Abstract
Background
The purpose of this study was to investigate the safety and efficacy of thrombolysis followed by early percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI).
Methods
A total of 161 patients were enrolled in the study. Fifty-three of them who underwent thrombolysis in non-PCI hospital and immediately transferred to receive early PCI were assigned to the early PCI group (E-PCI); the rest of the patients were assigned to the primary PCI group (P-PCI). Coronary angiography and PCI were performed via the transradial artery approach for patients in both groups. Angiographic parameters, bleeding complications and total hospital stay were compared between the two groups. All patients were followed-up for 30 days to evaluate major adverse cardiac events (MACE).
Results
Before PCI procedure, the thrombus score of IRA in the E-PCI group was lower, and the percentage of TIMI flow grade (TFG) 3 was higher (both p < 0.05) compared to those in the P-PCI group. The myocardial reperfusion in the E-PCI group was better than that in the P-PCI group. There was a trend towards a lower peak value of serum creatine kinase MB in the E-PCI group, and left ventricular ejection fraction (LVEF) before discharge in E-PCI was higher than that in the P-PCI group (54.38 ± 5.29% vs. 52.19 ± 7.00%, respectively, p = 0.028). No significant differences were found in the incidences of bleeding complications and hospital stay between the two groups. There was no significant difference in the 30-day MACE between the two groups (p = 0.863), and no significance of cumulative MACE-free survival rates were found between the two groups as well (p = 0.522). Variables predicting MACE upon patient follow-up according to univariable Cox regression analyses showed that a history of hyperlipidemia, smokers, TFG of infarction related artery before PCI < 2, and low levels of LVEF were associated with poor clinical outcomes (all p < 0.05).
Conclusions
It is safe and efficacious for STEMI patients to receive thrombolysis followed by early PCI via the transradial artery approach.
Keywords: Major adverse cardiac event, Percutaneous coronary intervention, Radial artery, ST-segment elevation myocardial infarction, Thrombolysis
INTRODUCTION
Complete and effective myocardial reperfusion as soon as possible is the final target for patients with ST-segment elevation myocardial infarction (STEMI), to best facilitate reduction in infarction size and improve clinical outcomes.1 Until now, the available reperfusion therapies have included primary percutaneous coronary intervention (primary PCI) and intravenous thrombolysis.2 Primary PCI performed by skilled surgical teams in large medical centers is considered to be the preferred strategy of myocardial reperfusion.3,4 However, due to the time-dependent nature of primary PCI, logistical barriers limit its use to no more than 20% of STEMI patients worldwide.5-7 In contrast, intravenous thrombolysis is widely applicable, and previous trials have shown that intravenous thrombolysis can unequivocally reduce mortality9 when given within 8-12 h of symptom onset. Nevertheless, the utility of thrombolytics is limited by the risk of bleeding complications, lower rates of repatency of infarction related artery (IRA), and the higher incidence of reocclusion, which has a detrimental impact on the mortality of STEMI patients. Recently, several studies have demonstrated that thrombolysis followed by routine early PCI may improve clinical outcomes for STEMI patients who were admitted in a non-PCI capable hospital9,10 but possible bleeding complications remained a concerning limitation of this strategy.
Bleeding complications could result in increased mortality and duration of hospitalization after thrombolysis and PCI procedures. There is mounting evidence suggesting that transradial PCI (TRI) can reduce the incidence of bleeding complications and improve long-term outcomes when compared with PCI via the transfemoral artery approach (TFI).11
However, there were few clinical trials comparing primary PCI with thrombolysis, followed by early PCI via transradial artery approach. The aim of this study was to investigate the safety and efficacy of thrombolysis followed by early PCI via transradial artery approach on STEMI patients.
METHODS
Study population
From January 2009 to June 2010, all consecutive STEMI patients within 12 hours from symptom onset in the Department of Cardiology of the Second Hospital of Hebei Medical University were enrolled in our study.
The inclusion criteria were as follows: 1) typical clinical presentation, ST elevation of over 0.2 mm in two or more adjacent precordial leads or 0.1 mm in adjacent limb leads, and a rise of creatine kinase (CK) twice over the upper limit of normal status or an elevation of troponin I; 2) patients were admitted within 12 hours from symptom onset; 3) with or without intravenous thrombolysis therapy in non-PCI capable hospitals before admission.
