Primary angioplasty in acute myocardial infarction at hospitals with no surgery on-site (the PAMI-No SOS study) versus transfer to surgical centers for primary angioplasty

OBJECTIVES: To investigate primary angioplasty (PA) for high-risk acute myocardial infarction (AMI) at hospitals with no cardiac surgery on-site (No SOS), we hypothesized that a nonrandomized registry of such patients treated with PA would show clinical outcomes similar to those of a group randomized to transfer for PA, and that reperfusion would occur faster. BACKGROUND: Primary angioplasty provides outcomes superior to fibrinolytic therapy in AMI, but its use in community hospitals with No SOS has been limited. METHODS: Fibrinolytic-eligible patients with high-risk AMI prospectively consented if they had one or more high-risk characteristic. Nineteen hospitals with No SOS prospectively enrolled 500 patients for PA on-site. Seventy-one similar Air Primary Angioplasty in Myocardial Infarction trial patients were randomized to transfer for PA. RESULTS: Primary angioplasty was performed in 88% of patients. Patients transferred for PA had a longer mean time to treatment (187 vs. 120 min; p < 0.0001). Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 was achieved in 96% for on-site PA, 86% in the transfer group (p = 0.004). The combined primary end point of 30-day mortality, re-infarction, and disabling stroke occurred in 27 (5%) on-site PA patients and 6 (8.5%) transfer patients (p = 0.27). Unadjusted one-year mortality was improved in on-site PA patients compared with those transferred (6% vs. 13%, p = 0.043), but after adjustment for differences in baseline variables, this difference was not significant. CONCLUSIONS: On-site PA and transfer groups had similar 30-day outcomes and more rapid reperfusion for on-site PA. Primary angioplasty in high-risk AMI patients at hospitals with No SOS is safe, effective, and faster than PA after transfer to a surgical facility.     

A randomized trial comparing myocardial salvage achieved by coronary stenting versus balloon angioplasty in patients with acute myocardial infarction considered ineligible for reperfusion therapy

OBJECTIVES: We assessed myocardial salvage achieved by reperfusion with percutaneous coronary interventions (PCI) and compared stenting with balloon angioplasty (PTCA) in patients with acute myocardial infarction (AMI) ineligible for thrombolysis. BACKGROUND: A substantial proportion of patients with AMI are currently considered ineligible for thrombolysis, and reperfusion treatment is frequently not recommended for them. It is not known whether these patients benefit from PCI. METHODS: The Stent or PTCA for Occluded Coronary Arteries in Patients with Acute Myocardial Infarction Ineligible for Thrombolysis (STOPAMI-3) trial, a randomized, open-label study, included 611 patients with AMI who were ineligible for thrombolysis (lack of ST-segment elevation on the electrocardiogram, late presentation >12 h after symptom onset, and contraindications to thrombolysis). Patients were randomly assigned to receive either coronary artery stenting (n = 305) or PTCA (n = 306). Scintigraphic myocardial salvage index (proportion of the initial myocardial perfusion defect that was salvaged by reperfusion) was the primary end point of the study. RESULTS: A considerable myocardial salvage was achieved with both stenting and PTCA. In patients assigned to receive stenting, the median size of the salvage index was 0.54 (25th and 75th percentiles, 0.29 and 0.87), as compared with a median of 0.50 (25th and 75th percentiles, 0.26 and 0.82) in the group assigned to receive PTCA (p = 0.20). Mortality at six months was 8.2% in the group of patients assigned to receive stenting and 9.2% in the group of patients assigned to receive PTCA (p = 0.69). CONCLUSIONS: Patients with AMI who are currently considered ineligible for thrombolysis by conventional guidelines may greatly benefit from primary PCI. The benefit seems to be comparable when a strategy of stenting is compared with a strategy of PTCA in these patients.     

Increased levels of plasma thrombomodulin in patients with acute myocardial infarction who had thrombolytic therapy and achieved successful reperfusion

BACKGROUND: There is a growing body of evidence from animal and in vitro studies for the existence of reperfusion injury after thrombolytic therapy for acute myocardial infarction (AMI), but the patient data are limited. HYPOTHESIS: We aimed to examine the plasma thrombomodulin (TM) levels as a marker of endothelial injury and to investigate the effect of successful reperfusion on these levels. METHODS: The study included 32 patients who had a first episode of acute myocardial infarction (AMI) and received intravenous streptokinase therapy. RESULTS: Thrombomodulin levels increased significantly at 60 min after thrombolysis compared with the levels before thrombolytic therapy (0 min) in 21 (66%) patients who had successful reperfusion (49.09 +/- 10.51 vs. 25.76 +/- 5.55 ng/ml, p < 0.001). There was no difference between the TM levels at 0 and at 60 min of thrombolysis in the remaining 11 (34%) patients who could not achieve reperfusion (27.81 +/- 6.32 vs. 28.72 +/- 7.28 ng/ml, p = 0.35). CONCLUSION: There was a significant increase in TM levels at 60 min after thrombolysis in a group of patients with AMI who achieved successful reperfusion; this increase may have been caused by the activation/injury of endothelial cells. Data also suggest that the increment in TM levels may be predictive of the potential success of thrombolytic therapy.     

