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COURAGE: Need for Subsequent Revascularization ƒ At a median 4.6 year follow-up, 21.1% of the PCI patients required an additional revascularization, compared to 32.6% of the OMT group wh

Chronic Stable Angina:

USA

Why do we treat?

ƒ To help the person live longer (reducing mortality)

ƒ To help the person live better (reducing symptoms)

Standard treatment options for

angina

Lifestyle modifications Medications

Angioplasty/stenting Bypass surgery

FAME

Tonino PA et al N Engl J Med 2009;360:213-224.

Fractional flow reserve (FFR)

measurements vs angiography

to guide PCI decision-making

Findings from FAME

Tonino PA et al N Engl J Med 2009;360:213-224.

Fractional flow reserve

Kaplan-Meier Survival Curves

Boden WE et al N Engl J Med 2007;356:1503-1516

COURAGE: No difference in long-term survival, ACS, MI

COURAGE: Angina-free (%)

ƒ Angina relief is higher

in the PCI group at 1

and 2 years, but there is

Weintraub WS et al N Engl J Med 2008;359:677-687

COURAGE: Need for

Subsequent Revascularization

ƒ At a median 4.6 year follow-up, 21.1% of the PCI patients required an additional revascularization, compared to 32.6% of the OMT group who required a 1st revascularization

ƒ 77 patients in the PCI group and 81 patients in the OMT group

required subsequent CABG surgery

ƒ Median time to subsequent revascularization was 10.0 mo in the PCI group and 10.8 mo in the OMT group

Mortality in Randomized Trials Comparing

the PCI With Medical Treatment

COURAGE: Risk factor goals

Smoking Cessation

Total Dietary Fat / Saturated Fat <30% calories / <7% calories

Dietary Cholesterol <200 mg/day

LDL cholesterol (primary goal) 60-85 mg/dL

HDL cholesterol (secondary goal) >40 mg/dL

Triglyceride (secondary goal) <150 mg/dL

Physical Activity 30-45 min moderate intensity 5X/week Body Weight by Body Mass index Initial BMI Weight Loss Goal

25-27.5 BMI <25

>27.5 10% relative weight loss Blood Pressure <130/85 mmHg

Diabetes HbAlc <7.0%

Optimal medical therapy

Percent of Patients Taking Medications During the Trial

Maron, D J et al J Am Coll Cardiol 2010;55:1348-1358

The COURAGE trial:

Take home messages

ƒ For every 1000 patients treated with a PCI-first strategy,

compared to optimal medical therapy

≈ 800+ will have the same outcome as those treated medically

+ 60-90 will have symptomatic benefit for 6-24 months

− 28 will have a periprocedural myocardial infarction

− 2 will die

ƒ Consider treating patients with stable symptoms with medical therapy first and reserving PCI for continued symptoms

Additional insights from

COURAGE

ƒ Identification of patients that will likely respond inadequately

to optimal medical therapy

ƒ Identification of patients at high-risk for future clinical events: Can revascularization be protective?

Benefit of PCI is related to

baseline frequency of angina

Multiple episodes per week About 1 episode per week

Episodes only rarely

Years from Baseline Seattle Angina Scores (higher scores = less angina)

Weintraub WS et al N Engl J Med 2008;359:677-687

COURAGE: Baseline and posttreatment gated MPS results

Shaw L J et al Circulation 2008;117:1283-1291

Kaplan–Meier survival for

patients by residual ischemia,

after 6 to 18 months of

PCI+OMT or OMT

Extent of residual ischemia is predictive of cardiac

events (death/MI)

Modification of message?

Although patients with ischemic heart disease and stable

symptoms should be offered optimal medical therapy initially, those with severe symptoms and/or a significant burden of ischemia may benefit from early rather than deferred

revascularization

BARI 2D: Trial design and enrollment

The BARI 2D Study Group N Engl J Med 2515

2009;360:2503-BARI 2D: Rates of Survival and Freedom from Major Cardiovascular Events, According to PCI and CABG Strata

• The subset of patients

with a greater extent of

CAD (selected for the

CABG vs medical

therapy stratum) may

benefit from earlier

revascularization

• Overall, the findings

confirm the results of

the COURAGE trial

Patient Selection Treatment and Follow-up

MASS II: Study Design

ƒ Primary endpoint composite

of death, MI, angina requiring revascularization

ƒ Follow-up every 6 months for 10 years

MASS II: Major Adverse Cardiac Events at 10-year Follow-up

Hueb W et al Circulation 2010;122:949-957

Conclusions from MASS II

ƒ In patients with stable angina and multivessel disease,

revascularization, especially bypass surgery, reduces cardiac death and MI

ƒ COURAGE and MASS II results, although apparently

contradictory, can be reconciled by considering the extent of disease

ƒ Single vessel disease (31% in COURAGE, 0% in MASS II)

ƒ Proximal LAD disease (34% in COURAGE, 92% in MASS II)

ƒ CCS Class 0 or I (42% in COURAGE, 0% in MASS II)

SYNTAX: PCI vs CABG for

patients with left main or 3-vessel CAD

Serruys PW et al N Engl J Med 2009;360:961-972.

Angina and health status measures

NEJM 2011;364:1016-1026

Take-home messages from the

ƒ Adding PCI to OMT leads to earlier symptomatic improvement but does not prevent death

or MI and is associated with greater complications

ƒ Effectiveness of true OMT

ƒ Possible benefit of PCI in patients with severe symptoms, more extensive ischemia

ƒ BARI 2D

ƒ Similar to COURAGE in diabetics

ƒ Advantage of CABG in patients with anatomically advanced disease

ƒ MASS II 10 year results

ƒ CABG superior to OMT in patients with multivessel disease in reducing death, MI, revasc

ƒ Trends favoring PCI over OMT in reducing death, MI

ƒ SYNTAX

ƒ PCI and CABG similar for death, MI in patients with left main and 3-vessel disease

ƒ CABG better for reducing subsequent revascularization but at the cost of a small increase

in strokes

revascularization (both PCI and CABG)

ƒ Each scenario reviewed by a 17-member technical panel consisting of general cardiologists, interventional

cardiologists, cardiothoracic surgeons, health outcome

researchers, and a health plan medical officer

ƒ Individual scenarios scored 1-9 for appropriateness

JACC 2009;53:530-553

Appropriateness Score

“Coronary revascularization

is appropriate when the

expected benefits, in terms of

survival or health outcomes

(symptoms, functional status,

and/or quality of life) exceed

the expected negative

Major clinical variables to consider

ƒ Clinical presentation (ACS, stable angina, etc)

Likely to be Appropriate Likely to be Inappropriate

Revascularization for patients with

ƒ Greater extent of CAD

ƒ Maximal medical therapy

ƒ Lesser symptoms

ƒ Low-risk findings on functional testing

ƒ Less CAD

ƒ No or minimal medical therapy

JACC 2009;53:530-553

Usefulness of appropriateness

scoring

ƒ Tool for decision-making by physicians

ƒ Education and evaluation of physicians-in-training

ƒ Explaining treatment recommendations to patients, referring physicians

ƒ Evaluating individual interventionalists and hospitals

JACC 2009;53:530-553