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Toshiya Muramatsu, MDKawasaki social Insurance Hospital, Kawasaki, Japan
The Japanese ASPARAGUSASPARAGUS Trial
ASPirAtion of LibeRated Debris in Acute MI
with GUardWire Plus TM System
•
•GIK•Nicorandil•Adenosine (pre-cond)•Na+/H+ pump inhib.•IIb/IIIa inhibitors
•
•IIb/IIIa inhibitors•Nicorandil•Adenosine (vaso-dil)•Adhesion antagonists (a-CD18)•Complement inhibitors•P-selectin inhibitors
Reperfusion of the IRA to the MyocardiumTherapeutic Targets and Agents
•Aqueous O2
•Hypothermia•Combination pharmacotherapy
•PTCA/Stents•Adjunct Anti-thrombotics
•Facilitated PCIMod from OMod from O’’Neill and GershNeill and Gersh
Myocardial Salvage
MicrocirculationEpicardial Flow
•Filters•Thromboembectomy
Investigator SiteToshiya Toshiya MuramatsuMuramatsu, MD Kawasaki social Insurance Hospital, MD Kawasaki social Insurance Hospital
Satoru Satoru SuwaSuwa, MD , MD JyuntendoJyuntendo Univ. Univ. IzuIzu--NagaokaNagaoka HospitalHospital
NaoyaNaoya Fujita, MD Eastern Japan Medical CenterFujita, MD Eastern Japan Medical Center
Shiho Koyama, MD Shiho Koyama, MD Saiseikai NoeSaiseikai Noe HospitalHospital
Masahiko Saito, MDMasahiko Saito, MD AgeoAgeo Central General HospitalCentral General Hospital
HaruoHaruo KamiyaKamiya, MD First Nagoya Red Cross Hospital, MD First Nagoya Red Cross Hospital
Akitsugu OidaAkitsugu Oida, MD , MD DokkyoDokkyo University CardiologyUniversity Cardiology
Takeshi Tsuchiya, MD Kanazawa Cardiovascular HospitaTakeshi Tsuchiya, MD Kanazawa Cardiovascular Hospitall
YuhkiYuhki HoritaHorita, MD Ishikawa , MD Ishikawa PrefecturalPrefectural Central HospitaCentral Hospital l
Shigeo Kawano, MD Shigeo Kawano, MD SakurabashiSakurabashi Watanabe HospitalWatanabe Hospital
Top 10 Enrollers
Total 341 cases randomized at 22 centers
Trial OrganizationPrincipal Investigator: Toshiya Muramatsu, MD
Kawasaki Social Insurance Hospital
Co-Principal Investigators: Kinzo Ueda, MDKoseikai Takeda Hospital
Masato Nakamura, MDToho University, Ohashi Hospital
QCA Core Lab: Ken Kozuma, MDCardio Core Japan
QCU Core Lab: Yoshiaki Ito, MDKawasaki Social Insurance Hospital
Data Management Core Lab: Hideki Hashimoto, MDCardio Core Japan
STEMISTEMI
Informed ConsentInformed Consent
CAGCAG
RandomizationRandomization
PCI (PCI (stentingstenting) ) with with PercuSurgePercuSurge
LVGLVG
PCI (PCI (stentingstenting) ) without protectionwithout protection
LVGLVG
180180--day FU (day FU (angioangio, clinical), clinical)
Trial Design Eligible for this study>18 yrs<12hrs from onsetculprit LAD, LCx, RCA
Exclusion criteriaLMT diseaseref diameter < 2.5 mmCardio pulmonary arrest
180180--day FU (day FU (angioangio, clinical), clinical)
14~3014~30--day FU (day FU (angioangio, clinical), clinical) 14~3014~30--day FU (day FU (angioangio, clinical), clinical)
Primary EndpointsFinal myocardial perfusion after primary PCI
TIMI flowCTFCBlush score
Myocardial damageCK, CK-MB, Troponin TST resolutionLVEF, LVEDV
Patient Enrollmentn=341
30-day F/Un=289
6 month F/Un= 328
Cardiac DeathProtected: 3Unprotected: 5Non-Cardiac DeathProtected: 2Unprotected: 3
Cardiac DeathProtected: 4Unprotected: 1Non-Cardiac DeathProtected: 2Unprotected: 3UnknownProtected: 8Unprotected: 8
Clinical Only
Protected Unprotected29 (16.8%) 24 (14.3%)
Clinical Only
Protected Unprotected29 (16.8%) 24 (14.3%)
Angiographic and Clinical
Protected Unprotected125 (72.3%) 124 (73.8%)
Angiographic and Clinical
Protected Unprotected125 (72.3%) 124 (73.8%)
Patient Flow
Protected Unprotected p value
