| 1. |
- Blauenfeldt, Rolf Ankerlund, et al.
(författare)
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Remote Ischemic Conditioning for Acute Stroke : The RESIST Randomized Clinical Trial
- 2023
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Ingår i: JAMA. - 0098-7484. ; 330:13, s. 1236-1246
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Tidskriftsartikel (refereegranskat)abstract
- Importance: Despite some promising preclinical and clinical data, it remains uncertain whether remote ischemic conditioning (RIC) with transient cycles of limb ischemia and reperfusion is an effective treatment for acute stroke. Objective: To evaluate the effect of RIC when initiated in the prehospital setting and continued in the hospital on functional outcome in patients with acute stroke. Design, Setting, and Participants: This was a randomized clinical trial conducted at 4 stroke centers in Denmark that included 1500 patients with prehospital stroke symptoms for less than 4 hours (enrolled March 16, 2018, to November 11, 2022; final follow-up, February 3, 2023). Intervention: The intervention was delivered using an inflatable cuff on 1 upper extremity (RIC cuff pressure, ≤200 mm Hg [n = 749] and sham cuff pressure, 20 mm Hg [n = 751]). Each treatment application consisted of 5 cycles of 5 minutes of cuff inflation followed by 5 minutes of cuff deflation. Treatment was started in the ambulance and repeated at least once in the hospital and then twice daily for 7 days among a subset of participants. Main Outcomes and Measures: The primary end point was improvement in functional outcome measured as a shift across the modified Rankin Scale (mRS) score (range, 0 [no symptoms] to 6 [death]) at 90 days in the target population with a final diagnosis of ischemic or hemorrhagic stroke. Results: Among 1500 patients who were randomized (median age, 71 years; 591 women [41%]), 1433 (96%) completed the trial. Of these, 149 patients (10%) were diagnosed with transient ischemic attack and 382 (27%) with a stroke mimic. In the remaining 902 patients with a target diagnosis of stroke (737 [82%] with ischemic stroke and 165 [18%] with intracerebral hemorrhage), 436 underwent RIC and 466 sham treatment. The median mRS score at 90 days was 2 (IQR, 1-3) in the RIC group and 1 (IQR, 1-3) in the sham group. RIC treatment was not significantly associated with improved functional outcome at 90 days (odds ratio [OR], 0.95; 95% CI, 0.75 to 1.20, P =.67; absolute difference in median mRS score, -1; -1.7 to -0.25). In all randomized patients, there were no significant differences in the number of serious adverse events: 169 patients (23.7%) in the RIC group with 1 or more serious adverse events vs 175 patients (24.3%) in the sham group (OR, 0.97; 95% CI, 0.85 to 1.11; P =.68). Upper extremity pain during treatment and/or skin petechia occurred in 54 (7.2%) in the RIC group and 11 (1.5%) in the sham group. Conclusions and Relevance: RIC initiated in the prehospital setting and continued in the hospital did not significantly improve functional outcome at 90 days in patients with acute stroke. Trial Registration: ClinicalTrials.gov Identifier: NCT03481777.
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| 2. |
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| 3. |
- Korsholm, Kasper, et al.
(författare)
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Left Atrial Appendage Occlusion versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation: Rationale and Design of the Multicenter Randomized Occlusion-AF Trial.
- 2021
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Ingår i: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703. ; 243, s. 28-38
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Tidskriftsartikel (refereegranskat)abstract
- The prevalence of atrial fibrillation (AF) is increasing globally, which is a major clinical and public health concern due to the five-fold increased risk of stroke. Oral anticoagulation with novel oral anticoagulants (NOACs) is the current primary option for stroke prevention in patients with AF, although it increases the risk of major bleeding. Patients with prior ischemic cerebrovascular events are at particularly high risk of both recurrent ischemic events and major bleeding. Left atrial appendage occlusion (LAAO) provides an alternative option for stroke prevention in high-risk patients, however, with currently limited evidence. Thus, randomized trials comparing LAAO to NOACs are needed.The Occlusion-AF trial is designed to assess whether LAAO is non-inferior to NOAC therapy for reduction of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium ≥ 3) and all-cause mortality in patients with AF and a recent ischemic stroke or transient ischemic attack (TIA).Investigator-initiated multicenter, multinational, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment. Major exclusion criteria are modified Rankin Scale > 3 at enrollment, glomerular filtration rate < 15 ml/min, and life-expectancy less than 2 years. A total of 750 patients will be randomized 1:1 to receive either a NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin 75 mg daily. Follow-up will be based on in-office and telephone follow-up in combination with long-term follow-up (10 years) through national hospital discharge registries in the individual Nordic countries. The primary outcome will be a composite endpoint of stroke, systemic embolism, major bleeding (BARC ≥ 3) and all-cause mortality at 2-year follow-up.The Occlusion-AF trial is designed to compare LAAO to NOAC therapy for secondary stroke prevention in AF patients with a high risk of recurrent thromboembolic events, i.e. with previous ischemic stroke or TIA, and otherwise eligible for anticoagulation. The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.
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| 4. |
- Kristensen, Pia Kjær, et al.