Exclusion criteria were: 1) history of old myocardial infarction; 2) contraindication for aspirin, clopidrogrel, tirofiban or heparin; 3) renal failure [indicated by a serum creatinine concentration above 2.5 mg/dL (221 mmol/L)]; 4) history of neutropenia, thrombocytopenia, or hepatic dysfunction; 5) participated in other clinical trials; 6) previously understood multivessel coronary artery disease which was not suitable for PCI; 7) a pathologic Allen’s test; 8) necessity for a preprocedural implantation of a transient pacemaker or IABP; and 9) patient refusal to participate.
The study protocol was approved by the Ethical Committee of the Second Hospital of Hebei Medical University, and the written informed consent was given by all patients before cardiac catheterization procedures were performed.
Study protocols
All eligible STEMI patients were divided into two groups according to whether or not patients received thrombolysis. In the early PCI group (E-PCI group), patients received thrombolytic agents in non-PCI capable hospital and were immediately transferred to receive early PCI. In the primary PCI group (P-PCI group), patients received primary PCI. Patients in the E-PCI group received 100 mg alteplase as a front-loaded 90-minute infusion (15 mg bolus, then 50 mg over a 30-minute period, then 35 mg over a 60-minute period) or double bolus (two 50 mg bolus injections 30 minutes apart). Coronary angiography (CAG) and PCI were performed immediately after admission via transradial artery approach for patients in both groups utilizing the standard technique. According to the results of angiography, PCI was performed unless the blood flow of IRA achieved TIMI flow grade 3 without significant stenosis. Heparin in the E-PCI group was administered as a 5000 U bolus injection followed by an adjusted-dose (800-1000 U/h) to 24 hours after thrombolysis to maintain target activated clotting time (ACT) 200-250 s. Heparin in the P-PCI group was administered as routine dose during PCI to maintain target ACT of 200-250 s. The use of glycoprotein IIb/IIIa antagonist tirofiban was left to the operator’s discretion during PCI procedure. Tirofiban was administered with a 10 μg/kg bolus intravenous injection for 3 minutes followed by 0.15 μg · kg-1 · min-1 infusion for 12 hours. The other medications were administered to the patients (including aspirin, clopidogrel, diuretics, isotropic agents, intravenous vasodilator, lipid-lowering, beta-blockade, and angiotensin of converting enzyme inhibitors) according to current best practices.
Time frames were recorded including onset to first medical contact (FMC), onset to thrombolysis, thrombolysis to balloon, onset to balloon, door to balloon (defined as a time interval from the patient’s arrival in the emergency department of our hospital to the repatency of IRA in the cardiac catheter lab). Patient blood pressure and electrocardiogram were monitored and recorded. Blood samples were examined for myocardium enzymes, hepatic and renal functions and coagulation function. Echocardiography was examined before discharge. Thrombus score, TIMI flow grade (TFG) of IRA before and after PCI, corrected TIMI frame count (CTFC), TIMI myocardial perfusion grade (TMPG) post-PCI were also analyzed. Bleeding complications was also observed and evaluated, and all patients were followed-up for 30 days to assess major adverse cardiac events (MACE).
Definitions and end points
The primary endpoint was myocardial perfusion post-PCI assessed by TFG, cTFC and TMPG, and the second endpoints were bleeding complications during hospital and 30-day MACE. TFG,12 CTFC,13 and TMPG14 were used to evaluate the angiographic results before and after PCI by two independent cardiologists who were blinded to the procedures, and the thrombus score was assessed as previously defined.15 The major adverse cardiac events (MACE) were defined as recurrent ischemic symptoms, death, target vessel related myocardial infarction, or the need for revascularization of the treated vessel.
