ORBITA:An Interventionalist’s

Perspective

James T. DeVries, MD, FACC, FSCAIDirector, Cardiac Catheterization Laboratory

Disclosures

• Speakers bureau

• Consultation to pharmaceutical companies

• Advisory board

• Individual stock in pharmaceutical or diagnostic testing company

• Institution has received funds for clinical trials

• Site PI for device trials

No

Yes

ORBITA

I’m Batman!

• What was so different about ORBITA?

• How does it shape our thinking about stable angina?

• How does it fit with current guidelines?

• Is there ever a time to consider stents for stable angina?

ACC/AHA GUIDELINES

• COURAGE trial (2007)• Med Rx versus PCI for stable angina

• All patients with catheterization• 70% stenosis with ischemia

• 80% stenosis alone

• No difference in event rates (death, MI,stroke)

• High cross over to PCI for symptoms (1/3 over 4 years)

• Less angina in PCI group despite using fewer medications

COURAGE Reshapes Role for PCI in Stable Angina

• FAME and FAME-2 Trials• Patients with angiographic CAD• Lesions assessed using flow wire• If FFR<0.8, randomized PCI vs

Medical Therapy

• In FFR (+) lesions, PCI reduced cumulative endpoint of death, MI, and revascularization

• Trial showed value of physiologic (not occulostenotic) lesion assessment

Role for Fractional Flow Reserve Assessment (FFR)

Stable Angina Acute Coronary Syndrome (STEMI/NSTEMI)

Different Populations

• ORBITA question: what is the added benefit of PCI in medically optimized stable angina?

• Enrollment at first angiogram• Single vessel stenosis

• Taken off table and “medical optimization” pursued

• After 6 weeks, repeat angiogram, physiologic lesion assessment (blinded) and PCI or sham PCI performed

• Follow up at 6 weeks to re-assess

ORBITA at a Glance

ORBITA Patient Flow

BP/HR monitoring24/7 direct Cardiologist contact for med titration2.9 calls/week

• At the time of randomization to PCI or sham:• 23% of patients in PCI arm 0,1 angina

• 25% of patients in sham arm 0,1 angina

• Physiologic lesion assessment in PCI:• 26% had NEGATIVE FFR

• 34% had NEGATIVE IFR

After 6 weeks of Medical Therapy, prior to Randomization

ORBITA Findings

• Less ischemia on DSE after PCI

• Duke treadmill score not different

ORBITA Findings

PLACEBO

• Good question with radical design (Sham control)

• Good data collection

• Physiologic data and angiographic data

• Transparency with results

• Selected patient population

• Unrealistic medical titration?

• High percentage of patients with no symptoms

• Enrolled at angiogram

• Follow up short (6 weeks)

ORBITA in Balance

• A word of caution:

53 yo with angina and positive stress test suggestive of single vessel disease with LAD ischemia, on medical therapy

Limitation: Enrollment at angiogram, not stress test!

ISCHEMIATRIAL.org

• Guidelines for stable angina- we already know how to manage this population- medical therapy works for many.

• Remember that ACS (NSTEMI/STEMI is different animal, not studied here!)

• Stents can reduce ischemia, and when used appropriately, can reduce angina. Stents are not right for every patient, nor are they wrong for every patient!

• Still need clinical judgement, equipoise

• ISCHEMIA trial results coming soon- stay tuned!

Overall Thoughts

Thank You

James.t.devries@Hitchcock.org