European Heart Journal Advance Access originally published online on March 4, 2008
European Heart Journal 2008 29(7):871-879; doi:10.1093/eurheartj/ehn078
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Adverse outcomes in fibrinolytic-based facilitated percutaneous coronary intervention: insights from the ASSENT-4 PCI electrocardiographic substudy
1 Division of Cardiology, University of Alberta, 251 Medical Sciences Building, Edmonton, Alberta, Canada T6G 2H7
2 Medizinische Klinik B, Ludwigshafen, Germany
3 Duke Clinical Research Institute, Durham, USA
4 University of Toronto, Toronto, Canada
5 Canadian Heart Research Centre, Toronto, Canada
6 George Washington University Medical Center, Washington DC, USA
7 University Hospital Gasthuisberg, Leuven, Belgium
Received 22 August 2007; revised 8 January 2008; accepted 31 January 2008; online publish-ahead-of-print 4 March 2008.
* Corresponding author. Tel: +1 780 492 0591, Fax: +1 780 492 9486, Email: paul.armstrong{at}ualberta.ca
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Abstract |
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Aims: Patients in ASSENT-4 PCI undergoing tenecteplase-facilitated percutaneous coronary intervention (PCI) had more adverse events than those undergoing primary PCI. We analysed this to gain further insights.
Methods and results: A total of 549 patients with facilitated PCI and 541 undergoing primary PCI were characterized according to the extent of ST resolution. We also examined the relationship between time from symptom onset, presence of baseline Q waves, and 90 day events. Irrespective of treatment, 90 day mortality was lowest among 186 patients with complete ST resolution at both 60 and 180 min (1.8% facilitated; 0% primary PCI group) and highest in those 502 patients without complete ST resolution at either 60 or 180 min (6.7% facilitated; 5.2% primary PCI group, all P 
0.05). Patients undergoing facilitated PCI presenting >3 h with baseline Q waves also had higher 90 day mortality compared with those without Q waves (10.4 vs. 2.5%, P = 0.056). No significant differences were found within primary PCI patients on the basis of time from symptom onset or presence of initial Q waves.
Conclusion: In this post hoc analysis, our data suggest that a fibrinolysis-facilitated PCI strategy was especially harmful in patients presenting beyond 3 h from symptom onset with established Q waves on their baseline ECG. This may relate to the convergence of later, less effective pre-procedural reperfusion but persisting exposure to the pro-thrombotic and bleeding risks of fibrinolysis.
Key Words: Facilitated PCI • Acute myocardial infarction • Outcomes
This paper was guest edited by Professor Bernard J. Gersh, Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA
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Introduction |
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Primary percutaneous coronary intervention (PCI) is the preferred treatment in patients with acute ST elevation myocardial infarction (STEMI), provided it occurs with minimal delay by an experienced team.1–3 This strategy is limited, however, by time delays including those imposed by transferring patients to PCI capable facilities. Establishing early pharmacological reperfusion prior to mechanical intervention has the potential to overcome these time-dependent limitations of primary PCI and thereby improve both procedural success and clinical outcomes.4,5 The ASSENT-4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) study evaluated a facilitated PCI strategy with full dose tenecteplase (TNK) prior to PCI vs. standard primary PCI in patients with acute STEMI. Notwithstanding higher rates of infarct artery patency prior to PCI, patients in the facilitated group were more likely to have major adverse events at 90 days including death, congestive heart failure (CHF), or shock, as well as re-infarction and were more likely to require repeat target vessel revascularization.6
Previous work has established a clear relationship between early ST-segment resolution and clinical outcomes in patients with acute STEMI undergoing both pharmacological and mechanical reperfusion.7–17 Moreover, it has been suggested that the benefits of fibrinolytic-based reperfusion for STEMI are mitigated by the presence of Q waves on the baseline ECG.18 Because time from symptom onset has been established as the primary determinant of successful pharmacological reperfusion, it follows that the benefits of fibrinolysis are best realized in those patients who present early and prior to significant infarct evolution as determined by the baseline ECG. Accordingly, we undertook a systematic electrocardiographic analysis from the ASSENT-4 PCI trial to gain mechanistic insights into the results of the primary study.
Our main objective was to determine whether we could identify those patients in whom the adverse effects of fibrinolytic-facilitated PCI occurred.
