Appropriateness Criteria for Revascularization – Making sense of the recommendations

Dr. Lalit Kapoor

Chief Cardiac Surgeon

Apollo Hospital, Ranchi

www.heartsurgery.in

Left Main

Left Main Equivalent

TVD

DVD with LAD

Which procedure is best?

Angioplasty of the culprit lesion has been proven to be of value:

1. ST elevation MI compared to thrombolytics Reduces mortality and strokes (and

likely reinfarction)

2. In high risk non-ST elevation ACS

Reduces new MI and likely deaths and avoids repeated rehospitalization for

UA.

In both acute conditions, appropriate and timely PCI is an important advance.

COURAGE

Showed that treating patients with PCI at the outset had no more impact on death or myocardial infarction (MI) than treating patients with an initial strategy of optimal medical therapy

Led to polarization of cardiovascular professionals. "Some people have pitted this as the mother of all battles between PCI and others - that is absolutely 100% incorrect

Remember that the COURAGE trial dealt with only a small subset — stable angina — of all the patients who are treated with revascularization.

Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trial

8%8%

0

1

2

3

4

5

6

7

8

9

Aspirin Aspirin-bloq

Aspirin-bloqStatin

Aspirin-bloqStatinACEI

None

6%6%

4,5%4,5%

3%3%2,3%2,3%RRRRRR

25%25%RRRRRR30%30% RRRRRR

25%25%

RRRRRR25%25%

SECONDARY PREVENTION

Eventrate*

(2 years)

Impact of pharmacological treatmentImpact of pharmacological treatment

**CV death, AMI or strokeYusuf S. Lancet 2002;360:2

StatinACE

I-bloq

Aspirin

25 40 60 70

Medical Treatment - Outcomes

Califf RM, Armstrong PW, Carver JR, et al. Task Force 5. Stratification of patients into high-, medium-, and low-risk subgroups for purposes of risk factor management. J Am Coll Cardiol. 1996;27:964–1047 (4).

Comparison of medical therapy, CABG and PTCA

Results from Duke trial

End point CABG (%) DES (%) p

MACCE 12.1 17.8 0.0015

Death/MI/stroke 7.7 7.6 0.98

Revascularization 5.9 13.7 <0.0001

Stroke 2.2 0.6 0.003

MI 3.2 4.8 0.11

All-cause death 3.5 4.3 0.37

Serruys PW et al. European Society of Cardiology Congress 2008; September 1, 2008; Munich, Germany.

Main results from SYNTAX randomized trial

Dr Friedrich W Mohr (University of Leipzig, Germany), pointed out, almost one-third of patients considered for randomization in SYNTAX were deemed ineligible for PCI, primarily due to complex disease or anatomy

Serruys PW, et al. N Engl J Med 2009;360:961-72

End point CABG (%) DES (%) p

Angina Free (1mth) 61.6 64.4

Angina Free (6mth) 72.0 68.5

Angina Free (12mth) 76.3 71.6 <0.05

Cost $33,254 $27,560

Additional Cost (1yr) $2,500

Cost in India 150000 550000

Additional Cost (1yr) 125000

Main results from SYNTAX randomized trial

%

0

5

15

5.9

13.5

20

SYNTAX

• MACCE was significantly lower in CABG arm compared with PCI (12.4% vs. 17.8%, p = 0.002), especially for diabetics (p = 0.0025)

• Significant ↓ in the need for repeat revascularization in CABG arm (p < 0.001)

• Death and MI were similar; CVA ↑ with CABG (p = 0.003)

Trial design: Patients with severe three-vessel or LM disease were randomized to CABG or DES-PCI with paclitaxel-eluting stents. Clinical outcomes were compared at 12 months.

Results

Conclusions• CABG was associated with fewer repeat

revascularizations compared with DES-PCI in patients with LM or three-vessel disease, but a higher rate of stroke

• No difference in death, MI, or thrombosis

• Diabetics are especially more likely to benefit with CABG compared with DES-PCI

Serruys PW, et al. N Engl J Med 2009;360:961-72

(p = 0.002)

CABG(n = 897)

DES-PCI(n = 903)

p < 0.001)

5

10

15

20

12.4

17.8

%

0MACCE Repeat

revascularization

10

Appropriateness Criteria for Coronary Revascularization

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization

A Report by the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions,

Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology

Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography

J Am Coll Cardiol, 2009; 53:530-553

Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple)

• "If anything, the number of cardiac bypasses being done is decreasing and the number of PCI procedures is decreasing. So this is not motivated in any way by the concern that these procedures are out of control, it's just a matter of making sure that indications for these procedures are appropriate."

Cont’d

• But all we were trying to do in all of this . . . was to come up with something that would help guide a physician to make the best decisions, to provide the right care for the right patients, at the right time

• a "useful supplement" to professional societies guidelines

Method

Combines 1. Evidence-based medicine

2. Guidelines

3. Practice experience

By engaging a technical panel in a modified Delphi exercise as described by RAND.

