1. It’s Both the Vulnerable Patient and the Vulnerable Plaque
James Muller MD
Brigham and Women’s Hospital
CRT
19 February 2017

2. Disclosure Statement of Financial Interest
No Disclosures

3. Cardiology Clinic Schedule Two Patients, Both Destined to Have a Coronary Event in the Next 2 Years
1:00 PM Joseph Smith MRN:
Dx: Vulnerable Patient
1:20 PM Ellen Jones MRN:
Dx: Vulnerable Patient due to Vulnerable Plaque

4. Vulnerable Patient Detection for Primary Prevention is Difficult

5. Is this a Vulnerable Patient?
60 year old female with atypical chest pain – April, 2008
Past Medical History: hypertension, obesity
No family history of CAD
No history of smoking
Medications: metoprolol, nifedipine,triamterene
Physical Exam: normal except for obesity
Courtesy Dr. Ryan Madder, Beaumont Hospital

6. Coronary Artery Calcium Score = 0
April 2008
Coronary Artery Calcium Score = 0
Courtesy Dr. Ryan Madder, Beaumont Hospital

7. March, 2008 CT Angiogram Interpretation: No Significant Coronary
Disease
Courtesy
Dr. Ryan
Madder
Beaumont
Hospital

8. In March, 2009, 11 months after CTA
Patient calls EMS due to sudden onset chest pain radiating to left arm.
Courtesy Dr. Ryan Madder, Beaumont Hospital

9. Coronary Angiography
Courtesy Dr. Ryan Madder, Beaumont Hospital

10. Courtesy Dr. Ryan Madder, Beaumont Hospital

11. Will it be Possible to Detect and Treat a Vulnerable Coronary Plaque
and Prevent a Coronary Event? For Primary or Secondary Prevention?
Courtesy Dr. Ryan Madder, Beaumont Hospital

12. Vulnerable Patient Detection for Secondary Prevention is Less Difficult – The Role of Invasive Imaging

13. Invasive NIRS Catheter Detection of Coronary Lipid-rich Plaques –
Autopsy Comparison
40 mm
36 mm
20 mm
26 mm

14. Invasive Detection of LCBI in Non-culprit Artery Identifies Vulnerable Patients
Above the Median
Median
LCBI = 43
Courtesy Drs. Rohit Oemrawsingh and Patrick Serruys, ESC, 2013

15. In the cohort of 70 post PCI patients, only 4 had maxLCBI4mm >600
Vulnerable Plaque?
Unstable
Angina
at 7
months
New
culprit at
vulnerable
plaque
site
Stent
placed in
STEMI
culprit
In the cohort of 70 post PCI patients,
only 4 had maxLCBI4mm >600
in non-stented area.
Courtesy of Dr. Ryan Madder
Spectrum Hospital
Grand Rapids, MI
Confidential

16. VP, 1989

17. Critics of Vulnerable Plaque Detection Efforts
After 28 years of searching, the vulnerable plaque field is doomed – you are wasting your time and our money.

18. The Vulnerable Plaque Hype-pothesis
Steve Nissen, MD, CRT Meeting, 2010
Requiem for the ‘vulnerable plaque’
Peter Libby and Gerard Pasterkamp, EHJ, March 2015
The Myth of the “Vulnerable Plaque”
Transitioning From a Focus on Individual Lesions to
Atherosclerotic Disease Burden for Coronary Artery Disease Risk Assessment
Armin Arbab-Zadeh, MD, PHD,* Valentin Fuster, MD, PHD: JACC 2015

19. The Lipid-rich Plaque (LRP) Study Dr. Ron Waksman, PI PI, Europe, Dr
The Lipid-rich Plaque (LRP) Study Dr. Ron Waksman, PI PI, Europe, Dr. Carlo Di Mario
2 year MACE from a new lesion at vulnerable patient and vulnerable plaque level
1,562
patients
with ACS or SA
underwent
NIRS-IVUS
imaging of
2 or more
Vessels during PCI

20. LRP Study Vulnerable Plaque Endpoint
Cause of Second Event
Relationship between
Max 4 mm LCBI and
new culprit lesion in
a given 30 mm segment
of proximal,
mid, or distal
artery
Max 4 mm LCBI 500
Suspected
vulnerable
plaque
Cause of First Event
Confidential 20

21. PROSPECT 2 Study PROSPECT / ABSORB RCT 900 ACS Patients Undergoing PCI
Drs. Stone, Erlinge, Co-PIs
Dr. Serruys, Chair, DSMB
900 ACS Patients Undergoing PCI
“PROSPECT 2”
600 Patients
“ABSORB”
300 pts > 70% Plaque Burden,Non-Flow -Limiting
BVS Scaffold
BVS Scaffold + GDMT 150 Patients
GDMT Only
150 Patients
NIRS/IVUS
Predicts MACE
LCP
No LCP
LCP
No LCP
Assess Treatment Effect in Sub-set with LCP

22. PROSPECT 2 – 900 Patients imaged and followed for events
PIs –Dr. David Erlinge and Dr. Gregg Stone
PROSPECT ABSORB patients with PB>70% randomized to scaffold or standard care
- Secondary endpoint -
Safety and efficacy of BVS in lesions with large plaque burden which are LRP+ vs LRP-

23. Soon, the Data will Speak
So when those results are available, you will no longer have to listen to Steve and me howling away -- Soon, the data will speak
Soon, the Data will Speak