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997 result(s) for "Myocardial Revascularization - mortality"
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Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial
Non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris are frequent causes of hospital admission in the elderly. However, clinical trials targeting this population are scarce, and these patients are less likely to receive treatment according to guidelines. We aimed to investigate whether this population would benefit from an early invasive strategy versus a conservative strategy. In this open-label randomised controlled multicentre trial, patients aged 80 years or older with NSTEMI or unstable angina admitted to 16 hospitals in the South-East Health Region of Norway were randomly assigned to an invasive strategy (including early coronary angiography with immediate assessment for percutaneous coronary intervention, coronary artery bypass graft, and optimum medical treatment) or to a conservative strategy (optimum medical treatment alone). A permuted block randomisation was generated by the Centre for Biostatistics and Epidemiology with stratification on the inclusion hospitals in opaque concealed envelopes, and sealed envelopes with consecutive inclusion numbers were made. The primary outcome was a composite of myocardial infarction, need for urgent revascularisation, stroke, and death and was assessed between Dec 10, 2010, and Nov 18, 2014. An intention-to-treat analysis was used. This study is registered with ClinicalTrials.gov, number NCT01255540. During a median follow-up of 1·53 years of participants recruited between Dec 10, 2010, and Feb 21, 2014, the primary outcome occurred in 93 (40·6%) of 229 patients assigned to the invasive group and 140 (61·4%) of 228 patients assigned to the conservative group (hazard ratio [HR] 0·53 [95% CI 0·41–0·69], p=0·0001). Five patients dropped out of the invasive group and one from the conservative group. HRs for the four components of the primary composite endpoint were 0·52 (0·35–0·76; p=0·0010) for myocardial infarction, 0·19 (0·07–0·52; p=0·0010) for the need for urgent revascularisation, 0·60 (0·25–1·46; p=0·2650) for stroke, and 0·89 (0·62–1·28; p=0·5340) for death from any cause. The invasive group had four (1·7%) major and 23 (10·0%) minor bleeding complications whereas the conservative group had four (1·8%) major and 16 (7·0%) minor bleeding complications. In patients aged 80 years or more with NSTEMI or unstable angina, an invasive strategy is superior to a conservative strategy in the reduction of composite events. Efficacy of the invasive strategy was diluted with increasing age (after adjustment for creatinine and effect modification). The two strategies did not differ in terms of bleeding complications. Norwegian Health Association (ExtraStiftelsen) and Inger and John Fredriksen Heart Foundation.
Revascularisation versus medical treatment in patients with stable coronary artery disease: network meta-analysis
Objective To investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease.Design Bayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials while maintaining randomisation. Eligibility criteria for selecting studies A strategy of initial medical treatment compared with revascularisation by coronary artery bypass grafting or Food and Drug Administration approved techniques for percutaneous revascularization: balloon angioplasty, bare metal stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease.Data sources Medline and Embase from 1980 to 2013 for randomised trials comparing medical treatment with revascularisation.Main outcome measure All cause mortality.Results 100 trials in 93 553 patients with 262 090 patient years of follow-up were included. Coronary artery bypass grafting was associated with a survival benefit (rate ratio 0.80, 95% credibility interval 0.70 to 0.91) compared with medical treatment. New generation drug eluting stents (everolimus: 0.75, 0.59 to 0.96; zotarolimus (Resolute): 0.65, 0.42 to 1.00) but not balloon angioplasty (0.85, 0.68 to 1.04), bare metal stents (0.92, 0.79 to 1.05), or early generation drug eluting stents (paclitaxel: 0.92, 0.75 to 1.12; sirolimus: 0.91, 0.75 to 1.10; zotarolimus (Endeavor): 0.88, 0.69 to 1.10) were associated with improved survival compared with medical treatment. Coronary artery bypass grafting reduced the risk of myocardial infarction compared with medical treatment (0.79, 0.63 to 0.99), and everolimus eluting stents showed a trend towards a reduced risk of myocardial infarction (0.75, 0.55 to 1.01). The risk of subsequent revascularisation was noticeably reduced by coronary artery bypass grafting (0.16, 0.13 to 0.20) followed by new generation drug eluting stents (zotarolimus (Resolute): 0.26, 0.17 to 0.40; everolimus: 0.27, 0.21 to 0.35), early generation drug eluting stents (zotarolimus (Endeavor): 0.37, 0.28 to 0.50; sirolimus: 0.29, 0.24 to 0.36; paclitaxel: 0.44, 0.35 to 0.54), and bare metal stents (0.69, 0.59 to 0.81) compared with medical treatment.Conclusion Among patients with stable coronary artery disease, coronary artery bypass grafting reduces the risk of death, myocardial infarction, and subsequent revascularisation compared with medical treatment. All stent based coronary revascularisation technologies reduce the need for revascularisation to a variable degree. Our results provide evidence for improved survival with new generation drug eluting stents but no other percutaneous revascularisation technology compared with medical treatment.
Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial
Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. The SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.
