Reduction In Cardiac Mortality Research Articles

Feasibility study of rehabilitation for cardiac patients aided by an artificial intelligence web-based programme: a randomised controlled trial (RECAP trial)—a study protocol

IntroductionCardiac rehabilitation (CR) delivered by rehabilitation specialists in a healthcare setting is effective in improving functional capacity and reducing readmission rates after cardiac surgery. It is also associated with a...

Two Years Door-to-Balloon Times for ST-segment Elevation Myocardial Infarction in a New Regional 24/7 Primary Percutaneous Coronary Intervention Centre

Primary percutaneous coronary intervention (PPCI) results in superior outcomes compared to fibrinolysis in ST-elevation myocardial infarction (STEMI) when delivered in a timely manner. A key performance metric of a PPCI service is providing door-to-balloon times (D2BT) in under 90 min. Shorter D2BT is associated with reduction in cardiac mortality and morbidity.

Effect of Sacubitril/Valsartan Combined with Dapagliflozin on Long-Term Cardiac Mortality in Heart Failure with Reduced Ejection Fraction

The angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril/valsartan and sodium-glucose cotransporter-2 (SGLT-2) inhibitor dapagliflozin have been shown to reduce rehospitalization and cardiac mortality in patients with heart failure (HF) with reduced ejection fraction (HFrEF). We aimed to compare the long-term cardiac and all-cause mortality of ARNI and dapagliflozin combination therapy against ARNI monotherapy in patients with HFrEF. This retrospective study involved 244 patients with HF with New York Heart Association (NYHA) class II-IV symptoms and ejection fraction ≤40%. The patients were divided into 2 groups: ARNI monotherapy and ARNI+dapagliflozin. Median follow-up was 2.5 (.16-3.72) years. One hundred and seventy-five (71.7%) patients were male, and the mean age was 65.9 (SD, 10.2) years. Long-term cardiac mortality rates were significantly lower in the ARNI+dapagliflozin group (7.4%) than in the ARNI monotherapy group (19.5%) (P = .01). Dapagliflozin [Hazard Ratio (HR) [95% Confidence Interval (CI)] = .29 [.10-.77]; P = .014] and left ventricular ejection fraction (LVEF) [HR (95% CI) = .89 (.85-.93); P < .001] were found to be independent predictors of cardiac mortality. Our study showed a significant reduction in cardiac mortality with ARNI and dapagliflozin combination therapy compared with ARNI monotherapy.

Clinical benefits of prolonged dual antiplatelet therapy following complex percutaneous coronary intervention.

Prolonged dual antiplatelet therapy (DAPT) requires consideration of both reduced thrombotic events and increased bleeding risk. The associated subtle balance between the benefits and harms depends upon patient's clinical factors and complexity of the coronary anatomy. Our aim was to assess the safety and efficacy of prolonged (>12 months) DAPT in patients undergoing complex percutaneous coronary intervention (PCI). A thorough computer-based search was performed using four major databases. Complex PCI was defined as a procedure with at least one of the following angiographic characteristics: 3 vessels treated, >3 stents implanted, >3 lesions treated, bifurcation lesions, total stent length >60 mm, left main or proximal left anterior descending, a vein graft stent, or chronic total occlusion as target lesion. Of the 3543 titles searched, 5 studies met the inclusion criteria comparing short and prolonged DAPT therapy. We applied a random-effects model to acknowledge the variation in study design, treatment duration, and length of follow-up among studies. There was a reduction in cardiac mortality [odds ratio (OR) 0.57, 95% confidence interval (CI): 0.35-0.92; P = 0.02, I = 0%] and major adverse cardiovascular events (OR 0.76, 95% CI: 0.59-0.96; P = 0.02, I = 22%) with prolonged DAPT. Major bleeding was increased with prolonged DAPT (OR 1.75, 95% CI: 1.20-2.20; P = 0.004, I = 0%). There was no difference in the all-cause mortality (OR 0.86, 95% CI: 0.61-1.22; P = 0.41, I = 0%). Prolonged DAPT reduces cardiac mortality and major adverse cardiovascular events in complex PCI. The results would need confirmation in a larger randomized study.

