well do we do?
Database study of 2839 patients with PADReviewed by ICD-9 codes, pharmacy, and labs
Rehring TF, etal. J Vasc Surg 2005;41:816
How well do we do?
Marchall C, etal. Vasc Endovasc Surg 2009;43:238
N = 325 vascular surgical patients
How well do we do?
Prande RL, etal. Circ 2011;124:17.
Risk adjusted rates of mortality with multiple preventative therapy: HR= .35; 95% CI .2-.86
NHANES 1999-2004ABI < .9
Preoperative Evaluation
• Accepted and non-controversial indications for full cardiac w/u prior to surgery
Fleisher LA, etal. Circulation 2007;116:1971
Preoperative Evaluation• Derived from VSGNE (N = 10,081)• Validated• More sensitive in vascular surgical patients
than RCRI
Bertges DJ, etal. JVS 2010;52:674
Preop Risk: Biomarkers
Choi JH, etal. Heart 2010;96:56
N = 2054 elective vascular surgery ptsPMCE = MI, pul. edema, deathRCRI improved
~ 20% on BB or statin
Preop Risk: Biomarkers
Owens CD, etal. JVS 2007;45:2
N = 91 LEB patientshsCRP, fibrinogen, SAAFU ~ 1 yr
Preop Risk: Biomarkers
Karthikeyan G, etal. JACC 2009;54:1599
Metaanalysis of 3,281 pts with perioperative CV complications
Preop Stress testingMeta-analysis of 68 studies with N = 10,049LR = 8.35; 5.6-12.5 of po MI if positive
Beattie WS, etal. Anesth Analg 2006;102:8
Does preoperative stress testing help?
Falcone RA, etal. J Cardio Vasc Anesth 2003;17:694
N = 99RCT of preop stress test vs. none after AHA guideline stratification
No difference at one year; 1 % CV morbidity/mortality
Individual Costs of Preop Work Up
1.EKG = $135 ($75)2.ECHO = $695 ($325)3.Stress ECHO = $1708 ($644)4.Nuclear Stress test = $725
($282)5.Catheterization = $3000 ($1013)6.Consult = $267-453
Professional fees are in ( )
Preop Cardiac Revascularization
McFalls E, etal. NEJM 2004;351:27
N = 510RCT of high risk vascular ptsExcl: AS, EF < 20%, LM dz
Preop Cardiac Revascularization
Schouten O, etal, JACC 2009;103:897
N = 101 RCT of high risk pts with
++ stress test
2.8 yr FU
No major differences in endpoints
What probably doesn’t need study• Individual comparison of antiplatelet, statin, b-
blocker, and ACEI therapy in vascular disease patient outcomes– Evidence very strong from large CV trials, Registries,
Guidelines• Preoperative cardiac revascularization in vascular
surgical patients– Done twice; very intensive trials
• Antiplatelet therapy types for primary/secondary prevention
Current Relevant Trialswww.clinicaltrials.gov
• Predictors of po outcome in PV surgical patients• NCT01417910
• Cardiopulmonary exercise testing and preoperative risk stratification
• NCT00737828
• Prospective study to assess screening value of NT-proBNP for the identification of pts that benefit from additional cardiac testing prior to vascular surgery
• NCT00519961
• POISE-2 (ASA and clonidine)• NCT00144937
Current Relevant Trials
• Multifactoral Intervention on CV risk factors in subjects with PAD
• NCT00144937
• Multifactoral risk reduction for optimal management of PAD
• NCT00537225
• Vascular events in noncardiac surgery patients cohort evaluation
• NCT00512109
Potential Topics to Study• Preoperative cardiac risk stratification comparative study
– Risk equation and added biomarkers to increase pretest probability
– Preoperative stress testing usefulness• Postoperative MI care – heterogeneous
– Large multicenter survey / Study best practices• Intensive vs. usual cardiovascular medical care in high
risk arterial disease patients– GWtG/GAP paradigm for following AMI pathway – Active pathway intervention vs. simple recommendation
reminders– Steno II paradigm of multimodal intensive therapy for DM
Steno-2 Model
• N = 160• RCT of intensive
multimodality therapy vs. usual care
• F/U ~ 8 yrs• Composite
endpoint of death, CV morbidity, amputation
Gaede P, etal. NEJM 2003;348:383
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