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Methods |
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The details of the ASSENT-4 PCI study have been published previously.6 In brief, 1667 patients with acute myocardial infarction, in whom a delay to cardiac catheterization of 1–3 h was anticipated, were randomly assigned to either full dose TNK-facilitated PCI or primary PCI. Although the study plan was to enrol 4000 patients, the Data and Safety Monitoring Board recommended early cessation of enrolment because of higher in-hospital mortality in the facilitated PCI group. ECG criteria for entry required total ST-segment elevations of
0.6 mV across multiple leads or, for inferior infarction, 0.6 mV ST-segment deviation with at least 0.4 mV of ST elevation in leads II, III, aVF, or new left bundle branch block with concordant ST-segment elevation 0.1 mV. The ASSENT-4 PCI ECG substudy included the entire trial population and pre-specified that standard 12-lead ECGs were obtained at baseline, 60 min (prior to PCI), and 180 min from randomization (following PCI). All ECGs were analysed blinded at independent ECG core laboratories (Canadian VIGOUR Centre, University of Alberta, Edmonton, Canadian Heart Research Centre, Toronto, and Duke Clinical Research Institute, Durham, USA) and good inter-observer agreement (96%) was demonstrated. To limit factors that could confound accurate ECG interpretation, 577 patients were excluded from this study for the following reasons: 29 had no protocol ECGs; 191 had no 60 min ECG; 81 had no 180 min ECG; 53 had neither 60 nor 180 min ECG; 16 had left bundle branch block; 179 had technically unsuitable ECGs; 10 had PCI prior to 60 min ECG; 18 had 180 min ECG prior to PCI. Mortality of these excluded patients at 30 days and 90 days was 8.0 and 9.5%, respectively. Hence, the ECG substudy population consisted of 1090 patients, of whom 549 were assigned to facilitated PCI and 541 were assigned to primary PCI.
TIMI flow grade of the infarct-related artery before and after PCI was assessed and recorded by site investigators.
Electrocardiographic analysis
ST-segment elevation was determined at the J-point with magnified callipers. For anterior infarction, total ST-segment deviation was the sum of ST elevation in leads I, and aVL and V1–V6 added to the sum of ST depression in leads II, III, and aVF. For inferior infarction, total ST deviation was the sum of ST elevation in leads II, III, and aVF added to the sum of ST depression in leads V1–V4. Using Schröder’s method,7 the degree of ST resolution at 60 and 180 min was calculated relative to the baseline ST deviation; complete resolution was defined by 70% ST-segment resolution. Regardless of the status of ST resolution at 60 min, if there was >10% further ST-segment deviation by 180 min (relative to baseline), patients were considered to have ST worsening.
Q wave or Q wave equivalent was determined at baseline using the Selvester QRS screening criteria19: a Q wave of 30 ms in aVF (inferior), 40 ms in I and aVL (lateral), 40 ms in two or more of V4, V5, V6 (apical), or any Q wave in V2 (anterior). As well, Q wave equivalents were defined as an R wave of 40 ms in V1 (posterior) or an R wave 0.1 mV and <10 ms in V2 (anterior). The ECG and clinical definitions of re-infarction (within the first 18 h and beyond 18 h) were those used in the parent trial.6
In order to assess the impact of 60 and 180 min ST resolution and its stability before and after PCI, patients were classified into four groups according to the timing of complete ST resolution: (i) sustained ST resolution—evidence of complete ST resolution at both 60 and 180 min; (ii) non-sustained ST resolution—evidence of complete ST resolution at 60 min with incomplete (<70%) ST resolution at 180 min; (iii) late ST resolution—evidence of complete ST resolution only on 180 min ECG, and (iv) no ST resolution—evidence of incomplete ST resolution on both 60 and 180 min ECGs.
Because current STEMI guidelines2 suggest fibrinolysis may be as effective as primary PCI for patients presenting <3 h, and based on prior work indicating that patients treated with fibrinolysis who have Q waves in the infarct leads at presentation have higher mortality,18 patients were further categorized according to the presence of a baseline Q wave and a 3 h time point.
Statistical analysis
Descriptive statistics were summarized as medians with 25th and 75th percentiles for continuous variables and the Mann–Whitney U test used for comparisons of two groups. For categorical variables, the data were summarized in percentages and the 
2 test used. Univariate logistic regression analysis of baseline variables was followed by multivariate logistic regression analyses through a backward stepwise variable selection procedure to identify important baseline characteristics and ECG variables associated independently with 90 day mortality and composite endpoint of death, CHF, or shock at 90 days. CHF and shock were centrally adjudicated by a clinical event committee unaware of the allocated treatment. Variables examined included age, gender, presence of hypertension or diabetes, chronic treatment with aspirin, previous myocardial infarction, previous CHF, previous coronary artery bypass grafting and PCI, systolic blood pressure, heart rate, location of infarction, Killip class, time from symptom onset to treatment, treatment assigned, baseline Q waves and their interaction with treatment assignment as well as time to treatment, and the extent of ST resolution at 60 and 180 min. The linearity assumption for baseline continuous variables was satisfied using the methodology described by Lee et al.20 The overall performance of the logistic regression models was assessed in terms of the C-index (or the area under a receiver–operator characteristic curve). All tests were two-sided, with a 5% level of significance. All analyses were performed using SPSS (Version 14).
