Although angina is common in patients with stable coronary artery disease, limited data are available on its prevalence, natural evolution, and outcomes in the era of effective cardiovascular drugs ...and widespread use of coronary revascularization.
Using data from 32 691 patients with stable coronary artery disease from the prospective observational CLARIFY registry (Prospective Observational Longitudinal Registry of Patients with Stable Coronary Artery Disease), anginal status was mapped each year in patients without new coronary revascularization or new myocardial infarction. The use of medical interventions in the year preceding angina resolution was explored. The effect of 1-year changes in angina status on 5-year outcomes was analyzed using multivariable analysis.
Among 7212 (22.1%) patients who reported angina at baseline, angina disappeared (without coronary revascularization) in 39.6% at 1 year, with further annual decreases. In patients without angina at baseline, 2.0% to 4.8% developed angina each year. During 5-year follow-up, angina was controlled in 7773 patients, in whom resolution of angina was obtained with increased use of antianginal treatment in 11.1%, with coronary revascularization in 4.5%, and without any changes in medication or revascularization in 84.4%. Compared to patients without angina at baseline and 1 year, persistence of angina and occurrence of angina at 1 year with conservative management were each independently associated with higher rates of cardiovascular death or myocardial infarction (adjusted hazard ratio, 1.32 95% CI, 1.12-1.55 for persistence of angina; adjusted hazard ratio, 1.37 95% CI, 1.11-1.70 for occurrence of angina) at 5 years. Patients whose angina had resolved at 1 year with conservative management were not at higher risk of cardiovascular death or myocardial infarction than those who never experienced angina (adjusted hazard ratio, 0.97 95% CI, 0.82-1.15).
Angina affects almost one-quarter of patients with stable coronary artery disease but resolves without events or coronary revascularization in most patients. Resolution of angina within 1 year with conservative management predicted outcomes similar to lack of angina, whereas persistence or occurrence was associated with worse outcomes. Because most patients with angina are likely to experience resolution of symptoms, and because there is no demonstrated outcome benefit to routine revascularization, this study emphasizes the value of conservative management of stable coronary artery disease. Registration: URL: https://www.isrctn.com; Unique identifier: ISRCTN43070564.
Abstract Objectives This study sought to evaluate the feasibility of transfemoral transcatheter heart valve (THV) implantation in failed mitral bioprostheses and ring annuloplasties. Background Redo ...mitral surgery may be high risk or contraindicated due to comorbidity. THV implantation has been recently reported in this setting. Methods Transfemoral implantation of Edwards Sapien prosthesis was performed in 17 patients for degenerated mitral bioprosthesis or previous ring annuloplasty (6 bioprostheses, 11 ring annuloplasties). The procedure was elective for 14 patients and attempted as a rescue in 3 patients. Mean age was 61 ± 24 years. All patients were in New York Heart Association class ≥III, and the surgical risk was high (EuroSCORE European System for Cardiac Operative Risk Evaluation: 37 ± 29%, Society of Thoracic Surgeons score: 18 ± 22%). Results Procedure was successful in 14 patients (82%). Two complications occurred during rescue procedures: 1 procedural death and 1 THV migration. One patient had moderate paraprosthetic regurgitation following the procedure, whereas residual regurgitation was trace or less in 11 patients (69%) and mild in 4 patients (25%). Mean gradient decreased from 12 ± 6 mm Hg to 8 ± 3 mm Hg. During a mean follow-up of 22 months, 4 patients died, 3 from cardiac cause. The 18-month survival was 68 ± 14% in the overall population and 78 ± 14% for patients with elective procedure. One patient underwent mitral valve replacement due to periprosthetic mitral regurgitation. At last follow-up, 12 patients were in New York Heart Association class ≤II (75%) and 4 in class III (25%). Conclusions This single-center series suggests that transfemoral THV implantation for deterioration of mitral bioprosthesis or surgical repair is feasible in selected patients and improves early hemodynamic and midterm functional status.
Abstract
Aims
The aims of the present study were to describe the proportion of patients eligible for the COMPASS trial within the Reduction of Atherothrombosis for Continued Health (REACH) registry, ...the reasons for ineligibility, and to put in perspective the characteristics and outcomes of trial-eligible patients from the REACH registry compared with those of patients enrolled in the reference aspirin arm of the COMPASS trial.
Methods and results
The COMPASS selection and exclusion criteria were applied to REACH patients with either coronary artery disease (CAD) or peripheral artery disease (PAD). We used the COMPASS primary composite outcome of cardiovascular (CV) death, myocardial infarction (MI), or stroke. In REACH, 31 873 patients had CAD or PAD and detailed information allowing evaluation of eligibility. Among these, 9518 (29.9%) patients had exclusion criteria and an additional 5480 patients (17.2%) did not fulfil the inclusion criteria and thus were not eligible. The ‘COMPASS-Eligible’ population therefore comprised 52.9% of the evaluable REACH patients (n = 16 875). The main reasons for exclusion were high-bleeding risk (51.8%), anticoagulant use (44.8%), requirement for dual antiplatelet therapy within 1 year of an ACS or PCI with stent, (25.9%), history of ischaemic stroke <1 year (12.4%), and severe renal failure (2.2%). Eligibility was highest among patients with PAD alone (68.4%). COMPASS-Eligible patients from REACH experienced higher annualized primary outcome event rates than patients actually enrolled in the reference aspirin arm of COMPASS (4.2% vs. 2.9% per year, P < 0.001).
