PCI after lytic therapy: when and how?
Department of Interventional Cardiology, Jagiellonian University Medical College, Kopernika 17 Street, 31-501 Krakow, Poland
* Corresponding author. Tel: +48 12 424 71 81; fax: +48 12 424 71 84. E-mail address: mcdudek{at}cyf-kr.edu.pl
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Primary percutaneous coronary intervention (PCI) and thrombolysis are approved therapies in the treatment of ST-elevation myocardial infarction (STEMI). Many clinical trials have shown that primary PCI provides better results than thrombolysis for the STEMI treatment. However, the advantages of invasive approach over fibrinolytic therapy may be blunted by low availability of experienced centres offering 24 h/7 days primary PCI service and by delay to mechanical reperfusion due to prolonged transport. Current guidelines recommend that primary PCI should be performed by skilled professionals within less than 90 (120) min after first medical contact. In practice, these requirements prohibit a large number of STEMI patients from benefiting from primary PCI because of the lack of access to an established primary PCI centre at the site of first presentation and long anticipated interhospital transfer time. Many of them are treated with lytics and referred to angiography with subsequent PCI in different time mode. Current data support the strategy of immediate PCI after lytics than waiting for rescue PCI if lysis is non-effective. The purpose of this article is to review the current approaches to patients after fibrynolytic therapy referred for PCI for STEMI.
Key Words: Myocardial infarction • Primary percutaneous coronary intervention • Thrombolysis • Networking • Pharmaco-invasive strategy
Thrombolysis and primary percutaneous coronary intervention (PCI) are approved therapies in the treatment of ST-elevation myocardial infarction (STEMI).1–4 Many clinical trials have shown that primary PCI provides better results than thrombolysis for the STEMI treatment.5 However, advantages of invasive approach over fibrinolytic therapy may be blunted by low availability of experienced centres offering 24 h/7days primary PCI service and delay to mechanical reperfusion due to prolonged transport. The relationship of symptom onset to reperfusion time with mortality, which was established in thrombolytic therapy, was not so clear in early studies evaluating primary PCI, which suggests that superiority of invasive approach over fibrinolysis in restoring blood flow in the infarct related artery (IRA) was independent of ischaemia duration.6 However recent studies have abolished that hypothesis. De Luca et al.7 showed that there was a definite relationship between time delay to treatment and 1 year mortality. Each 30 min of delay was associated with a relative risk increase by 7.5% at 1 year follow-up. Necessity of patients’ transfer for primary PCI and importance of time delay on outcome have drawn attention on the impact of PCI-related delay on outcome. Nallamothu et al.8 showed that the mortality benefit associated with primary PCI was lost if PCI-related delay exceeded 60 min. Combined analysis of the NRMI-2, -3, and -4 by Pinto et al.9 showed that this accepted PCI-related delay was much longer, i.e. 114 min and varied considerably depending on various factors like symptoms duration, age, infarction location. PCI-related delay is an important factor in choosing optimal reperfusion strategy, whereas duration of ischaemia is one of the most important determinants of outcome for patients with STEMI (Figure 1). Current guidelines recommend that primary PCI should be performed by skilled professionals within <90 min after first medical contact.1–3 In practice, these requirements prohibit a large number of STEMI patients from benefiting from primary PCI because of the lack of access to an established primary PCI centre at the site of first presentation and long anticipated transfer time.10 Many of them are treated with lytics and referred to angiography with subsequent PCI in different time mode. The question is whether all patients after lytic administration should be routinely transferred for invasive treatment and, if so, when is the optimal time for coronary angiography/PCI after lysis.
