1. Atherosclerosis and Erectile Dysfunction: Is PTA with DES the answer?
James P. Zidar, MD, FACC, FSCAI
Professor of Medicine
Duke University Medical Center
Director, Cardiovascular Services
Duke Raleigh Hospital

2. James P. Zidar, MD DISCLOSURES - Jason Rogers, MD of UC- Davis.
Consulting Fees
Abbott Vascular, Medtronic CardioVascular, Inc., Cordis, a Johnson & Johnson company
Grants/Contracted Research
EV3, Inc.
Special thanks:
- Jason Rogers, MD of UC- Davis.

3. Erectile Dysfunction is Prevalent
Massachusetts Male Aging Study men, ages % of men experienced some degreee of ED
~25 million men in the United States
>300 million men worldwide
Laumann et al. JAMA 1999:10:281:537. 4

4. Causes of Erectile Dysfunction
Etiology
80% Vasculogenic
Traumatic
Post-surgical
Hormonal
Chronic disease- DM, CRI
Medication
Psychological
Lue. NEJM 2000;342:1803 5

5. ED and CAD Share Risk Factors
Age DM
HTN
Dyslipidemia
Smoking
Endothelial
Dysfunction +
Atherosclerosis
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Gazzaruso et al. Circulation 2004;110:22.
Rosen et al. J Urol 1991;145:759. 6

6. Relationship of ED and CAD
Up to 70% of men with CAD have ED
The development of ED predates the onset of symptomatic cardiovascular atherosclerotic disease by ~ 36 mos
Presence of ED is not routinely screened by vascular specialists
Thompson: additional risk of CAD with ED is in the range of risk associated with current smoking or family history of MI
Chirlia: 70 pts with vascular ED (by penile doppler after intracavernosal PGE-1 with PSV < 35 cm/s or RI < 0.9) vs. 73 controls. CAC by MSCT was more common. Predicts risk independent of traditional risk factors.
Thompson et al. JAMA 2005;294:2996.
Chiurlia et al. JACC 2005;46: 1503 7

7. Campbell. J Manag Care Pharm 2005;11:151.
Unmet Clinical Need
Many men who take PDE-5 inhibitors do not respond adequately
There is need for additional therapies for erectile dysfunction not addressed by currently available treatments
Therapies that address vascular inflow may in theory improve erectile function
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Campbell. J Manag Care Pharm 2005;11:151. 8

8. Penile Arterial Inflow

9. Physiology

10. Normal Erectile Function is Dependent on Adequate Arterial Inflow

11. Atherosclerotic Disease Can Result in Erectile Dysfunction

12. Veno-Occlusive Mechanism
cGMP
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13. Treatment Continuum for ED
Sildenafil (Viagra, Pfizer)
Vardenafil (Levitra, Bayer)
Tadalafil (Cialis, Lilly)
PDE-5 Inhibitor Oral Therapy
Penile Injection
Intraurethral Suppository
PDE-5 Inhibitors (treatment method for 97.5% of ED patients)
Includes Viagra, Cialis, and Levitra
Taken orally
Effective treatment window of 4-36 hours
57% discontinuation rate
Prevent the release of phosphodiesterase type 5 (PDE-5), which is responsible for degradation of an erection
High failure rate (up to 50% failure)
Vacuum Constriction Devices (VCDs) (1%)
Least invasive ED treatment; uses a vacuum pump to draw blood into the penis and a constriction band to prevent outflow
Specifically recommended by the American Urologist Association as a treatment
Unfavored by patients because of the necessary interruption to lovemaking
Intraurethral Drugs (.7%)
Involves depositing a suppository inside the urethra
Effective within ten minutes; effects last for up to an hour
65% effective
Very low incidence of side effects or complications
Injectable Drugs (.6%)
Delivered via injection into the base of the penis immediately before sexual activity
Highly effective in causing erection (75 – 85% effective)
Discontinuation rate of 70% due to invasiveness, delivery method
Examples include papaverine, Alprostadil, and phentolamine
Implants (.2%)
Most invasive procedure available; involved insertion synthetic cylinders within the corpus cavernosum
Irreversible; requires the destruction of the normal cavernosum vasculature
Considered a last-resort treatment
Vacuum Constriction Device
Penile Prosthesis

14. Surgical Revascularization
Only potentially “curative” therapy for ED described to date
Usually applied to younger patients with a history of perineal or penile trauma
Review of prior surgical reports reveals major limitations are: adequate conduit, target and morbidity
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Goldstein et al. Curr Urol Reports 2007;8:491.
Lue. NEJM 2000; 15