The use of modern telemedicine technologies in an innovative optimal cardiac rehabilitation program for patients after myocardial revascularization: Concept and design of RESTORE, a randomized clinical trial
Despite proven efficacy of cardiac rehabilitation (CR) in reducing the all-cause mortality in patients after myocardial revascularization, the penetration of CR, due to patient-related factors and referral rates remains limited. To improve the outcomes, home-based tele-rehabilitation (TR) has been proposed recently. In theory TR enhances the effects of standard CR procedures due to implementation of an intelligent monitoring system designed to ensure optimal training through on-demand transmission of vital signs, aimed at motivating the patients through daily schedule reminders, setting daily goals and creating a platform for mutual feedback. Several meta-analyses assessing various studies comparing these two methods (CR and TR) have proven that they are at least equally effective, with some of the research showing superiority of TR. Although there was a small sample size, lack of long-term follow-up, reporting effects of TR itself, no integration with tools designed for coaching, motivating and promoting a healthy lifestyle constitutes an important limitation. The latter carries a hopeful prognosis for improvement when utilizing a broad-spectrum approach, especially with use of dedicated technological solutions exploiting the fact of a large and yet rapidly increasing penetration of smartphones, mobile PCs and tablets in the population. The above-mentioned findings worked as the basis and rationale for commencing the RESTORE project aimed at developing and delivering state-of-the-art, comprehensive TR for patients after myocardial revascularization and evaluating its molecular aspect in view of how it influences the atherosclerosis progression attenuation. This paper presents the current state and rationale behind the project based on up-to-date TR efficacy data.
Association of chronic kidney disease with clinical outcomes after coronary revascularization: The arterial revascularization therapies study (ARTS)
Chronic kidney disease (CKD) is associated with adverse outcomes after coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCI), but it is unclear which of these revascularization strategies is associated with lower risk for morbidity and mortality in this population. In the Arterial Revascularization Therapies Study (ARTS), we compared long-term clinical outcomes after CABG or PCI with multivessel stenting in patients with CKD. The ARTS randomly assigned 1205 participants with and without CKD to CABG or PCI with multivessel stenting. We defined CKD as creatinine clearance ≤60 mL/min, estimated by the Cockroft-Gault equation. The primary outcome was the composite of death, myocardial infarction (MI), or stroke; and, a secondary outcome was repeat revascularization. Participants were followed for a mean of 3 years after their intervention. We evaluated whether randomization to CABG or PCI was associated with different outcomes among participants with CKD. Two hundred ninety participants (25%) had CKD at entry into ARTS. One hundred fifty-one received PCI, and 139 received CABG. No difference was observed in the primary endpoint with CABG or PCI among CKD participants (adjusted Hazard Ratio [HR] CABG vs PCI = 0.93; 95% CI 0.54-1.60; P = .97). However, CABG was associated with a reduced risk for repeat revascularization (HR = 0.28; 95% CI 0.14-0.54; P < .01). Compared with participants with normal renal function, CKD was associated with a nearly 2-fold risk for the primary outcome (unadjusted HR = 1.9; 95% CI 1.4-2.7; P < .01). After multivariate adjustment, this association remained significant (HR 1.6; 95% CI 1.1-2.4). In patients with multivessel CAD and CKD, treatment with CABG or PCI with multivessel stenting led to similar outcomes of death, MI, or stroke, but CABG was associated with decreased repeat revascularizations. When compared with ARTS participants with normal renal function, those with CKD had substantially elevated risk of adverse clinical outcomes after coronary revascularization.
Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial
Background Current guidelines for the diagnosis and management of patients with stable coronary artery disease (CAD) recommend functional stress testing for risk stratification prior to revascularization procedures. Cardiac magnetic resonance imaging (CMR) is a modality of choice for stress testing because of its capability to detect myocardial ischemia sensitively and specifically. Nevertheless, evidence from randomized trials evaluating a CMR-based management of stable CAD patients in comparison to a more common angiography-based approach still is limited. Methods/design Patients presenting themselves with symptoms indicating a stable CAD and a class I or IIa indication for diagnostic coronary angiography are prospectively screened and enrolled in the study. All subjects receive a basic cardiological work-up and guideline-directed medical therapy. A 1:1 randomization in two groups is being performed. Patients in group 1 undergo diagnostic coronary angiography and subsequent revascularization according to current guidelines. Subjects in group 2 undergo adenosine stress CMR and in case of myocardial ischemia are sent to coronary angiography. Follow-up is planned for 3 years. During this time, the number of primary endpoints (defined as cardiac death and non-fatal myocardial infarction) and unplanned invasive procedures will be documented. Furthermore, symptom burden and quality of life will be assessed by use of the Seattle Angina Questionnaire. Sample size is calculated to prove non-inferiority of the CMR-based approach. Discussion In case this study is able to accomplish its aim to prove non-inferiority of the CMR-based management in patients with stable CAD; the importance of this emerging modality may further increase. Trial registration ClinicalTrials.gov, identifier: NCT02580851 . Registered on 14 October 2015. Unique Protocol ID: 237/11
