Clinical investigations: interventional cardiology
Clinical outcome of percutaneous coronary intervention with antecedent mutant t-PA administration for acute myocardial infarction

https://doi.org/10.1016/j.ahj.2003.10.028Get rights and content

Abstract

Objective

We investigated the acute-phrase and chronic-phase outcomes of patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) with or without antecedent mutant tissue-type plasminogen (t-PA) administration.

Methods

Thirty-nine patients with a first AMI within 6 hours of onset were randomly assigned to the treatment group (1,600,000 IU IV monteplase, n = 19) or the nontreatment group (n = 20), followed by PCI. Clinical outcomes were then evaluated.

Results

Patient characteristics did not differ between the 2 groups. A significantly higher number of patients in the monteplase group achieved Thrombolysis In Myocardial Infarction trial (TIMI) grade 2 flow or more at the first angiography (84.2% vs 40.0%; P < .005), reduced number of devices (1.44 vs 1.80 devices, P < .05), and reduced procedure times (59.7 vs 86.7 minutes; P < .01), with no differences in peak creatine kinase and rates of major complications and no reflow or distal embolization. Observation over an average of 5.5 months revealed a tendency toward lower target lesion revascularization rates in the monteplase group (17.6% vs 31.6%) but no intergroup difference in rates of major complications. Pretreatment quantitative coronary angioplasty only showed a significant difference in minimal lumen diameter and percent diameter stenosis in the acute phase (1.13 mm in the monteplase group vs 0.66 mm in the nontreatment group, 57.0% vs 73.0%; P < .05). 99mTc-QGS (quantitative electrocardiographically gated single-photon emission computed tomographic scintigraphy) showed no intergroup differences in left ventricular end-diastolic volume index, end- systolic volume index, and ejection fraction in the acute and chronic phases.

Conclusions

Our results suggest that PCI with antecedent mutant t-PA for AMI not only accelerates reperfusion, thereby facilitating PCI, but also attenuates restenosis in the chronic phase.

Section snippets

Study protocol

We determined that a sample size of 36 patients who completed the study would have 80% power to detect the clinically important difference of 35% at α = 0.05 in the percentage of Thrombolysis In Myocardial Infarction trial (TIMI) grade 2 or 3 flow achieved at first angiography. Between March 2001 and March 2002, 39 consecutive patients with a first AMI, who were transferred to our institution within 6 hours of symptom onset and from whom informed consent was obtained, were randomly assigned but

Results

Baseline characteristics of the 2 groups are shown in Table I. There were no significant differences between the 2 groups in terms of age, sex, coronary risk factors, Killip class at admission, and time from onset to admission. Restoration of TIMI grade 2 or 3 flow at initial angiography was significantly higher in the monteplase group (in 16 patients, or 84.2%) compared with the control group (8 patients, or 40.0%) (Figure 1). Device size tended to be greater in the monteplase group. Less

Discussion

After the PACT study demonstrated the benefit of PCI with antecedent administration of a low-dose t-PA for AMI, other studies have also shown superior outcomes in patients treated with a combination of thrombolysis by using mutant t-PA and PCI.10, 11, 12, 13 This study was conducted only at an institution experienced with both thrombolytic therapy and PCI, strictly excluded patients at risk of bleeding complications, and used an almost standard dose of mutant t-PA for thrombolysis alone. As a

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      These strategies are distinct from a routine PCI approach where the angiography and intervention is performed several days after successful fibrinolysis. Routine immediate angiography post fibrinolytic therapy is associated with increased intracranial haemorrhage (ICH) and major bleeding without offering any benefit in terms of mortality or reinfarction.148–152 It is reasonable to perform angiography and PCI when necessary in patients with failed fibrinolysis according to clinical signs and/or insufficient ST-segment resolution.153

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      Eleven studies supported a facilitated PCI strategy (LOE 1538; LOE 2;464,539–541 LOE 3542–544; LOE 5545–547). Thirty studies show no benefit of PPCI over fibrinolysis (LOE 1405,491,548–554; LOE 2555–560; LOE 5451,561–566,567–574). The routine use of fibrinolysis-facilitated PPCI, compared with PPCI, is not recommended in patients with suspected STEMI.

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      Except for these 2 transport trials, there exists only a limited amount of recent data regarding facilitated PCI with full-dose thrombolytics. A small study from Japan randomized 39 patients to either monteplase or placebo before PCI (46). As seen in previous studies, the thrombolytic group had greater TIMI flow grade and lower percentage stenosis; however, perhaps limited by its size, the study did not demonstrate any change in follow-up angiography, target lesion revascularization, or in clinical outcomes.

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