Statistical analysis
Absolute numbers and percentages were computed to describe the patient population. Continuous variables are expressed as mean ± SD and are compared using the unpaired t test for normal distributions and Mann-Whitney U test for non-normally distributed variables. Categorical variables are expressed as absolute or relative frequencies and are compared using chi-square analyses or the Fisher’s exact test, as appropriate to the cell frequencies. The cumulative MACE-free survival was analyzed according to the Kaplan-Meier method and compared with results from the log-rank test. Values of p < 0.05 were considered statistically significant, and hazard ratios (95% CI) are presented. The proportional hazard assumption was checked for each categorical variable by use of Cox regression. SPSS 17.0 for Windows (SPSS Inc., Chicago, Illinois, USA) was used for statistical analysis.
RESULTS
Among the overall 170 STEMI patients who were admitted within 12 hours of symptom onset, 9 of them were excluded: 6 patients with implanted IABP or transient pacemaker, 2 patients with negative Allen’s test, and 1 patient with refusal of PCI. A total of 161 patients were finally enrolled, 53 of whom were assigned to the E-PCI group and the rest of them to the P-PCI group.
Comparisons of baseline clinical characteristics
The baseline clinical characteristics of the patients were summarized in Table 1. The patients in E-PCI group were younger than those in P-PCI group (51.36 ± 12.24 vs. 57.31 ± 9.87, p = 0.003). The other baseline clinical characteristics such as gender distribution, baseline levels of serum type-B natriuretic peptide (BNP), creatinine (SCr) and Hemoglobin (Hb), and medication therapies were similar between the two groups (all p > 0.05).
Table 1. Baseline clinical characteristics .
| Early PCI (n = 53) | Primary PCI (n = 108) | p | |
| Age (years) | 51.36 ± 12.24 | 57.31 ± 9.87 | 0.003 |
| Gender (male)-n (%) | 46 (86.8) | 95 (88.0) | 0.832 |
| BMI (kg/m2) | 24.27 ± 2.08 | 24.40 ± 2.53 | 0.741 |
| History | |||
| DM-n (%) | 11 (20.8) | 29 (26.9) | 0.400 |
| Hypertension-n (%) | 27 (50.9) | 60 (55.6) | 0.581 |
| Hyperlipidemia-n (%) | 6 (11.3) | 18 (16.1) | 0.371 |
| Smoker-n (%) | 28 (54.9) | 60 (55.6) | 0.938 |
| Premature coronary artery disease-n (%) | 10 (18.9) | 21 (19.4) | 0.931 |
| Anterior wall MI-n (%) | 36 (67.9) | 61 (56.5) | 0.163 |
| Killip classification-n (%) | 0.967 | ||
| I | 29 (54.7) | 61 (56.5) | |
| II | 18 (34.0) | 36 (33.3) | |
| III | 6 (11.3) | 11 (10.2) | |
| Baseline medications | |||
| B-blocker-n (%) | 40 (75.5) | 69 (63.9) | 0.140 |
| ACEI-n (%) | 42 (79.2) | 73 (67.6) | 0.124 |
| Statins-n (%) | 45 (84.9) | 99 (91.7) | 0.190 |
| Lab examinations | |||
| BNP (pg/ml) | 102.86 ± 189.53 | 106.52 ± 165.71 | 0.884 |
| SCr (μmol/L) | 86.58 ± 15.63 | 88.36 ± 31.15 | 0.695 |
| Hb (g/L) | 142.27 ± 16.22 | 139.56 ± 15.91 | 0.297 |
ACEI, angiotensin converting enzyme inhibitors; BMI, body mass index; BnP, type-B natriuretic peptide; DM, diabetes mellitus; Hb, hemoglobin; PCI, percutaneous coronary intervention; SCr, creatinine.