15. ILIAC INTERVENTION
PTA/stent of the common iliac has resulted in multiple anecdotal reports of improved erectile function

16. Percutaneous IPA Revascularization
Data on PTA of the internal pudendal artery are needed
Few published reports (n=10) & studies of either the disease or angioplasty of the IPA - initial improvement
Limitations: clinical restenosis (after balloon angioplasty)
No publications regarding stenting of the IPA
More investigation is required
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Angelini, CCD, 1987; Becker, Indiana Med. J, 1986; Castenada-Zuniga, AJR, 1982; Valji, Cardio & Int. Radio, 1988 17

17. PANPI Erectile Dysfunction with Poor Response to PDE-5 Inhibitors
Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors
10 patients undergoing clinically indicated coronary angiography
DESIGN: Pilot angiographic study
OBJECTIVE: Describe the arterial disease and feasibility of stenting the IPA
SITE: University of California, Davis Medical Center- Jason Rogers, MD
Erectile Dysfunction with
Poor Response to PDE-5 Inhibitors
Coronary Angiography
and
Pelvic Angiography (DSA)
Quantitative Coronary and Pelvic Angiography

18. 1st Study to Correlate Angiographic CAD with Pudendal Arterial disease
PANPI: Procedure
1st Study to Correlate Angiographic CAD with Pudendal Arterial disease
Used standard femoral access
Abdominal aortography & iliofemoral angiography
Selective angiography of the internal pudendal arteries after intra-arterial nitroglycerin
Gonadal shielding
Rogers, UCD, 2009.

19. Baseline Demographics
PANPI
Baseline Demographics
n=10
Age (yrs) 57
BMI 32
IIEF-5 Score 7
Hypertension
60%
Hyperlipidemia
90%
Diabetes Mellitus
20%
Smoking History
80%
Rogers, UC-Davis, 2009

20. PANPI Pelvic Arteriography Stenosis (%) Diameter (mm) Pelvic Arteries
Common iliac
Left
Right
25 ± 31
10 ± 13
10.4 ± 1.4
10.8 ± 1.4
Internal iliac
15 ± 6.5
25 ± 19
6.7 ± 1.7
6.4 ± 1.3
Internal pudendal
60 ± 32
52 ± 30
2.7 ± 0.5
2.7 ± 0.4
Rogers, UC-Davis, 2009

21. PANPI Coronary Angiography Coronary Arteries Stenosis (%)
Diameter (mm)
Left main
15 ± 17
4.6 ± 0.9
Left anterior descending
56 ± 28
3.0 ± 0.9
Circumflex
55 ± 33
2.8 ± 0.7
Right coronary artery
65 ± 29
3.5 ± 0.6
Rogers, UC-Davis, 2009

22. PANPI: Example
Rogers, UC-Davis, 2009

23. PANPI: Conclusions
Represents the first angiographic report of coronary artery disease correlated with internal pudendal artery disease in patients with ED.
Erectile dysfunction not responsive to PDE-5 inhibitors may be due to severe disease of the IPA and may be a potential target for modern percutaneous intervention, including stenting.
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Rogers, UC-Davis, 2009 24

24. ZEN Trial Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Suboptimal Response to PDE5 Inhibitors
Enrolling 50 patients at 9 US centers
Data expected by 2011
Study will add insight on safety, feasibility, and patient selection

25. Atherosclerotic Disease Can Result in Erectile Dysfunction

26. Percutaneous Revascularization Medtronic Zotarolimus-Eluting Platform

27. ZEN - Key Inclusion Criteria
General
Angiographic
Males > 18 years old
Successful completion of “run in phase”
In a stable, active sexual relationship
baseline and pre-procedure IIEF-5 domain score >6 and < 21 despite PDE5-I use
No other organic cause for ED
Not diabetic
Stenosis of the internal pudendal artery:
Severe Unilateral or moderate-severe bilateral vessel treatment
Target vessel reference diameter > 2.25 mm and < 4.2 mm
Target lesion length < 27 mm

28. Conclusions Erectile dysfunction largely has a vascular basis
Many men are not optimally treated with conventional medical therapies
Patients with angiographic CAD who are poor responders to PDE-5i therapy have IPA stenoses
The ZEN feasibility study will investigate the identification of the proper patient subset, safety, feasibility and efficacy of percutaneous IPA revascularization with a zotarolimus-based system
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