Outcome of different reperfusion strategies in patients with former contraindications to thrombolytic therapy: A comparison of primary angioplasty and tissue plasminogen activator

High-risk patients have been excluded from most thrombolytic trials because of concern over hemorrhagic complications or lack of efficacy. However, based on several recent studies suggesting that patients with relative thrombolytic contraindications may also benefit from reperfusion, recommendations have been made to broadly expand the eligibility criteria for thrombolytic therapy, despite higher absolute complication rates. Primary percutaneous transluminal coronary angioplasty (PTCA) may be an attractive alternative for patients presenting at appropriately equipped hospitals who would otherwise remain at high risk after thrombolytic therapy. In the Primary Angioplasty in Myocardial Infarction (PAMI) trial, 395 patients with acute myocardial infarction were randomized to tissue plasminogen activator (t-PA) or primary PTCA. Conditions were present In 151 patients (38%) which formerly would have contraindicated thrombolytic therapy (age >70 yr, symptom duration >4 hr, or prior bypass surgery). In-hospitality was 4.3-fold higher in patients with former thrombolytic contraindications compared to lytic-eligible patients (8.6% vs. 2.0%, P = .002). Lytic-eligible patients treated with t-PA and PTCA had similar in-hospital mortality (1.7% vs. 2.4%, P = NS). In contrast, both in-hospital (2.9% vs. 13.2%, P = .025) and 6-mo mortality (2.9% vs. 15.7%, P = .009) were significantly reduced in patients with former thrombolytic contraindications treated by primary PTCA compared to t-PA. By logistic regression analysis, treatment by PTCA rather than t-PA was the strongest predictor of survival in patients with former thrombolytic contraindications. We conclude that patients with conditions formerly contraindicating thrombolytic therapy constitute a high-risk group with significant morbidity and mortality after lytic reperfusion. Our data suggest that patients with former contraindications to thrombolytic therapy may benefit by preferential management with primary PTCA without antecedent thrombolysis. © 1996 Wiley-Liss, Inc.     

Early referral for intentional rescue PTCA after initiation of thrombolytic therapy in patients admitted to a community hospital because of a large acute myocardial infarction

BACKGROUND: If no in-house facilities for percutaneous transluminal coronary angioplasty (PTCA) are present, thrombolytic therapy is the treatment of choice for acute myocardial infarction (AMI). A few studies have shown benefit from rescue PTCA in patients directly admitted to centers with PTCA facilities. The obvious question arises whether patients with AMI initially admitted to a community hospital can benefit from early transfer for intentional rescue PTCA. METHODS AND RESULTS: One hundred sixty-five patients were transferred early for intentional rescue PTCA from a community hospital at a distance of 20 miles. On arrival at the angioplasty center, bedside markers were used to determine reperfusion. In case of obvious reperfusion, no invasive procedure was done; otherwise, coronary angiography and rescue PTCA, if necessary, was performed. During transfer, 1 (1%) patient died and 15 (9%) patients had arrhythmic or hemodynamic problems. Median time delay between onset of chest pain and arrival at the community hospital and the PTCA center was 61 minutes (range 0 to 413) and 150 minutes (range 28 to 472), respectively. In 66 (40%) patients, reperfusion was diagnosed by noninvasive reperfusion criteria on arrival at the PTCA center (group 1). Ninety-eight (59%) patients without evident noninvasive criteria of reperfusion underwent angiography 187 median minutes after the onset of chest pain. Forty-one (25%) patients had Thrombolysis In Myocardial Infarction grade 3 flow, and no further intervention was performed (group 2). In the remaining 57 (35%) patients, rescue PTCA was performed, which was successful in 96% (group 3). In-hospital mortality rate was lowest in group 1 compared with the other 2 groups (0% vs 7% vs 11%; P <.05). Reinfarction was highest in group 1 compared with the other groups (17% vs 5% vs 2%; P <.01). No significant differences were found in coronary artery bypass grafting, stroke, or bleeding complications. The 1-year follow-up data showed low revascularization rates; 2 (1%) patients died after discharge from the hospital. CONCLUSIONS: Early transfer of patients with large AMI for intentional rescue PTCA can be done with acceptable safety and is feasible within therapeutically acceptable time limits and results in additional early reperfusion in 33% of patients. A large, randomized, multicenter trial is needed to compare efficacy of intravenous thrombolytic treatment in a community hospital versus early referral for either rescue or primary PTCA.     

