The Japanese ASPARAGUS Trial

Transcription

1 The Japanese ASPARAGUS Trial ASPirAtion of LibeRated Debris in Acute MI with GUardWire Plus TM System Toshiya Muramatsu, MD Kawasaki social Insurance Hospital, Kawasaki, Japan

2 Reperfusion of the IRA to the Myocardium Therapeutic Targets and Agents Epicardial Flow Microcirculation Myocardial Salvage Combination pharmacotherapy PTCA/Stents Adjunct Antithrombotics Facilitated PCI Filters Thromboembectomy IIb/IIIa inhibitors Nicorandil Adenosine (vaso-dil) Adhesion antagonists (a-cd18) Complement inhibitors P-selectin inhibitors Aqueous O 2 Hypothermia GIK Nicorandil Adenosine (pre-cond) Na + /H + pump inhib. IIb/IIIa inhibitors Mod from O Neill O and Gersh

3 Investigator Site Toshiya Muramatsu,, MD Kawasaki social Insurance Hospital Satoru Suwa,, MD Jyuntendo Univ. Izu-Nagaoka Hospital Naoya Fujita, MD Eastern Japan Medical Center Shiho Koyama, MD Saiseikai Noe Hospital Masahiko Saito, MD Top 10 Enrollers Ageo Central General Hospital Haruo Kamiya,, MD First Nagoya Red Cross Hospital Akitsugu Oida,, MD Dokkyo University Cardiology Takeshi Tsuchiya, MD Kanazawa Cardiovascular Hospital Yuhki Horita,, MD Ishikawa Prefectural Central Hospital Shigeo Kawano, MD Sakurabashi Watanabe Hospital Total 341 cases randomized at 22 centers

4 Trial Organization Principal Investigator: Co-Principal Investigators: QCA Core Lab: QCU Core Lab: Toshiya Muramatsu, MD Kawasaki Social Insurance Hospital Kinzo Ueda, MD Koseikai Takeda Hospital Masato Nakamura, MD Toho University, Ohashi Hospital Ken Kozuma, MD Cardio Core Japan Yoshiaki Ito, MD Kawasaki Social Insurance Hospital Data Management Core Lab: Hideki Hashimoto, MD Cardio Core Japan

5 Trial Design STEMI Informed Consent CAG Randomization Eligible for this study >18 yrs <12hrs from onset culprit LAD, LCx, RCA Exclusion criteria LMT disease ref diameter < 2.5 mm Cardio pulmonary arrest PCI (stenting( stenting) with PercuSurge LVG PCI (stenting( stenting) without protection LVG 14~30-day FU (angio( angio,, clinical) 14~30-day FU (angio( angio,, clinical) 180-day FU (angio( angio,, clinical) 180-day FU (angio( angio,, clinical)

6 Primary Endpoints Final myocardial perfusion after primary PCI TIMI flow CTFC Blush score Myocardial damage CK, CK-MB, Troponin T ST resolution LVEF, LVEDV

7 Secondary Endpoints Rate of complications related to protection device MACE at 6 months

8 Cardiac Death : 3 : 5 Non-Cardiac Death : 2 : 3 Patient Flow Patient Enrollment n= day F/U n=289 6 month F/U n= 328 Cardiac Death : 4 : 1 Non-Cardiac Death : 2 : 3 Unknown : 8 : 8 Angiographic and Clinical (72.3%) (73.8%) Clinical Only (16.8%) (14.3%)

9 Patient Demographics p value (n=165) (n=164) Age, years 63.5 ± ± 11.1 NS Male, % NS Hypertension, % NS Hyperlipidemia,, % NS Diabetes, % NS Smoking, % NS Family history, % NS History of MI, % NS Killip class II IV, % NS Chest pain to Hosp., hrs 4.2 ± ± 3.4 NS CK at ER, IU/dl NS CK-MB at ER NS

10 Lesion Demographics p (n=165) (n=164) value Vessel disease, % NS NS NS Target vessel, % RCA NS LAD NS LCx NS Pre TIMI flow NS NS NS NS

11 Procedural Results (1) Protection p (n=165) (n=164) value Procedural success, % NS Vascular Complications, % NS Fluorescent time (min) 26.1± ± Operation time (min) 29.7± ±18.2 NS

