Summary Background In the RESOLUTE All Comers trial, the Resolute zotarolimus-eluting stent was non-inferior to the Xience V everolimus-eluting stent for the primary stent-related endpoint of target ...lesion failure (cardiac death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation) at 1 year. However, data for long-term safety and efficacy from randomised studies of new generation drug-eluting coronary stents in patients treated in routine clinical practice are scarce. We report the prespecified 2-year clinical outcomes from the RESOLUTE All Comers trial. Methods In 2008, patients with at least one coronary lesion 2·25–4·0 mm in diameter, with greater than 50% stenosis, were randomly assigned to a Resolute zotarolimus-eluting stent or a Xience V everolimus-eluting stent at 17 centres in Europe and Israel. Randomisation was by an interactive voice response system stratified by centre. Study investigators were not masked to treatment allocation; but those who did data management and analysis, and patients were masked. There were no restrictions as to the number of vessels or lesions treated, or the number of stents implanted. We assessed prespecified safety and efficacy outcomes at 2 years with specific focus on patient-related composite (all death, all myocardial infarction, all revascularisation) and stent-related composite outcomes. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov , number NCT00617084. Findings 1140 patients were assigned to the zotarolimus-eluting stent and 1152 to the everolimus-eluting stent; 1121 and 1128 patients, respectively, completed 2-year follow-up. The patient-related outcome (231 20·6% zotarolimus vs 231 20·5% everolimus; difference 0·1%, 95% CI −3·2 to 3·5; p=0·958) and stent-related outcome (126 11·2% vs 121 10·7%; difference 0·5%, −2·1 to 3·1; p=0·736) did not differ between groups, although rates of the stent-related outcome were substantially lower than were those for the patient-related outcome. Three patients in each group (0·3%) had very late (after 1 year) stent thrombosis. Interpretation Similar safety and efficacy outcomes were sustained between two new generation drug-eluting stents at 2-year follow-up. The greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasises that during long-term follow-up, the optimisation of secondary prevention is at least as important as the selection of which new generation drug-eluting stent to implant in a specific lesion. Funding Medtronic (USA).
Objectives The aim of the study was to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, ...Minneapolis, Minnesota) and XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Abbott Park, Illinois) in the RESOLUTE (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) All-Comers trial. Background Data on long-term outcomes of new-generation drug-eluting stents are limited, and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown. Methods Patients were randomly assigned to treatment with the R-ZES (n = 1,140) or the EES (n = 1,152). We assessed pre-specified safety and efficacy outcomes at 4 years including target lesion failure and stent thrombosis. Predictors of revascularization at 4 years were identified by Cox regression analysis. Results At 4 years, the rates of target lesion failure (15.2% vs. 14.6%, p = 0.68), cardiac death (5.4% vs. 4.7%, p = 0.44), and target vessel myocardial infarction (5.3% vs. 5.4%, p = 1.00), clinically-indicated target lesion revascularization (TLR) (7.0% vs. 6.5%, p = 0.62), and definite/probable stent thrombosis (2.3% vs. 1.6%, p = 0.23) were similar with the R-ZES and EES. Independent predictors of TLR were age, insulin-treated diabetes, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score, treatment of saphenous vein grafts, ostial lesions, and in-stent restenosis. Independent predictors of any revascularization were age, diabetes, previous percutaneous coronary intervention, absence of ST-segment elevation myocardial infarction, smaller reference vessel diameter, SYNTAX score, and treatment of left anterior descending, right coronary artery, saphenous vein grafts, ostial lesions, or in-stent restenosis. Conclusions R-ZES and EES demonstrated similar safety and efficacy throughout 4 years. TLR represented less than one-half of all repeat revascularization procedures. Patient- and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap. (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention RESOLUTE-AC; NCT00617084 )
New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety ...between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration.
In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months.
At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/-SD) of in-stent stenosis (21.65+/-14.42% for zotarolimus vs. 19.76+/-14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27+/-0.43 mm in the zotarolimus-stent group versus 0.19+/-0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events.