Magnesium use in the treatment of acute myocardial infarction in the United States (observations from the Second National Registry of Myocardial Infarction)

The use of magnesium in patients with acute myocardial infarction (AMI) is debated, largely as a result of conflicting data from randomized controlled trials. This study evaluated the use and impact on mortality of intravenous magnesium in the treatment of patients with AMI in the United States based on data from the Second National Registry of Myocardial Infarction. Only 5.1% of 173,728 patients from 1,326 hospitals received intravenous magnesium within the first 24 hours after an AMI, and this was more common in the 59,798 patients who received thrombolytic therapy or who underwent primary percutaneous transluminal coronary angioplasty (PTCA) or coronary bypass grafting (CABG) than in the 113,930 patients who did not receive any reperfusion therapy (8.5% vs 3.4%, p <0.01). Magnesium use was associated with younger age, Q-wave AMI, congestive heart failure on admission, thrombolytic therapy, primary PTCA or CABG, ventricular tachycardia or ventricular fibrillation, and beta blocker or lidocaine use in the first 24 hours (all odds ratio > 1.2, p <0.001). Magnesium use was associated with increased mortality (odds ratio 1.25, 95% confidence interval 1.12 to 1.34) and with a higher mortality in patients without initial reperfusion therapy (20.2% vs 13.2%, p <0.0001) or who underwent primary PTCA or CABG (10.2% vs 7.3%, p = 0.002), but not in patients who received thrombolytic therapy (6.2% vs 5.9%, p = NS). Thus, magnesium is used infrequently in the treatment of AMI and may be associated with worse outcome.     

Efficacy of early reperfusion therapy at the acute stage of myocardial infarction in elderly patients: the USIK database

The role of early reperfusion therapy at the acute stage of myocardial infarctus in elderly patients is debated. The aim of this study was to analyze the prognostic role of reperfusion with i.v. thrombolysis or primary PTCA in the nationwide USIK database, which prospectively included all pts admitted to a CCU for an AMI < 48 hours in France in November 1998. For the purpose of the present study, only patients admitted within 24 hours of AMI and with one-year follow-up available were included. Of the 1838 patients included, 785 were > 70 years-old, of whom 225 (29%) had early reperfusion therapy with thrombolysis (N = 173) or primary PTCA (N = 52). Patients treated with early reperfusion had a baseline profile that differed substantially from that of patients treated conventionally: women (31% vs 50%, p < 0.001), admission within six hours of symptom onset (84% vs 55%, p < 0.001), history of systemic hypertension (48% vs 60%, p < 0.002), stroke (5% vs 11%, p < 0.01), peripheral arterial disease (8% vs 18%, p < 0.001); congestive heart failure (5% vs 20%, p < 0.001) or previous MI (12% vs 25%, p < 0.001), more anterior location of current MI (40% vs 28%, p < 0.002). Overall one-year Kaplan-Meier survival was 78% for patients with versus 64% for those without reperfusion therapy (p < 0.01). In patients with Q wave myocardial infarction, Cox multivariate analysis showed that reperfusion therapy was an independent predictor of survival (RR 0.66; 95% Confidence Interval: 0.45-0.96), along with age, anterior location and history of congestive heart failure. Therefore, data from this large "real life" registry indicate that reperfusion therapy with either thrombolysis or primary PTCA is associated with improved one-year survival in patients over 70 years of age.     

Primary percutaneous transluminal coronary angioplasty accelerates early myocardial reperfusion compared to thrombolytic therapy in patients with acute myocardial infarction

Background

Successful early reperfusion of the infarcted myocardium as indicated by complete resolution of ST-segment elevations has been shown to be associated with an improved outcome in patients with acute ST-elevation myocardial infarction (AMI). The aim of this study was to compare early ST resolution in patients treated with primary percutaneous transluminal coronary angioplasty (PTCA) or thrombolytic therapy for AMI.

Methods

A total of 1379 patients with AMI whose symptoms began <6 hours previously were enrolled in the Evaluation of the Safety and Cardioprotective effects of eniporide in Acute Myocardial Infarction (ESCAMI) trial and treated with primary PTCA (n = 528) or thrombolytic therapy (n = 851). Twelve-lead electrocardiograms (ECG) were obtained at baseline, directly after PTCA and at 90 minutes after the initiation of thrombolytic therapy.

Results

There were no differences with respect to clinical or ECG baseline variables between the 2 groups. The time intervals between hospital admission and ECG 2 (obtained 0-30 min after PTCA and 90 min after start of thrombolysis) were 121 ± 62 minutes in the PTCA group and 137 ± 57 minutes in the thrombolysis group, respectively. In ECG 2, complete (≥70%) ST resolution was observed more often in the PTCA treated patients (35 vs 27%, P = .003). The incidence of congestive heart failure until 6 weeks was lower in the PTCA group (11.2% vs 17.6, P = .001). Mortality after 6 weeks (3.4% vs 5.6%, P = .07) and after 6 months (4.5% vs 7.1%, P = .06) tended to be lower in the PTCA group.

Conclusion

Primary PTCA compared to thrombolytic therapy is associated with an accelerated myocardial reperfusion within 90 minutes after the start of reperfusion therapy. This early advantage in myocardial reperfusion is associated with an improved clinical outcome.     

