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In a trial involving over 9000 patients with coronary artery disease who were assigned to receive either contemporary drug-eluting stents or bare-metal stents, there was no significant between-group difference in a composite outcome of death from any cause or nonfatal MI at 6 years. Percutaneous coronary intervention (PCI) with implantation of drug-eluting or bare-metal stents has become one of the most frequently performed therapeutic procedures in medicine. 1 Each year, millions of patients are treated worldwide. 1 , 2 The use of drug-eluting stents has been shown to be more effective in the prevention of restenosis than the use of bare-metal stents, 1 and the use of newer-generation drug-eluting stents, as compared with first-generation devices, 3 , 4 may also reduce the rate of stent thrombosis. 5 – 8 It has been suggested that the benefits associated with the use of newer-generation drug-eluting stents may translate into reduced rates of death and . . .

Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial. The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651. Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24–2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74–1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66–5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25–2·40]; p=0·0009). In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation. Biosensors.

Acute myocardial infarction (AMI) is a potentially deadly disease and significant efforts have been concentrated on improving hospital performance. A 30-day survival rate has become a key quality of care indicator. In Northern Norway, some patients undergoing AMI are directly transferred to the Regional Cardiac Intervention Center at the University Hospital of North Norway in Tromsø. Here, coronary angiography and percutaneous coronary intervention is performed. Consequently, local hospitals may be bypassed in the treatment chain, generating differences in case mix, and making the treatment chain model difficult to interpret. We aimed to compare the treatment chain model with an alternative based on patients' place of living. Between 2013 and 2015, a total of 3,155 patients were registered in the Norwegian Patient Registry database. All patients were categorized according to their local hospital's catchment area. The method of Guo-Romano, with an indifference interval of 0.02, was used to test whether a hospital was an outlier or not. We adjusted for age, sex, comorbidity, and number of prior hospitalizations. We revealed the 30-day AMI survival figure ranging between 88.0% and 93.5% (absolute difference 5.5%) using the hospital catchment method. The treatment chain rate ranged between 86.0% and 94.0% (absolute difference 8.0%). The latter figure is the one published as the National Quality of Care Measure in Norway. Local hospitals may get negative attention even though their catchment area is well served. We recommend the hospital catchment method as the first choice when measuring equality of care.

Coronary artery bypass grafting (CABG) is recommended over percutaneous coronary intervention (PCI) for patients with significant unprotected left main coronary artery disease. We aim to provide long-term outcome data comparing PCI with newer generation drug-eluting stents and CABG, which are scarce. This previously published, prospective, randomised, open-label, non-inferiority trial enrolled patients with unprotected left main coronary artery stenosis at 36 hospitals in Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Norway, Sweden, and the UK. Eligibility was determined by a multidisciplinary heart team and defined by clinical criteria (chronic or acute coronary syndrome and a life expectancy of >1 year) and angiographic criteria (left main coronary artery diameter stenosis ≥50% or fractional flow reserve ≤0·80 in the left main ostium, mid-shaft, or bifurcation). Patients with ST elevation myocardial infarction within 24 h or considered at too high risk for CABG or PCI were excluded. Patients with angiographically confirmed significant left main coronary artery disease were randomly assigned (1:1) to PCI or CABG using an online system and stratified by site, sex, distal left main coronary artery bifurcation lesions, and diabetes. The primary outcome was the difference in 10-year all-cause mortality in the intention-to-treat (ITT) population, which was analysed using Kaplan–Meier estimates and unadjusted Cox regression. Patients were censored at the date of death, emigration, withdrawal, or loss to follow-up. Variation in all-cause mortality was assessed in prespecified subgroups. The trial is registered with ClinicalTrials.gov, NCT01496651 (active, not recruiting). From Dec 9, 2008, to Jan 21, 2015, 1201 patients were randomly assigned to PCI (n=598) or CABG (n=603). 17 patients were lost to follow-up before 1 year. 592 patients in each group were included in the ITT population. Mean age was 66·2 years (SD 9·9) in the PCI group and 66·2 years (9·4) in the CABG group. 256 (22%) of 1184 participants were female and 928 (78%) were male. There was no difference in all-cause mortality at 10 years (136 [23%] of 592 in the PCI group and 145 [25%] of 592 in the CABG group; hazard ratio 0·93 [95% CI 0·74–1·18]; p=0·56). No significant difference in all-cause mortality with SYNTAX score was identified. There was no significant difference in all-cause mortality at 10 years between PCI and CABG for patients with unprotected left main coronary artery disease and no additional complex lesions, indicating that PCI is equally as safe as CABG in patients eligible for both treatments. These results will aid heart teams in developing an individualised patient-centred strategy. Biosensors and Aarhus University Hospital.