Conclusion
COMPASS-Eligible patients represent a substantial fraction of stable CAD/PAD patients encountered in routine clinical practice in the large international REACH registry suggesting good external applicability. COMPASS-Eligible patients experienced a higher rate of the primary outcome compared with COMPASS participants in the aspirin alone treatment arm.
Renal dysfunction is a key risk factor for all-cause mortality in patients with type 2 diabetes (T2D). Circulating tumor necrosis factor receptor 1 (TNFR1) was recently suggested as a strong ...biomarker for end-stage renal failure in T2D. However, its relevance regarding all-cause death has yet to be conclusively established. We aimed to assess the prognostic value of serum TNFR1 concentration for all-cause death in T2D and diabetic kidney disease (DKD) from the SURDIAGENE (Survie, Diabete de type 2 et Genetique) study.
A total of 522 T2D patients with DKD (estimated glomerular filtration rate eGFR <60 and/or urinary albumin-to-creatinine ratio uACR >30 mg/mmol) were followed for a median duration of 48 months, and 196 deaths occurred.
Incidence rate (95% CI) for death increased as quartiles of TNFR1 concentration increased (first quartile: 4.7% patient-years 3.0-6.3%; second quartile: 7.7% 5.4-10.0%; third quartile: 9.3% 6.7-11.9%; fourth quartile: 15.9% 12.2-19.5%). In multivariate analysis taking age, diabetes duration, HbA1c, uACR, and eGFR into account, compared with the first quartile, patients from the fourth quartile had an adjusted hazard ratio for death of 2.98 (95% CI 1.70-5.23). The integrated discrimination improvement index was statistically significant when adding TNFR1 concentration to the UK Prospective Diabetes Study outcome equation (P = 0.031).
TNFR1 is a strong prognostic factor for all-cause mortality in T2D with renal dysfunction, and its clinical utility is suggested in addition to established risk factors for all-cause mortality.
Objectives We sought to describe the results of a strategy offering either transfemoral or transapical aortic valve implantation in high-risk patients with severe aortic stenosis. Background Results ...of transfemoral and transapical approaches have been reported separately, but rarely following a uniform assessment to select the procedure. Methods Of 160 consecutive patients at high risk or with contraindications to surgery, referred between October 2006 and November 2008, 75 were treated with transcatheter aortic valve implantation. The transfemoral approach was used as the first option and the transapical approach was chosen when contraindications to the former were present. The valve used was the Edwards Lifesciences SAPIEN prosthesis. Results Patients were age 82 ± 8 years (mean ± SD), in New York Heart Association functional classes III/IV, with predicted mean surgical mortalities of 26 ± 13% using the European System for Cardiac Operative Risk Evaluation and 16 ± 7% using the Society of Thoracic Surgeons Predicted Risk of Mortality. Fifty-one patients were treated via the transfemoral approach, and 24 via the transapical approach. The valve was implanted in 93% of the patients. Hospital mortality was 10%. Mean (± SD) 1-year survivals were 78 ± 6% in the whole cohort, 81 ± 7% in the transfemoral group, 74 ± 9% in the transapical group (p = 0.22), and 60 ± 10% in the first 25 patients versus 93 ± 4% in the last 50 patients treated (p = 0.001). In multivariate analysis, early experience was the only significant predictor of late mortality. Conclusions Being able to offer either transfemoral or transapical aortic valve implantation, within a uniform assessment, expands the scope of the treatment of aortic stenosis in high-risk patients and provides satisfactory results at 1 year in this population. The results are strongly influenced by experience.
The diagnostic evaluation of acute chest pain has been augmented in recent years by advances in the sensitivity and precision of cardiac troponin assays, new biomarkers, improvements in imaging ...modalities, and release of new clinical decision algorithms. This progress has enabled physicians to diagnose or rule-out acute myocardial infarction earlier after the initial patient presentation, usually in emergency department settings, which may facilitate prompt initiation of evidence-based treatments, investigation of alternative diagnoses for chest pain, or discharge, and permit better utilization of healthcare resources. A non-trivial proportion of patients fall in an indeterminate category according to rule-out algorithms, and minimal evidence-based guidance exists for the optimal evaluation, monitoring, and treatment of these patients. The Cardiovascular Round Table of the ESC proposes approaches for the optimal application of early strategies in clinical practice to improve patient care following the review of recent advances in the early diagnosis of acute coronary syndrome. The following specific 'indeterminate' patient categories were considered: (i) patients with symptoms and high-sensitivity cardiac troponin <99th percentile; (ii) patients with symptoms and high-sensitivity troponin <99th percentile but above the limit of detection; (iii) patients with symptoms and high-sensitivity troponin >99th percentile but without dynamic change; and (iv) patients with symptoms and high-sensitivity troponin >99th percentile and dynamic change but without coronary plaque rupture/erosion/dissection. Definitive evidence is currently lacking to manage these patients whose early diagnosis is 'indeterminate' and these areas of uncertainty should be assigned a high priority for research.