Effects of Exercise-Based Cardiac Rehabilitation in Patients with Acute Coronary Syndrome: A Meta-Analysis.

BackgroundAcute coronary syndrome (ACS) has become an important cause of death from cardiovascular disease. Cardiac rehabilitation (CR) plays an essential role in ACS patients after treatment. Therefore, in order to detect the impact of CR on mortality and major adverse cardiac events in patients with ACS, we conducted this meta-analysis.Material/MethodsWe searched PubMed, Web of science, and EMBASE databases to obtain published research results from 2010 to August 2018 to determine the relevant research. Random-effects model or fixed-effects model were used to calculate relative risk (RR) and 95% confidence interval (CI).ResultsOverall, a total of 25 studies with 55 035 participants were summarized in our meta-analysis. The results indicated that the hazard ratio (HR) of mortality significantly lower in the CR group than in the non-CR group (HR=−0.47; 95% CI=(−0.56 to −0.39; P<0.05). Fourteen studies on mortality rate showed exercise was associated with reduced cardiac death rates (RR=0.40; 95% CI=0.30 to 0.53; P<0.05). We found the risk of major adverse cardiac events (MACE) was lower in the rehabilitation group (RR=0.49; 95% CI=0.44 to 0.55; P<0.05). In 11 articles on CR including 8098 participants, the benefit in the CR group was greater than in the control group concerning revascularization (RR=0.69, 95% CI: 0.53 to 0.88; P=0.003). The recurrence rate of MI was reported in 13 studies, and the risk was lower in the CR group (RR=0.63, 95% CI: 0.57–0.70; P<0.05).ConclusionsOur meta-analysis results suggest that CR is clearly associated with reductions in cardiac mortality, recurrence of MI, repeated PCI, CABG, and restenosis.

Impact of recanalization of chronic total occlusion on left ventricular electrical remodeling

BackgroundSuccessful percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) is associated with reduction of cardiac mortality, as well as reducing fatal ventricular arrhythmias. The aim of this study was to evaluate the effect of recanalization of CTO on endocardial left ventricular voltages by paired electrophysiological studies.MethodsSixteen consecutive patients who underwent PCI for de novo CTO lesions were included. High‐density mapping was performed during sinus rhythm before and 8 months after PCI. According to the amplitude of bipolar electrograms, the left ventricular endocardium was classified into a preserved normal voltage (>1.5 mV), border zone (0.5–1.5 mV), and dense scar areas (<0.5 mV).ResultsThe border zone area had a significant positive correlation with CTO length, as well as a significant negative correlation observed in the preserved voltage region. In the successful PCI patient, the median dense scar area did not change significantly (reported as [median difference: 95% confidence interval]) between baseline and after PCI (0.1 cm2: –2.8 to 2.9). However, the area of the border zone decreased (–10.5 cm2: –16.8 to –4.1) and the preserved voltage area increased significantly (19.2 cm2: 7.7–30.6). In addition, successful PCI was related to slight, but significant, increase in the amplitude of unipolar and bipolar voltage (1.55 mV: 0.88–3.33, 0.23 mV: 0.08–0.36).ConclusionsRecanalization of CTO may promote reverse electrical remodeling in the border zone of the left ventricle, without affecting the dense scar tissue.

Long-Term Beta-Blocker Therapy after Myocardial Infarction in the Reperfusion Era: A Systematic Review.

