Randomized Studies of Primary Angioplasty

Table 2 details the important characteristics of the 10 randomized studies (approx 2700 patients) (20,21,43-50) comparing primary angioplasty with various regimens of intravenous fibrinolytic therapy, according to time of publication. All patients were candidates for both interventions and received at least 100 mg of aspirin and an antithrom-bin agent for at least 2 d after the intervention. Consistently, the first balloon inflation occurred later (17-59 min) than the initiation of lytic therapy. The principal end points were assessed at hospital discharge or 30 d. Some of the studies provided additional follow-up up to 2 yr. According to the overview by Weaver et al. (51), as compared to fibrinolytic therapy, primary angioplasty reduces the relative risk of death by 34%, death plus nonfatal reinfarction by 42%, and nonfatal reinfarction by 47%, by hospital discharge or 30 d. Among the various small trials, there were no differences in outcome among the lytic agents and regimens used. The absolute reduction for the above-mentioned end points was 2.1, 4.6, and 2.4%, respectively (Fig. 9). Except for GUSTO lib, the studies were insufficiently powered to show a statistically significant difference in mortality or death and reinfarction, respectively, as demonstrated in Fig. 10.

Importantly, as compared to lytic therapy, the rate of stroke was reduced by 65% with primary angioplasty, while the incidence of hemorrhagic stroke was even more drastically affected (93% relative reduction). The difference in stroke was particularly striking in the trials using tissue-type plasminogen activator (tPA) (0.6% for PTCA vs 2.1% for tPA) and less impressive in those using streptokinase (1.0% for PTCA vs 1.6% for streptokinase). Major bleeding episodes (other than intracranial) associated with blood product transfusions were as common in the angioplasty patients (8.8%) as in the lytic group (8.4%).

The Primary Coronary Angioplasty Trials (PCAT) collaborator group followed the patients in the 10 studies mentioned above for at least 6 mo. As shown in Fig. 11, there was a substantial reduction in death and death or reinfarction among angioplasty patients, compared with those receiving pharmacological reperfusion. This advantage

Table 2

Randomized Studies of Primary Angioplasty Vs Fibrinolytic Therapy3

Table 2

Randomized Studies of Primary Angioplasty Vs Fibrinolytic Therapy3

Author

Lytic

Duration

10 End

No. patients

Time to

No. patients

Time to

(reference)

agent

of sx.

point time

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