In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide ...Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)-guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up.
In this multicenter trial, we randomly assigned patients with ST-segment-elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577).
After 3 years, a primary outcome event occurred in 52 of 498 patients (9.40%) in the FFR-guided group and in 44 of 502 patients (8.17%) in the angiography-guided group (hazard ratio, 1.19 95% CI, 0.79-1.77;
=0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 95% CI, 0.53-1.71); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 95% CI, 0.84-3.16); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 95% CI, 0.61-2.16), respectively.
Although event rates in the trial were lower than expected, in patients with ST-segment-elevation myocardial infarction undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization up to 3 years.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954.
With ongoing progress in the prevention and treatment of coronary artery disease (CAD), a continued decrease in prevalence and lethality is expected in high-income countries. Prevention will include ...lipid-lowering, antithrombotic and anti-inflammatory therapies. With respect to the former, potent, safe and prolonged drugs (such as generic forms of PCSK9 inhibitors relying on monoclonal antibodies or miRNA) should result in a decreased incidence of acute coronary syndromes. Another key aspect will be the ability to identify genetic predictors of CAD and therefore implement targeted personalized prevention early in life. Curative treatment will involve a short course of potent and reversible antithrombotics, but long-term therapy will rely on the ability to stabilize or even regress plaque (eg, using PCSK9 inhibition or modified high-density lipoprotein infusions or anti-inflammatory therapies). Antithrombotic therapy will rely on highly reversible agents (or agents with specific titratable antagonists), and on personalized therapies in which the doses, combinations and duration of therapy will be determined differentially for each patient on the basis of clinical characteristics, genetic profiling and biomarkers. Finally, the need for revascularization in stable CAD will be rare, given the expected progress in prevention. The main challenge, 20 years from now, is likely to be the provision of such effective care at acceptable costs in low- and middle-income countries. (Circ J 2016; 80: 1067–1072)
Although trials comparing antiplatelet strategies after percutaneous coronary intervention report average risks of bleeding and ischemia in a population, there is limited information to guide choices ...based on individual patient risks, particularly beyond 1 year after treatment. Patient-level data from Patient Related Outcomes With Endeavor vs Cypher Stenting Trial (PROTECT), a broadly inclusive trial enrolling 8,709 subjects treated with drug-eluting stents (sirolimus vs zotarolimus-eluting stent), and PROTECT US, a single-arm study including 1,018 subjects treated with a zotarolimus-eluting stent, were combined. The risk of ischemic events, cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis, and bleeding events, Global Use of Strategies to Open Occluded Arteries moderate or severe bleed, were predicted using logistic regression. At median follow-up of 4.1 years, major bleeding occurred in 260 subjects (2.8%) and ischemic events in 595 (6.3%). Multivariate predictors of bleeding were older age, smoking, diabetes mellitus, congestive heart failure, and chronic kidney disease (all p <0.05). Ischemic events shared all the same predictors with bleeding events and gender, body mass index, previous MI, previous coronary artery bypass graft surgery, ST-segment elevation MI on presentation, stent length, and sirolimus-eluting stent use (all p <0.05). Within individual subjects, bleeding and ischemic risks were strongly correlated; 97% of subjects had a greater risk of ischemic events than bleeding. In conclusion, individual patient risks of ischemia and bleeding are related to many common risk factors, yet the predicted risks of ischemic events are greater than those of major bleeding in the large majority of patients in long-term follow-up.
The aim of this study was to report the predictors and clinical impact of transcatheter heart valve (THV) thrombosis in patients undergoing transcatheter mitral valve implantation (TMVI).
We included ...130 patients who consecutively underwent TMVI. Transoesophageal echocardiography (TOE) and/or computed tomography (CT) were performed in 91.7% of patients at discharge, in 73.3% at three months and in 72% beyond three months. THV thrombosis was defined as the presence of at least one thickened leaflet with restricted motion confirmed by TOE or contrast CT and classified as immediate, early, or late according to the timing of diagnosis. THV thrombosis was observed in 16 (12.3%) patients: immediate in 43.7%, early in 37.5% and late in 18.8%. Most of these thromboses were subclinical (93.7%) and non-obstructive (87.5%). No thromboembolic event occurred. After optimisation of antithrombotic treatment, THV thromboses resolved in all but one patient. Predictors were shock for immediate (p<0.001), male sex for early (p=0.045) and absence of anticoagulation for both early (p=0.018) and late (p=0.023) THV thromboses.
THV thrombosis is frequent after TMVI, occurs mainly within the first three months, is mostly subclinical and resolves after optimisation of antithrombotic treatment. An anticoagulation therapy for at least three months after the procedure is mandatory.
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