Disclosures Advisory committee: Boston Scientific, Medtronic, - - PDF document

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Gender Related Differences in Peripheral Artery Disease Outcomes

Maureen P. Kohi, MD, FSIR Associate Professor of Clinical Radiology Chief, Interventional Radiology University of California, San Francisco

Disclosures

• Advisory committee: Boston Scientific,

Medtronic, Philips

• Consulting: Medtronic, Cook, Boston

Scientific, Bard, Philips

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Women are not 70 kg men

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Must be Hormones…

Hirsch AT et al. Circulation 2012;125:1449-72

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Different Comorbidities for PAD

Women-specific or “Novel” comorbidities

• Depression
• Hypothyroidism
• Arthritis
• Osteoporosis
• Inflammation

Traditional risk factors

• r comorbidities
• Diabetes mellitus
• Cigarette smoking
• Advanced age
• Dyslipidemia
• Hypertension

Grenon SM et al. J Vasc Surg 2014; 60: 396-403 Barochiner J et al. Vasc Health Risk Manag 2014;10:115-28

Different Presentation of PAD for Women

• More likely to be older

– Postmenopausal state lacks the atheroprotective effects of hormones – Symptoms go unnoticed or mistaken for other diseases – Less likely to present with intermittent claudication – More likely to live alone and socially isolated

• More likely to present with advanced disease

– Chronic limb ischemia – More femoropopliteal and multi-level infrainguinal disease

• Have poor lower extremity strength and greater

functional impairment

McCoach CE et al. Vasc Med 2013;18:19-26 Vouyouka AG et al. J Vasc Surg 2010;52:1196-202

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Treatments & Outcomes

POBA DCB

• Outcomes from a multisite 12-month follow-up data set

from the Excellence in Peripheral Artery Disease (XLPAD) registry

– 898 patients, 50% women

• Propensity score method used to balance sample sizes

and baseline characteristics between genders

• No difference in mortality rate
• Women had higher 12-month reintervention rate

Jeon-Slaughter H et al. Am J Cardiol 2017; 119:490-6

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• Meta-analysis with 10 articles comprised a sample size of 1,292 patients
• Rate of TLR in DCB-treated patients was significantly lower compared with

patients treated with PTA at 6 months (odds ratio [OR], 0.24; 95% confidence interval [CI], 0.11-0.53; P<.0004), 12 months (OR, 0.28; 95% CI, 0.13-0.62; P<.002), and 24 months (OR, 0.25; 95% CI, 0.10-0.61; P<.002)

• Decreased late lumen loss and binary restenosis was demonstrated at 6

months in patients treated with DCBs compared with patients treated with PTA (mean difference, 0.74; 95% CI, 0.97 to 0.51; <.00001; OR, 0.34; 95% CI, 0.23-0.49; P< .00001)

• CONCLUSIONS: Treatment with DCBs compared with PTA results in

reduced rates of reintervention in patients with PAD

J Vasc Surg 2017;65:558-70

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Women are not 70 kg men

Tepe G et al. JACC 2015;8:102-8

• Conclusions: The reduced TLR rate following DCB

treatment was maintained over the 5-year follow up period

• LLL at 6-month follow up

– Men: 0.42 mm DCBs vs. 1.76mm PTA – Women: 0.37mm DCBs vs. 1.61mm PTA

• TLR at 5-years follow up

– Men: 17% DCBs vs. 71% PTA – Women: 38% DCBs vs. 52% PTA

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Schmidt A et al. JACC Cardiovasc Interv 2016;9:715-24

• CONCLUSIONS: DCB are safe and effective in delaying

rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract

• At 12 months, the rate of primary patency among patients who had undergone

angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P = 0.02)

• The proportion of patients free from primary safety events was 83.9% with the drug-

coated balloon and 79.0% with standard angioplasty (P = 0.005 for noninferiority)

• There were no significant between-group differences in functional outcomes or in the

rates of death, amputation, thrombosis, or reintervention

• CONCLUSIONS: Among patients with symptomatic femoropopliteal peripheral artery

disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety

Rosenfield K et al. N Engl J Med 2015;373:145-53

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http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ CirculatorySystemDevicesPanel/UCM400614.pdf

Thieme M et al. JACC Cardiovasc Interv 2017 Aug 28;10(16):1682-1690

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• Primary patency remained significantly higher among patients treated with DCB

compared with PTA (69.5% versus 45.1%; P<0.001)

• The rates of clinically driven target lesion revascularization were 15.2% and 31.1%

(P=0.002) for the DCB and PTA groups, respectively

• Functional outcomes were similarly improved between treatment groups even though

subjects in the DCB group required significantly fewer reinterventions versus those in the PTA group (P<0.001 for target lesion revascularization, P=0.001 for target vessel revascularization)

• There were no device or procedure-related deaths
• CONCLUSIONS: Durable and superior treatment effect among patients treated with

DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions

Schneider PA et al. Circ Cardiovasc Interv 2018;11(1):e005891

IN.PACT SFA Trial Primary Patency at 3-years

2

• Dr. Kohi, LINC 2018

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IN.PACT SFA Trial Primary Patency through 3 Years

Females performed as well as males

1

• Dr. Kohi, LINC 2018

IN.PACT SFA Trial Freedom from CD-TLR through 3 Years

Females performed as well as males

1

• Dr. Kohi, LINC 2018

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• Primary patency rate was significantly higher with DCB (76.3% for

DCB versus 57.6% for PTA, P=0.003)

• Rate of clinically driven target lesion revascularization was

significantly lower in the DCB cohort (7.9% versus 16.8%, P=0.023)

• Improvements in ankle-brachial index, Rutherford class, and quality
• f life were comparable, but the PTA cohort required twice as many

revascularizations

• CONCLUSIONS: The data demonstrate superior safety and

effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour

Krishnan P et al. Circulation 2017;136:1102-1113 Maureen Kohi, MD

Stellarex Results

5.2% 9.9% 0% 25% 50% 75% 100% male female

12 month CD-TLR P = 0.078

81.7% 78.8% 0% 25% 50% 75% 100% male female

12 month Primary Patency P = 0.48

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• Primary patency rate was higher in males

than females (84.5% vs.72.8%, P value=0.015)

• Rate of freedom from CD-TLR was 96.2% in

males and 90.7% in females (P value=0.0370)

• Angiographic core lab geographic miss was

higher in females (18.4% of cases) versus 11.6% in males P=0.067)

Schroë H et al. Catheter Cardiovasc Interv 2018;91(3):497-504

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Why is there a Gender Gap??

• Lack of awareness – “Women don’t get atherosclerotic

disease!”

• Higher reintervention rate at long term follow up for women
• Several data points have demonstrated worse outcomes for

women following DCBs when compared to men, yet other trials have demonstrated no differences

• There may exist a potential platform difference
• We need a larger data set in order to determine the role of

DCBs in the treatment and management of women with PAD

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This is NOT our Patient Population!

This is…

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Thank you!

maureen.kohi@ucsf.edu