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Should all patients be transferred for angiography/percutaneous coronary intervention after lysis? |
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Minimal variant: rescue PCI only: actual concept or just history
The efficacy of lytic therapy is related to many factors and there is still relatively large group of patients in whom such therapy failed. In such situation shift for invasive approach, called rescue PCI is recommended. Assessment of the reperfusion efficacy is usually done based on relief of chest pain, ST-segment resolution on 12-lead electrocardiogram (ECG) presence of reperfusion arrhythmias, and the rapid release of biochemical markers. However, accurate identification of patients for whom fibrinolytic therapy has not restored IRA patency is still a major problem of implementation of such strategy, and this assessment is usually done about 45–60 min after drug administration, which creates delay in patient transfer. In the Middlesbrough Early Vascularization to Limit Infarction (MERLIN) trial, 307 patients who failed to achieve 50% ECG ST-segment resolution at 60 min following fibrinolytic therapy were randomized to either rescue PCI or conservative treatment (without repeat administration of fibrinolytic therapy).11 There was no difference in the mortality at 30 days, but there was lower rate of composite end-point (death/re-infarction/stroke/subsequent revascularization/heart failure) in the rescue PCI arm. This difference was mainly driven due to a decrease in subsequent revascularization procedures, and was observed also during 1-year follow-up.11,12 The Rescue Angioplasty vs. Conservative Treatment or Repeat Thrombolysis (REACT) trial enrolled 427 patients with <50% ST-segment resolution at 90 min and confirmed the important role of rescue PCI showing significant reduction in the composite primary end-point in patients undergoing rescue PCI compared with those randomized to either fibrinolytic re-administration or conservative therapy.13 Moreover, both MERLIN and REACT trials included patients who required transfer to another institution with interventional facilities. In the meta-analysis of Wijeysundera et al.14 including 1177 patients from eight trials, rescue PCI was associated with no significant reduction in all-cause mortality but showed significant risk reductions in heart failure and re-infarction when compared with conservative treatment. The potential risk of performing PCI shortly after lytic administration is higher number of bleeding complications. However, the REACT trial showed no significant difference in major bleedings rate in the rescue PCI arm compared with the conservative treatment arm. The meta-analysis of Wijeysundera et al. also showed the higher rate of minor bleeding after rescue PCI, which was mainly localized at artery puncture site. These may be overcome by wider use of radial approach.15,16 The meta-analysis also demonstrated a significant increase in the absolute risk of stroke associated with rescue PCI. However, it was based on only 10 events in the rescue PCI group and two events in the conservative therapy group and the majority of strokes in that trial were thrombo-embolic rather than haemorrhagic.14 Despite lack of strict recommendations for clopidogrel use during rescue PCI, it should be given as a loading dose (at least 300 mg), and continued with a dose of 75 mg per day for 12 months after PCI. Safety and benefits of concomitant use of aspirin and clopidogrel in STEMI patients treated with fibrinolytic therapy were confirmed by Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) and Clopidogrel and Metoprolol in Myocardial Infarction Trial (COMMIT/CC2) studies.17,18
In the European Society of Cardiology STEMI Guidelines published in the year 2003, rescue PCI was recommended after failed thrombolysis in patients with large infarcts in class IIa and level of evidence B, but at that time the results of both REACT and MERLIN were not present.4 However in European Society of Cardiology PCI Guidelines both trials are discussed and rescue PCI after failed thrombolysis is recommended in class I with level of evidence B.3 The important disadvantage of the rescue PCI strategy is that it offers angiography only to minority of patients in bail-out situations of ineffective thrombolytic treatment. According to the last evidence, it may not be an effective way of STEMI treatment.
Maximal variant: routine angiography/PCI in all patients: The justice for all ...
Routine coronary angiography, and if applicable, PCI in all patients after successful thrombolysis is indicated by current European Society of Cardiology PCI Guidelines, however optimal time from thrombolysis initiation to intervention is not clearly defined.3 In many old clinical trials, immediate PCI for STEMI following full-dose fibrinolysis was found to be associated with low angiographic efficacy and a higher risk of haemorrhagic and ischaemic complications.19,20 However, the use of antiplatelet drugs including aspirin was markedly limited at that time. Moreover, a meta-analysis by Collet et al.21 has concluded that in STEMI patients treated with fibrinolysis, systematic and early PCI performed during the ‘stent era’ led to a non-significant reduction in mortality compared with delayed or ischaemia-guided PCI and to a four-fold reduction in the rate of death or re-infarction. This benefit contrasted with a non-significant increase in the rate of both mortality or death or re-infarction observed in the ‘balloon era’. PCI after fibrinolysis was associated with more re-infarction when compared with primary PCI alone without significant impact on mortality.21
