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1.
  • Angerås, Oskar, 1976, et al. (författare)
  • Impact of Thrombus Aspiration on Mortality, Stent Thrombosis, and Stroke in Patients with ST-Segment-Elevation Myocardial Infarction: A Report From the Swedish Coronary Angiography and Angioplasty Registry
  • 2018
  • Ingår i: Journal of the American Heart Association. - : John Wiley & Sons. - 2047-9980. ; 7:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background-Thrombus aspiration is still being used in a substantial number of patients despite 2 large randomized clinical trials showing no favorable effect of routine thrombus aspiration during primary percutaneous coronary intervention in patients with STsegment- elevation myocardial infarction. The aim of this observational study was to evaluate the impact of thrombus aspiration on mortality, stent thrombosis, and stroke using all available data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Methods and Results--We identified 42 829 consecutive patients registered in SCAAR between January 2005 and September 2014 who underwent percutaneous coronary intervention for ST-segment-elevation myocardial infarction. Thrombus aspiration was used in 25% of the procedures. We used instrumental variable analysis with administrative healthcare region as the treatmentpreference instrumental variable to evaluate the effect of thrombus aspiration on mortality, stent thrombosis, and stroke. Thrombus aspiration was not associated with mortality at 30 days (risk reduction: -1.2; 95% confidence interval [CI] , -5.4 to 3.0; P=0.57) and 1 year (risk reduction: -2.4; 95% CI, -7.6 to 3.0; P=0.37). Thrombus aspiration was associated with a lower risk of stent thrombosis both at 30 days (risk reduction: -2.7; 95% CI, -4.1 to -1.4; P < 0.001) and 1 year (risk reduction: -3.5; 95% CI, -5.3 to -1.7; P < 0.001). In-hospital stroke and neurologic complications did not differ between groups (risk reduction: 0.1; 95% CI, -0.8 to 1.1; P=0.76). Conclusions--Mortality was not different between the groups. Thrombus aspiration was associated with decreased risk of stent thrombosis. Our study provides important evidence for the external validity of previous randomized studies regarding mortality.
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  • Arora, Satish, et al. (författare)
  • Effect of Everolimus Initiation and Calcineurin Inhibitor Elimination on Cardiac Allograft Vasculopathy in De Novo Heart Transplant Recipients
  • 2018
  • Ingår i: Circulation. Heart failure. - 1941-3297. ; 11:9, s. 004050-004050
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Cardiac allograft vasculopathy (CAV) limits survival after heart transplantation, and the effect of different immunosuppressive regimens on CAV is not fully understood. The randomized SCHEDULE trial (Scandinavian Heart Transplant Everolimus De Novo Study With Early Calcineurin Inhibitors Avoidance) evaluated whether initiation of the proliferation signal inhibitor everolimus and early cyclosporine elimination can reduce CAV development. Methods and Results The SCHEDULE trial was a multicenter Scandinavian trial, where 115 de novo heart transplantation recipients were randomized to everolimus with complete cyclosporine withdrawal 7 to 11 weeks after heart transplantation or standard cyclosporine-based immunosuppression. Seventy-six (66%) patients had matched intravascular ultrasound examinations at baseline and 12 and 36 months. Intravascular ultrasound analysis evaluated maximal intimal thickness, percent atheroma volume, and total atheroma volume. Qualitative plaque analysis using virtual histology assessed fibrous, fibrofatty, and calcified tissue as well as necrotic core. Serum inflammatory markers were measured in parallel. The everolimus group (n=37) demonstrated significantly reduced CAV progression as compared with the cyclosporine group (n=39) at 36 months (Δ maximal intimal thickness, 0.09±0.05 versus 0.15±0.16 mm [ P=0.03]; Δ percent atheroma volume, 5.3±2.8% versus 7.6±5.9% [ P=0.03]; and Δ total atheroma volume, 33.9±71.2 versus 54.2±96.0 mm3 [ P=0.34], respectively]. At 36 months the number of everolimus patients with rejection graded ≥2R was 15 (41%) as compared with 5 (13%) in the cyclosporine group ( P=0.01). Everolimus did not affect CAV morphology or immune marker activity during the follow-up period. Conclusions The SCHEDULE trial demonstrates that everolimus initiation and early cyclosporine elimination significantly reduces CAV progression at 12 months, and this beneficial effect is clearly sustained at 36 months. Clinical trial registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01266148.