Beta-blockers are recommended as standard of care for patients who experience a myocardial infarction (MI). However, evidence to support this recommendation is primarily derived from the pre-reperfusion era. In the reperfusion era, short-term (≤ 30 days) beta-blocker therapy has been demonstrated to reduce recurrent MI and angina, but not mortality. The objective of this review was to evaluate the evidence for long-term (≥ 1 yr) beta-blocker therapy in patients post-MI without left ventricular dysfunction in the reperfusion era. A systematic search of MEDLINE, EMBASE, CENTRAL, and Google from inception to September 2017 was performed. Included were randomized controlled trials and observational propensity score cohort studies published within the past 10 years that compared beta-blockers to placebo/no beta-blockers at discharge in patients with an acute MI but without left ventricular dysfunction or heart failure. Outcomes of interest included all-cause and cardiovascular mortality, nonfatal MI, and nonfatal stroke. Eight cohort studies were included. Follow-up ranged from 1 to 5 years. Two smaller studies demonstrated a reduction in all-cause mortality with beta-blockers, whereas there was no difference observed in six studies. One study showed reduced cardiovascular mortality at 1 year, but no difference in sudden cardiac death. One study demonstrated a reduction in cardiac mortality at 3 years, but no difference in MI or stroke. None of the four studies that reported adverse cardiovascular events demonstrated a benefit with beta-blocker therapy. Though these data are limited by observational methodology, the majority of the included studies failed to demonstrate a benefit in survival or cardiovascular events with long-term beta-blockers in post-MI patients with normal left ventricular function. In the absence of a contemporary randomized controlled trial, this evidence imparts uncertainty regarding the current standard of care and suggests that it may be reasonable to discontinue beta-blockers in patients without impaired left ventricular function at 1-year post-MI who do not have another indication for use.

Resource requirements and reduction in cardiac mortality from deep inspiration breath hold (DIBH) radiation therapy for left sided breast cancer patients: A prospective service development analysis

IntroductionUse of deep inspiration breath hold (DIBH) radiation therapy may reduce long-term cardiac mortality. The resource and time commitments associated with DIBH are impediments to its widespread adoption. We report the dosimetric benefits, workforce requirements, and potential reduction in cardiac mortality when DIBH is used for left-sided breast cancers. Methods and materialsData regarding the time consumed for planning and treating 50 patients with left-sided breast cancer with DIBH and 20 patients treated with free breathing (FB) radiation therapy were compiled prospectively for all personnel (regarding person-hours [PH]). A second plan was generated for all DIBH patients in the FB planning scan, which was then compared with the DIBH plan. Mortality reduction from use of DIBH was calculated using the years of life lost resulting from ischemic heart disease for Indians and the postulated reduction in risk of major cardiac events resulting from reduced cardiac dose. ResultsThe median reduction in mean heart dose between the DIBH and FB plans was 166.7 cGy (interquartile range, 62.7-257.4). An extra 6.76 PH were required when implementing DIBH as compared with FB treatments. Approximately 3.57 PH were necessary per Gy of reduction in mean heart dose. The excess years of life lost from ischemic heart disease if DIBH was not done in was 0.95 per 100 patients, which translates into a saving of 12.8 hours of life saved per PH of work required for implementing DIBH. DIBH was cost effective with cost for implementation of DIBH for all left-sided breast cancers at 2.3 times the annual per capita gross domestic product. ConclusionAlthough routine implementation of DIBH requires significant resource commitments, it seems to be worthwhile regarding the projected reductions in cardiac mortality.

Psychological interventions for coronary heart disease.

Psychological interventions can form part of comprehensive cardiac rehabilitation programmes (CCR). These interventions may include stress management interventions, which aim to reduce stress, either as an end in itself or to reduce risk for further cardiac events in patients with heart disease.To determine the effectiveness of psychological interventions, in particular stress management interventions, on mortality and morbidity, psychological measures, quality of life, and modifiable cardiac risk factors, in patients with coronary heart disease (CHD).We searched CCTR to December 2001 (Issue 4, 2001), MEDLINE 1999 to December 2001 and EMBASE 1998 to the end of 2001, PsychINFO and CINAHL to December 2001. In addition, searches of reference lists of papers were made and expert advice was sought.RCTs of non-pharmacological psychological interventions, administered by trained staff, either single modality interventions or a part of CCR with minimum follow up of 6 months. Adults of all ages with CHD (prior myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angioplasty, angina pectoris or coronary artery disease defined by angiography). Stress management (SM) trials were identified and reported in combination with other psychological interventions and separately.Studies were selected, and data were abstracted, independently by two reviewers. Authors were contacted where possible to obtain missing information.Thirty six trials with 12,841 patients were included. Of these, 18 (5242 patients) were SM trials. Quality of many trials was poor with the majority not reporting adequate concealment of allocation, and only 6 blinded outcome assessors. Combining the results of all trials showed no strong evidence of effect on total or cardiac mortality, or revascularisation. There was a reduction in the number of non-fatal reinfarctions in the intervention group (OR 0.78 (0.67, 0.90), but the two largest trials (with 4809 patients randomized) were null for this outcome, and there was statistical evidence of publication bias. Similar results were seen for the SM subgroup of trials. Provision of any psychological intervention or SM intervention caused small reductions in anxiety and depression. Few trials reported modifiable cardiac risk factors or quality of life.Overall psychological interventions showed no evidence of effect on total or cardiac mortality, but did show small reductions in anxiety and depression in patients with CHD. Similar results were seen for SM interventions when considered separately. However, the poor quality of trials, considerable heterogeneity observed between trials and evidence of significant publication bias make the pooled finding of a reduction in non-fatal myocardial infarction insecure.

