Bleeding complications after pacemaker or cardioverter-defibrillator implantation in patients receiving dual antiplatelet therapy: Results of a prospective, two-centre registry.

Introduction. The aim of the study was to define the prevalence of bleeding events in patients treated with dual antiplatelet therapy (DAT) in comparison with patients receiving only acetylsalicylic acid (ASA).Methods. Prospective two-centre registry of all first implantations of pacemakers, cardioverter-defibrillators and cardiac resynchronisation therapy units in patients receiving ASA (n=194) or DAT (n=53).Results. Bleeding complications were detected in 27 (16.2%) patients in the ASA group and in 13 (24.5%) in the DAT group. There was no significant difference in the overall number of complications between the patients receiving ASA or DAT, although there was a trend towards a higher incidence of overall complication rates in the DAT group (p=0.0637). The incidence of major complications (requiring blood transfusion or surgical intervention or prolonging hospital stay) was low (3.6%), and similar in both groups (3.6 and 3.8% respectively, ns). The rate of minor complications (subcutaneous haematomas) was greater in the DAT group (p=0.015).Conclusions. Treatment with DAT does not increase the risk of major bleeding complications as a result of device implantation; however, minor complications are significantly more frequent. Our results suggest that DAT could be continued in patients undergoing device implantation with a moderate risk of bleeding complications. (Neth Heart J 2010;18:230-5.).

Efficacy of trimetazidine in patients with recurrent angina: a subgroup analysis of the TRIMPOL II study.

OBJECTIVES: The revascularization procedures become more and more popular to treat coronary artery disease, in many countries. Some patients are free of angina after revascularization, without any documented re-stenosis present with recurrent angina symptoms after a period of time. The aim of this work was to assess the efficacy of trimetazidine in the subpopulation of patients with a history of PTCA or CABG, who were included in the TRIMPOL II study. METHODOLOGY: A subgroup of 94 patients was retrospectively analysed from the TRIMPOL II study, a multicentre, double-blind randomised placebo-controlled trial in 426 patients with stable effort angina. These patients have a history of revascularization for coronary artery disease, and they are still symptomatic after 6 months despite a treatment with metoprolol (50 mg twice daily). They were randomly allocated to receive either trimetazidine (20 mg 3 times daily) or placebo for 12 weeks, on top of the beta-blocker. Exercise test parameters, clinical efficacy and safety were assessed. Results were analysed using the Student test, the Mann-Whitney test or the Shapiro-Wilk test. RESULTS: Compared to placebo, the 12-week treatment with trimetazidine significantly improved: time to 1 mm ST segment depression (385.1 s +/- 144.6 s versus 465.0 s +/- 143.8 s [p < 0.01]); exercise test duration (466.9 s +/- 144.8 s versus 524.4 s +/- 131.5 s [p = 0.048]), total workload (9.0 m.e. +/- 2.4 m.e versus 10.1 m.e. +/- 2.4 m.e [p = 0.035]) as well as time to onset of angina (433.6 s +/- 164 s versus 508.1 s +/- 132.4 s [p = 0.031]). Weekly number of angina attacks and nitrate consumption were significantly reduced in the trimetazidine group when compared to placebo. Three mild gastro-intestinal side-effects were reported in the trimetazidine group. CONCLUSION: These results show that trimetazidine provides anti-anginal efficacy in post-revascularized patients with recurrent angina despite a monotherapy with metoprolol. The treatment was well accepted.

Combination treatment in stable effort angina using trimetazidine and metoprolol: results of a randomized, double-blind, multicentre study (TRIMPOL II). TRIMetazidine in POLand.

