Table 1.
Characteristics of clinical trials that evaluated the use of pretreatment with thienopyridines in patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS)
| Study | Type of study | NSTE-ACS n (%) | Patients undergoing PCI n (%) | Pretreatment | Loading dose in the group of patients without pretreatment | Main study outcome (composite) | Safety outcome | NNT/ NNH |
|---|---|---|---|---|---|---|---|---|
| Clopidogrel | ||||||||
| CREDO | Randomized, clinical trial | 1,407/2,116 (66.5) | 1,820/2,116 (86.0) | 300 mg of loading dose 3-24 hours before PCI (mean of 9.8 hours) | Without loading dose; patients received clopidogrel 75 mg during 28 days | Death, AMI, UTVR (per protocol analysis) | TIMI major and minor bleeding | */* |
| CURE | Randomized, clinical trial | 12,562/12,562 (100) | 2,663/12,562 (21.2) | 300 mg of loading dose (median of 10 days pre-PCI), followed by 75 mg for 3-12 months | Without loading dose; patients with PCI received clopidogrel 75 mg during 28 days | Cardiovascular death, AMI, stroke | Major bleeding | 48/100 |
| PCI-CURE | Subgroup of a randomized, clinical trial | 2,658/2,658 (100) | 2,658/2,658 (100) | 300 mg of loading dose (median of 10 days pre-PCI), followed by 75 mg for 3-12 months | Without loading dose; patients received clopidogrel 75 mg during 28 days | Cardiovascular death, AMI, UTVR | Major bleeding | 53/* |
| ACUITY | Subgroup of a randomized, clinical trial | 7,523/7,523 (100) | 4,243/7,523 (56.4) | Subgroup ≥ 300 mg of loading dose | Subgroup ≥ 300 mg of loading dose post-PCI < 2 hours | Cardiovascular death, AMI, UTVR | Major bleeding | */* |
| ACUITY-PCI | Non randomized, prespecified analysis of a subgroup of a clinical trial | 5,039/5,039 (100) | 5,039/5,039 (100) | Subgroup ≥ 300 mg of loading dose | Subgroup ≥ 300 mg of loading dose post-PCI < 2 hours | Cardiovascular death, AMI, UTVR | Major bleeding | */* |
| Prasugrel | ||||||||
| ACCOAST | Randomized, clinical trial | 4,033/4,033 (100) | 2,770/4,033 (68.7) | 30 mg of Prasugrel 30 mg 2-48 hours before angiography (median of 4.4 hours), followed by 30 mg prior to PCI | 60 mg of Prasugrel prior to PCI (after angiography) | Cardiovascular death, AMI, UTVR, stroke. Use of glycoprotein iib/iiia inhibitors | TIMI major and minor bleeding | */83 |
*
No statistically significant difference was observed between the pretreated group and the group without pretreatment. NNT/NNH: number needed to treat / number needed to cause harm; PCI: percutaneous coronary intervention; AMI: acute myocardial infarction; UTVR: urgent target-vessel revascularization; TIMI: thrombolysis in myocardial infarction.