Outcomes After Percutaneous Coronary Intervention or Bypass Surgery in Patients With Unprotected Left Main Disease

BackgroundCurrently available randomized data on the comparison between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) for the treatment of unprotected left main coronary disease (LMD) lacks statistical power due to low numbers of patients enrolled. ObjectivesThis study assessed long-term outcomes of PCI and CABG for the treatment of LMD in specific subgroups according to disease anatomic complexity. MethodsWe conducted a pooled analysis of individual patient-level data of the LMD patients included in the PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) and SYNTAX (Synergy Between PCI With TAXUS and Cardiac Surgery) trials. Incidences of major adverse cardiac events were assessed at 5 years follow-up. ResultsStudy population comprised 1,305 patients. The incidence of major adverse cardiac and cerebrovascular events at 5 years was 28.3% in the PCI group and 23.0% in the CABG group (hazard ratio [HR]: 1.23; 95% confidence interval [CI]: 1.01 to 1.55; p = 0.045). This difference is mainly driven by a higher rate of repeat revascularization associated with PCI (HR: 1.85; 95% CI: 1.38 to 2.47; p < 0.001). The 2 strategies showed similar rates of the safety composite endpoint of death, myocardial infarction, or stroke (p = 0.45). In patients with isolated LM or LM + 1-vessel disease, PCI was associated with a 60% reduction in all-cause mortality (HR: 0.40; 95% CI: 0.20 to 0.83; p = 0.029) and 67% reduction in cardiac mortality (HR: 0.33; 95% CI: 0.12 to 0.88; p = 0.025) when compared with CABG. ConclusionsIn patients with unprotected LMD, CABG, and PCI result in similar rates of the safety composite endpoint of death, myocardial infarction, or stroke. In patients with isolated LM or LM + 1-vessel disease, PCI is associated with lower all-cause and cardiac mortality when compared to CABG.

Meta-analysis of the impact of intervention versus symptom-driven management in asymptomatic severe aortic stenosis

ObjectiveThe management of patients with asymptomatic, severe aortic stenosis (AS) is controversial. We performed a meta-analysis to examine the impact on outcomes of aortic valve replacement (AVR) in patients with...

Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: conceptual evolution based on emerging evidence.

The objective of this article is to review the contemporary literature on optimal dual antiplatelet therapy (DAPT) duration after drug-eluting stent (DES) implantation. Relevant studies were searched through MEDLINE, the Cochrane database, and the EMBASE database. Of the 6852 publications retrieved, 23 were considered relevant, including 11 randomized controlled trials (RCTs) and 12 meta-analyses. Initially prescribed for 3-6 months after first-generation DES, the recommended duration of DAPT was subsequently prolonged to at least 1 year, a response to reports of late stent thrombosis after DAPT discontinuation. Seven RCTs subsequently suggested that 1-year DAPT may not be necessary after DES implantation, and that a 6-month or even a 3-month course of DAPT may be as effective and safer. In contrast, four RCTs examining the benefit of DAPT beyond 1 year reached conflicting conclusions. In the DAPT trial, 30-month compared with 12-month DAPT after DES resulted in reduced rates of stent thrombosis and major adverse cardiovascular events, but greater rates of major bleeding with increased non-cardiac mortality. Several meta-analyses have subsequently been performed collectively demonstrating increased rates of all-cause mortality with prolonged DAPT compared with shorter DAPT after DES, due to greater non-cardiovascular mortality with prolonged DAPT not offset by a concomitant reduction in cardiac mortality. The benefit-risk ratio of prolonged DAPT appears to be better in patients with myocardial infarction (MI) than in those without prior MI. On the basis of these findings, a personalized approach is advisable when deciding upon the optimal duration of DAPT after DES, wherein the individualized risks of ischaemic vs. bleeding events are carefully considered for each patient.