Direct percutaneous transluminal coronary angioplasty (PTCA) for treatment of acute myocardial infarction: comparison with PTCA immediately after thrombolysis

We studied 73 patients with acute myocardial infarction (AMI) treated by percutaneous transluminal coronary angioplasty (PTCA) without thrombolysis (direct PTCA) and 52 patients with AMI treated by PTCA immediately after thrombolysis (PTCR + PTCA). The initial results, angiographic findings and preservation of ventricular functions of the direct PTCA group were compared with those of the PTCR + PTCA group. 1. The success rate of coronary recanalization was higher in the direct PTCA group than in the PTCR + PTCA group, but there was no statistical significance (89% vs 77%; p = NS). 2. Major complications occurred in 4.1% of the direct PTCA group and in 5.8% of the PTCR + PTCA group (p = NS). 3. The incidence of acute coronary reocclusion was higher in the PTCR + PTCA group than in the direct PTCA group (7.4% vs 22%; p less than 0.05). 4. Angiographic haziness at the dilated site following PTCA was seen more frequently in patients in the PTCR + PTCA group than in those of the direct PTCA group (43% vs 23%; p less than 0.05). 5. Patients with haziness at the dilated site had a significantly higher incidence of acute coronary reocclusion than did the patients without such haziness (28% vs 6.3%; p less than 0.05). 6. Left ventricular ejection fraction and regional wall motion were better preserved in the direct PTCA group than in the PTCR + PTCA group, but there was not statistical significance. It was suggested that direct PTCA is safe and can be performed with good success rates. It is superior to PTCR + PTCA in avoiding acute coronary reocclusion, and thus we supposed that the response of lesions to angioplasty may be altered by the administration of thrombolytic agents.     

Efficacy of percutaneous transluminal coronary angioplasty in patients with acute myocardial infarction--comparison with intracoronary thrombolysis

We retrospectively compared the efficacy of percutaneous transluminal coronary angioplasty (PTCA) and intracoronary thrombolysis (ICT) in patients with acute myocardial infarction (AMI). The ICT group consisted of 62 consecutive patients who underwent ICT before the introduction of PTCA for AMI and who were considered to be candidates for PTCA based on review of their cine-films. The PTCA group consisted of 92 consecutive patients who underwent PTCA thereafter. The reperfusion rate was significantly higher in the PTCA group than in the ICT group (92.4% vs 71.4%, p less than 0.01) and the residual stenosis was significantly lower in the former. Furthermore, the incidences of reinfarction and post-infarction angina were significantly lower in the former than in the latter (3.3% vs 12.9%, p less than 0.05 and 6.5% vs 29.0%, p less than 0.001 respectively). Although the degree of improvement in left ventricular function was influenced by the result of reperfusion, it was not affected by the reperfusion method. Therefore, PTCA did not improve left ventricular function more than ICT unless ICT alone failed to achieve reperfusion.     

Importance of time to reperfusion on outcomes with primary coronary angioplasty for acute myocardial infarction (results from the Stent Primary Angioplasty in Myocardial Infarction Trial).

The mortality benefit of thrombolytic therapy for acute myocardial infarction (AMI) is strongly dependent on time to treatment. Recent observations suggest that time to treatment may be less important with primary percutaneous transluminal coronary angioplasty (PTCA). Patients with AMI of <12 hours duration, without cardiogenic shock, who were treated with primary PTCA from the Stent PAMI Trial (n = 1,232) were evaluated to assess the effect of time to reperfusion on outcomes. Thrombolysis In Myocardial Infarction grade 3 flow was achieved in a high proportion of patients regardless of time to treatment. Improvement in ejection fraction from baseline to 6 months was substantial with reperfusion at <2 hours but was modest and relatively independent of time to reperfusion after 2 hours (<2 hours, 12.3% vs > or =2 hours, 4.2%, p = 0.004). There were no differences in 1- or 6-month mortality by time to reperfusion (6-month mortality: <2 hours [5.5%], 2 to <4 hours [4.6%], 4 to <6 hours [4.5%], >6 hours [4.2%], p = 0.97). There were also no differences in other clinical outcomes by time to reperfusion, except that reinfarction and infarct artery reocclusion at 6 months were more frequent with later reperfusion. The lack of correlation between time to treatment and mortality in patients without cardiogenic shock suggests that the survival benefit of primary PTCA may be related principally to factors other than myocardial salvage. These data may also have implications regarding the triage of patients with AMI for primary PTCA.     

Half-dose thrombolysis to begin with, when immediate coronary angioplasty in acute myocardial infarction is not possible.