CAG and PCI procedural characteristics
CAG and PCI procedural characteristics were shown in Table 2. The mean time from symptom onset to thrombolysis was 3.62 ± 1.85 h in the E-PCI group, and the time from thrombolysis to PCI was 5.13 ± 3.03 h. Compared to the P-PCI group, the mean time from onset to PCI was longer in the E-PCI group (8.75 ± 2.86 vs. 6.03 ± 3.19 h, p < 0.001). There were no differences in door to balloon time and IRA distribution between the two groups. Of the 53 patients treated with thrombolysis, 51 patients underwent early PCI when transferred to our hospital except 2 patients who only underwent CAG. In the P-PCI group, 106 patients underwent primary PCI, while 2 patients underwent CAG. Before the PCI procedure, the thrombus score of IRA in E-PCI group was lower, and the percentage of TIMI 3 flow was higher (both p < 0.05) compared to those in the P-PCI group. TFG of IRA after PCI was similar, and there was no significant difference in the volume of contrast medium (p > 0.05). However, cTFC of IRA post PCI in E-PCI group was lower than that in the P-PCI group (18.12 ± 5.06 vs. 20.89 ± 8.74, p < 0.05), and the rate of TMPG 3 in the E-PCI group was higher than that in the P-PCI group (82.8% vs. 68.0%, p < 0.05). All of the implanted stents were drug-eluting stents. No differences were found in the number of stent implantations between the two groups (all p > 0.05).
Table 2. Characteristics of PCI procedure .
| Early PCI (n = 53) | Primary PCI (n = 108) | p | |
| Time frame | |||
| Onset to FMC (min) | 63.51 ± 19.70 | 59.84 ± 17.26 | 0.228 |
| Onset to thrombolysis (h) | 3.62 ± 1.85 | - | |
| Thrombolysis to balloon (h) | 5.13 ± 3.03 | - | |
| Onset to balloon (h) | 8.75 ± 2.86 | 6.03 ± 3.19 | < 0.001 |
| Door to balloon (min) | 67.23 ± 18.34 | 70.19 ± 22.65 | 0.409 |
| Multivessel disease-n (%) | 15 (28.3) | 37 (34.3) | 0.447 |
| IRA-n (%) | 0.527 | ||
| LM | 1 (1.9) | 0 (0) | |
| LAD | 28 (52.8) | 61 (56.5) | |
| LCX | 10 (18.9) | 18 (16.7) | |
| RCA | 14 (26.4) | 29 (26.9) | |
| Thrombus score-n (%) | < 0.001 | ||
| 0 | 9 (17.0) | 1 (0.9) | |
| 1 | 8 (15.1) | 2 (1.9) | |
| 2 | 11 (20.8) | 4 (3.7) | |
| 3 | 6 (11.3) | 3 (2.8) | |
| 4 | 7 (13.2) | 6 (5.5) | |
| 5 | 12 (22.6) | 92 (85.2) | |
| TFG of IRA before PCI-n (%) | < 0.001 | ||
| 0 | 12 (22.6) | 92 (85.2) | |
| 1 | 5 (9.6) | 9 (8.3) | |
| 2 | 13 (24.5) | 5 (4.6) | |
| 3 | 23 (43.4) | 2 (1.9) | |
| TFG of IRA after PCI-n (%) | 0.076 | ||
| 0 | 0 (0) | 0 (0) | |
| 1 | 0 (0) | 2 (1.9) | |
| 2 | 5 (9.4) | 24 (22.2) | |
| 3 | 48 (90.6) | 82 (75.9) | |
| CTFC | 28.12 ± 5.06 | 30.89 ± 8.74 | 0.034 |
| TMPG 3-n (%) | 48 (82.8) | 70 (68.0) | 0.042 |
| Stent (/person) | 1.31 ± 0.69 | 1.37 ± 0.65 | 0.590 |
| Post-MLD (mm) | 3.02 ± 0.41 | 2.97 ± 0.38 | 0.446 |
| Length of stents (mm) | 27.5 ± 6.7 | 28.8 ± 7.3 | 0.277 |
| Tirofiban-n (%) | 5 (9.4) | 47 (43.5) | < 0.001 |
| Volume of contrast medium (ml) | 167.92 ± 58.49 | 174.40 ± 48.04 | 0.456 |
CTFC, corrected TIMI frame count; FMC, first medical contact; LAD, left anterior descending; LCX, left circumflex; LM, left mail; MLD, minimal lumen diameter; PCI, percutaneous coronary intervention; RCA, right coronary artery; TFG, TIMI flow grade.
Post-PCI characteristics
The left ventricular ejection fraction (LVEF) before discharge in the E-PCI group was higher than that in the P-PCI group (54.38 ± 5.29% vs. 52.19 ± 7.00%, p = 0.028). There was a trend toward lower peak value of serum CK-MB in the E-PCI group. However, no significant differences were found in the incidence of bleeding complications and hospital stay between the two groups (Table 3). All of the patients were followed up for 30 days. Overall, there was no significant difference in 30-day MACE between the two groups (p = 0.863).