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Results |
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Table 1 outlines baseline characteristics and clinical outcomes in the ASSENT-4 ECG substudy according to treatment assignment. As in the parent trial, patients in both groups were well matched with respect to demographic and presenting features, including total baseline ST-segment deviation. Patients in the facilitated PCI group had a significantly higher rate of complete 60 min ST resolution prior to undergoing catheterization compared with patients in the primary PCI group (24.4 vs. 15.5%, P < 0.001). In contrast, following PCI, complete ST resolution at 180 min was evident in
51% of patients in both treatment groups. At 90 day follow-up, those in the facilitated PCI group had higher mortality (4.9 vs. 2.8%, P = 0.067), higher rate of the composite endpoint of death, CHF or shock (17 vs. 10.9%, P = 0.004), and a trend towards more re-infarction (5.6 vs. 3.4%, P = 0.080). The majority of these clinical events occurred within 30 days during the index hospitalization.
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The relationship between ST-segment evolution from 60 to 180 min and clinical outcomes was explored according to treatment assignment shown in Figure 1. In Figure 1A, 90 day mortality was lowest in patients with sustained ST resolution and highest in those patients without complete ST-segment resolution at either 60 or 180 min, irrespective of treatment group (P for trend: 0.046 and 0.008 for facilitated PCI group and primary PCI group, respectively). Similar observations were made for the composite endpoint (Figure 1B, P for trend <0.001 and 0.005 for facilitated PCI group and primary PCI group, respectively).
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To further explore the association between ST-segment evolution and ischaemic events, we evaluated the incidence of ST-segment re-elevation, i.e. worsening between 60 and 180 min across all patient subsets. ST-segment worsening was more frequent in the facilitated PCI group than in the primary PCI group (14.4 vs. 10%, P = 0.027). As seen in Figure 2A, this occurred more often among patients with complete ST-segment resolution at 60 min, irrespective of treatment assignment. Moreover (Figure 2B) ST worsening was associated with significantly higher rates of in-hospital re-infarction in the facilitated PCI group (7.6 vs. 2.6%, P = 0.032).
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In order to assess the effects of time from symptom onset and ECG evidence of infarct progression on the probability of successful reperfusion and clinical outcomes, we categorized patients according to the presence or absence of Q waves on the initial ECG. In Table 2, the prevalence of baseline Q waves and clinical outcomes are illustrated according to treatment assignment. Compared with those with Q waves (n = 307), patients without initial Q waves (n = 230) in the facilitated PCI group presented 15 min earlier (150 vs. 165 min, P = 0.027), had more complete 60 min ST resolution (27.8 vs. 21.2%, P = 0.074), and complete 180 min ST-segment resolution (59.1 vs. 44.0%, P = 0.001). Patients without Q waves were more likely to have TIMI 3 flow before PCI (48.9 vs. 40.1%, P = 0.045) and following PCI (92.1 vs. 85.2%, P = 0.022). These non-Q wave patients also had a lesser infarct size as assessed by peak CK >5x upper limit of normal (62.4 vs. 73.6%, P = 0.016). Patients without baseline Q waves had lower mortality (2.2 vs. 7.2%, P = 0.008) and a lower composite endpoint (10.4 vs. 22.4%, P < 0.001) at 90 days, and this association was evident by 30 days. As well, patients without baseline Q waves undergoing primary PCI were more likely to have TIMI 3 flow following PCI (93.3 vs. 86.6%, P = 0.015), complete ST resolution at 180 min (56.1 vs. 46.4%, P = 0.029), and a trend towards lower rates of the 90 day composite endpoint (7.9 vs. 12.9%, P = 0.067).
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When stratified by time to presentation, those patients with initial Q waves who presented >3 h undergoing facilitated PCI were less likely to achieve complete ST-segment resolution at 60 min prior to PCI compared with patients presenting without Q waves within the same time window (15.6 vs. 34.2%, P = 0.002). In the primary PCI group, complete ST-segment resolution at 60 min was uninfluenced by either time from symptom onset or baseline Q waves.
