J. Matthew Brennan, MD, MPH Interventional Cardiology Duke University Medical Center
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Embolic Protection for Vein Graft PCI Results from the ACC/SCAI NCDR CathPCI Registry J. Matthew Brennan, MD, MPH Interventional Cardiology Duke University Medical Center
description
Embolic Protection for Vein Graft PCI Results from the ACC/SCAI NCDR CathPCI Registry. J. Matthew Brennan, MD, MPH Interventional Cardiology Duke University Medical Center. Investigator Team. J. Matthew Brennan, MD, MPH Wesam Al- Hejily , MD David Dai, PhD - PowerPoint PPT Presentation
Transcript of J. Matthew Brennan, MD, MPH Interventional Cardiology Duke University Medical Center
Embolic Protection for Vein Graft PCI Results from the
ACC/SCAI NCDR CathPCI Registry
J. Matthew Brennan, MD, MPHInterventional Cardiology
Duke University Medical Center
Investigator Team
• J. Matthew Brennan, MD, MPH
• Wesam Al-Hejily, MD• David Dai, PhD• Richard E. Shaw, PhD• Marina Trilesskaya, MD• Sunil V. Rao, MD
• Emmanouil S. Brilakis, MD, PhD
• Kevin J. Anstrom, PhD• John Messenger, MD• Eric D. Peterson, MD,
MPH• Pamela S. Douglas, MD• Michael H. Sketch Jr.,
MD
Funding Support and Disclaimer
This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR). The views expressed in this presentation represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at www.ncdr.com.
Disclosures
No financial relationships to disclose
Personal practice: ~50% EPD use in SVG PCI cases
Existing EPD Evidence
SAFER ('99-'00)TRAP
FIRECAPTIVE
PRIDESPIDER ('03-'06)
ISAR-CABG ('07-'10)
0 2 4 6 8 10 12 14 16 18 20
Study EPD Control
30-day MACE (%)
Placebo-controlled(superiority)
Active-controlled(non-inferiority)
Study Aims1. Evaluate the incidence of inhospital
and long-term adverse outcomes in contemporary, ‘real world’ SVG PCI practice;
2. Evaluate the safety and effectiveness of embolic protection devices (EPD) in contemporary practice;
3. Evaluate outcomes associated with a ‘balanced practice’ vs. ‘no use’ strategy.
MethodsCOHORT: NCDR CathPCI, 2005-2009 Seniors (65+)TREATMENT COMPARISONS: Embolic Protection Device vs. ‘No EPD’ Treatment Strategy
‘Balanced’ EPD vs. No EPD UseOUTCOME ASSESSMENT: Inhospital – CathPCI To 3 yrs – Medicare-linkedRISK-ADJUSTMENT METHODS: Cox Proportional Hazards Propensity Matching
Study Cohort
EPD Type NFilterWire EZ 6,113FilterWire EX 3,204SpideRx 640Spider FX 558*Excluding Proxis, Percusurge, Guardwire & TriActiv devices (<1% of EPD use)
Patient Characteristic
EPD(n=10,43
2)
No EPD(n=38,89
3)Age, yrs (IQR) 75 (70, 80) 75 (70, 80)Female 23% 25%Diabetes, Insulin 15% 15%iGFR 62 (48, 76) 62 (48, 76)LVEF, % (IQR) 50 (40, 59) 50 (40, 60)ACS 72% 68%TIMI 3 Flow, pre 63% 52%# stents, 1 59% 59%SVG Age, yrs (IQR) 13 (9, 17) 12 (8, 16)DeNovo 93% 89%Graft Body 73% 61%GP 2b3a Inh 37% 37%
No Refl
ow
Dissect
ion
Perfo
ration
Peri-o
p MI
Death
0
1
2
3
4
5
EPD No EPD
Inci
denc
e (%
)
Inhospital Outcomesp<0.001
p=0.045 p=0.0
01
p<0.001
p=ns
Favors EPD
Long-term Outcomes
0.0 0.5 1.0 1.5 2.0 2.5 3.00%
10%
20%
30%
40%
50%
EPD No EPD
Follow-up (yrs)
Cum
ulat
ive
In-
cide
nce
(%)
0.0 0.5 1.0 1.5 2.0 2.5 3.00%
10%
20%
30%
40%
50%
EPD No EPD
Follow-up (yrs)
Cum
ulat
ive
In-
cide
nce
(%)
0.0 0.5 1.0 1.5 2.0 2.5 3.00%
10%
20%
30%
40%
50%
EPD No EPD
Follow-up (yrs)
Cum
ulat
ive
In-
cide
nce
(%)
DEATHPM HR 0.96 (0.91, 1.02)
MYOCARDIAL INFARCTIONPM HR 1.00 (0.93, 1.09)
REPEAT REVASCPM HR 1.02 (0.96, 1.08)
Treatment Preference
No Refl
ow
Dissect
ion
Perfo
ration
Peri-o
p MI
Death
0
1
2
3
4
5
EPD No EPD
Inci
denc
e (%
)
Outcomes evaluated for patients treated at ‘no use’ vs ‘balanced use’
centers.
Patient Char.
Balanced EPD(2,483)
No EPD(n=5,52
3)
Age 75yrs 75yrsFemale 24% 25% LVEF 50% 50%ACS 76% 64%TIMI 3 flow, pre
63% 39%
1 stents
59% 61%
In Context
SAFER ('99-'00)TRAP
FIRECAPTIVE
PRIDESPIDER ('03-'06)
CathPCI ('05-'09)
ISAR-CABG ('07-'10)
0 5 10 15 20
Study EPD Control 30-day MACE (%)
Placebo-controlled(superiority)Active-controlled(non-inferiority)Placebo-controlled(superiority)
5.5%
17%
Summary1. 30-day MACE following SVG PCI has
decreased substantially over the past decade;
2. Among Seniors treated at CathPCI Centers, there was no evidence that filter-design EPDs improved peri-procedural or long-term outcomes;
3. Current practice patterns and outcomes support equipoise for a contemporary, placebo-controlled evaluation of EPDs for the treatment of degenerated SVGs.
Limitations
• Non-randomized treatment comparisons;
• Results derived from patients 65+ years;
• Potential for exposure misclassification;
• Post-PCI cardiac biomarker assessment is not routine at all PCI centers, particularly in uncomplicated cases.