BACKGROUND: Low-dose lytic drugs are sometimes administered to patients with ST-elevation acute myocardial infarction (AMI) as a bridge to coronary angioplasty (facilitated PTCA). Reports are scarce. The characteristics and outcomes of a recent series of consecutive patients treated in our Center are presented. METHODS: In August 2000 facilitated PTCA with half-dose reteplase was started in our Center in all cases when the cath lab was not immediately (< 30 min) available, or the patient had to be transferred to us. Since August 2000, 153 patients were admitted to our cath lab to undergo facilitated (n = 80) or primary (n = 73) PTCA. The data of all patients were prospectively collected, and were analyzed on an "intention-to-treat" basis. RESULTS: No significant differences were found between facilitated and primary PTCA patients with regard to: gender, diabetes, hypertension, previous PTCA/bypass surgery, heart rate at admission, systolic blood pressure, anterior AMI, number of leads with ST-segment elevation, total ST-segment deviation, collateral flow to the infarct-related artery, and three-vessel disease. In our series, facilitated vs primary PTCA patients had a better risk profile: they were younger (61 +/- 13 vs 66 +/- 11 years, p = 0.016), less frequently had a previous AMI (7 vs 24%, p = 0.01), had a shorter time from pain onset to first emergency room admission (122 +/- 104 vs 168 +/- 162 min, p = 0.045), and a trend to a shorter total time to the cath lab (209 +/- 121 vs 255 +/- 183 min, p = 0.073) despite a similar emergency room-to-cath lab component (89 +/- 50 vs 98 +/- 92 min, median 74 vs 65 min, p = NS). Moreover, they presented with a lower Killip class on admission (1.1 +/- 0.4 vs 1.5 +/- 0.98, p = 0.01), with more patients in Killip class 1 (95 vs 74%, p = 0.001). One vs 8% of patients were in shock. Facilitated vs primary PTCA patients had an initial TIMI 2-3 flow in 42 vs 25% of cases (p = 0.031), a final TIMI 3 flow in 82 vs 71% (p = NS), > or = 50% ST-segment resolution in 73 vs 58% (p = NS), and both of the latter in 62 vs 45% (p = 0.099); distal coronary embolization occurred in 9 vs 14% of cases (p = NS); intra-aortic balloon counterpulsation was used in 5 vs 12% and glycoprotein IIb/IIIa inhibitors in 10% of the whole population. The overall in-hospital mortality was 3.7 vs 9.6% (p = NS), and 2.5 vs 4.5% (p = NS) when patients in shock at admission were not considered. Reinfarction occurred in 2 patients submitted to facilitated PTCA (who had had no immediate PTCA, due to full reperfusion) and in none of the patients submitted to primary PTCA; no patient presented with stroke or major bleeding. CONCLUSIONS: Pre-treatment with thrombolysis often provides a patent vessel before PTCA, appears to be safe, and may improve reperfusion after PTCA. In this setting, the additional use of glycoprotein IIb/IIIa inhibitors before PTCA only in non-reperfused patients may be significantly risk- and cost-effective.     

Management and outcomes of patients transferred for rescue coronary angioplasty in acute myocardial infarction.

BACKGROUND: Rescue coronary angioplasty (PTCA), though recommended by the guidelines, is not regularly performed after failed lysis in patients with ST-elevation acute myocardial infarction (AMI), and data from large contemporary studies are not available. The outcomes of a recent series of consecutive patients in our Center are presented. METHODS: Between August 2000 and November 2003, 270 patients with AMI < 12 hours were referred to our cath lab for emergency PTCA: 117 (43%) for rescue PTCA after failed lysis, and 153 for primary or facilitated PTCA. The baseline, procedural and outcome data of all patients were prospectively collected, analyzed on an "intention-to-treat" basis and compared. Cineangiographic data were reviewed by three angiographers who were unaware of the clinical data. RESULTS: No significant differences were found between rescue PTCA and primary/facilitated PTCA patients as to: age, female gender, diabetes, hypertension, previous AMI, time from pain onset to the first emergency room admission, heart rate at admission, systolic blood pressure, number of leads with ST-segment elevation, total ST-segment deviation, collateral flow to the infarct-related artery, initial TIMI 2-3 flow, and three-vessel disease. Patients with rescue PTCA, as compared to primary/facilitated PTCA, had a longer time from pain onset to the cath lab (336 +/- 196 vs 229 +/- 155 min, p = 0.0001) and more frequently had an anterior AMI (52 vs 38%, p = 0.027), a higher Killip class (1.5 +/- 0.98 vs 1.26 +/- 0.7, p = 0.02), shock (11 vs 5%, p = 0.073), and intra-aortic balloon pump use (17 vs 8%, p = 0.048); fewer patients were in Killip class 1 (74 vs 85%, p = 0.043). PTCA was performed immediately in 78 vs 95% of patients (p = 0.0001); 8 vs 3 patients had PTCA of the infarct-related artery and 8 vs 1 had bypass surgery later during hospitalization. Patients with rescue PTCA, as compared to primary/facilitated PTCA, had a final TIMI 3 flow in 62 vs 76% of cases (p = 0.017), > or = 70% ST-segment resolution in 36 vs 50% (p = 0.086), and both of the latter in 24 vs 45% (p = 0.006); the overall hospital mortality was 12 vs 6.5%, and 5.8 vs 3.4% when patients in shock on admission were not considered; reinfarction and stroke occurred in 0.9 vs 1.3% and in 2.6 vs 0% of the patients respectively. CONCLUSIONS: Due to referral, rescue PTCA patients were admitted to the cath lab later after the onset of infarction, and had a higher risk profile, as compared to primary/facilitated PTCA patients; both recanalization and reperfusion were less satisfactory, as were the outcomes. Thrombolysis is often ineffective but, as long as it remains a widespread treatment, efforts should be made to improve reperfusion and survival in these patients, possibly by an earlier referral for rescue PTCA.     