(författare)
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Disentangling the contribution of hospitals and municipalities for understanding patient level differences in one-year mortality risk after hip-fracture : A cross-classified multilevel analysis in Sweden
- 2020
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Ingår i: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 15:6
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: One-year mortality after hip-fracture is a widely used outcome measure when comparing hospital care performance. However, traditional analyses do not explicitly consider the referral of patients to municipality care after just a few days of hospitalization. Furthermore, traditional analyses investigates hospital (or municipality) variation in patient outcomes in isolation rather than as a component of the underlying patient variation. We therefore aimed to extend the traditional approach to simultaneously estimate both case-mix adjusted hospital and municipality comparisons in order to disentangle the amount of the total patient variation in clinical outcomes that was attributable to the hospital and municipality level, respectively.METHODS: We determined 1-year mortality risk in patients aged 65 or above with hip fractures registered in Sweden between 2011 and 2014. We performed cross-classified multilevel analysis with 54,999 patients nested within 54 hospitals and 290 municipalities. We adjusted for individual demographic, socioeconomic and clinical characteristics. To quantify the size of the hospital and municipality variation we calculated the variance partition coefficient (VPC) and the area under the receiver operator characteristic curve (AUC).RESULTS: The overall 1-year mortality rate was 25.1%. The case-mix adjusted rates varied from 21.7% to 26.5% for the 54 hospitals, and from 18.9% to 29.5% for the 290 municipalities. The VPC was just 0.2% for the hospital and just 0.1% for the municipality level. Patient sociodemographic and clinical characteristics were strong predictors of 1-year mortality (AUC = 0.716), but adding the hospital and municipality levels in the cross-classified model had a minor influence (AUC = 0.718).CONCLUSIONS: Overall in Sweden, one-year mortality after hip-fracture is rather high. However, only a minor part of the patient variation is explained by the hospital and municipality levels. Therefore, a possible intervention should be nation-wide rather than directed to specific hospitals or municipalities.
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| 5. |
- Kristensen, Pia Kjær, et al.
(författare)
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Hospital differences in mortality rates after hip fracture surgery in Denmark
- 2019
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Ingår i: Clinical Epidemiology. - 1179-1349. ; 11, s. 605-614
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Tidskriftsartikel (refereegranskat)abstract
- Background: Thirty-day mortality after hip fracture is widely used when ranking hospital performance, but the reliability of such hospital ranking is seldom calculated. We aimed to quantify the variation in 30-day mortality across hospitals and to determine the hospital general contextual effect for understanding patient differences in 30-day mortality risk. Methods: Patients aged ≥65 years with an incident hip fracture registered in the Danish Multidisciplinary Fracture Registry between 2007 and 2016 were identified (n=60,004). We estimated unadjusted and patient-mix adjusted risk of 30-day mortality in 32 hospitals. We performed a multilevel analysis of individual heterogeneity and discriminatory accuracy with patients nested within hospitals. We expressed the hospital general contextual effect by the median odds ratio (MOR), the area under the receiver operating characteristics curve and the variance partition coefficient (VPC). Results: The overall 30-day mortality rate was 10%. Patient characteristics including high sociodemographic risk score, underweight, comorbidity, a subtrochanteric fracture, and living at a nursing home were strong predictors of 30-day mortality (area under the curve=0.728). The adjusted differences between hospital averages in 30-day mortality varied from 5% to 9% across the 32 hospitals, which correspond to a MOR of 1.18 (95% CI: 1.12–1.25). However, the hospital general context effect was low, as the VPC was below 1% and adding the hospital level to a single-level model with adjustment for patient-mix increased the area under the receiver operating characteristics curve by only 0.004 units. Conclusions: Only minor hospital differences were found in 30-day mortality after hip fracture. Mortality after hip fracture needs to be lowered in Denmark but possible interventions should be patient oriented and universal rather than focused on specific hospitals.
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| 6. |
- Schjødt, Inge, et al.
(författare)
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Risk factors for readmission to hospital in adult patients with heart failure and reduced ejection fraction: a systematic review protocol
- 2017
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Ingår i: The JBI Database of Systematic Reviews and Implementation Reports. - 2202-4433. ; 15:6, s. 1561-1574
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Forskningsöversikt (refereegranskat)abstract
- The objective of this systematic review is to identify and synthesize the best available evidence on risk factors associated with hospital readmission at different time points within the first year after heart failure (HF) hospitalization in patients suffering from HF with reduced ejection fraction (EF).More specifically, the question is: what are the risk factors for the prediction of hospital readmission within seven, 15, 30, 60, 90, 180 and 365 days of discharge in hospitalized patients with HF with reduced EF aged 18 years or older?
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| 7. |
- Wierup, Per, et al.
(författare)
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Moderate mitral regurgitation in patients undergoing CABG--the MoMIC trial.
- 2009
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Ingår i: Scandinavian cardiovascular journal. - : Informa UK Limited. - 1651-2006 .- 1401-7431. ; 43:1, s. 50-6
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The presence of mild to moderate ischemic mitral regurgitation (IMR) marks a significantly reduced long-term survival and increased hospitalizations due to heart-failure. However, it is common practice in many institutions to refrain from repairing the mitral valve in these patients. There are no available conclusive data to support this practice, and thus there is a need for an adequately powered randomized trial. STUDY DESIGN: The Moderate Mitral Regurgitation In Patients Undergoing CABG (MoMIC) trial is the first international multi-center, large-scale study to clarify whether moderate IMR in CABG patients should be corrected. A total of 550 CABG patients with moderate IMR are to be randomized to treatment of either CABG alone or CABG plus mitral valve correction. The primary end point is a composite end point of mortality and rehospitalization for heart failure at five years. The inclusion and randomization of patients started in February 2008. IMPLICATION: If correction of moderate IMR in CABG patients proves to be the superior strategy, most patients should be treated accordingly.
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