Acute myocardial infarction in the elderly. Is primary coronary angioplasty the treatment of choice? In-hospital follow-up results

BACKGROUND: Acute myocardial infarction (AMI) is one of the main causes of death in the elderly, however, the optimal therapy of AMI in this age-group has not yet been established. AIM: To compare the early outcome of patients with AMI aged > or =75 years who underwent primary percutaneous coronary interventions (PCI) or were treated conservatively. METHODS: In-hospital outcome of 180 patients aged > or =75 years, hospitalised due to AMI, was retrospectively analysed. Ninety two consecutive patients, admitted with AMI between May 2001 and October 2002, underwent primary PCI whereas 88 patients, treated for AMI between 1993 and 2002, received standard pharmacological therapy without thrombolysis. CONCLUSIONS: Primary PCI in the elderly with AMI is significantly more effective than conservative therapy, except with patients with cardiogenic shock in whom mortality is similar regardless of the therapy used.     

Primary angioplasty versus intravenous thrombolysis in acute myocardial infarction: can we define subgroups of patients benefiting most from primary angioplasty? Results from the pooled data of the Maximal Individual Therapy in Acute Myocardial Infarction Registry and the Myocardial Infarction Registry

OBJECTIVES: We sought to determine the effectiveness of primary angioplasty compared with thrombolysis in clinical practice. BACKGROUND: In clinical practice, primary angioplasty for the treatment of acute myocardial infarction (AMI) has not yet been proven more effective than intravenous thrombolysis, nor have subgroups of patients been identified who would perhaps benefit from primary angioplasty. METHODS: The pooled data of two AMI registries--the Maximal Individual TheRapy in Acute myocardial infarction (MITRA) study and the Myocardial Infarction Registry (MIR)--were analyzed. A total of 9,906 lytic-eligible patients with AMI, with a pre-hospital delay of < or =12 h, were treated with either primary angioplasty (n = 1,327) or thrombolysis (n = 8,579). RESULTS: Despite differences in the patients' characteristics and concomitant diseases between the two groups, the prevalence of adverse risk factors was balanced. Univariate analysis of hospital mortality showed a more favorable course for patients treated with primary angioplasty: 6.4% versus 11.3% (odds ratio [OR] 0.54, 95% confidence interval [CI] 0.43 to 0.67). This was confirmed by logistic regression analysis (multivariate OR 0.58, 95% CI 0.44 to 0.77). Primary angioplasty was associated with a lower mortality in all subgroups analyzed. We observed a significant correlation between mortality and absolute risk reduction (r = 0.82, p < 0.0001) in the different subgroups: as mortality increased, there was an increase in absolute benefit of primary angioplasty compared with thrombolysis. CONCLUSIONS: These large registry data showed the effect of primary angioplasty to be more favorable than thrombolysis for the treatment of patients with AMI in clinical practice. This effect was not restricted to special subgroups of patients. As mortality increased, the absolute benefit of primary angioplasty also increased.     

The Effect of Verapamil on Left Ventricular Remodelling and Diastolic Function after Acute Myocardial Infarction (The Verapamil Infarction Study on Remodelling and Relaxation—VISOR)

The VISOR is a double blind, randomized, placebo-controlled study aimed to assess the effects of early and prolonged administration of verapamil on the left ventricular geometry and diastolic function in patients with anterior acute myocardial infarction treated with thrombolysis. Patients with heart failure or ejection fraction < 45% were excluded. Within 12 hours from starting thrombolysis, 70 patients were given verapamil (5 mg/hour intravenously for the first 24 hours, followed by 120 mg t.i.d. perorally for 6 months) or equivalent placebo. Echocardiograms were performed on admittance, before discharge, after 3 months and 6 months. The following parameters were calculated: left ventricular volumes, ejection fraction, sphericity index, early (E) and late (A) transmitral peak flow velocities and time-velocity integrals with their ratios, deceleration time and half-time of E, isovolumic relaxation time (IVRT), and non-invasive time constant of ventricular relaxation (). The basal and the last available parameters were considered for statistical analysis. The effects of the treatment on the left ventricular volumes, ejection fraction, and sphericity index were not statistically relevant. Conversely, a reduction of E/A ratio (P < .05) and increases of A integral (P < .01), deceleration time and half-time E, IVRT and (P < .05) were found in the placebo group and not in the verapamil group. No significant changes in the blood pressure, heart rate, PQ interval, and biochemical parameters were observed in the two groups. In conclusion, in patients with a thrombolysed anterior acute myocardial infarction and preserved systolic function, verapamil can prevent alterations of the diastolic function in absence of effect on ventricular remodelling, and has a good safety profile.     