At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.)
Context: To date, it is unclear which measure of obesity is the most appropriate for risk stratification.
Objective: The aim of the study was to compare the associations of various measures of ...obesity with incident cardiovascular events and mortality.
Design and Setting: We analyzed two German cohort studies, the DETECT study and SHIP, including primary care and general population.
Participants: A total of 6355 (mean follow-up, 3.3 yr) and 4297 (mean follow-up, 8.5 yr) individuals participated in DETECT and SHIP, respectively.
Interventions: We measured body mass index (BMI), waist circumference (WC), waist-to-height ratio (WHtR), and waist-to-hip ratio (WHR) and assessed cardiovascular and all-cause mortality and the composite endpoint of incident stroke, myocardial infarction, or cardiovascular death.
Results: In both studies, we found a positive association of the composite endpoint with WHtR but not with BMI. There was no heterogeneity among studies. The relative risks in the highest versus the lowest sex- and age-specific quartile of WHtR, WC, WHR, and BMI after adjustment for multiple confounders were as follows in the pooled data: cardiovascular mortality, 2.75 (95% confidence interval, 1.31–5.77), 1.74 (0.84–3.6), 1.71 (0.91–3.22), and 0.74 (0.35–1.57), respectively; all-cause mortality, 1.86 (1.25–2.76), 1.62 (1.22–2.38), 1.36 (0.93–1.69), and 0.77 (0.53–1.13), respectively; and composite endpoint, 2.16 (1.39–3.35), 1.59 (1.04–2.44), 1.49 (1.07–2.07), and 0.57 (0.37–0.89), respectively. Separate analyses of sex and age groups yielded comparable results. Receiver operating characteristics analysis yielded the highest areas under the curve for WHtR for predicting these endpoints.
Conclusions: WHtR represents the best predictor of cardiovascular risk and mortality, followed by WC and WHR. Our results discourage the use of the BMI.
Measures of abdominal obesity but not body mass index predict cardiovascular risk and mortality.
This study sought to explore the association between biomarker elevation, with creatine kinase–myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) ...and mortality in patients undergoing PCI for stable angina with normal baseline values.
Several studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated.
Patient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB.
A total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB <5 × ULN and cTn <35 × ULN. Among patients with CK-MB ≥5 × ULN (n = 315), 212 (67.3%) also had cTn ≥35 × ULN. Conversely, 390 of patients (64.8%) who had cTn ≥35 × ULN did not have CK-MB ≥5 × ULN. A total of 259 patients (1.9%) died at 1 year; 20 (7.7%) had CK-MB ≥5 × ULN, and 23 (8.8%) had cTn ≥35 × ULN. In the Cox multivariate analysis, in which the CK-MB and cTn ratios post-procedure were forced into the model, age, prior myocardial infarction, lesion complexity, hyperlipidemia, and CK-MB ratio (≥10) post-procedure were associated with increased 1-year mortality.
Following elective PCI in patients in stable condition treated with second-generation drug-eluting stent, CK-MB and cTn elevations remain common. After multivariate adjustment, there was an increased mortality rate with elevation of CK-MB after PCI, whereas cTn elevation was not independently associated with mortality at 1 year.
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Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations.
We conducted a ...randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients.
Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.
Guidelines for prevention of cardiovascular diseases use risk scores to guide the intensity of treatment. A comparison of these scores in a German population has not been performed. We have evaluated ...the correlation, discrimination and calibration of ten commonly used risk equations in primary care in 4044 participants of the DETECT (Diabetes and Cardiovascular Risk Evaluation: Targets and Essential Data for Commitment of Treatment) study. The risk equations correlate well with each other. All risk equations have a similar discriminatory power. Absolute risks differ widely, in part due to the components of clinical endpoints predicted: The risk equations produced median risks between 8.4% and 2.0%. With three out of 10 risk scores calculated and observed risks well coincided. At a risk threshold of 10 percent in 10 years, the ACC/AHA atherosclerotic cardiovascular disease (ASCVD) equation has a sensitivity to identify future CVD events of approximately 80%, with the highest specificity (69%) and positive predictive value (17%) among all the equations. Due to the most precise calibration over a wide range of risks, the large age range covered and the combined endpoint including non-fatal and fatal events, the ASCVD equation provides valid risk prediction for primary prevention in Germany.