The role of manual aspiration thrombectomy in the management of STEMI: a TOTALly different TASTE of TAPAS.

In the latest ACC/AHA/SCAI guideline update on primary percutaneous coronary intervention (PCI) for patients with ST-elevation myocardial infarction (STEMI), routine use of manual thrombectomy as an adjunct to primary PCI is not recommended (class III: no benefit, level of evidence A) [1]. The guidelines also state that the usefulness of selective and bailout aspiration thrombectomy in patients undergoing primary PCI is not well established (class IIb, level of evidence C). A change in the recommendation occurred following publication of two large randomized studies, the TOTAL trial (a trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI) (n = 10 732) [2] and the TASTE study (Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia) (n = 7244) [3], which both showed no difference in clinical outcomes between PCI plus thrombectomy versus PCI alone. Previously, the smaller (n = 1071) randomized TAPAS study (Thrombus Aspiration during Percutaneous Coronary Intervention in Acute Myocardial Infarction Study) [4] had shown that manual thrombectomy was associated with better postPCI myocardial perfusion, as measured by the myocardial blush grade (MBG), and a reduction in cardiac mortality, although this study was not powered to detect differ ences in clinical events. However, we believe that there are important observations that should be taken into account when weighing the impact of these trials on everyday practice. In this issue of Advances in Interventional Cardiology, 2 case reports describe successful application of manual thrombectomy beyond the scope of routine STEMI management (a patient with breast cancer and paraneoplastic syndrome, who suffered non-ST-segment myocardial infarction and a patient with bacterial endocarditis of the aortic valve and anterior STEMI caused by embolization of thrombotic material into the left anterior descending (LAD) coronary artery) [5, 6]. Taken together with the recently published data on the lack of clinical benefit of routine manual thrombectomy, the two described reports seem to raise the following question: Has the role of thrombectomy shifted from being considered part of the routine practice of STEMI treatment to being a non-standard therapeutic tool for an exceptional acute MI patient? To attempt an answer to this question, we analyze the results of the main and secondary publications from the TOTAL and the TASTE trials and relate these findings to the knowledge base from earlier clinical studies that seemed to be in favor of the routine use of manual thrombectomy. In the TOTAL trial, patients undergoing manual aspiration thrombectomy as an adjunct to primary PCI had a similar rate of the combined primary endpoint of cardiovascular death, recurrent MI, cardiogenic shock or NYHA IV heart failure at 180 days, as compared with PCI alone (6.9% vs. 7.0%, respectively; HR = 0.99, 95% CI: 0.85–1.15, p = 0.86) [2]. There were no significant differ ences in individual components of the primary endpoint or in the rate of stent thrombosis (1.5% vs. 1.7%, p = 0.42) or target vessel revascularization (4.5% vs. 4.3%, p = 0.77), at 180 days [2]. The crossover rate was 4.6% from thrombectomy to PCI alone and 1.4% from PCI alone to thrombectomy, while the rate of bailout thrombectomy in the PCI-alone group was 7.1% [2]. Nevertheless, the on-treatment analysis that compared patients who received thrombectomy irrespective of randomization (both upfront and bailout) with PCI alone showed no significant difference in the rate of the primary endpoint. At 1 year, the occurrence of the primary composite end

Significant Improvement of Survival By T2* Cardiovascular Magnetic Resonance in Thalassemia Major