Prognostic implications of glucose-lowering treatment in patients with acute myocardial infarction and diabetes: experiences from an extended follow-up of the Diabetes Mellitus Insulin–Glucose Infusion in Acute Myocardial Infarction (DIGAMI) 2 Study

Aims/hypothesis  

This post hoc analysis from the Diabetes Mellitus Insulin–Glucose Infusion in Acute Myocardial Infarction (DIGAMI) 2 trial reports on extended long-term outcome in relation to glucose-lowering agents in patients with myocardial infarction and type 2 diabetes.     

Intra-aortic balloon counterpulsation and delayed revascularization for myocardial infarction and shock in the absence of primary angioplasty: a treatment strategy with or without thrombolysis?

OBJECTIVE: When revascularization facilities are not available, thrombolytic therapy (TT) added to intra-aortic balloon counterpulsation (IABC) has been proposed as initial therapy for the management of patients presenting with postmyocardial infarction (MI) cardiogenic shock, followed by prompt transfer to another institution for revascularization. The use of TT in this setting, however, remains controversial. METHODS: We reviewed the records of 81 consecutive patients admitted with cardiogenic shock after acute MI and compared the outcomes of patients initially stabilized, including IABC as an adjunct to TT (IABC+TT group, n=40), with those patients initially stabilized with IABC and no TT (IABC group, n=41). RESULTS: The baseline characteristics of the two study groups were similar. The in-hospital and 6-month survival rates were 47.5 and 33.3% in the IABC+TT group versus 43.9 and 31.6% in the IABC group, respectively (NS). Except for mechanical ventilation more frequently required in the IABC group, other outcome measures were similar in both groups. The in-hospital (76.5 vs. 36.5%, P=0.008) and 6-month (60 vs. 25.4%, P=0.01) survival rates were significantly higher in patients who underwent delayed invasive revascularization, than in patients who underwent no invasive revascularization attempt. CONCLUSION: In patients presenting with acute MI and cardiogenic shock, TT as an adjunct to IABC added no therapeutic benefit when compared with IABC alone. In contrast, the survival of patients was significantly increased by delayed invasive revascularization in both treatment groups. These observations suggest that, when revascularization facilities are not available, stabilization with IABC, followed by prompt transfer for delayed revascularization to a tertiary care hospital, might be the preferred management strategy for patients presenting with post-MI cardiogenic shock.     

Clinical Outcomes after Treating Acute Coronary Syndrome Patients with a Drug-Eluting Stent: Results from REWARDS-EMI (Endeavor® for Myocardial Infarction Registry)

