Adjunctive Therapy in ACS Patients: TRITON-TIMI 38, EVA-AMI, and BRIEF-PCI

Eptifibatide vs Abciximab in Primary PCI for Acute STEMI -- The Randomized EVA-AMI Study

Presenter: Uwe Zeymer, MD (Institute fur Herzinfarktforschung Ludwigshafen, Germany)

A large number of randomized, controlled studies performed in the late 1990s demonstrated that the GP IIb/IIIa inhibitor abciximab reduces ischemic complications in patients undergoing primary PCI. Eptifibatide, another GP IIb/IIIa inhibitor, has shown similar event reductions in patients undergoing elective PCI to those of abciximab. To date, no large prospective head-to-head comparison between these GP IIb/IIIa inhibitors in the primary PCI setting has been conducted.

Aim and Study Design

The Eptifbatide vs Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction (EVA-AMI) trial was an international randomized study designed to demonstrate the non-inferiority of eptifibatide vs abciximab as an adjunctive treatment for patients undergoing primary PCI.

Patients with an STEMI <12 hours who were treated with aspirin, clopidogrel, and unfractionated heparin or enoxaparin and scheduled for primary PCI were randomized to receive either:

Eptifibatide double bolus and 24 hour infusion; or
Abciximab bolus plus 12 hour infusion

Primary endpoint: Complete ST resolution (>70%) at 60 minutes.

Secondary endpoints: Death, reinfarction, target vessel revascularization, and bleeding complications.

Results

A total of 429 patients were randomized in the study. Baseline characteristics were well-balanced between the 2 groups, with no differences in time from symptom onset to study medication or time to angiography ( Table 3 ).

TIMI 3 blood flow at the end of the procedure was present in 84.3% of patients treated with abciximab and 82.4% of patients treated with eptifibatide (P = NS). Complete ST resolution was achieved in 59.6% and 63.1% of patients in the abciximab and eptifbatide groups, respectively (Figure 3). Secondary endpoints and major and minor bleeding complications were also similar in both arms of the study ( Table 4 ).

(Enlarge Image)

Figure 3.

EVA-AMI: ST resolution at 60 minutes.

Conclusions

Eptifibatide given as a double bolus is equally effective as adjunct to primary PCI with respect to myocardial reperfusion.
The preliminary clinical events did not show any differences between the 2 GP IIb/IIIa agents.
Eptifibatide may be an alternative to abciximab in patients undergoing primary PCI in the acute STEMI setting.

Cite this: Adjunctive Therapy in ACS Patients: TRITON-TIMI 38, EVA-AMI, and BRIEF-PCI - Medscape - Feb 14, 2008.

Table 1. TRITON-TIMI 38: Baseline Characteristics
Characteristic	Prasugrel (n = 6813)	Clopidogrel (n = 6795)
Unstable angina/NSTEMI (%)	74	74
STEMI (%)	26	26
Age (yrs)	61	61
Male (%)	75	73
Hypertension (%)	64	64
Diabetes (%)	23	23
Hypercholesterolemia (%)	56	56
Smoker (%)	38	38
S/P MI (%)	18	18
S/P CABG (%)	8	7
Renal insufficiency (%)	11	12

CABG = coronary artery bypass graft; MI = myocardial infarction; NSTEMI = non-ST-segment elevation myocardial infarction; S/P = status-post

Table 2. TRITON-TIMI 38: Outcomes at 15-month Follow-up
Endpoint	Prasugrel(n = 6813)	Clopidogrel(n = 6795)	HR (95% CI)	P Value
CV death/MI/stroke (%)	9.9	12.1	0.81 (0.73-0.90)	.0004
Nonfatal MI (%)	7.3	9.5	0.76 (0.67-0.85)	<.001
CV death (%)	2.1	2.4	0.89 (0.70-1.12)	.31
Stroke (%)	1.0	1.0	1.02 (0.71-1.45)	.93
CV death/MI/ stroke/rehospitalization for ischemia (%)	12.3	14.6	0.84 (0.76-0.92)	<.001
Urgent target vessel revascularization (%)	2.5	3.7	0.66 (0.54-0.81)	<.001
Stent thrombosis (%)	1.1	2.4	0.48 (0.36-0.64)	<.0001
TIMI major bleeding	2.4	1.8	1.32 (1.03-1.68)	.03

CI = confidence interval; CV = cardiovascular; HR = hazard ratio; MI = myocardial infarction

Table 3. EVA-AMI: Baseline Characteristics
Characteristic	Abciximab (n = 203)	Eptifibatide (n = 226)
Age (yrs)	61	61
Male (%)	80	76
Diabetes (%)	17	15
Killip >1 (%)	10	10
Anterior wall MI (%)	45	43
S/P MI (%)	9	8
Onset of symptoms to study medication (min)	224	234
Study medication to angiography (min)	30	29

MI = myocardial infarction; S/P = status-post

Table 4. EVA-AMI: In-hospital Events
Event	Abciximab (n = 201)	Eptifibatide (n = 226)
Death (%)	3.5	3.5
Reinfarction (%)	1.5	0.0
Heart failure (%)	8.5	6.4
TVR (%)	4.0	2.7
Stroke (%)	0.5	0.0
Major bleeding (%)	0.0	1.8
Minor bleeding (%)	4.5	4.1

TVR = target vessel revascularization

Table 5. BRIEF-PCI: Baseline Characteristics
Demographic	Brief (<2 Hours) (n = 312)	Standard (n = 312)
Age (yrs)	62	63
Female gender (%)	20	16
Diabetes (%)	12	15
Stable angina (%)	47	51
ACS (%)	39	35
STEMI (%)	15	14
Multivessel disease (%)	52	51
Closure device (%)	26	25

ACS = acute coronary syndrome; STEMI = ST-elevation myocardial infarction

Table 6. BRIEF-PCI: Endpoints at 30 Days
Endpoint	Brief (<2 Hours) (n = 312)	Standard (n = 312)
Death (%)	0	0
MI (%)	4.8	4.5
TVR (%)	0.6	0.6
Triple composite (%)	4.8	4.5
Major bleeding (%)	1.0	4.2*
Minor bleeding (%)	17.6	21.2
Quadruple composite (%)	5.4	8.7

*P = .02;
MI = myocardial infarction; TVR = target vessel revascularization

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