Analyses of Increased Mortality in New and Known Diabetes in Patients with Coronary Disease Enrolled in the NORSTENT Randomized Study

Background: NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention with drug-eluting stents (DES) or bare-metal stents (BMS) with a 5-year follow-up. Among the patients, 5,512 had measured either fasting glucose level or percent glycated hemoglobin (HbA1c) at the index procedure. That cohort constitutes the present study population analyzing mortality and evaluating treatment heterogeneity of randomized stent in diabetic versus nondiabetic subgroups. Results: The cohort consisted of 4,174 (75.7%) patients without diabetes, 716 (13.0%) with known diabetes, and 622 (11.3%) with no diabetes in history but elevated fasting glucose level >7.0 mmol/L or HbA1c >6.5% and therefore defined as new diabetes. Patients with known diabetes had a significantly increased all-cause (hazard ratio [HR] 1.99, 95% CI 1.51–2.62, p < 0.001), cardiac (subhazard ratio [SHR] 2.47, 95% CI 1.55–3.93, p < 0.001), and noncardiac (SHR 1.74, 95% CI 1.23–2.44, p = 0.002) mortality after adjustment for baseline variables. In the follow-up of 5 years, patients with new diabetes, however, had a marginally increased all-cause (HR 1.40, 95% CI 1.01–1.93, p = 0.043) and significantly increased noncardiac mortality (SHR 1.52, 95% CI 1.06–2.20, p = 0.025), but no increase in cardiac mortality (SHR 1.06, 95% CI 0.53–2.12, p = 0.86) after the same adjustment. The majority of the mortality was cardiac in the first 1–2 years after intervention; thereafter, noncardiac mortality dominated. However, the time period for when noncardiac mortality became the dominating cause varied considerably and significantly between the groups. There was no heterogeneity in mortality in response to randomized stent between diabetics and nondiabetics. Conclusion: Known diabetes has increased cardiac and noncardiac mortality in contrast to new diabetes which is only associated with increased noncardiac mortality during the 5-year follow-up. Diabetic and nondiabetic patients have the same response to the treatment with BMS or DES.acceptedVersio

The effect of drug-eluting stents on target lesion revascularization in native coronary arteries: Results from the NORSTENT randomized study

This is the accepted manuscript version of an article published by S. Karger AG in Cardiology, 2020;145(6):333-341, available at https://doi.org/10.1159/000506042. Background: The NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) or bare-metal stent (BMS) with 5-year follow-up. No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularizations, which were reduced by DES. We report the occurrence of target lesion revascularization (TLR) in time and across demographic and clinical subgroups in patients with lesions in native coronary arteries (n = 8,782). Results: Clinically driven TLR was performed on 488 (5.6%) of the 8,782 patients during 5 years of follow-up. Male gender, older age, visible thrombus in the lesion, and larger stent diameter were associated with less TLR; multivessel disease and longer stents were associated with a higher risk of TLR. There was a substantial and highly significant reduction of the risk of any TLR after 5 years in the DES group (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.36–0.52], p Conclusion: DES have a time-limited effect on the rate of TLR, but with a substantial and highly significant reduction in the first 2 years after the procedure. This effect was found to be consistent across all important clinical subgroups

Analyses of Increased Mortality in New and Known Diabetes in Patients with Coronary Disease Enrolled in the NORSTENT Randomized Study

Background: NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention with drug-eluting stents (DES) or bare-metal stents (BMS) with a 5-year follow-up. Among the patients, 5,512 had measured either fasting glucose level or percent glycated hemoglobin (HbA1c) at the index procedure. That cohort constitutes the present study population analyzing mortality and evaluating treatment heterogeneity of randomized stent in diabetic versus nondiabetic subgroups. Results: The cohort consisted of 4,174 (75.7%) patients without diabetes, 716 (13.0%) with known diabetes, and 622 (11.3%) with no diabetes in history but elevated fasting glucose level >7.0 mmol/L or HbA1c >6.5% and therefore defined as new diabetes. Patients with known diabetes had a significantly increased all-cause (hazard ratio [HR] 1.99, 95% CI 1.51–2.62, p < 0.001), cardiac (subhazard ratio [SHR] 2.47, 95% CI 1.55–3.93, p < 0.001), and noncardiac (SHR 1.74, 95% CI 1.23–2.44, p = 0.002) mortality after adjustment for baseline variables. In the follow-up of 5 years, patients with new diabetes, however, had a marginally increased all-cause (HR 1.40, 95% CI 1.01–1.93, p = 0.043) and significantly increased noncardiac mortality (SHR 1.52, 95% CI 1.06–2.20, p = 0.025), but no increase in cardiac mortality (SHR 1.06, 95% CI 0.53–2.12, p = 0.86) after the same adjustment. The majority of the mortality was cardiac in the first 1–2 years after intervention; thereafter, noncardiac mortality dominated. However, the time period for when noncardiac mortality became the dominating cause varied considerably and significantly between the groups. There was no heterogeneity in mortality in response to randomized stent between diabetics and nondiabetics. Conclusion: Known diabetes has increased cardiac and noncardiac mortality in contrast to new diabetes which is only associated with increased noncardiac mortality during the 5-year follow-up. Diabetic and nondiabetic patients have the same response to the treatment with BMS or DES