Efficacy of Rescue Thrombolysis in Patients with Acute Myocardial Infarction: Preliminary Findings

Thrombolysis reduces mortality in patients with acute myocardial infarction (AMI) who are hospitalized within 6 hours from the onset of symptoms. AMIs involving a small area of myocardium show a lower mortality in comparison with AMI involving a large area. The present study was aimed at evaluating the safety and efficacy of rescue thrombolysis in patients with large AMI who had failed thrombolysis.Ninety patients (69 males and 21 females), mean age 56.7 ± 9 years, hospitalized for suspected AMI within 4 hours from the onset of symptoms, suitable for thrombolysis (First episode), and showing pain and persistent ST segment elevation 120 minutes after starting thrombolysis, were randomized (double-blind) into two groups. Group A (45 patients: 10 Females and 35 males) received an additional thrombolytic treatment (rTPA 50 mg), 10 mg as bolus plus 40 mg in 60 minutes. Group B (45 patients: 11 Females and 34 males) received placebo. Positive noninvasive markers were defined as follows: (1) resolution of chest pain, (2) 50% reduction in ST segment elevation, (3) double marker of creatine kinase (CK) and CK-MB activity 2 hours after the start of thrombolysis, and (4) occurrence of reperfusion arrhythmias within the First 120 minutes of thrombolytic therapy. Blood pressure, heart rate, and ECG were continuously monitored. An echocardiogram was carried out at entry, and before discharge, to control ejection fraction and segmentary kinetics. Adverse events such as death, re-AMI, recurrent angina, incidence of major and minor bleeding, and emergency CABG/PTCA were checked.The groups were similar in terms of age, sex, diabetes, smoking habits, hypertension, and adjuvant therapy (beta-blockers). No significant difference was observed between the two groups regarding the time elapsed from the onset of symptoms to thrombolysis and AMI localization.Thirty-five patients (77.7%) showed reperfusion (10–50 minutes) after commencement of additional rTPA. Of the patients receiving placebo, 12 (26.6%) showed reperfusion within 35–85 minutes. Group A showed an earlier and lower CK and CK-MB peak than the control group, (respectively p = 0.0001–0.009 and 0.002). Mortality (17.7%, 16 patients) was higher in group B than in the additional rTPA group, i.e. 28.8% (3 patients) in group A) versus 6.6% (13 patients) in Group B (p = 0.041). Seven patients from group A showed nonfatal re-AMI. Angina was observed in 18 patients (40%) from group A and 3 (6.6%) from group B, (p = 0.006). Ten of these patients underwent urgent PTCA (9 from group A and 1 from group B), and 3 from group A underwent urgent CABG. Minor bleeding was higher in group A than in group B (44.4% versus 15.5%, p = 0.047). Major bleeding was observed in group A (nonfatal stroke). At predischarge the echocardiogram ejection fraction was higher in group A than in group B (46 ± 8% versus 38 ± 7%, p = 0.0001).Our data suggest that an additional dose of thrombolytic drug in patients with unsuccessful thrombolysis is feasible and also that the bleeding increase is an acceptable risk in comparison with the advantages obtained in reducing AMI extension. Rescue thrombolysis can allow a gain in time to perform mechanical revascularization in patients admitted to hospital without an interventionist cardiology laboratory or in those who have to be referred to another hospital for urgent CABG.     