Table 3. Clinical outcomes after PCI .
| Early PCI (n = 53) | Primary PCI (n = 108) | p | |
| Before discharge | |||
| Peak CK-MB (U/L) | 229.08 ± 189.53 | 275.35 ± 129.67 | 0.071 |
| LVEF | 54.38 ± 5.29% | 52.19 ± 7.00% | 0.028 |
| Bleeding complications-n (%) | |||
| TIMI major | 2 (3.8) | 4 (3.7) | 1.000 |
| TIMI minor | 3 (5.7) | 8 (7.4) | 1.000 |
| Local hematoma | 3 (5.7) | 6 (5.6) | 1.000 |
| Transfusion | 2 (3.8) | 3 (2.8) | 0.665 |
| CHF-n (%) | 1 (1.9) | 4 (3.7) | 0.467 |
| Hospitalization stay (days) | 11.2 ± 3.7 | 12.5 ± 4.1 | 0.053 |
| MACE after 30-day follow-up-n (%) | 4 (7.5) | 9 (8.3) | 0.863 |
| Recurrent ischemic symptoms | 2 (3.8) | 4 (3.7) | 0.645 |
| Death | 0 (0) | 1 (0.9) | 0.671 |
| Target vessel related MI | 1 (0.9) | 2 (1.9) | 0.701 |
| Revascularization of IRA | 2 (3.8) | 2 (1.9) | 0.400 |
CHF, congestive heart failure; CK-MB, creatine kinase MB; IRA, infarction related artery; LVEF, left ventricular ejection fraction; MACE, major adverse cardiac events; MI, myocardial infarction; PCI percutaneous coronary intervention.
Cumulative MACE-free survival rates
The unadjusted, 30-day cumulative MACE-free survival curve was shown as Figure 1. No significance of cumulative MACE-free survival rates was found between the two groups (p = 0.522). Variables predicting MACE at follow-up according to univariable Cox regression analyses are presented in Table 4. A history of hyperlipidemia, smoking, TFG of IRA before PCI < 2 and low levels of LVEF were associated with poor clinical outcomes (all p < 0.05).
Figure 1.
Cumulative MACE-free survival of the two groups after 30-day follow-up. Unadjusted Kaplan-Meier survival curves for different treatments (p = 0.522). E-PCI, early percutaneous coronary intervention; P-PCI, primary percutaneous coronary intervention
Table 4. Prognostic significance of selected variables concerning MACE at follow-up according to univariable Cox regression analyses .
| HR | 95% CI | 95% CI | p | |
| Lower | Upper | |||
| Age | 0.950 | 0.896 | 1.007 | 0.082 |
| High risk factors | ||||
| Diabetes | 1.750 | 0.419 | 7.310 | 0.443 |
| Hypertension | 0.256 | 0.056 | 1.172 | 0.079 |
| Hyperlipidemia | 0.127 | 0.028 | 0.574 | 0.007 |
| Smoker | 5.733 | 1.292 | 25.444 | 0.022 |
| Premature coronary artery disease | 0.508 | 0.106 | 2.432 | 0.397 |
| Characteristics of PCI procedure | ||||
| TFG of IRA before PCI < 2 | 8.672 | 1.171 | 64.193 | 0.017 |
| TFG of IRA after PCI < 2 | 1.746 | 0.165 | 18.437 | 0.898 |
| TMPG < 2 | 0.419 | 0.062 | 2.823 | 0.371 |
| No reflow | 0.358 | 0.081 | 1.59 | 0.177 |
| Clinical data | ||||
| Anterior wall MI | 1.969 | 0.523 | 7.41 | 0.316 |
| Killip classificassion | 9.462 | 0.000 | 1.859 | 0.098 |
| LVEF | 0.942 | 0.888 | 0.998 | 0.043 |
| Peak value of CK-MB | 1.001 | 0.999 | 1.002 | 0.348 |
CK-MB, creatine kinase MB; HR, hazard ratio; LVEF, left ventricular ejection fraction; MACE, major adverse cardiac events; MI, myocardial infarction; PCI, percutaneous coronary intervention; TFG, TIMI flow grade; TMPG, TIMI myocardial perfusion grade.