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4.
  • Dworeck, Christian, et al. (författare)
  • Radial artery access is associated with lower mortality in patients undergoing primary PCI : a report from the SWEDEHEART registry
  • 2020
  • Ingår i: European Heart Journal. - : Sage Publications. - 2048-8726 .- 2048-8734. ; 9:4, s. 323-332
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: The purpose of this observational study was to evaluate the effects of radial artery access versus femoral artery access on the risk of 30-day mortality, inhospital bleeding and cardiogenic shock in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.Methods: We used data from the SWEDEHEART registry and included all patients who were treated with primary percutaneous coronary intervention in Sweden between 2005 and 2016. We compared patients who had percutaneous coronary intervention by radial access versus femoral access with regard to the primary endpoint of all-cause death within 30 days, using a multilevel propensity score adjusted logistic regression which included hospital as a random effect.Results: During the study period, 44,804 patients underwent primary percutaneous coronary intervention of whom 24,299 (54.2%) had radial access and 20,505 (45.8%) femoral access. There were 2487 (5.5%) deaths within 30 days, of which 920 (3.8%) occurred in the radial access and 1567 (7.6%) in the femoral access group. After propensity score adjustment, radial access was associated with a lower risk of death (adjusted odds ratio (OR) 0.70, 95% confidence interval (CI) 0.55-0.88,P = 0.025). We found no interaction between access site and age, gender and cardiogenic shock regarding 30-day mortality. Radial access was also associated with a lower adjusted risk of bleeding (adjusted OR 0.45, 95% CI 0.25-0.79,P = 0.006) and cardiogenic shock (adjusted OR 0.41, 95% CI 0.24-0.73,P = 0.002).Conclusions: In patients with ST-elevation myocardial infarction, primary percutaneous coronary intervention by radial access rather than femoral access was associated with an adjusted lower risk of death, bleeding and cardiogenic shock. Our findings are consistent with, and add external validity to, recent randomised trials.
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6.
  • Erlinge, D., et al. (författare)
  • Bivalirudin versus Heparin Monotherapy in Myocardial Infarction
  • 2017
  • Ingår i: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 377:12, s. 1132-1142
  • Tidskriftsartikel (refereegranskat)abstract
    • Background The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y12 inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors. Methods In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent P2Y12 inhibitor (ticagrelor, prasugrel, or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors. The patients were randomly assigned to receive bivalirudin or heparin during PCI, which was performed predominantly with the use of radial-artery access. The primary end point was a composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up. Results A total of 6006 patients (3005 with STEMI and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point event had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients with STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction occurred in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin group (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6% and 8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite stent thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27 to 1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95% CI, 0.78 to 1.41; P=0.76). Conclusions Among patients undergoing PCI for myocardial infarction, the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin than among those who received heparin monotherapy. (Funded by the Swedish Heart-Lung Foundation and others; VALIDATE-SWEDEHEART ClinicalTrialsRegister.eu number, 2012-005260-10 ; ClinicalTrials.gov number, NCT02311231 .).
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  • James, Stefan, 1964-, et al. (författare)
  • Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction
  • 2021
  • Ingår i: Circulation. Cardiovascular Interventions. - : Lippincott Williams & Wilkins. - 1941-7640 .- 1941-7632. ; 14:12
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y12-inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy-Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry).METHODS: In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days.RESULTS: Among the 6006 patients enrolled in the trial, 3005 patients with ST-segment-elevation MI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years. According to protocol recommendations, 87% were treated with potent oral P2Y12-inhibitors before start of angiography and radial access was used in 90%. GPI was used in 51 (3.4%) and 74 (4.9%) of patients randomized to receive bivalirudin and heparin, respectively. The primary end point occurred in 12.5% (187 of 1501) and 13.0% (196 of 1504; hazard ratio [HR], 0.95 [95% CI, 0.78-1.17], P=0.64) with consistent results in all major subgroups. All-cause death occurred in 3.9% versus 3.9% (HR, 1.00 [0.70-1.45], P=0.98), MI in 1.7% versus 2.2% (HR, 0.76 [0.45-1.28], P=0.30), major bleeding in 8.3% versus 8.0% (HR, 1.04 [0.81-1.33], P=0.78), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42 [0.18-0.96], P=0.04).CONCLUSIONS: In patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with radial access and receiving current recommended treatments with potent P2Y12-inhibitors rate of the composite of all-cause death, MI, or major bleeding was not lower in those randomized to receive bivalirudin as compared with heparin.REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.