BackgroundDrug-eluting stents have shown promising clinical results in the treatment of acute coronary syndrome (ACS) patients. We aimed to evaluate the long-term outcome of Endeavor® zotarolimus-eluting stent (EZES) implantation in an ACS population and to compare these results with those obtained in patients treated with sirolimus-eluting (SES) and paclitaxel-eluting stents (PES).MethodsThis prospective study included 1481 consecutive ACS patients (72% myocardial infarction, age 65 ± 13 years, 62% male) treated with a drug-eluting stent: (SES, n = 925; PES, n = 417; EZES, n = 139). The primary end point was major adverse cardiac events (MACE) at 2 years, defined as the composite of death, myocardial infarction, and target vessel revascularization. Two-year follow-up was obtained in all patients.ResultsBaseline clinical and angiographic characteristics were mostly similar. Unadjusted 2-year MACE and death rates were lower in the EZES group than in the SES and PES groups (MACE: 18.7% vs. 25.3% vs. 30.2%, p = 0.02; death: 10.1% vs. 16.4% vs. 22.2%, p = 0.002, respectively). The rate of definite stent thrombosis at 2 years was lower in the EZES group without statistically significant difference (0.7% vs. 2.9% SES vs. 1.7% PES, p = 0.16). After adjusting for differences in baseline characteristics, EZES use was an independent correlate for 2-year MACE (vs. SES, hazard ratio 0.65, p = 0.049; vs. PES, hazard ratio 0.57, p = 0.01).ConclusionIn an ACS patient population, a lower long-term MACE rate was observed in patients treated with an EZES when compared to treatment with first-generation drug-eluting stents. The use of EZES in contemporary practice has excellent long-term outcome in terms of low rates of revascularization and clinical events.     

Temperature-controlled radio frequency energy delivery (Secca® procedure) for the treatment of fecal incontinence: results of a prospective study

PURPOSE: Fecal incontinence (FI) is a debilitating condition that can be socially and personally incapacitating. A broad range of treatment options, often stepwise, are available, depending on severity. This prospective study reports a large single-centered series of patients who have benefited of temperature-controlled radio frequency (Secca) energy delivered to the anal canal. MATERIAL AND METHODS: This investigation was a single-center, nonrandomized, prospective, clinical study of a single patient group with each serving as the control. All patients had experienced FI for at least 3 months and had attempted, but were not satisfied, with the results of medical and/or surgical therapies. The study aims to evaluate changes in FI symptom scores and quality of life between the baseline and follow-up intervals. RESULTS: Between March 2005 and March 2006, 15 Secca procedures were performed. All 15 patients were alive and in contact with the investigational site at time of 12 months. There were no long term complications. The mean Wexner score improved from 14.07 (+/-4.5) at baseline to 12.33 (+/-4.6) at 1 year (p = 0.02). The mean fecal incontinence quality of life of life score was only improved in the depression subscore. There were no changes in endoanal ultrasound and anorectal manometry. CONCLUSION: This prospective trial confirmed the safety of the Secca procedure. Although we demonstrated a significant improvement in the Wexner Score, these clinical results have to be mitigated because most patients remained in the moderate incontinences category as defined by the scoring system and did not improved their quality of life excepted in the depression subscore.     

Cost-effectiveness of enoxaparin compared with unfractionated heparin in ST elevation myocardial infarction patients undergoing pharmacological reperfusion: A Canadian analysis of the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment – Thrombolysis in Myocardial Infarction (ExTRACT-TIMI) 25 trial

OBJECTIVE:

To evaluate the cost-effectiveness of enoxaparin versus unfractionated heparin in conjunction with fibrinolysis in ST elevation myocardial infarction patients within Canada.

DESIGN:

Based on the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment – Thrombolysis in Myocardial Infarction (ExTRACT-TIMI) 25 trial, a model was created to analyze the cost-effectiveness of enoxaparin compared with unfractionated heparin in conjunction with fibrinolysis among ST elevation myocardial infarction patients within Canada. Clinical outcomes were derived from published results of the main trial. Resource use costs were first assessed based on United States Diagnosis-Related Group values for hospitalizations and Current Procedural Terminology codes for outpatient visits and tests. Both were then converted using Canadian local costs. Survival and life expectancy were estimated from Framingham survival data. The incremental cost-effectiveness ratio was expressed as cost per life year gained.