ObjectivePatients referred for acute coronary angiography (CAG) with unstable angina (UA) have low mortality and low rate of obstructive coronary artery disease (CAD). Better pre-test selection criteria are warranted. We aimed to assess the current guidelines against other clinical variables as predictors of obstructive CAD in patients with UA referred for acute CAG.MethodsFrom 2005 to 2012, all CAGs performed at the University Hospital of North Norway, the sole provider of CAG in the region, were recorded in a registry. We included 979 admissions of UA and retrospectively collected data regarding presenting clinical parameters from patient hospital records. Obstructive CAD was defined as ≥50% stenosis and considered prognostically significant if found in the left main stem, proximal LAD or all three main coronary arteries. Characteristics were analysed by logistic regression analysis. A score was developed using ORs from significant factors in a multivariable model.ResultsThe overall rate of obstructive CAD was 45%, and the rate of prognostically significant CAD was 11%. The risk criteria recommended in American College of Cardiology/American Heart Association and European Society of Cardiology guidelines had an area under the curve (AUC) of 0.58. Adding clinical information increased the AUC to 0.77 (95% CI 0.74 to 0.80). Applying the derived score, we found that 56% (n=546) of patients had a score of <13, which was associated with a negative predictive value of 95% for prognostic significant CAD.ConclusionsThe current results suggest that CAG may be postponed or cancelled in more than half of patients with UA by improving pre-test selection criteria with the addition of clinical parameters to current guidelines.

BackgroundIt is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.MethodsThe study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.ResultsA total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI −0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.ConclusionIn the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.Trial registration numberNCT01496638.

Purpose Numerous studies have documented suboptimal adherence to guideline recommendations in secondary prevention of coronary heart disease (CHD SP ). Clinical practice guidelines (CPGs) are continuously developed to define appropriate patient care, aiming to reduce risk of morbidity and death. The Medication Assessment Tool for CHD SP (MAT-CHD SP ) was developed to assess adherence to CPGs concerning medication therapy and follow-up of patients with CHD SP . The aim of this study was to explore whether the MAT-CHD SP could be applied retrospectively to assess guideline adherence and therapy goal achievement in secondary prevention of CHD. Methods We collected data from electronic medical records of all patients who underwent percutaneous coronary intervention with stent implantation from January to March 2008 ( n  = 300) and applied the MAT-CHD SP . We measured time for data collection and MAT application and tested reproducibility by calculating Cohen’s kappa (κ) value for inter and intraobserver agreement. Results A total of 247 MAT applications were analyzed, showing overall applicability of 66 % of the 4,446 MAT-CHD SP criteria and a high reproducibility of MAT-CHD SP application (κ values 0.93 and 0.95 for intra- and interobserver agreement, respectively). Mean time for data collection and MAT-CHD SP application was 11 min. Adherence to criteria concerning prescription was high (>75 %), but achievement of therapy goals for cholesterol and blood pressure was low (<50 %). Documentation of lifestyle advice achieved intermediate (50–75 %) or low adherence, as did therapy amendments in patients in whom therapy goals were unachieved at hospital admission. Conclusions The MAT-CHD SP offers a means to identify both adherence and nonadherence to CPGs concerning CHD SP is applicable in retrospective assessment of CHD SP , and identifies potentials for improved patient care.