Age, yearsAge, years 63.5 63.5 ±± 12.312.3 64.7 64.7 ±±11.111.1 NSNSMale, %Male, % 78.678.6 72.972.9 NSNSHypertension, %Hypertension, % 42.242.2 44.144.1 NSNSHyperlipidemiaHyperlipidemia, %, % 32.932.9 32.932.9 NSNSDiabetes, %Diabetes, % 31.831.8 32.332.3 NS NS Smoking, %Smoking, % 51.451.4 49.449.4 NSNSFamily history, %Family history, % 4.64.6 4.14.1 NSNSHistory of MI, %History of MI, % 1.71.7 2.92.9 NSNSKillipKillip class II class II –– IV, %IV, % 2.32.3 0.00.0 NSNSChest pain to Hosp., hrsChest pain to Hosp., hrs 4.2 4.2 ±± 2.82.8 4.4 4.4 ±± 3.43.4 NSNSCK at ER, IU/dlCK at ER, IU/dl 589589 569569 NSNSCKCK--MB at ERMB at ER 4646 4545 NSNS
Patient Demographics
((n=165)n=165) ((n=164)n=164)
Protected Unprotected pvalue
Vessel disease, %1 59 58 NS2 32 27 NS3 9 15 NS
Target vessel, %RCA 40 42 NSLAD 50 48 NSLCx 10 10 NS
Pre TIMI flow0 44 44 NS1 17 14 NS2 21 19 NS3 5 11 NS
Lesion Demographics((n=165)n=165) ((n=164)n=164)
Protection Unprotected pvalue
Procedural success, % 98.9 97.1 NS
Vascular Complications, % 7.0 7.5 NS
Fluorescent time (min) 26.1±11.0 22.9±11.10.02
Operation time (min) 29.7±18.3 29.5±18.2NS
(n=165) ((n=164)n=164)
Procedural Results (1)
Procedural Results (2)Protection Unprotected p
value
After stentingSlow flow 7 (4.1%) 15 (8.8%) 0.07
No flow 1 (0.6%) 3 (1.7%) NS
Distal embolization 4 (2.3%) 10 (5.9%) NS
Post PCISlow flow 7 (4.1%) 13 (7.8%) 0.15
No flow 2 (1.2%) 6 (3.6%) 0.15
Slow flow or No flow 9 (5.3%) 19 (11.4%) 0.05
Distal embolization 4 (2.3%) 7 (4.1%) 0.35
Total incidence 13 (7.6%) 26 (15.5%) 0.027
(n=165) ((n=164) n=164)
GuardWireTM crossed the lesion, % 97Without any procedure, % 41With buddy wire, % 53After balloon dilatation, % 4
Unsuccessful for crossing the lesion, % 1.2Not performed distal protection, % 0.6
Distal embolization after GuardWireTM insertion, % 1.2
n=173
Device Performance Results
Protection Unprotected p Value
In-hospital MACEDeath 5 (3%) 7 (4.0%) NSre-MI 0 1 (0.6%) NSTLR/TVR 0 1 (0.6%) NS
6 month MACE (n=160) (n=152)Death 6 (3.8%) 4 (2.6%) NSre-MI 0 0 NSTLR/TVR 17 (10.6%) 15 (9.9%) NS
((n=173)n=173) ((n=168)n=168)
Clinical Outcomes
Peak CK / CK-MB
29382640
0
500
1000
1500
2000
2500
3000
3500
Protected Unprotected
228 222
0
50
100
150
200
250
300
Protected Unprotected
CKCK CK-MB
n=95 n=85n=95 n=85 n=102 n=97n=102 n=97
IU/ lIU/ l IU/ lIU/ l
11.213
4.6
8.75
6.77.5
0
24
68
1012
14
6hr 18hr 48hr
ProtectedUnprotected
Troponin-Tp=NSp=NS
n=47 n=36n=47 n=36 n=47 n=35n=47 n=35 n=38 n=34n=38 n=34
ng/ml
ST Resolution (90min)
37.534
28.534.3 33.6 32.1
0
10
20
30
40
50
Complete Partial None
ProtectedUnprotectedp=NS%
n=36 n=67n=36 n=67 n=42 n=52n=42 n=52 n=37 n=49n=37 n=49
ST Resolution (180min)
44.9
30.125
42.3
32.525.2
0
10
20
30
40
50
Complete Partial None
ProtectedUnprotectedp=NSp=NS%
n=41 n=71n=41 n=71 n=35 n=44n=35 n=44 n=29 n=35n=29 n=35
LVEF
5455.3
57.1
53.8
55.4
57.1
50
55
60
Post PCI 1M 6M
ProtectedUnprotected
p=NSp=NS
%
p=NS
n=144 n=141n=144 n=141 n=133 n=123n=133 n=123 n=108 n=117n=108 n=117
Angiographic Results
5
77
00 3.5
1720
78
0102030405060708090
100
Protected Unprotected
TIMI 0 TIMI 1 TIMI 2 TIMI 3
% Post-procedural TIMI flowp=0.73
Angiographic Results
2.1
88.8
2.13 05.18.2
90.7
0102030405060708090
100
Protected Unprotected
TIMI 0 TIMI 1 TIMI 2 TIMI 3
%TIMI flow at 6 month
p=0.41
Corrected TIMI Frame Count
24.529 27.3
24.327.8
24.2
0
5
10
15
20
25
30
35
40
Post PCI 1M 6M
Protected Unprotected
p=NSp=NS%%
p=NSp=NS
n=148 n=157n=148 n=157 n=123 n=125n=123 n=125 n=114 n=112n=114 n=112
p=NSp=NS
Post-procedural Blush Score
22.8
