Assessing the cost effectiveness of using prognostic biomarkers with decision models: case study in prioritising patients waiting for coronary artery surgery

Objective To determine the effectiveness and cost effectiveness of using information from circulating biomarkers to inform the prioritisation process of patients with stable angina awaiting coronary artery bypass graft surgery

Utvärdering av Socialstyrelsens riktlinjer för prioritering i hjärtsjukvård 2001-2006

Socialstyrelsens riktlinjer för hjärtsjukvård har utvecklats successivt och 2004 publicerades "Beslutsstöd för prioriteringar" med ett tillhörande medicinskt faktadokument. De riktlinjerna omfattade 118 rangordnade åtgärder varav 72 hade en rangordning 3 eller högre på en 10-gradig skala där 1 gavs till åtgärder med högsta prioritet. Vi har valt sju av dessa prioriterade åtgärder med rangordning mellan 1 och 3 att fungera som indikatorer på hur riktlinjerna tillämpas i svensk hjärtsjukvård. Denna rapport är den tredje och sista i en serie där dessa indikatorer följts över tid. En del av åtgärderna/indikatorerna var relativt etablerade behandlingar initialt medan andra befann sig i en introduktionsfas. Syftet med den avslutande rapporten är dels att uppdatera trenderna för de olika indikatorerna och åter studera omfattningen på variationen i hjärtsjukvård i riket och dels att presentera en förbättrad analysmetod. Behandling med ACE-hämmare och reperfusion var de två behandlingar som i våra tidigare rapporter betraktades som ganska väletablerade och de har också uppvisat minst relativ variation mellan landstingen. Båda behandlingarna ökar trots det med i genomsnitt cirka tio procent under analysperioden. Behandling med statiner ansågs vara på god väg att gå in i en balanserad och etablerad fas efter 2004 och med en fortsatt ökande förskrivning under perioden får nog behandlingen anses närma sig en etablering som praxis. Av de övriga två indikatorerna, kombinationsbehandling (ASA tillsammans med clopidogrel) och kranskärlsröntgen för patienter med instabil kranskärlssjukdom, har det varit en avsevärd större spridning mellan landstingen. Fördelningen mellan landstingen är mer homogen när det gäller utförd röntgen än vad läget är för kombinationsbehandling men ingen av behandlingarna kan anses ha etablerat sig färdigt nationellt ännu. Det är svårt att påvisa någon omedelbar effekt på nationell nivå efter publiceringen av riktlinjerna - i flera fall är trenderna linjära utan plötsliga uppgångar. Undantagen är kranskärlsröntgen för patienter med instabil kranskärlssjukdom där vi ser ett trendbrott uppåt efter 2004 och reperfusion på sjukhus som ökar tydligt efter 2004. Vi kan dock notera plötsliga förändringar i vissa landsting. Som exempel ändras förekomsten av prehospital trombolys i Jönköpings län; från att ha behandlat runt 20 procent av alla patienter med akut hjärtinfarkt prehospitalt 2005 behandlades så gott som alla patienter i den gruppen nästkommande år med PCI. En utveckling från prehospital trombolys till förmån för PCI är påtaglig i många län men kanske inte så tydlig som i Jönköping. Norrlandslänen nyttjar dock metoden och har även utökat andelen patienter som fått trombolys prehospitalt vilket är en utveckling som motiveras med långa transporter och tillhörande väntetider innan en PCI kan genomföras. Just den typen av val mellan olika strategier och val av reperfusionstyp har vi tagit hänsyn till när vi slagit ihop resultaten i ett index på de indikatorer som ingår i studien. Våra metoder att rangordna landstingen efter följsamhet till riktlinjerna indikerar att kortare vårdtider kan bli en effekt av följsamhet, de landsting som har relativt god följsamhet har de kortaste vårdtiderna för akut hjärtinfarkt. Andel återinläggningar skiljer inte åt mellan grupperna och är opåverkad av följsamheten medan vi får lite olika utfall när det gäller mortalitet inom 30 dagar. Oberoende av hur man konstruerar ett index för de valda indikatorerna framgår det att variationen är stor mellan landstingen i vilken utsträckning som riktlinjerna följs. I vårt uppdrag har det inte ingått att utreda metodologiska aspekter på det kvalitetsregister (RIKS-HIA) som utgör dataunderlaget men man måste ändå ställa sig frågan om regionala skillnader till viss del kan förklaras av olika inklusionskriterier till registret? Vår analys av antalet registrerade fall med akut hjärtinfarkt i RIKS-HIA kontra slutenvårdsregistret ger en vink om att så kan vara fallet och framtida projekt med trendanalyser och jämförelser mellan landsting bör fokusera mer på den delen eftersom det idag är möjligt att mer i detalj utreda skillnader i täckningsgrad länsvis

Cardiovascular and cancer mortality in very elderly post-myocardial infarction patients receiving statin treatment.