Abstract Aims Coronary angiography is the gold standard diagnostic test for coronary artery disease (CAD), and the diagnostic results can have an immediate effect on symptoms. The aim of this study was to explore the long-term impact of diagnostic angiography on symptoms of anxiety and depression in a group of patients without previous CAD. Methods and results The prospective cohort study included 459 consecutive patients undergoing invasive angiography and was approved by the regional board of ethics. Data were collected at baseline and after 6 and 12 months using self-reports. Symptoms of anxiety and depression were measured with the Hospital Anxiety and Depression Scale (HADS). The sample population had a mean age of 62 years and included 197 (43%) women. Fifty-three percent had hypertension, and 17% had diabetes. The diagnostic results indicated that 41% of patients had normal vessels; 21% had wall changes; and 38% had obstructive stenosis. No significant difference was found between the diagnostic groups at baseline regarding the levels of anxiety or depression. After 6 months, participants with obstructive stenosis had significantly lower levels of anxiety than those without obstructive stenosis. Improvements were observed in all groups over time in both HADS subscale scores; the largest improvement occurred in patients with obstructive stenosis. Conclusion This study demonstrates that patients with normal coronary arteries or minimal coronary disease/non-obstructive coronary disease do not seem to obtain the same benefit from the receipt of information about their coronary status in terms of anxiety and depression as patients with significant obstructive stenosis.

Numerous studies have documented suboptimal adherence to guideline recommendations in secondary prevention of coronary heart disease (CHD^sub SP^). Clinical practice guidelines (CPGs) are continuously developed to define appropriate patient care, aiming to reduce risk of morbidity and death. The Medication Assessment Tool for CHD^sub SP^ (MAT-CHD^sub SP^) was developed to assess adherence to CPGs concerning medication therapy and follow-up of patients with CHD^sub SP^. The aim of this study was to explore whether the MAT-CHD^sub SP^ could be applied retrospectively to assess guideline adherence and therapy goal achievement in secondary prevention of CHD. We collected data from electronic medical records of all patients who underwent percutaneous coronary intervention with stent implantation from January to March 2008 (n=300) and applied the MAT-CHD^sub SP^. We measured time for data collection and MAT application and tested reproducibility by calculating Cohen's kappa ([kappa]) value for inter and intraobserver agreement. A total of 247 MAT applications were analyzed, showing overall applicability of 66 % of the 4,446 MAT-CHD^sub SP^ criteria and a high reproducibility of MAT-CHD^sub SP^ application ([kappa] values 0.93 and 0.95 for intra- and interobserver agreement, respectively). Mean time for data collection and MAT-CHD^sub SP^ application was 11 min. Adherence to criteria concerning prescription was high (>75 %), but achievement of therapy goals for cholesterol and blood pressure was low (<50 %). Documentation of lifestyle advice achieved intermediate (50-75 %) or low adherence, as did therapy amendments in patients in whom therapy goals were unachieved at hospital admission. The MAT-CHD^sub SP^ offers a means to identify both adherence and nonadherence to CPGs concerning CHD^sub SP^ is applicable in retrospective assessment of CHD^sub SP^, and identifies potentials for improved patient care.[PUBLICATION ABSTRACT]

Introduction. Acute myocardial infarction (AMI) is a potentially deadly disease and significant efforts have been concentrated on improving hospital performance. A 30-day survival rate has become a key quality of care indicator. In Northern Norway, some patients undergoing AMI are directly transferred to the Regional Cardiac Intervention Center at the University Hospital of North Norway in Tromsø. Here, coronary angiography and percutaneous coronary intervention is performed. Consequently, local hospitals may be bypassed in the treatment chain, generating differences in case mix, and making the treatment chain model difficult to interpret. We aimed to compare the treatment chain model with an alternative based on patients’ place of living.Methods. Between 2013 and 2015, a total of 3,155 patients were registered in the Norwegian Patient Registry database. All patients were categorized according to their local hospital’s catchment area. The method of Guo-Romano, with an indifference interval of 0.02, was used to test whether a hospital was an outlier or not. We adjusted for age, sex, comorbidity, and number of prior hospitalizations.Conclusions. We revealed the 30-day AMI survival figure ranging between 88.0% and 93.5% (absolute difference 5.5%) using the hospital catchment method. The treatment chain rate ranged between 86.0% and 94.0% (absolute difference 8.0%). The latter figure is the one published as the National Quality of Care Measure in Norway. Local hospitals may get negative attention even though their catchment area is well served. We recommend the hospital catchment method as the first choice when measuring equality of care.