Several new studies were conducted to assess safety and benefits of routine angiography/PCI vs. conservative approach in STEMI patients treated with fibrinolysis. In the Southwest German Interventional Study in Acute Myocardial Infarction (SIAM III), a total of 197 patients with STEMI receiving thrombolysis (full-dose reteplase) <12 h were randomized either to early coronary angiography/PCI (within 6 h from thrombolysis) or to elective coronary angiography 2 weeks after thrombolysis with stenting of the infarct-related artery.22 Strategy of early angiography and immediate stenting (3.5 ± 2.3 h after thrombolysis) was associated with significant reduction of the combined end point of death, re-infarction, target lesion revascularization, and other ischaemic events after 30 days (8.5 vs. 30.9%, P < 0.001) and 6 months (25.6 vs. 50.6%, P < 0.001), without significant difference in bleeding risk. Similarly, in the Grupo de Análisis de la Cardiopatía Isquémica Aguda (GRACIA-1) study, 500 STEMI patients treated with thrombolysis (alteplase) were assigned to angiography and intervention if indicated 6–24 h of thrombolysis, or to an ischaemia-guided conservative approach.23 Patients allocated to interventional strategy received oral ticlopidine (500 mg) or clopidogrel (300 mg). Use of abciximab was recommended in patients with clear angiographic thrombus evidence. The mean time from thrombolytic agent infusion to coronary angiography was 16.7 ± 5.6 h. Early angiography/PCI approach was associated with significant risk reduction of the combined endpoint of death, non-fatal re-infarction and revascularization by 1 year in comparison to conservative group (9 vs. 21%, P = 0.0008). Frequency of major bleeding was equal in both study groups (2.4%).23 In the Combined Angioplasty and Pharmacological Intervention vs. Thrombolysis Alone in Acute Myocardial Infarction (CAPITAL AMI) study, 170 patients with high-risk STEMI treated with fibrinolysis (full-dose tenecteplase) were randomized either to immediate angiography/PCI or conservative approach.24 Patients received aspirin and clopidogrel loading dose of 300 mg in the cathlab and the median of time from randomization to first balloon inflation was 95 min. The incidence of the primary endpoint (death, re-infarction, recurrent unstable ischaemia, or stroke) at 6 months was lower in patients undergoing PCI (11.6 vs. 24.4%, P = 0.04). Observed difference was driven mainly by a reduction in the rate of recurrent unstable ischaemia (20.7 vs. 8.1%, P = 0.03). Importantly, there was no difference in frequency of major bleedings.24 Based on the results of SIAM III, GRACIA-1, and CAPITAL AMI routine post-thrombolysis coronary angiography and PCI, if applicable up to 24 h after thrombolysis, independent of angina and/or ischaemia are recommended by European Society of Cardiology PCI Guidelines.3
Recent studies indicated that the time from fibrinolysis initiation to angiography can be safely shortened even to 2–3 h, if optimal antiplatelet therapy with early loading dose of clopidogrel and/or abciximab is administered. The safety and advantages of immediate PCI after combination of reduced dose fibrinolytic and full-dose abciximab have been confirmed by the data of the Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) trial. This randomized trial, in fact, has shown that transfer of high-risk STEMI patients (with at least on high risk feature: sum of ST-segment elevation or depression >15 mm in 12-lead ECG or new onset complete left bundle-branch block, prior myocardial infarction, Killip class 2 or 3, and left ventricular ejection fraction <35%) for early routine PCI soon after the administration abciximab and half-dose reteplase reduces the risk of recurrent ischaemia and all ischaemic complications (death, repeat myocardial infarction, recurrent ischaemia; immediate PCI group vs. standard care/rescue PCI group: 4.4 vs. 10.7%, P = 0.004) at 30 days in comparison to conservatively treated patients with ischaemia guided PCI (rescue PCI), without a significant increase in major bleeding complications (immediate PCI group vs. standard care/rescue PCI group: 3.4 vs. 2.3%, P = 0.47), as well as stroke (0.7 vs. 1.3%, P = 0.50).25 Median of time from fibrinolysis initiation to angiography in immediate PCI group was 135 min. In the Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI), high-risk STEMI patients were randomized to either standard treatment after fibrinolysis with tenecteplase (rescue PCI for failed reperfusion, with elective PCI encouraged for successfully reperfused patients after 24 h) or a pharmaco-invasive strategy (immediate transfer for PCI within 6 h of fibrinolysis). All patients received aspirin, heparin, and most of them loading dose of clopidogrel. In 73% of patients undergoing immediate PCI glycoprotein IIb/IIIa inhibitors were administered. Median of time from fibrinolysis initiation to angiography was 3 h. A composite end point of 30-day death, re-infarction, congestive heart failure, severe recurrent ischaemia, or shock, occurred in 16.6% of patients in the standard treatment group and in 10.6% of the pharmaco-invasive group (P = 0.0013). Also, the observed risk of re-infarction and recurrent ischaemia was lower in patients treated with immediate PCI. Importantly, pharmaco-invasive strategy was not associated with increase in bleedings.