RESULTS:

Through 30 days after random assignment, the primary composite end point favoured the enoxaparin group over the unfractionated heparin group (death or recurrent myocardial infarction rate 9.9% versus 12.0%, P<0.001), and was associated with a modest increased cost of $169.50 ($8,757.00 versus $8,587.50, respectively). Life years gained as a result of treatment with enoxaparin was increased by 0.11 years (P<0.05). Enoxaparin was found to be cost-effective, as indicated by an incremental cost-effectiveness ratio of $4,930 with a 99% probability of costing less than $20,000.

CONCLUSIONS:

Although associated with modest increased direct medication costs, enoxaparin following fibrinolysis improved the clinical efficacy in STEMI patients and increased the life years gained.     

Is angiotensin-converting enzyme inhibitor useful in a Japanese population for secondary prevention after acute myocardial infarction? A final report of the Japanese Acute Myocardial Infarction Prospective (JAMP) study

Background

Although angiotensin-converting enzyme (ACE) inhibitors have appeared to be useful for secondary prevention after acute myocardial infarction (AMI) in Western countries, that has not been confirmed in non-western countries. We investigated whether ACE inhibitors improve survival rates in patients who have survived an AMI in Japan.

Methods

A randomized controlled trial, the first non-pharmaceutical company-supported multicenter trial of a medication in Japan, was carried out in 48 institutions from 1993 to 2000. A total of 888 of 1163 patients with AMI were eligible for the full analysis set (FAS). The mean patient age was 62 years, and 78% of patients were men. Subjects were randomized to 2 groups; 422 received ACE inhibitors and 466 did not receive ACE inhibitors. The primary end point was combined cardiac events, which was defined as cardiac or non-cardiac death, recurrent non-fatal myocardial infarction, coronary revascularization, and hospitalization because of worsening angina or congestive heart failure. The mean follow-up period was 5.8 years.

Results

There were no significant differences in the 2 groups in baseline data. During the follow-up period, 3 patients were lost to follow-up. With Kaplan-Meier analysis, the annual rate of total cardiac events was 32% in both groups. After adjustment for clinical baseline data, ACE inhibitor administration was not revealed with Cox regression analysis to have a significant prognostic effect in our study.

Conclusion

We did not show a significant improvement in outcome with ACE inhibitor administration in subjects who survived after AMI in a Japanese study population. Further evaluations with a larger population or in subjects who are at a higher risk for AMI are necessary to confirm our findings.     

Encouraging results with the compassionate use of hydralazine/valproate (TRANSKRIP™) as epigenetic treatment for myelodysplastic syndrome (MDS)

The hypomethylating agents azacytidine and decitabine are unaffordable for many patients with MDS. The combination of the DNA methyltransferase inhibitor hydralazine and the histone deacetylase inhibitor valproate has shown preliminary efficacy in MDS. The aim of this study is to evaluate the clinical efficacy and safety of hydralazine/valproate in a case series of MDS patients treated in a compassionate manner. Hydralazine was dosed according to the acetylation genotype of patients (slow acetylators 83 mg daily; fast acetylators 182 mg daily), and valproate was dosed at 30 mg/kg/day. Both drugs were given daily until disease progression. Response and toxicity were evaluated with the International Working Group criteria and CTCAE, version 4, respectively. Survival parameters were estimated with the Kaplan-Meier method. From 2009 to 2012, 14 patients were treated. The median age ± SD was 55.2 ± 19.52 (range 23–87) years. According to the IPSS, cases were graded as intermediate-1 (n = 8/14; 57.2%) or intermediate-2 (n = 6/14; 42.8%). Responses were as follows: five (35.7%) complete response, one (7.1%) partial response, and two (14.28%) became transfusion independent. The mean duration of response ± SD was 60 ± 35.28 months (range 5–94). Three patients progressed to AML. At a median follow-up of 57 months (range 1–106), the median OS was 27 months. At that point, five patients remained on the treatment, one with partial response and four with complete response. The median OS was not reached in the eight patients who saw a clinical benefit from the treatment, in comparison to an OS of 7 months in the six patients who had no treatment. The combination of hydralazine and valproate is safe and effective in MDS, and its further testing is highly desirable.