12 Procedural Results (2) Protection p (n=165) (n=164) value After stenting Slow 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 PCI Slow 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

13 Device Performance Results n=173 GuardWire TM crossed the lesion, % 97 Without any procedure, % 41 With buddy wire, % 53 After balloon dilatation, % 4 Unsuccessful for crossing the lesion, % 1.2 Not performed distal protection, % 0.6 Distal embolization after GuardWire TM insertion, % 1.2

14 Clinical Outcomes Protection p (n=173) (n=168) Value In-hospital MACE Death 5 (3%) 7 (4.0%) NS re-mi 0 1 (0.6%) NS TLR/TVR 0 1 (0.6%) NS 6 month MACE (n=160) (n=152) Death 6 (3.8%) 4 (2.6%) NS re-mi 0 0 NS TLR/TVR 17 (10.6%) 15 (9.9%) NS

15 Peak CK / CK-MB IU/ l CK 2640 IU/ l CK-MB n=95 n=85 n=102 n=97 0 0

16 Troponin-T ng/ml p=ns hr 18hr 48hr 7.5 n=47 n=36 n=47 n=35 n=38 n=34

17 ST Resolution (90min) % 50 p=ns n=36 n=67 n=42 n=52 n=37 n= Complete Partial None

18 ST Resolution (180min) % p=ns n=41 n=71 n=35 n=44 n=29 n= Complete Partial None

19 LVEF % 60 p=ns p=ns p=ns n=144 n=141 n=133 n=123 n=108 n= Post PCI 1M 6M

20 100 Angiographic Results % Post-procedural TIMI flow p= TIMI 0 TIMI 1 TIMI 2 TIMI 3

21 Angiographic Results % TIMI flow at 6 month p= TIMI 0 TIMI 1 TIMI 2 TIMI 3

22 Corrected TIMI Frame Count % p=ns p=ns p=ns n=148 n=157 n=123 n=125 n=114 n= Post PCI 1M 6M

23 Post-procedural Blush Score n= p=0.26 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

24 Blush Score at 30-day n= p=0.035 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

25 Blush Score at 6 month n= p=0.91 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

26 Post-procedural Blush Score n= Aspiration w/o protection n= p=0.46 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

27 Blush Score at 30-days n= Aspiration w/o protection n= p=0.08 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

28 Blush Score at 6 months n= Aspiration w/o protection n= p=0.99 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

29 Post-procedural Blush Score Proximal RCA n= p=0.06 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

30 Blush Score at 30-day Proximal RCA n=30 p=0.06 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

31 Blush Score at 6 month Proximal RCA n= p=0.55 n= % 20% 40% 60% 80% 100% Blush 0&1 Blush 2 Blush 3

32 Angiographic Results QCA at 6 month p (N=173) (N=168) value Post Ref. Vessel Diam. (mm) 3.07± ± Diameter stenosis, % pre (n= 172, 165) 88±19 89 ± post (n= 173, 168) 19.3 ± ± Mo (n= 144, 136) 18.0 ± ± Mo (n= 122, 122) 36.3 ± ± MLD, mm pre 0.32 ± ± post 2.48 ± ± Mo 2.59 ± ± Mo 1.79± ± Binary restenosis, %

33 Sub-Analysis Data Flow Trial Total Enroll 341 cases Eligible Flow Wire analysis 50 cases CFR: 50 cases Unroteted:25 cases : 25 cases Pzf: 35 cases Unroteted:16 cases : 19 cases

34 Zero-flow pressure Coronary flow (cm/sec) Pzf Pzf=48mmHg BP2 mmhg APV 21 cm/s ADPV 27 cm/s ASPV 12 cm/s DVSR 2.2 ESRF (-) CFR 1.6 Coronary Pressure (mmhg)

35 Correlation of Pzf and EF (All) % y= -0.36x r = 0.09 p = LVEF Pzf mm Hg

36 Correlation of Pzf and EF (LAD) % r = -1.06x r = 0.49 p = 0.01 LVEF Pzf mm Hg

37 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.

38 Conclusions (2) A higher incidence of Blush 3 post procedure and at 30days has been observed in the group treated with PercuSurge TM, 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 microvascular myocardial perfusion. However, further study is necessary to prove the clinical impact of the distal protection therapy on the AMI patients.