DISCUSSION
The present clinical trial reported the results observed in STEMI patients of a single center in which interventional cardiology was well performed. The results of this consecutive study showed excellent outcomes that the clinical effects of thrombolysis followed by TRI was similar with primary PCI, with better myocardial reperfusion and heart function, while bleeding complications did not increase in the E-PCI group.
Complete and effective myocardial reperfusion as quickly as possible is the key goal for STEMI patients, to help reduce infarction size and improve clinical outcomes.1 In past years, either thrombolysis or primary PCI was considered to be an alternative strategy of reperfusion. Consequently, some reminders are necessary regarding the practice of transferring STEMI patients for subsequent angioplasty with the intention of pharmacoinvasive reperfusion before mechanical recanalization, in conjunction with the appropriate time interval to perform such strategies.16 Early PCI is not a simplified combination of primary PCI and thrombolysis. Previous studies have proven the importance of time delay for reperfusion therapies in STEMI patients.17 Patients benefit from admission to a PCI-capable hospital following thrombolysis for two reasons. On the one hand, if reperfusion has failed, rescue PCI is more readily available; on the other hand, on the basis of many recent studies, routine angiography and PCI (where appropriate) overrides a selective ischemia-driven invasive approach as the recommended management after thrombolysis.8 In this study, the protocols were similar with the ASSENT-4 and other clinical trials, but the results were significantly different, which may in part be due to the following reasons. First, eligible candidates included thrombolysis with clot-selective drugs and the use of conjunctive agents in this study, including glycoprotein IIb/IIIa inhibitors, clopidogrel, aspirin, and heparin. Secondly, the temporal window for efficacy of PCI was broadened by employing pharmacologic components as part of the pharmacoinvasive recanalization strategy. Current median times from onset to FMC was similar, while time from onset to reperfusion therapy for E-PCI patients (3.62 ± 1.85 h) and P-PCI patients (6.03 ± 3.19 h) implies that the strategy of thrombolysis followed by early PCI can broaden the temporary window for STEMI patients. This may be beneficial to obtain optimal myocardial reperfusion and persistent repatency of IRA. Third, microvascular reperfusion is a powerful indicator and perhaps determinant of prognosis after STEMI. Thus, end points such as TIMI frame count, perfusion grade, and ST-segment resolution are strong descriptors of outcomes.18 In this study, myocardial perfusion assessed by TFG, cTFC and TMPG of IRA post PCI was defined as the primary end point, and the results found that microvascular reperfusion of thrombolysis followed by early PCI via transradial artery approach was better than primary PCI.
Various studies have shown that there are many advantages of TRI compared with transfemoral intervention (TFI), such as fewer vascular access site bleeding complications, immediate post-procedural ambulation, no postural limitation, and improved clinical outcomes, particularly in patients who were at high risk of vascular complications.19,20 This access advantage is especially suitable under the condition of anticoagulation and antiplatelet therapies. In this study, both early PCI and primary PCI were performed via radial artery, and the blood complications in E-PCI group didn’t increase compared with primary PCI. These results indicated that the potential benefit of thrombolysis followed by early PCI may decrease the thrombus load of IRA and persistent repatency of IRA. Although the incidences of MACE between the two groups were similar, the heart function in the E-PCI group was better. Cox regression showed that better heart function and myocardium reperfusion was associated with improved clinical outcomes. We could infer that the incidence of MACE may be reduced in E-PCI group due to improved heart function and myocardium reperfusion if the sample size increased upon further study.
To our knowledge, this is the first study focusing on the safety and efficacy of thrombolysis followed by early PCI via transradial artery approach. The limitation of this study is that the study size was small and involved a non-randomized trial. In addition, we excluded cardiogenic shock with STEMI from this study due to the fact that hypotension would have precluded the use of vasodilators, hence introducing a selection bias.
CONCLUSIONS
In conclusion, it is safe and efficacious for STEMI patients to receive thrombolysis followed by early PCI via radial approach.
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