OBJECTIVES: The purpose of this study was to determine whether statin treatment is effective and safe in very elderly (80 years and older) acute myocardial infarction (AMI) patients. BACKGROUND: Elderly individuals constitute an increasing percentage of patients admitted to hospitals for AMI. Despite that these patients have a higher mortality risk, the application of evidence-based medicine remains much lower than for younger patients. METHODS: We included all patients 80 years and older who were admitted with the diagnosis of AMI in the Register of Information and Knowledge About Swedish Heart Intensive Care Admissions between 1999 and 2003 (n = 21,410). Of these, complete covariate and follow-up data were available for 14,907 patients (study population A). To limit the bias related comorbidity on statin therapy, we also performed analyses excluding patients who died within 14 days of the acute event (study population B) and all patients who died within 365 days (study population C). A propensity score was used to adjust for initial differences between treatment groups. RESULTS: All-cause mortality was significantly lower in patients receiving statin treatment at discharge in study population A (relative risk: 0.55, 95% confidence interval: 0.51 to 0.59), in study population B (relative risk: 0.65; 95% confidence interval: 0.60 to 0.71), and in study population C (relative risk: 0.66; 95% confidence interval: 0.59 to 0.76). Similar observations were made for cardiovascular mortality as well as for AMI mortality. There was no increase in cancer mortality in statin-treated patients. CONCLUSIONS: Statin treatment is associated with lower cardiovascular mortality in very elderly post-infarction patients without increasing the risk of the development of cancer

Risk assessment of the working environment in the company LTD "Alūksnes Energoceltnieks" and a plan develoment of preventive risk mitigation measures

Objective To evaluate if female gender is associated with renal insufficiency in patients with ST-elevation myocardial infarction (STEMI) and if there is a gender difference in the prognostic importance of renal insufficiency in STEMI. Design Single-centre observational study. Setting One tertiary cardiac centre. Patients All consecutive patients with STEMI planned for primary percutaneous coronary intervention in one Swedish county in 2005 (98 women and 176 men). Main outcome measures Logistic regression analyses were conducted to evaluate the predictors of renal insufficiency, associations between estimated glomerular filtration rate (eGFR) and outcome in each gender and a possible interaction between gender and eGFR regarding outcome. Results Renal insufficiency was defined as eGFR less than 60 ml/min per 1.73 m(2). 67% of women had renal insufficiency compared with 26% of men, OR 5.06 (95% CI 2.66 to 9.59) after multivariable adjustment. In women each 10 ml/min per 1.73 m 2 increment of eGFR was associated with a 63% risk reduction for 1-year mortality, OR 0.37 (95% CI 0.15 to 0.89). No such association was found in men, OR 1.05 (95% CI 0.63 to 1.76). A trend towards a significant interaction between gender and eGFR regarding 1-year mortality was found, OR 2.05 (95% CI 0.93 to 4.50). Conclusions A considerable gender difference in the prevalence of renal insufficiency in STEMI was found and renal insufficiency seemed to be a more important prognostic marker in women. These results are important as previous STEMI studies have shown higher multivariable adjusted mortality in women than in men but renal function has seldom been taken into consideration.Original Publication:Sofia Lawesson, Tim Tödt, Joakim Alfredsson, Magnus Janzon, Ulf Stenestrand and Eva Swahn, Gender difference in prevalence and prognostic impact of renal insufficiency in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention, 2011, HEART, (97), 4, 308-314.http://dx.doi.org/10.1136/hrt.2010.194282Copyright: BMJ Publishing Group; 1999http://group.bmj.com

Gender difference in prevalence and prognostic impact of renal insufficiency in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention

Objective To evaluate if female gender is associated with renal insufficiency in patients with ST-elevation myocardial infarction (STEMI) and if there is a gender difference in the prognostic importance of renal insufficiency in STEMI. Design Single-centre observational study. Setting One tertiary cardiac centre. Patients All consecutive patients with STEMI planned for primary percutaneous coronary intervention in one Swedish county in 2005 (98 women and 176 men). Main outcome measures Logistic regression analyses were conducted to evaluate the predictors of renal insufficiency, associations between estimated glomerular filtration rate (eGFR) and outcome in each gender and a possible interaction between gender and eGFR regarding outcome. Results Renal insufficiency was defined as eGFR less than 60 ml/min per 1.73 m(2). 67% of women had renal insufficiency compared with 26% of men, OR 5.06 (95% CI 2.66 to 9.59) after multivariable adjustment. In women each 10 ml/min per 1.73 m 2 increment of eGFR was associated with a 63% risk reduction for 1-year mortality, OR 0.37 (95% CI 0.15 to 0.89). No such association was found in men, OR 1.05 (95% CI 0.63 to 1.76). A trend towards a significant interaction between gender and eGFR regarding 1-year mortality was found, OR 2.05 (95% CI 0.93 to 4.50). Conclusions A considerable gender difference in the prevalence of renal insufficiency in STEMI was found and renal insufficiency seemed to be a more important prognostic marker in women. These results are important as previous STEMI studies have shown higher multivariable adjusted mortality in women than in men but renal function has seldom been taken into consideration.Original Publication:Sofia Lawesson, Tim Tödt, Joakim Alfredsson, Magnus Janzon, Ulf Stenestrand and Eva Swahn, Gender difference in prevalence and prognostic impact of renal insufficiency in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention, 2011, HEART, (97), 4, 308-314.http://dx.doi.org/10.1136/hrt.2010.194282Copyright: BMJ Publishing Group; 1999http://group.bmj.com