The question which is still open for debate is when is the optimal time to perform angiography/PCI after lytic administration. Published trials showed different strategy from about 2 h in CARESS in AMI to almost 17 h in GRACIA-1. The problem of safe PCI performed shortly after lysis may depend on antiplatelet therapy. In the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen-4 PCI (ASSENT-4 PCI) study, this strategy was harmful however the antiplatelet therapy was not optimal in this study and many procedures were performed on top of platelet activation caused by tenecteplase.26,27 The phenomenon of increased prothrombotic state and increased risk of PCI periprocedural ischaemic complications was described previously. This limitation could be potentially overcome by aggressive antiplatelet therapy. In CARESS in AMI study, invasive approach was relatively safe for a short time after lysis, but the pharmacological pre-treatment consists of reduced dose of lytic and full dose of antiplatelet drug—abciximab.25,28 After presentation of CARESSS in AMI and TRANSFER AMI trials it seems to be indisputable that all patients after lytic or lytic/GP IIb/IIIa receptor inhibitor administration should be immediately transferred to the centre with invasive facilities for angiography. Immediate angiography after lysis should be a part of patient assessment after lysis administration and this allows to decide of the optimal time of PCI if indicated.
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Facilitated percutaneous coronary intervention |
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In the meta-analysis of 17 trials of STEMI patients assigned to facilitated (routine, immediate PCI after fibrinolysis) or primary PCI, increase in mortality (5 vs. 3%, P = 0.04), rates of non-fatal re-infarction (3 vs. 2%, P = 0.006), and urgent target vessel revascularization (4 vs. 1%, P = 0.01) in facilitated the PCI group were observed.29 The increased rates of adverse events seen with the facilitated PCI approach were mainly seen in the fibrinolytic-therapy-based regimens, mainly based on the results of the ASSENT-4 trial.30 Mentioned meta-analysis has a number of limitations. One of them is a high heterogeneity of included studies (nine studies with early GPIIb/IIIa inhibitor administration, six studies with full-dose fibrinolytic regimen, and two studies with combined fibrinolytic therapy). Also, data concerning time from symptom onset to pharmacological treatment and to PCI were not incorporated into the model. This point is crucial, since the facilitated PCI approach could be beneficial in a subset of STEMI patients receiving pharmacological therapy within a specific interval after symptom onset.31 Data from a recently completed Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial have shown no difference at 90 days in all-cause mortality and complications of myocardial infarction, between patients treated with conventional primary PCI, abciximab-facilitated PCI, or half-dose reteplase/abciximab-facilitated PCI. However, it must be pointed out that this study clearly demonstrated that the adjunctive use of abciximab improves the safety of a facilitated PCI in comparison to approach with full-dose lytic therapy only. Rates of Thrombolysis in Myocardial Infarction (TIMI) non-intracranial major bleeding and minor bleeding were significantly higher for the abciximab/lytic-facilitated PCI strategy as compared with primary PCI. One of the study limitations is low percentage of patients (<40%) enrolled in non-PCI centres with anticipated long transfer delay to PCI and potentially highest benefit of facilitated PCI approach. In the GRACIA-2 study, 212 STEMI patients were randomized to full tenecteplase followed by stenting within 3–12 h of randomization (early routine post-fibrinolysis angioplasty), or to undergo primary stenting with abciximab within 3 h of randomization. The time median between randomization and angiography was longer in early routine post-fibrinolysis angioplasty group (4.6 h) than in primary PCI group (1 h). Despite this delay, early routine post-fibrinolysis angioplasty resulted in higher frequency of complete epicardial and myocardial reperfusion (TIMI 3 epicardial flow and TIMI3 myocardial perfusion and resolution of the initial sum of ST-segment elevation
70%) and similar infarct size and preserving left ventricular function. GRACIA-2 results showed that PCI may be safely performed 3–12 h later after lytic administration and that this strategy allows to obtain better myocardial reperfusion in comparison to primary angioplasty. |
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Majority of STEMI patients should be treated with primary PCI and all efforts should be made to shorten transfer delays and to increase primary PCI availability. In STEMI patients with anticipated delay to primary PCI, more than 90–120 min fibrinolysis is still recommended, but certainly should not be the end of the reperfusion therapy in STEMI. In our opinion, all patients treated with fibrinolysis should be transferred to primary-PCI facilities for reperfusion success assessment, immediate angiography, and PCI, if needed. Nowadays, if good antiplatelet coverage with loading dose of clopidogrel and/or glycoprotein IIb/IIIa inhibitors is ensured, PCI after fibrynolytic therapy is safe even after 2–3 h after its initiation.
Conflict of interest: none declared.
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