Analyses of Increased Mortality in New and Known Diabetes in Patients with Coronary Disease Enrolled in the NORSTENT Randomized Study

Background: NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention with drug-eluting stents (DES) or bare-metal stents (BMS) with a 5-year follow-up. Among the patients, 5,512 had measured either fasting glucose level or percent glycated hemoglobin (HbA1c) at the index procedure. That cohort constitutes the present study population analyzing mortality and evaluating treatment heterogeneity of randomized stent in diabetic versus nondiabetic subgroups. Results: The cohort consisted of 4,174 (75.7%) patients without diabetes, 716 (13.0%) with known diabetes, and 622 (11.3%) with no diabetes in history but elevated fasting glucose level >7.0 mmol/L or HbA1c >6.5% and therefore defined as new diabetes. Patients with known diabetes had a significantly increased all-cause (hazard ratio [HR] 1.99, 95% CI 1.51–2.62, p < 0.001), cardiac (subhazard ratio [SHR] 2.47, 95% CI 1.55–3.93, p < 0.001), and noncardiac (SHR 1.74, 95% CI 1.23–2.44, p = 0.002) mortality after adjustment for baseline variables. In the follow-up of 5 years, patients with new diabetes, however, had a marginally increased all-cause (HR 1.40, 95% CI 1.01–1.93, p = 0.043) and significantly increased noncardiac mortality (SHR 1.52, 95% CI 1.06–2.20, p = 0.025), but no increase in cardiac mortality (SHR 1.06, 95% CI 0.53–2.12, p = 0.86) after the same adjustment. The majority of the mortality was cardiac in the first 1–2 years after intervention; thereafter, noncardiac mortality dominated. However, the time period for when noncardiac mortality became the dominating cause varied considerably and significantly between the groups. There was no heterogeneity in mortality in response to randomized stent between diabetics and nondiabetics. Conclusion: Known diabetes has increased cardiac and noncardiac mortality in contrast to new diabetes which is only associated with increased noncardiac mortality during the 5-year follow-up. Diabetic and nondiabetic patients have the same response to the treatment with BMS or DES

Kartlegging av begrepet pasientsikkerhet

I notatet ser Kunnskapssenteret nærmere på begrepsbruk og ulike tilnærminger til pasientsikkerhetsarbeid.Bakgrunn: Nasjonalt kunnskapssenter for helsetjenesten, ved Nasjonal enhet for pasientsikkerhet tok i november 2007 initiativ til å danne en arbeidsgruppe for begrepsbruk innen pasientsikkerhet. Målet med arbeidsgruppens arbeid var å se nærmere på begrepsbruk og ulike tilnærminger til feltet. Arbeidsmetode: arbeidsgruppen har hatt tre møter, samt holdt korrespondanse per e-post. På det første møtet i arbeidsgruppen diskuterte en ulike tilnærminger til pasientsikkerhetsbegrepet og hva målsettingen med arbeidet skulle være. Arbeidsgruppen tok utgangspunkt i en diskusjon om pasientsikkerhet skal forstås som et begrep eller perspektiv innenfor kvalitetsforbedring, eller som et selvstendig perspektiv. Konklusjon: systematisk arbeid med begrepsutvikling innen pasientsikkerhet i Norge bør reflektere diskusjonene som pågår både nasjonalt og internasjonalt. Det er behov for en klar og entydig begrepsbruk. Begrepsutvikling skal støtte opp om fagutviklingen innen pasientsikkerhetsarbeidet, og ikke stå i veien

Stenting in small coronary arteries (SISCA) trial A randomized comparison between balloon angioplasty and the heparin-coated beStent

AbstractOBJECTIVESThe purpose of this study was to assess the clinical and angiographic benefits of elective stenting in coronary arteries with a reference diameter of 2.1 to 3.0 mm, as compared with traditional percutaneous transluminal coronary angioplasty (PTCA).BACKGROUNDThe problems related to small-vessel stenting might be overcome using modern stents designed for small vessels, combined with effective antiplatelet therapy.METHODSIn five centers, 145 patients with stable or unstable angina were randomly assigned to elective stenting treatment with the heparin (Hepamed)-coated beStent or PTCA. Control angiography was performed after six months. The primary end point was the minimal lumen diameter (MLD) at follow-up. Secondary end points were the restenosis rate, event-free survival and angina status.RESULTSAt follow-up, there was a trend toward a larger MLD in the stent group (1.69 ± 0.52 mm vs. 1.57 ± 0.44 mm, p = 0.096). Event-free survival at follow-up was significantly higher in the stent group: 90.5% vs. 76.1% (p = 0.016). The restenosis rate was low in both groups (9.7% and 18.8% in the stent and PTCA groups, respectively; p = 0.15). Analyzed as treated, both the MLD and restenosis rate were significantly improved in patients who had stents as compared with PTCA.CONCLUSIONSIn small coronary arteries, both PTCA and elective stenting are associated with good clinical and angiographic outcomes after six months. Compared with PTCA, elective treatment with the heparin-coated beStent improves the clinical outcome; however, there was only a nonsignificant trend toward angiographic improvement