Figure 3A demonstrates the relationship between baseline Q waves on 90 day mortality according to time from symptom onset in the overall population. Notably, in those with Q waves presenting more than 3 h, there is more than five-fold increase in mortality (7.1 vs. 1.3% without Q waves, P = 0.008). This relationship is further defined according to treatment assignment in Figure 3B and C. Patients in the facilitated PCI group (Figure 3B) presenting >3 h with initial Q waves constituted the highest risk subset within this treatment arm with a 90 day mortality of 10.4% compared with those without Q waves presenting within this time window (2.5%, P = 0.056). This mortality difference remained after the adjustment of baseline key risk factors (P = 0.047). In contrast, mortality of patients in the primary PCI group was not significantly influenced by time to presentation (>3 vs.3 h) or the presence of Q waves on the baseline ECG (Figure 3C). After excluding the highest risk subgroup (i.e. patients presenting >3 h with initial Q waves), the difference in 90 day mortality between treatment groups disappeared. As well, subsequent analysis excluding 128 patients with prior myocardial infarction did not affect these results.
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Table 3 highlights the results of our multivariate logistic regression analysis. After adjusting for baseline covariates, the presence of baseline Q waves in patients assigned to facilitated PCI was an independent predicator of mortality at 90 days (OR 2.70, 95% CI 1.32–5.38, P = 0.006), as was achieving sustained ST-segment resolution (OR 0.13, 95% CI 0.02–0.97, P = 0.046). With respect to the 90 day composite endpoint, sustained (OR 0.18, 95% CI 0.08–0.39, P < 0.001) and late complete ST resolution (OR 0.51, 95% CI 0.33–0.79, P = 0.003) were independent predictors, as was the presence of baseline Q waves (OR 1.71, 95% CI 1.12–2.62, P = 0.013). The models demonstrated very good discriminatory performance with c-statistics of 0.87 and 0.80 for 90 day mortality and 90 day composite endpoint, respectively.
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Discussion |
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Our findings from the ASSENT-4 PCI electrocardiographic analysis provide new insights into the adverse effects associated with a fibrinolysis-facilitated PCI strategy relative to primary PCI in acute myocardial infarction. In this study, a principal novel finding was that outcomes following TNK-facilitated PCI were dependent on the ability to achieve prompt, successful reperfusion, as assessed by early and sustained complete ST-segment resolution between 60 and 180 min after initiation of therapy. Furthermore, our results suggest that the presence of Q waves on the baseline ECG as well as the time from symptom onset help delineate the risk associated with fibrinolysis prior to PCI.
Multiple studies have demonstrated improved outcomes among patients who achieve early ST-segment resolution following pharmacological or mechanical reperfusion.7–17 It is thought that ST resolution mirrors tissue and microvascular perfusion and might therefore be a better marker of successful reperfusion than TIMI 3 flow alone.13,21–23 Indeed, patients undergoing facilitated PCI in our study were significantly more likely to achieve ST resolution prior to catheterization (24.4 vs. 15.5%); moreover those with evidence of successful reperfusion by 60 min that was sustained following PCI at 180 min had very low mortality (1.8%) and few composite endpoint events (6.2%) at 90 days. In comparison, the primary PCI cohort had an overall mortality of 2.8% with a composite endpoint rate of 10.9%. The subgroup of primary PCI patients with evidence of spontaneous reperfusion prior to catheterization (i.e. complete ST resolution by 60 min) that was sustained at 180 min had an excellent prognosis with no deaths and only 4.1% composite endpoint event rate. It appears likely that patients with spontaneous ST resolution prior to intervention achieve very early infarct artery patency and may experience greater myocardial salvage.5
As expected, there was a graded effect on outcomes in both treatment groups according to the degree ST-segment evolution. In the absence of complete ST resolution by 60 min, there was an incremental benefit (fewer events) for those patients who achieved complete ST resolution following PCI at 180 min. Taken together, these findings confirm the importance of ST-segment resolution following PCI and provide support to the hypothesis that successful reperfusion before mechanical co-intervention is an important determinant of outcome.5 Importantly, this highlights that the balance between risk and benefit with any facilitated strategy may hinge on the ability to establish myocardial reperfusion both before and after PCI.