Abstract Aims We aimed to compare differences in risk and timing of recurrent ischemic events among patients with stable ischemic heart disease (SIHD), Non-ST-segment elevation acute coronary ...syndrome (NSTE-ACS) and ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). Methods and Results We performed an individual data pooled analysis of five randomized controlled all-comer trials including a total of 8,859 patients and investigated the risk and timing of recurrent ischemic events among patients with SIHD (n=3543), NSTE-ACS (n=3364), and STEMI (n=1952) throughout 2 years of follow-up. At 2 years, all-cause mortality was higher among patients with STEMI (6.4%) and NSTE-ACS (6.1%) compared to those with SIHD (4.2%) (STEMI vs SIHD: HR 1.40, 95% CI 1.09 to 1.78, p=0.007; NSTE-ACS vs SIHD 1.40, 95% CI 1.13 to 1.73, p=0.002). In a landmark analysis, the risk of mortality among patients with STEMI compared to those with SIHD was confined to the first 30 days after PCI (HR 6.19, 95% CI 3.15 to 12.16, p<0.001), but was similar between 30 days and 2 years (HR 1.00, 95% CI 0.76 to 1.33, p=0.974) (pinteraction <0.001). Conversely, patients with NSTE-ACS had higher risk of mortality compared to those with SIHD both within the first 30 days (HR 2.19, 95% CI 1.08 to 4.47, p=0.031) and beyond (HR 1.34, 95% CI 1.07 to 1.67, p=0.012) (pinteraction <0.001). A similar pattern in the differential timing of events was observed for cardiac death. Beyond 30 days, the risk of myocardial was comparable in patients with STEMI and SIHD, while the risk in patients with NSTE-ACS was increased (HR 1.65, 95% CI 1.23 to 2.21; p=0.001). Conclusion While patients with NSTE-ACS are at increased risk for death at any time after PCI, the mortality of STEMI patients is higher during the first 30 days after PCI but not thereafter compared to patients with SIHD.
Chronic coronary heart disease (CHD) and acute myocardial infarction are endemic conditions. In Germany, an estimated 900 000 cardiac catheterizations were performed in the year 2014, and a ...percutaneous intervention was carried out in 40% of these procedures. It would be desirable to lessen the number of invasive diagnostic procedures while preserving the reliability of diagnosis. In this article, we present the updated recommendations of the German National Care Guideline for Chronic CHD with regard to diagnostic evaluation.
Updated recommendations for the diagnostic evaluation of chronic CHD were developed on the basis of existing guidelines and a systematic literature review and approved by a formal consensus process.
8-11% of patients with chest pain who present to a general practitioner and 20-25% of those who present to a cardiologist have chronic CHD. General practitioners should estimate the probability of CHD with the Marburg Heart Score. Specialists can use detailed tables for determining the pre-test probability of CHD; if this lies in the range of 15% to 85%, then non-invasive tests should be primarily used for evaluation and treatment planning. If the pretest probability is less than 15%, other potential causes should be ruled out first. If it is over 85%, the presence of CHD should be presumed and treatment planning should be initiated. Coronary angiography is needed only if therapeutic implications are expected (revascularization). Psychosocial risk factors for the development and course of CHD and the patient's quality of life should be regularly assessed as well.
Non-invasive testing and invasive coronary angiography should be used only if their findings are expected to have therapeutic implications. Psychosocial risk factors, the quality of life, and adherence to treatment are important components of these patients' diagnostic evaluation and long-term care.
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