▪Background: In 2004 seven Italian centers reported survival data for patients with thalassemia major (TM) and showed that heart disease due to iron overload was the most common cause of death (Borgna et al Haematologica 2004). In the same years the accurate and noninvasive assessment of cardiac siderosis was made possible in Italy by the introduction of the T2* cardiovascular magnetic resonance (CMR).Purpose: We aimed to evaluate if the deployment of T2* CMR had an impact on the mortality rate.Methods: Four centers contributed to the present study, updating the data of the enrolled patients until August 31, 2010. For the patients who died, the date of the death represented the end of the study. 577 patients (264 females and 313 males) were included.Results: One-hundred and fifty-nine (27.6%) patients died, 124 of whom (77.9%) died before the year 2000.The Table shows the comparison between dead patients and survivors. Dead patients were significantly younger and they were more frequently males. Dead patients started chelation therapy significantly later. HIV, arrhythmias and heart failure were significantly more frequent in dead patients. According to the Cox model, the following variables were identified as significant univariate prognosticators for the death: male sex (HR=1.87, 95%CI=1.34-2.60, P<0.0001), HIV (HR=2.55, 95%CI=1.25-5.20, P=0.010) and heart failure (HR=8.86, 95%CI=6.37-12.31, P<0.0001).MRI was not performed in 406 patients (70.4%) and no patient had been scanned before his/her death. Among the survivors, MRI was not performed in the 59% of the cases (P<0.0001). The absence of an MRI scan was a significant univariate prognosticator for death (HR=43.25, 95%CI=11.32-165.33, P<0.0001).The study was restricted to the patients dead after 2004 (19/159=12%) or followed until August 2010 (N=357). In this subgroup of 376 patients, MRI was not performed in the 52.4% of the survivors and in all dead patients (P<0.0001). The absence of a MRI exam was reconfirmed as a strong predictive factor for death (HR=49.37, 95%CI=1.08-2263.24, P=0.046). The Kaplan-Meier curve is showed in Figure 1. The log-rank test revealed a significant difference in the curves (P<0.0001).Conclusions: Our data suggests that the use of T2* CMR, that enables individually tailored chelation regimes reducing the likelihood of developing decompensated cardiac failure, allowed the reduction of cardiac mortality in chronically transfused TM patients. [Display omitted] [Display omitted] DisclosuresPepe:Novartis: Speakers Bureau; Chiesi: Speakers Bureau; ApoPharma Inc: Speakers Bureau.

Mortality in patients treated with extended duration dual antiplatelet therapy after drug-eluting stent implantation: a pairwise and Bayesian network meta-analysis of randomised trials

Despite recent studies, the optimum duration of dual antiplatelet therapy (DAPT) after coronary drug-eluting stent placement remains uncertain. We performed a meta-analysis with several analytical approaches to investigate mortality and other clinical outcomes with different DAPT strategies. We searched Medline, Embase, Cochrane databases, and proceedings of international meetings on Nov 20, 2014, for randomised controlled trials comparing different DAPT durations after drug-eluting stent implantation. We extracted study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes. DAPT duration was categorised in each study as shorter versus longer, and as 6 months or shorter versus 1 year versus longer than 1 year. Analyses were done by both frequentist and Bayesian approaches. We identified ten trials published between Dec 16, 2011, and Nov 16, 2014, including 31,666 randomly assigned patients. By frequentist pairwise meta-analysis, shorter DAPT was associated with significantly lower all-cause mortality compared with longer DAPT (HR 0·82, 95% CI 0·69-0·98; p=0·02; number needed to treat [NNT]=325), with no significant heterogeneity apparent across trials. The reduced mortality with shorter compared with longer DAPT was attributable to lower non-cardiac mortality (0·67, 0·51-0·89; p=0·006; NNT=347), with similar cardiac mortality (0·93, 0·73-1·17; p=0.52). Shorter DAPT was also associated with a lower risk of major bleeding, but a higher risk of myocardial infarction and stent thrombosis. We noted similar results in a Bayesian framework with non-informative priors. By network meta-analysis, patients treated with 6-month or shorter DAPT and 1-year DAPT had higher risk of myocardial infarction and stent thrombosis but lower risk of mortality compared with patients treated with DAPT for longer than 1 year. Patients treated with DAPT for 6 months or shorter had similar rates of mortality, myocardial infarction, and stent thrombosis, but lower rates of major bleeding than did patients treated with 1-year DAPT. Although treatment with DAPT beyond 1 year after drug-eluting stent implantation reduces myocardial infarction and stent thrombosis, it is associated with increased mortality because of an increased risk of non-cardiovascular mortality not offset by a reduction in cardiac mortality. None.