AIMS: To assess the antiischaemic efficacy and tolerability of the metabolic agent trimetazidine in combination with metoprolol in patients with stable effort angina. METHODS: This was a randomized, multicentre, double-blind, placebo-controlled parallel group study. A total of 426 male and female patients with stable, effort-induced angina and documented coronary artery disease received either placebo or trimetazidine 20 mg three times daily in addition to metoprolol 50 mg twice daily. Treadmill exercise tests were performed at weeks (-1), 0, 4 and 12. RESULTS: After 12 weeks, there were significantly greater improvements in the metoprolol + trimetazidine group than in the metoprolol + placebo group in: time to 1 mm ST segment depression, total workload, time to onset of angina, maximum ST segment depression, mean weekly number of angina attacks, mean weekly nitrate consumption, and grade of anginal pain. There was no evidence of any development of tolerance to trimetazidine. The tolerability of trimetazidine was excellent. CONCLUSIONS: Therapy with trimetazidine plus metoprolol produced significant improvements in exercise stress tests and the symptoms of angina relative to metoprolol alone. With its metabolic effect, devoid of any haemodynamic action, trimetazidine is useful for combination therapy in patients with stable angina insufficiently controlled by monotherapy with a beta-blocker.

[Surgical revascularization of the myocardium in patients with chronic coronary disease and depressed left ventricular function: 1-year observation]. / Chirurgiczna rewaskularyzacja miesnia sercowego u chorych z przewlekla choroba niedokrwienna serca i uposledzona czynnoscia lewej komory: 1-roczna obserwacja.

Many reports confirm the importance and benefit of the surgical revascularization (CABG) in patients with ischemic heart disease and severely depressed left ventricular (LV) systolic function. This mode of treatment is better than medical therapy in patients with very low LV ejection fraction (LVEF) and can prolong the life. However, the effect of CABG on LV hemodynamics is still unclear. The aim of the study was: 1) to assess the effect of CABG on LV hemodynamics in patients with low LVEF and 2) to examine the influence of two types of cardioplegia-crystalloid (CC) and blood (BC) cardioplegia--on LV function during 1 year follow-up. 122 patients with stable angina pectoris qualified for CABG were included in the study. Patients were divided into two groups: group I-47 pts with LVEF < or = 40% and group II--75 pts with LVEF > 40% and then patients were randomized for two types of antegrade-retrograde cardioplegia (CC--subgroups Ia, IIa and BC--subgroups Ib, IIb). Before operation and 4 times after CABG (after 2-6 weeks, 3 months, 6 months and 1 year) echocardiographic examination was performed. Diameters of left atrium and ventricle, LVEF and wall motion score index (WMSI) were calculated. During 1 year 8 patients died (5 of them during perioperative period and 3 patients during follow-up). Patients in group I before operation were in higher NYHA and CCS class and had more often myocardial infarction. During each of the five echocardiographic examination the values of LVEF and WMSI did not differ between subgroups Ia vs Ib and IIa vs IIb. In group I, especially in patients with very low LVEF < or = 30%, the values of LVEF and WMSI improved significantly (p < 0.001) during 1 year of follow-up. But in group II a transient deterioration of LVEF (p < 0.05) 2-6 weeks after CABG was noted. We conclude that surgical revascularization in patients with severe depressed hemodynamics improves LV systolic function during 1 year follow-up. The use of CC or BC did not seem to make any difference to the early and long-term hemodynamic effect of the revascularization.

Heart rate variability: its association with hemodynamic function of the left ventricle in patients with coronary heart disease.

Patients with heart failure secondary to coronary heart disease (CHD) are characterized by an imbalance of the autonomic nervous system, which can be assessed by analysis of the heart rate variability (HRV). However it is still unclear whether all patients with CHD reveal suppression of HRV and if it is related to hemodynamic function and contractile disturbances of the left ventricle. To answer these questions data from 105 consecutive patients were analyzed and compared with 17 healthy subjects. All study participants underwent 24-hour ambulatory ECG recordings with calculation of HRV parameters and angiographic examination after collection of clinical data and other noninvasive evaluations. Time- (SDRR, SDANN, SD, pNN50) and frequency- (LF, HF) domain parameters of HRV were assessed. All ventriculographic and hemodynamic measurements were used in the analysis. Highly significant correlations were found between all HRV parameters, and left ventricular ejection fraction (LVEF) and left ventricular end-diastolic pressure (P < 0.001). Patients with LVEF < 40% were characterized by significantly lower values of HRV and impairment or lack (LVEF < 20%) of diurnal variation of frequency-domain measurements of HRV. Patients with segmental akinesis or dyskinesis also had lower values of HRV. The group with dyskinesis was characterized by significantly lower diurnal rhythms of LF and HF, independent of LVEF.