1. an open, prospective, randomized, multicentre trial
EARLY-MYO Trial
EARLY routine catheterization after half-dose alteplase fibrinolysis vs. primary PCI in acute ST-segment–elevation MYOcardial infarction:
an open, prospective, randomized, multicentre trial
Ben He MD FACC FESC FSCAI
for the EARLY-MYO Investigators
Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai, China

2. - Research contracts (Study grant from Boehringer Ingelheim to pe1form the EARLY-MYO trial, paid to the Shanghai Jiaotong niversity China)

3. Background
Primary PCI (PPCI) within the guidelines recommended time window cannot be offered to all STEMI patients
Pharmaco-invasive (PhI) strategy has been shown to be a valid alternative to PPCI for patients who cannot get PPCI within 1 hour after first medical contact (STREAM study and registries)
We conducted the first randomized trial designed to evaluate the efficacy and safety of a PhI strategy with half-dose alteplase versus routine PPCI in STEMI patients

4. Study Aim
To compare a pharmaco-invasive strategy of early fibrinolysis followed by coronary angiography within hours or rescue PCI (if needed) with routine PPCI in
STEMI patients presenting within 6 h of symptom onset and with an expected “PCI-related delay time” ≥60 min
(*Defined as estimated time of Door-To Device minus time of Door-to-Needle)

5. Primary Endpoint and Sample Size
Primary endpoint：Complete epicardial and myocardial reperfusion after PCI defined as : TIMI flow grade 3 and TIMI myocardial perfusion grade 3 and ST-segment resolution => 70
% (core labs were blinded to allocated treatment)
Sample size：with 175 patients per group (total 350 patients) the study has 80% power to show non-inferiority of the PhI strategy vs PPCI (to exclude a 30% worse relative outcome of the primary endpoint)

6. FLOW CHART

7. Treatment in both arms
PhI group : Half-dose alteplase (8-mg bolus followed by 42 mg in 90 min) followed by coronary angiography within 3-24 h of randomization or rescue PCI
PPCI group：Routine PPCI without fibrinolytic therapy

8. MEDIAN TIMES TO TREATMENT (min)
Sx onset
Randomize IWRS
start rt-PA
190（ ）
57（7-88）
210（ ）
70 min
difference
Sx onset
Randomize IWRS
sheath insertion
185（ ）
110（50-160）
280（ ）
n=344
2 Hours
3 Hours

9. MEDIAN TIMES TO TREATMENT (min)
Sx onset
Randomize IWRS
start rt-PA
25.5% Rescue PCI at 2.1h
190（ ）
57（7-88）
74.5% non-urgent cath at 10.2h
Sx onset
Randomize IWRS
sheath insertion
185（ ）
110（50-160）
n=344
2 Hours
3 Hours

10. ST-Segment Resolution in PhI arm ± 60min after start rt-PA (judged by local Investigator)
Pharmaco-invasive (N=161)
ST segment resolution
≥ 50 %
< 50 %
74.5%
25.5%
Rescue PCI performed
25.5 %
25.5%
74.5%
Successful fibrinolysis

11. Epicardial(A) and Myocardial(B) Perfusion Pre-PCI

12. Epicardial and Myocardial Perfusion Post PCI
categorical measurements

13. Quantitative assessment of Epicardial and Myocardial Perfusion Post PCI
Continuous measurements

14. PRIMARY ENDPOINT Post PCI
Pharmaco-invasive (n=161)
PPCI (n=167)
P value
ST=>70%
51.0%(n=82)
45.5%n=76)
0.377
TIMI Flow grade3
91.3%(n=147)
89.2%(n=149)
0.580
TIMI Perfusion grade3
65.8%(n=106)
62.9%(n=105)
0.730
Complete Reperfusion
34.2%(n=54)
22.8% (n= 39)
P value for non-inferiority: < P value for superiority: 0.022

15. PRIMARY ENDPOINTS by Subgroups

16. Left Ventricular Function & Structure

17. Clinical Outcomes Clinical Outcome Total (n=344) PhI (n=171)
PPCI (n=173)
P value
Death
3 (0.9)
1 (0.6)
2 (1.2)
1.000
Re-infarction
2 (0.6)
Heart failure
51 (14.8)
23 (13.5)
28 (16.2)
0.545
Stroke -
Combined clinical Endpoint
56 (16.3)
25 (14.6)
31 (17.9)
0.466

18. Kaplan–Meier survival curve

19. Safety Outcomes Outcome Total (n=344) PhI (n=171) PPCI (n=173) P value
Minor non-ICH bleeding
65 (18.9)
47 (26.9)
18 (11.0)
<0.001
Major non-ICH bleeding
1 (0.3)
1 (0.6)
0 (0)
0.497
ICH bleeding -

20. Conclusions
In STEMI patients presenting within 6 hours of symptom onset for whom the expected PCI-related delay is > 60 min , a PhI strategy with half-dose alteplase and timely PCI is safe and shows significantly more complete epicardial and myocardial reperfusion than routine PPCI
More clinical outcome data must be obtained to confirm the reperfusion benefit observed in this study
If confirmed , a PhI treatment could be very beneficial for eligible STEMI patients, particularly in countries without well-organized STEMI networks or with significant system delays

21. Acknowledgments EARLY-MYO Investigators：
Ben He, Jun Pu, Song Ding, Heng Ge
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
Yaling Han
General Hospital of Shenyang Military Region, Shenyang, China
Jinchen Guo
Beijing Luohe Hospital, Capital Medical University, Beijing, China
Rong Lin
Fujian Medical University Affiliated the First Quanzhou Hospital, Quanzhou, China
Xi Su
Wuhan Asia Heart Hospital, Wuhan, China
Heng Zhang
Bengbu Medical University Affiliated the First Hospital, Bengbu, China
Lianglong Chen
Union Hospital, Fujian Medical University, Fuzhou, China
DSMB Members:
Frans Van de Werf, MD, PhD, University of Leuven, Leuven, Belgium
Junbo Ge, MD, PhD, Zhongshan Hospital, Fudan University , Shanghai, China
Yingchun Zhou, PhD, School of Statistics, East China Normal University, Shanghai, China

22. Published online

23. Thank You for Your Attention