TABLE 3.
Results of trials using fibrinolytics alone for facilitated percutaneous coronary intervention (PCI)
|
SANI (8) 1992 |
LIMI (11) 1999 |
PACT (10) 1999 |
PRAGUE-1 (9) 2000 |
ASSENT-4 (14) 2006 |
GRACIA-2 (12) 2007 |
WEST (13) 2006 |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fac | Nonfac | Fac | Nonfac | Fac | Nonfac | Fac | Nonfac | Fac | Nonfac | Fac | Nonfac | Fac | Nonfac | |
| Angiographic outcomes | ||||||||||||||
| TIMI-3 flow at initial angiography, % | 19* | 24* | 58† | 11† | 33† | 15† | 30† | 12† | 43† | 15† | 67† | 14† | N/R | N/R |
| TIMI-3 flow after PCI, % | 85 | 87 | 82 | 92 | 77 | 79 | 91 | 92 | 88 | 89 | 87 | 84 | 81 | 90 |
| TIMI blush score | N/R | N/R | N/R | N/R | N/R | N/R | N/R | N/R | N/R | N/R | 2–3: 55%† | 2–3: 17%† | N/R | N/R |
| Left ventricular ejection fraction, % | 51 | 51 | N/R | N/R | 58 | 58 | 50 | 51 | N/R | N/R | 59 | 56 | N/R | N/R |
| Clinical outcomes, % | ||||||||||||||
| Mortality‡ | 6.5 | 5.1 | 8.1§ | 6.7§ | 3.6 | 3.3 | 12.0§ | 7.0§ | 6.7¶ | 4.9¶ | 2.9 | 5.6 | 1.0 | 1.0 |
| Reinfarction | N/R | N/R | 5.4 | 1.3 | 3.0 | 2.6 | 7.0 | 1.0 | 6.1† | 3.7† | 1.0 | 0.9 | 5.8 | 3.0 |
| Reintervention | 10.3† | 1.6† | 23.0 | 8.0 | 7.3 | 7.2 | 7.0 | 6.9 | 6.6† | 3.4† | 6.7 | 6.5 | N/R | N/R |
| Congestive heart failure | N/R | N/R | N/R | N/R | N/R | N/R | 15.0 | 8.0 | 12.0 | 9.2 | N/R | N/R | 14.4 | 18.0 |
| Major adverse cardiac events** | N/R | N/R | 14.0 | 8.0 | N/R | N/R | 15.0 | 8.0 | 18.6† | 13.4† | 9.6 | 12.0 | 24.0 | 23.0 |
| Safety outcomes, % | ||||||||||||||
| Any stroke | N/R | N/R | 4.1 | 2.7 | 0.7 | 0.7 | 3.0 | 0 | 2.7† | 0.1† | 1.0 | 0.0 | 1.0 | 1.0 |
| Intracranial hemorrhage | 1.7 | 0 | 2.7 | 0 | 0.3 | 0.3 | 1.0 | 0 | 1.1† | 0.1† | 1.0 | 0 | 0 | 0 |
| Major bleeding episode | 10.0 | 0 | 0 | 0 | 8.5 | 8.2 | 7.2 | 0 | 5.6 | 4.4 | 1.9 | 2.8 | 1.9 | 1.0 |
| Transfusion requirement | 39.0† | 8.0† | N/R | N/R | N/R | N/R | N/R | N/R | 6.2 | 4.2 | N/R | N/R | N/R | N/R |
SANI Thrombolysis In Myocardial Infarction (TIMI) grade 2 or 3 flow at intial angiography performed before streptokinase administration;
Significant difference P<0.05;
Mortality – LIMI: 42-day; PACT: 30-day; PRAGUE-1: 30-day; GRACIA-2: 45-day; ASSENT-4: 90-day; WEST: 30-day;
1-year mortality – LIMI: facilitated PCI (Fac) 9.5% versus nonfacilitated PCI (Nonfac) 12.0%; PRAGUE-1: Fac 12.0% versus Nonfac 13.0%;
ASSENT-4 mortality by site of randomization – PCI hospital: Fac 8.5% versus Nonfac 5.2%; Non-PCI hospital: Fac 5.3% versus Nonfac 4.8%; Ambulance: Fac 3.1% versus Nonfac 4.1%;
Major adverse cardiac events – LIMI: 42-day death or reinfarction; PACT: 30-day death or reinfarction or stroke; GRACIA-2: 6-month death or reinfarction or repeat revascularization; ASSENT-4: 90-day death or congestive heart failure or cardiogenic shock; WEST: 30-day death or reinfarction or heart failure or cardiogenic shock or refractory ischemia or major ventricular arrhythmias. N/R Not reported