Cardiac risk factors reduction by modification of lifestyle in cardiac rehabilitation in patients with CHD

Background: It is unclear how much of the reduction in cardiac mortality in coronary heart disease (CHD) patients with cardiac rehabilitation is the result of direct effects on the heart and coronary vasculature, or indirect effects, via primary risk factors.

Bivalirudin: Treatment Effect Versus Side Effect

Alexopoulos et al. 1 presented interesting data showing that in “real-life” scenario, there are no differences in one-month outcome between bivalirudin- and no bivalirudin-treated patients. When talking about bivalirudin efficacy, we have to consider two distinct features: treatment effect (antithrombotic action) and side effect (bleeding events). In HORIZONS-AMI trial, there was a reduction in cardiac mortality in the bivalirudin group that can only partly be attributed to prevention of bleeding 2. Notwithstanding, in EUROMAX trial, there was a substantial decline in bleeding events which did not transfer into survival benefit 3. Repeatedly, however, there was a higher incidence of stent thrombosis and a trend toward a higher incidence of myocardial infarction 3, 4, despite investigators' attempts to prevent it by prolonging bivalirudin infusion to 4 h following PCI. So actually, in terms of treatment effect, the study proved the drug not to be so efficacious. Bleeding events are independently associated with a worse long-term prognosis across a wide spectrum of patients with coronary artery disease and the risk of death progresses with increasing severity of bleeding 5, 6. However, in this instance, it would seem that we have decreased the risk of side effects (excellent safety profile) at the trade-off of increasing the risk of thrombotic events – events that, one would expect, should decline using antithrombotic agent 7. In addition, the cost of bivalirudin far exceeds that of standard treatment, thereby calling into question the ancillary benefits of the drug that would justify its use in place of the conventional regimen. Accordingly, we emphasize caution when talking about therapeutic effect. Until then, findings should be considered signals warranting further investigation. The authors declare no conflict of interest.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

Reduction in Cardiac Mortality With Bivalirudin in Patients With and Without Major Bleeding: The HORIZONS-AMI Trial (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction)

The purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH+GPI) can be fully attributed to reduced bleeding. The association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin. A total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH+GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding. When compared with UFH+GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs. 10.5%, hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.51 to 0.80], p < 0.0001) and cardiac mortality (2.9% vs. 5.1%, HR: 0.56 [95% CI: 0.40 to 0.80], p = 0.001). Three-year cardiac mortality was reduced in bivalirudin-treated patients with major bleeding (20 fewer deaths with bivalirudin; 5.8% vs. 14.6%, p = 0.025) and without major bleeding (18 fewer deaths with bivalirudin; 2.6% vs. 3.8%, p = 0.048). In a fully-adjusted multivariable model accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR: 0.57 [95% CI: 0.39 to 0.83], p = 0.003). Bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966).

Perioperative B-blockers in Non-cardiac Surgery: Actual Situation

Cardiac events occur in 1% to 5% of patients undergoing non-cardiac surgery. Myocardial ischemia and nonfatal myocardial infarction constitute the most significant risk factors for mortality and cardiovascular morbidity, in patients with coronary artery disease. Perioperative b- blockade has been reported to reduce the risk of perioperative cardiac complications. Seven multicentre randomized trials have evaluated the impact of perioperative b-blocker administration on incidence of cardiovascular events.The Study of Perioperative Ischemia Research Group, the DECREASE and the BBSA trials focused on high risk patients for perioperative complications. The POBBLE, MaVS, and DIPOM trials did not target at patients with specific clinical risk factors, except DIPOM that included patients with diabetes. Finally, the POISE trial randomized patients with a wide variety of risk factors for perioperative cardiac complications. Interestingly, five meta-analyses reported a significant reduction in patients receiving b-blockers, with respect to perioperative myocardial ischemia and myocardial infarction. In conclusion, consistent evidence demonstrated a reduction in cardiac mortality and myocardial infarction by perioperative b-blockade in patients with clinical risk factors, undergoing high-risk non-cardiac surgery. However, patients with extensive preoperative ischemia were at high risk of perioperative cardiac complications, despite b-blocker therapy. Conversely, perioperative b-blocker therapy did not reduce the incidence of cardiac complications in patients without clinical risk factors. While, the safety and effectiveness of perioperative b-blockers in intermediate-risk patients, still remain a debatable issue.