Outcomes of Coronary Revascularization (Percutaneous or Bypass) in Patients With Diabetes Mellitus and Multivessel Coronary Disease
Clinical outcomes in patients with diabetes mellitus and multivessel disease (MVD) undergoing coronary revascularization have not been extensively evaluated, we sought to examine outcomes in a diabetic cohort of 195 consecutive patients with MVD characterized by SYNTAX scores (SSs) undergoing nonrandomized revascularization, 102 (52%) by percutaneous intervention (PCI) and 93 (48%) by coronary artery bypass grafting (CABG) at Liverpool Hospital (Sydney, Australia) from June 2006 to March 2010. Clinical outcomes were assessed at a median term of 14 months. The overall median SS was 44, with significantly higher SSs in CABG- than PCI-treated patients (48 vs 39, p <0.0001). There was a similar incidence of all-cause death, nonfatal myocardial infarction and stroke in PCI- and CABG-treated patients (6.1% vs 8.3%, p = 0.383; 12% vs 4.9%, p = 0.152; 3.1% vs 3.5%, p = 0.680 respectively). However, the rates of target vessel revascularization and major adverse coronary and cerebral event were significantly higher in PCI-treated patients than in those undergoing CABG (20% vs 1.2%, p <0.0001; 29% vs 15%, p = 0.034). Despite a much higher SS, patients who underwent PCI achieved comparable outcomes at 1 year to those with diabetes mellitus and a SS ≥33 as reported in the SYNTAX trial. In conclusion, in this single-center nonrandomized observational study, coronary revascularization by PCI is associated with increased major adverse coronary and cerebral events at 1-year follow-up, predominantly driven by a high rate of target vessel revascularization. Thus, CABG should remain the revascularization procedure of choice for diabetic patients with MVD and high SSs.
Warfarin after anterior myocardial infarction in current era of dual antiplatelet therapy: a randomized feasibility trial
In the current era of early revascularization and routine use of dual antiplatelet therapy, the incremental benefit of warfarin to reduce the incidence of left ventricular thrombus (LVT) in patients with impaired left ventricular ejection fraction post anterior ST-elevation myocardial infarction (aSTEMI), remains uncertain. The purpose of this study is to assess the feasibility of evaluating the added benefit and safety of triple therapy (TT-warfarin, ASA, and clopidogrel) versus dual therapy (DT-ASA and clopidogrel) in patients at risk of LVT post aSTEMI. Design: Open-label randomized controlled trial. Inclusion: aSTEMI, ejection fraction <40%, and no evidence of LVT. Exclusion: contraindication to, or alternate indication for anticoagulation. Intervention: TT versus DT. Follow-up: pre-discharge and 3 month echocardiogram. Outcomes: composite of death, MI, stroke, systemic embolizarion, LVT or major bleeding at three months. 295 patients with aSTEMI were screened: 27% of patients with LVEF < 40% had an LVT; 20/52 eligible patients were randomized to receive TT ( n  = 10) or DT ( n  = 10). Baseline characteristics: mean age 60 years, male gender 65%, diabetics 20%, and in hospital PCI 95%. There was no significant difference in the composite endpoint at 3 months (TT-20% with 1 LVT and 1 major bleed versus DT-10% with 1 MI). The incidence of definite or probable LVT in the screened population of patients post aSTEMI with an LVEF < 40% was 26.6% despite 94% having early revascularization. STEMI patients have a high incidence of LVT despite the routine use of early revascularization and dual antiplatelet therapy. More effective antithrombotic strategies merit evaluation in adequately powered randomized trials.
Impact of myocardial ischemia on myocardial revascularization in stable ischemic heart disease
In patients with stable ischemic heart disease (SIHD), myocardial revascularization should be performed to either improve survival or improve symptoms and functional status among patients who are not well controlled with optimal medical therapy (OMT). A general consensus exists on the core elements of OMT, which include both lifestyle intervention and intensive secondary prevention with proven pharmacotherapies. By contrast, however, there is less general agreement as to what constitutes the optimal approach to revascularization in SIHD patients. The COURAGE and FAME 2 randomized trials form the foundation of the current clinical evidence base and raise the important question: “What is the impact of myocardial ischemia on myocardial revascularization in stable ischemic heart disease?”
Ischaemic cardiomyopathy: pathophysiology, assessment and the role of revascularisation
Ischaemic cardiomyopathy: adaptation versus pathology ICM consists of a spectrum of pathophysiological states that relate to perfusion contraction matching and mismatching. 15 An ischaemia model in conscious dogs in the 1980s demonstrated a correlation between myocardial blood flow and regional contractile function, with only small reductions in flow resulting in significant reductions in regional myocardial function. 16 It has also been shown that coronary flow reserve is reduced and changes in metabolism are seen in areas of myocardium subtended by normal coronary arteries in patients with chronic stable angina secondary to coronary stenoses, 17 indicating that areas of myocardium remote from ischaemia are also impacted. Many historical observational studies have shown a mortality benefit in patients with ICM undergoing revascularisation, however the largest randomised study to date, STICH, was negative in terms of its primary end point. [...]at present there are no randomised trial data to support revascularisation in patients with ICM who do not have significant angina or an acute coronary syndrome.