Differences in Restenosis Rate With Different Drug-Eluting Stents in Patients With and Without Diabetes Mellitus A Report From the SCAAR (Swedish Angiography and Angioplasty Registry)

ObjectivesOur aim was to evaluate restenosis rate of drug-eluting stents (DES) in patients with and without diabetes mellitus (DM) in a real-world setting.BackgroundDES seem less effective in patients with DM.MethodsThe SCAAR (Swedish Coronary Angiography and Angioplasty Registry) includes all patients undergoing percutaneous coronary intervention in Sweden. From April 1, 2004, to April 20, 2008, all restenoses detected at a subsequent angiography and all DES types implanted at more than 500 occasions were assessed using Cox regression.ResultsFour DES types qualified for inclusion. In total, 35,478 DES were implanted at 22,962 procedures in 19,004 patients and 1,807 restenoses were reported over a mean 29 months follow-up. In the entire population, the restenosis rate per stent was 3.5% after 1 year and 4.9% after 2 years. The adjusted risk of restenosis was higher in patients with DM compared with that in patients without DM (relative risk [RR]: 1.23, 95% confidence interval [CI]: 1.10 to 1.37). In patients with DM, restenosis was twice as frequent with the zotarolimus-eluting Endeavor stent (Medtronic, Minneapolis, Minnesota) compared with that in the other DES types. The Endeavor stent and the sirolimus-eluting Cypher stent (Cordis, Johnson & Johnson, Miami, Florida) had higher restenosis rates in patients with DM compared with those in patients without DM (RR: 1.77, 95% CI: 1.29 to 2.43 and RR: 1.25, 95% CI: 1.04 to 1.51). Restenosis rate with the paclitaxel-eluting Taxus Express and Liberté (Boston Scientific, Natick, Massachusetts) stents was unrelated to DM. Mortality did not differ between different DES.ConclusionsRestenosis rate with DES was higher in patients with DM compared with that in patients without DM. There seem to be important differences between different brands of DES

Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria

ObjectivesThe aim of this study was to investigate the outcome of bare-metal stents (BMS) versus drug-eluting stents (DES) after on-label as well as off-label use.BackgroundDES lower restenosis rates while not influencing the risk for death and myocardial infarction when used in Federal Food and Drug Administration (FDA)-approved indications. It is debated whether the clinical results of this so-called on-label use might be extrapolated to off-label situations.MethodsThe SCAAR (Swedish Coronary Angiography and Angioplasty Registry) was used to investigate the outcomes in 17,198 patients who underwent stenting with an on-label indication (10,431 BMS and 6,767 DES patients) and 16,355 patients in the context of an off-label indication (9,907 BMS and 6,448 DES patients). The patients were included from 2003 to 2005 with a minimum follow-up of 1 year and a maximum of 4 years. The analysis was adjusted for differences in baseline characteristics.ResultsThere were not significant differences between on-label DES and BMS (adjusted hazard ratio: 1.02; 95% confidence interval: 0.92 to 1.13) or between off-label DES and BMS (adjusted hazard ratio: 0.95; 95% confidence interval: 0.87 to 1.04) use with regard to the incidence of myocardial infarction and death. Off-label use of DES did not lead to significant differences in the combined risk of death and myocardial infarction compared with BMS throughout the whole spectrum of clinical indications.ConclusionsIn contemporary Swedish practice, neither on- nor off-label use of DES is associated with worse outcome than use of BMS

Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Patients with diabetes mellitus have more extensive coronary artery disease, more disease progression, and restenosis. The use of drug-eluting stents (DES) in these patients is widespread, despite uncertain long-term safety and efficacy. All consecutive patients with diabetes mellitus in Sweden who underwent percutaneous coronary intervention were entered into the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2003-06 with complete follow-up for 1-4 years (median 2.5). Patients who received at least one DES (n = 4754) were compared with those who received only bare metal stents (BMS) (n = 4956) at the index procedure. Combined outcome of death or myocardial infarction (MI) showed no difference for DES vs. BMS, relative risk (RR), 0.91 [95% confidence interval (CI), 0.77-1.06]. Myocardial infarction was significantly less common with DES in patients who received only one stent RR, 0.80 (95% CI, 0.66-0.96). The restenosis rate was 50% lower in DES-treated patients RR, 0.50 (95% CI, 0.35-0.70) and was associated with a higher adjusted RR of MI, RR, 5.03 (95% CI, 4.25-5.97). DES was associated with reduced restenosis rates in all subgroups of diabetic patients with the greatest benefit in stent diameters 20 mm. The number of lesions treated with DES to prevent one restenosis ranged from 11 to 47 in various subgroups. This real-life registry study shows that restenosis was halved by DES in diabetic patients with stable or unstable coronary disease, with similar risk of death or MI up to 4 years compared with BMS