急性心肌梗死患者的直接经皮腔内冠状动脉成形术与溶栓治疗疗效比较

为探讨急性心肌梗死直接经皮腔内冠状动脉成形术的安全性及临床疗效 ,选择 6 2例未经静脉和冠状动脉内溶栓治疗的急性心肌梗死患者 ,在紧急冠状动脉造影后即行直接经皮腔内冠状动脉成形术 ;另外选择 5 9例急性心肌梗死患者 ,采用溶栓治疗 ,溶栓治疗后不再接受介入治疗和外科冠状动脉搭桥 ,然后比较直接经皮腔内冠状动脉成形术和溶栓治疗的疗效、安全性及预后。结果发现 ,直接经皮腔内冠状动脉成形术组 6 0例再灌注成功 ,成功率为 96 .7% ,其中 4例合并心源性休克的患者均再灌注成功 ,血压回升 ,急性上消化道出血 1例 ,死亡率为 0 ;溶栓治疗组 38例再灌注成功 ,成功率为 6 4 .4 % ,住院期间死亡 5例 ,出院 6月内死亡 2例 ,急性上消化道出血 1例 ,血尿 1例 ,溶栓治疗后心源性休克 5例 ,死亡率为 1 1 .9%。直接经皮腔内冠状动脉成形术再灌注成功率明显高于溶栓治疗 ,死亡率和主要心脏事件的发生率明显低于溶栓治疗 (P <0 .0 1 )。结果提示 ,急性心肌梗死的直接经皮腔内冠状动脉成形术治疗安全有效 ,再灌注成功率明显高于溶栓治疗 ,疗效及预后优于溶栓治疗     

Thrombolysis in myocardial infarction myocardial perfusion grade in angiography correlates with myocardial salvage in patients with acute myocardial infarction treated with stenting or thrombolysis

OBJECTIVES: We sought to assess the relationship between the Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion (TMP) grade and myocardial salvage as well as the usefulness of TMP grade in comparing two different reperfusion strategies. BACKGROUND: The angiographic index of TMP grade correlates with infarct size and mortality after thrombolysis for acute myocardial infarction (AMI). Its relationship to myocardial salvage and its usefulness in comparing different reperfusion strategies are not known. METHODS: We analyzed the TMP grade on angiograms obtained at one to two weeks after treatment in 267 patients enrolled in two randomized trials that compared stenting with thrombolysis in AMI. Patients were classified into two groups: 159 patients with TMP grade 2/3 and 108 patients with TMP grade 0/1. Two scintigraphic studies were performed: before and one to two weeks after reperfusion. The salvage index was calculated as the proportion of the area at risk salvaged by reperfusion. RESULTS: Patients with TMP grade 2/3 had a higher salvage index (0.49 +/- 0.42 vs. 0.34 +/- 0.49, p = 0.01), a smaller final infarct size (15.4 +/- 15.5% vs. 22.1 +/- 16.2% of the left ventricle, p = 0.001), and a trend toward lower one-year mortality (3.8% vs. 8.3%, p = 0.11) than patients with TMP grade 0/1. The relationship between TMP and salvage index was independent of the form of reperfusion therapy. The proportion of patients with TMP grade 2/3 was significantly higher after stenting than after thrombolysis (70.9% vs. 48.1%, p = 0.001). CONCLUSIONS: These findings show that the TMP grade is a useful marker of the degree of myocardial salvage achieved with reperfusion and a sensitive indicator of the efficacy of reperfusion strategies in patients with AMI.     

A multicenter, randomized study of argatroban versus heparin as adjunct to tissue plasminogen activator (TPA) in acute myocardial infarction: myocardial infarction with Novastan and TPA (MINT) study

OBJECTIVES

This study examined the effect of a small-molecule, direct thrombin inhibitor, argatroban, on reperfusion induced by tissue plasminogen activator (TPA) in patients with acute myocardial infarction (AMI).

BACKGROUND

Thrombin plays a crucial role in thrombosis and thrombolysis. In vitro and in vivo studies have shown that argatroban has advantages over heparin for the inhibition of clot-bound thrombin and for the enhancement of thrombolysis with TPA.

METHODS

One hundred and twenty-five patients with AMI within 6 h were randomized to heparin, low-dose argatroban or high-dose argatroban in addition to TPA. The primary end point was the rate of thrombolysis in myocardial infarction (TIMI) grade 3 flow at 90 min.

RESULTS

TIMI grade 3 flow was achieved in 42.1% of heparin, 56.8% of low-dose argatroban (p = 0.20 vs. heparin) and 58.7% of high-dose argatroban patients (p = 0.13 vs. heparin). In patients presenting after 3 h, TIMI grade 3 flow was significantly more frequent in high-dose argatroban versus heparin patients: 57.1% versus 20.0% (p = 0.03 vs. heparin). Major bleeding was observed in 10.0% of heparin, and in 2.6% and 4.3% of low-dose and high-dose argatroban patients, respectively. The composite of death, recurrent myocardial infarction, cardiogenic shock or congestive heart failure, revascularization and recurrent ischemia at 30 days occurred in 37.5% of heparin, 32.0% of low-dose argatroban and 25.5% of high-dose argatroban patients (p = 0.23).

CONCLUSIONS

Argatroban, as compared with heparin, appears to enhance reperfusion with TPA in patients with AMI, particularly in those patients with delayed presentation. The incidences of major bleeding and adverse clinical outcome were lower in the patients receiving argatroban.     