Study Design

• 180 clinical scenarios mimicking practice• Clinical scenario

• Symptoms severity

• Extent of Medical Therapy

• Risk level (Non-invasive)

• Coronary Anatomy

• 17 member panel – 4 Interventional Cardiologist, 4 Cardiac Surgeons, 8 non-invasive cardiologists, 1 medical officer from a health plan

• Only considered Revascularization and did not specify CABG / PCI

• Only in a small subset was the type specified

• Scores (7-9) for appropriate and 1-3 for inappropriate

Copyright ©2009 American College of Cardiology Foundation. Restrictions may apply.

Patel, M. R. et al. J Am Coll Cardiol 2009;53:530-553

Appropriateness Ratings by Risk Findings on Noninvasive Imaging Study and Symptom Status

Copyright ©2009 American College of Cardiology Foundation. Restrictions may apply.

Patel, M. R. et al. J Am Coll Cardiol 2009;53:530-553

Appropriateness Ratings by High-Risk Findings on Noninvasive Imaging Study and CCS Class III or IV Angina (Patients Without Prior Bypass Surgery)

``

Copyright ©2009 American College of Cardiology Foundation. Restrictions may apply.

Patel, M. R. et al. J Am Coll Cardiol 2009;53:530-553

Appropriateness Ratings by Intermediate-Risk Findings on Noninvasive Imaging Study and CCS Class I or II Angina (Patients Without Prior Bypass Surgery)

` `

Copyright ©2009 American College of Cardiology Foundation. Restrictions may apply.

Patel, M. R. et al. J Am Coll Cardiol 2009;53:530-553

Appropriateness Ratings by Low-Risk Findings on Noninvasive Imaging Study and Asymptomatic (Patients Without Prior Bypass Surgery)

` `

Copyright ©2009 American College of Cardiology Foundation. Restrictions may apply.

Patel, M. R. et al. J Am Coll Cardiol 2009;53:530-553

Method of Revascularization of Advanced Coronary Artery Disease

SYNTAX

Copyright ©2009 American College of Cardiology Foundation. Restrictions may apply.

Patel, M. R. et al. J Am Coll Cardiol 2009;53:530-553

Acute Coronary Syndromes*

High-Risk Features for Short-Term Risk of Death or Nonfatal MI for UA/NSTEMI

At least 1 of the following:

• History—Accelerating tempo of ischemic symptoms in preceding 48 hours• Character of pain—Prolonged ongoing (greater than 20 minutes) rest pain• Clinical findings

– Pulmonary edema, most likely due to ischemia– New or worsening mitral regurgitation murmur– S3 or new/worsening rales– Hypotension, bradycardia, tachycardia– Age greater than 75 years

• Electrocardiogram– Angina at rest with transient ST-segment changes greater than 0.5 mm– Bundle-branch block, new or presumed new– Sustained ventricular tachycardia

Clinical scenarios appropriate for coronary revascularization

• ST-segment elevation MI within 12 hours of symptom onset

• Left main stenosis

• Any patient with 2- or 3-vessel coronary artery disease and at least moderate-risk findings on stress testing; receiving maximal anti-ischemic medical therapy

• 1-vessel coronary artery disease involving the proximal LAD; low-risk findings on stress testing; slight impairment of activity because of angina; receiving maximal anti-ischemic medical therapy

• 1- or 2-vessel coronary artery disease without involvement of the proximal LAD; low-risk findings on stress testing; marked limitation of activity because of angina; receiving maximal anti-ischemic medical therapy

• 1- or 2-vessel coronary artery disease without involvement of the proximal LAD; high-risk findings on stress testing; slight limitation of activity because of angina; not receiving anti-ischemic medical therapy

Clinical scenarios in which the benefit vs risk for coronary revascularization is uncertain

• 1-vessel coronary artery disease involving the proximal LAD; intermediate-risk findings on stress testing; slight or no impairment of activity because of angina; not receiving anti-ischemic medical therapy

• 2-vessel coronary artery disease involving the proximal LAD; intermediate-risk findings on stress testing; asymptomatic (uncertain regardless of use of anti-ischemic medical therapy)

• In patients with advanced coronary artery disease, PCI was considered inappropriate in patients with left main stenosis. Coronary artery bypass grafting is preferred for these patients as well as patients with 3-vessel coronary artery disease.

Clinical scenarios not appropriate for coronary revascularization

• ST-segment elevation MI for 12 hours or more after symptom onset; patient asymptomatic

• ST-segment elevation MI with presumed successful treatment with fibrinolysis; patient asymptomatic with normal left ventricular ejection fraction

• 1- or 2-vessel coronary artery disease without involvement of the proximal LAD; low-risk findings on stress testing; asymptomatic; not receiving anti-ischemic medical therapy

• Chronic total occlusion of 1 major epicardial artery without other coronary stenosis; low-risk findings on stress testing; asymptomatic; not receiving anti-ischemic medical therapy

For copies of this presentation please send a request to drlalitkapoor@gmail.com