26.9 47.9
57
25.2
20.3
0% 20% 40% 60% 80% 100%
Protected
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.26
n=158
n=167
Blush Score at 30-day
9.6
13.4 43.7
60
42.9
30.4
0% 20% 40% 60% 80% 100%
Protected
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.035
n=125
n=126
Blush Score at 6 month
10.6
12.2 44.7
46.9
43.1
42.5
0% 20% 40% 60% 80% 100%
Protected
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.91
n=113
n=114
Post-procedural Blush Score
20.8
23.8 54.3 21.9
27 47.9
62.3
25.2
17
0% 20% 40% 60% 80% 100%
Protected
Aspiration w/oprotection
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.46
n=105
n=53
n=167
Blush Score at 30-days
13.3
7.5 58.8 33.8
13.5 43.7
62.2
42.9
24.4
0% 20% 40% 60% 80% 100%
Protected
Aspiration w/oprotection
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.08
n=80
n=45
n=126
Blush Score at 6 months
11.9
9.9 46.5 43.7
12.3 44.7
47.6
43
40.5
0% 20% 40% 60% 80% 100%
Protected
Aspiration w/oprotection
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.99
n=71
n=42
n=114
Post-procedural Blush Score Proximal RCA
32.4
42.9 38.1
62.2
19.1
5.4
0% 20% 40% 60% 80% 100%
Protected
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.06
n=37
n=42
Blush Score at 30-dayProximal RCA
16.7
14.3 50
73.3
35.7
10
0% 20% 40% 60% 80% 100%
Protected
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.06n=30
n=28
Blush Score at 6 monthProximal RCA
12
7.4 63
48
29.6
40
0% 20% 40% 60% 80% 100%
Protected
Unprotected
Blush 0&1 Blush 2 Blush 3
p=0.55n=25
n=27
Protected Unprotected p(N=173) (N=168) value
Post Ref. Vessel Diam. (mm) 3.07±0.62 3.02±0.54 0.39Diameter stenosis , %
pre (n= 172, 165) 88±19 89 ±17 0.50post (n= 173, 168) 19.3 ±11.7 20.2 ±13.1 0.511Mo (n= 144, 136) 18.0 ±14.2 18.8 ±13.8 0.646Mo (n= 122, 122) 36.3 ±22.3 36.2 ±22.2 0.98
MLD, mmpre 0.32 ±0.49 0.27±0.42 0.30post 2.48 ±0.59 2.40 ±0.53 0.221Mo 2.59 ±0.66 2.47 ±0.60 0.106Mo 1.79±0.76 1.72 ±0.70 0.44
Binary restenosis, % 21.3 23.8 0.65
Angiographic ResultsQCA at 6 month
Trial Total Enroll 341 cases
Sub-Analysis Data Flow
CFR: 50 casesUnroteted:25 casesProtected: 25 cases
Pzf: 35 casesUnroteted:16 casesProtected: 19 cases
Eligible Flow Wire analysis50 cases
-0.000 50.000 100.00 150.00mmHg
BP2
APV 21 cm/sADPV 27 cm/sASPV 12 cm/sDVSR 2.2ESRF (-) CFR 1.6
Pzf=48mmHg
Zero-flow pressure
CoronaryPressure(mmHg)
Coronaryflow
(cm/sec)Pzf
Correlation of Pzf and EF (All)
UnprotectedProtected
20.0 30.0 40.0 50.0 60.0 70.0Pzf
30.0
40.0
50.0
60.0
70.0
80.0LV
EFy= -0.36x + 72.99r = 0.09p = 0.098
%
mm Hg
Correlation of Pzf and EF (LAD)
UnprotectedProtected
40.0 50.0 60.0 70.0Pzf
30.0
40.0
50.0
60.0
70.0
80.0L
VE
Fr = -1.06x + 110.81r = 0.49p = 0.01
%
mm Hg
Conclusions (1)There was no detrimental effect in patients with AMI regarding the usage of the PercuSurge™ distal protection system.
The frequency of in-hospital and 6-month MACE was similar among the protected and control groups.
The incidence of slow flow, no reflow, and distal embolism was lower in the group treated with distal protection than that of unprotected group.
Conclusions (2)A higher incidence of Blush 3 post procedure and at 30days has been observed in the group treated with PercuSurgeTM, especially in the cases with proximal RCA lesions.
These findings may indicate that distal protection is beneficial in terms of prevention of severe flow disturbance and microvascularmyocardial perfusion.
However, further study is necessary to prove the clinical impact of the distal protection therapy on the AMI patients.
Recommended