Usefulness of combination therapy of hybrid thrombolysis followed by back-up percutaneous transluminal coronary angioplasty in patients with acute myocardial infarction

OBJECTIVES: Conventional thrombolytic therapy for acute myocardial infarction is effective for early reperfusion but has the disadvantage of a higher rate of bleeding complications. The purpose of this study is to elucidate efficacy and safety of a combined approach using a bolus injection of low dose of mutant tissue plasminogen activator (mt-PA) with heparin and aspirin to ensure definite antithrombin and antiplatelet efficacy, followed by back-up percutaneous transluminal coronary angioplasty(PTCA). METHODS: Patients with acute myocardial infarction aged < 80 years who were admitted to our institution within 3 hr of onset of symptoms were immediately treated with oral aspirin 330 mg and intravenous heparin 5,000 IU and were randomized to receive an intravenous bolus of mt-PA (monteplase) 15,000 IU/kg (thrombolytic group, n = 25) or no mt-PA (control group, n = 21), followed by angiography with PTCA if indicated. RESULTS: There were no differences between the two groups in patient characteristics, time from onset to hospital arrival, time to initial angiography, or infarct-related arteries. Significantly more patients had Thrombolysis in Myocardial Infarction flow grade 3 and grade 2/3 at the initial angiography in the thrombolytic group than in the control group (32.0% vs 4.8%, 68.0% vs 14.3%; p = 0.020, p = 0.0003, respectively). PTCA was performed in 88% of the thrombolytic group (stenting employed in 64%) and 95.5% of the control group (stenting in 57%), and the success rate was 95.5% and 100%, respectively. No acute or subacute coronary occlusion was found in either group. Bleeding complications occurred in only one patient in the thrombolytic group, which was bleeding associated with vomiting, and no difference was found in other complications between the two groups. Radionuclide ventriculography using quantitative gated single photon emission computed tomography showed left ventricular end-diastolic volume and left ventricular end-systolic volume tended to be smaller, and the ejection fraction after 3 months of treatment tended to be higher in the thrombolytic group. Myocardial salvage volume was significantly higher in the thrombolytic group. CONCLUSIONS: Hybrid thrombolysis using a low dose of mt-PA with aspirin and heparin promoted significantly early reperfusion. Also, successful reperfusion is achievable at higher rates with back-up PTCA without an increase in complications.     

Early reperfusion assessment and repeated thrombolysis in acute myocardial infarction estimated by repeated standard electrocardiography. A randomised, double-blind, placebo-controlled pilot study

Thrombolytic therapy with streptokinase (SK) in acute myocardial infarction (AMI) does not result in early reperfusion in approximately 25% of patients. We hypothesized that early repeated thrombolysis with rt-PA in patients with early failed reperfusion would result in myocardial reperfusion. Fifty-nine AMI patients with a symptom delay of <6 h, treated with SK were included. ECG was taken on admission and after 90 and 180 min. An ST recovery of > or =25% at 90 min was interpreted as successful reperfusion. Sixteen patients had failed reperfusion at 90 min and were randomized to repeated thrombolysis with rt-PA or placebo. At 180 min from SK start, ST recovery was higher in the placebo group than in the rt-PA group (71 vs. 40%, p = 0.05). No serious bleeding complications were observed. Due to the limited sample size it was not possible to draw prominent conclusions.     

Importance of mitral regurgitation inpatients undergoing percutaneous coronary intervention for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial

OBJECTIVES: We sought to determine the prognostic importance of mitral regurgitation (MR) in patients undergoing percutaneous coronary intervention for acute myocardial infarction (AMI). BACKGROUND: Mitral regurgitation has been associated with a poor prognosis in patients treated with thrombolytic therapy for AMI. The prognostic significance of MR in patients undergoing mechanical reperfusion therapy for AMI is unknown. METHODS: Left ventriculography was performed during the index procedure in 1,976 (95%) of 2,082 non-shock patients enrolled in a prospective, multicenter, randomized trial of mechanical reperfusion strategies in AMI. The severity of operator-assessed MR was divided into four strata: none (n = 1,726), mild (n = 192), and moderate/severe (n = 58). RESULTS: Patients with progressively more severe MR were older (p < 0.0001), were more often women (p < 0.0001), and had higher Killip class (p = 0.0007). More severe grades of MR correlated with triple-vessel disease (p < 0.0001) and lower left ventricular ejection fraction (LVEF) as measured during the index procedure (p = 0.0004). Increasingly severe MR was strongly associated with a higher mortality at 30 days (1.4% vs. 3.7% vs. 8.6%, respectively; p < 0.0001) and at one year (2.9%, 8.5%, 20.8%, respectively; p < 0.0001). By multivariate analysis, the presence of even mild MR was an independent predictor of long-term mortality (mild MR, relative risk [RR] = 2.40, p = 0.005; moderate/severe MR, RR = 2.82, p = 0.006). CONCLUSIONS: Mitral regurgitation of any degree present on the baseline left ventriculogram during the index procedure is a powerful, independent predictor of mortality in patients undergoing mechanical reperfusion therapy for AMI. The presence of MR identifies high-risk patients in whom close out-patient follow-up is warranted, and who may benefit from aggressive adjunctive medical or surgical therapies.