It has been suggested that ischaemic events occurred with greater frequency in the facilitated PCI arm of the ASSENT-4 PCI trial as a consequence of a pro-thrombotic post fibrinolytic milieu.6 Although 24.4% of patients in the facilitated PCI group achieved complete ST resolution at 60 min, this was less than anticipated on the basis of our findings in the ASSENT-3 study,24 in which ST-segment resolution at 60 min occurred in 34.2% of patients who received TNK plus a weight-adjusted unfractionated heparin infusion for 48 h.25 One explanation for the suboptimal reperfusion post fibrinolytic may relate to differences in the ASSENT-4 PCI protocol; bolus unfractionated heparin was given with TNK, without a subsequent continuous infusion, and clopidogrel was not used. In addition, routine glycoprotein IIb/IIIa inhibitor use was prohibited in the facilitated group, with only 9.7% receiving these medications vs. 49.5% in the primary PCI group. An analysis from the TIMI 14 study demonstrated the importance of glycoprotein IIb/IIIa inhibitors (as an adjunct to reduced-dose fibrinolytic therapy) in promoting ST-segment resolution and preventing ST re-elevation.26
In our analysis, worsening of the ST-segments from 60 to 180 min was significantly more common in the facilitated PCI group. This may relate to the increased rates of ST worsening observed among patients achieving complete initial ST resolution by 60 min (more common in the facilitated PCI group). The association between ST worsening and increased in-hospital re-infarction in the facilitated PCI group provides support for the suggestion that PCI without optimal antithrombotic co-therapy in a post-fibrinolytic environment may have contributed to the adverse outcomes seen in the facilitated PCI arm of ASSENT-4 PCI. Earlier and more effective antithrombotic co-therapy should be considered if future studies of pharmacological-facilitated PCI are undertaken. Given the recent negative report of the FINESSE results, the enthusiasm for such approaches has understandably diminished.27
We further sought to identify patients in whom a facilitated PCI strategy posed excess risk, and tested the hypothesis that patients with established Q waves on the baseline ECG would not benefit from fibrinolysis. In an analysis from the Hirulog Early Reperfusion Occlusion (HERO) 2 trial, Wong et al.18 showed that the presence of initial Q waves and longer times to presentation were associated with increased mortality and lower rates of complete ST resolution at 60 min in patients treated with fibrinolysis. In support of these observations, facilitated PCI patients in our study presenting to hospital >3 h from symptom onset with baseline Q waves comprised a very high risk subgroup with a mortality of 10.4% at 90 days. Interestingly, only 15.6% of these patients had complete ST resolution at 60 min; this approximates the rate of spontaneous complete ST resolution in the primary PCI group (14.8%), irrespective of time to presentation or baseline Q waves.
Taken together, these findings suggest that fibrinolysis in patients presenting >3 h with Q waves at baseline does not result in any incremental benefit beyond the background rate of spontaneous reperfusion. Our multivariate analysis highlights the importance of achieving clinical reperfusion, as sustained ST resolution before and after PCI is associated with lower 90 day mortality. Moreover, this analysis implies that the increased mortality associated with facilitated PCI is limited to those patients exhibiting Q waves on the presenting ECG.
A potential limitation of our study is the exclusion of 577 patients from the parent trial with incomplete or confounding ECG data. As is the case in other studies of this nature, the majority was excluded for missing 60 and/or 180 min ECG data which may have reflected, in part, a higher risk patient subset. Although the excluded patients did have a higher mortality than our study population, baseline characteristics in the current report were well aligned with those in the primary ASSENT-4 PCI study, providing reassurance about the applicability of our findings.
Overall, our results suggest that a fibrinolysis-facilitated PCI strategy was especially harmful in patients who present beyond 3 h from symptom onset with established Q waves on the baseline ECG. We speculate that these patients have more mature, organized clot less amenable to resolution with fibrinolysis and hence undergo less myocardial salvage. The potential benefits of establishing pre-procedural myocardial reperfusion would thus go unrealized, and such patients would be exposed only to the bleeding risks and pro-thrombotic effects of fibrinolysis.
Conversely, for patients presenting <3 h, in whom protracted delay to PCI is anticipated, a fibrinolytic-facilitated PCI strategy (especially when Q waves are absent on the index ECG) remains a potentially interesting therapeutic option; prospective evaluation of this subgroup may be warranted.28 Given the post hoc nature of our study and the excluded patients, our findings should be considered hypothesis-generating. Further insights into the potential benefits of a pharmaco-invasive strategy in patients presenting early (<3 h) may be provided by the STrategic Reperfusion Early After Myocardial Infarction (STREAM) trial, which will compare primary PCI vs. strategic rescue and timely adjunctive PCI following pre-hospital fibrinolysis in patients with high-risk STEMI.
Conflict of interest: none declared.
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This research was supported by Boehringer-Ingelheim, Germany, and Genentech, South San Francisco, CA, USA.
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Footnotes |
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This paper was guest edited by Professor Bernard J. Gersh, Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA
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 P. W. Armstrong, C. M. Westerhout, and R. C. Welsh Duration of Symptoms Is the Key Modulator of the Choice of Reperfusion for ST-Elevation Myocardial Infarction Circulation, March 10, 2009; 119(9): 1293 - 1303. [Full Text] [PDF]
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