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  • Koutouzis, Michael, 1973, et al. (författare)
  • Recurrent bare metal stent thrombosis: Six years, single center experience
  • 2009
  • Ingår i: International Journal of Cardiology. - 1874-1754. ; 144:2, s. 234-235
  • Tidskriftsartikel (refereegranskat)abstract
    • PURPOSE: To evaluate clinical characteristics, treatment and outcomes of patients suffering from recurrent bare metal stent thrombosis (RST). METHODS: A retrospesctive evaluation of patients who underwent percutaneous coronary intervention (PCI) with bare metal stent implantation between January 2002 and December 2007 was performed. Patients who experienced more than one in stent thrombotic episode were identified and procedural and clinical outcomes were investigated. RESULTS: Eight thousand eight hundred sixteen patients underwent PCI with bare metal stent implantation during the study period. Ninety five patients (1.1%) underwent PCI due to stent thrombosis and 6 (6.3%) of them [mean age 69+/-14 years (range 43-83 years)] underwent a second procedure due to RST. Emergency PCI was performed in all patients, with a favourable angiographic outcome in 4 (67%) of them. The procedure was complicated by death in 1, major ischemic stroke in 1 and acute coronary by pass grafting in 1 patient. The ejection fraction before the initial intervention and after the second thrombotic episode declined from 52+/-14% to 33+/-15% (p<0.05). CONCLUSION: Recurrent stent thrombosis is a rare, but major complication following stent implantation, which dramatically affects patients' outcomes.
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  • Lagerqvist, Bo, et al. (författare)
  • Outcomes 1 year after thrombus aspiration for myocardial infarction.
  • 2014
  • Ingår i: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 371:12, s. 1111-1120
  • Tidskriftsartikel (refereegranskat)abstract
    • Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) has not been proved to reduce short-term mortality. We evaluated clinical outcomes at 1 year after thrombus aspiration.
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11.
  • Louca, Antros, et al. (författare)
  • Coronary angiography following transcatheter aortic valve replacement : insights from the SWEDEHEART registry
  • 2024
  • Ingår i: Catheterization and cardiovascular interventions. - : John Wiley & Sons. - 1522-1946 .- 1522-726X.
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Transcatheter aortic valve replacement (TAVR) is the most common treatment in patients with symptomatic severe aortic stenosis (AS). As concomitant coronary artery disease is common in AS patients, access to the coronary arteries following TAVR is of increasing importance.Objectives: This study evaluated the incidence and risk factors for unplanned coronary angiography following TAVR and, using fluoroscopic time as a surrogate, analyzed the complexity of coronary artery cannulation.Methods: All patients who underwent TAVR in Sweden between 2008 and 2022 were identified using the SWEDEHEART registry. The cumulative incidence of coronary angiography after TAVR was analyzed with mortality as a competing risk. Angiography and PCI complexity were analyzed using fluoroscopic time and compared across different transcatheter heart valve designs.Results: Out of 9806 patients, 566 subsequently required coronary angiography. The incidence was highest for three-vessel and/or left main disease. Younger age, the extent of prior coronary artery disease, and peripheral vascular disease were associated with an increased risk of coronary angiography. Fluoroscopy time was increased in TAVR patients compared to the control group with the longest fluoroscopy times observed in cases involving supra-annular and self-expanding valves.Conclusions: The incidence of coronary angiography following TAVR is still low. Younger patients and patients with concomitant coronary artery disease have a higher risk. Procedural time is longer in patients with a previous THV replacement. As TAVR is emerging as the first-line treatment in patients with longer life expectancy, facilitating coronary access is an important factor when considering which THV device to implant.
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12.
  • Omerovic, Elmir, et al. (författare)
  • Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two years
  • 2024
  • Ingår i: Cardiovascular Revascularization Medicine. - : Elsevier. - 1553-8389 .- 1878-0938.
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years.METHODS: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here.RESULTS: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85-1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96-1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups.CONCLUSIONS: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin.REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02311231.
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13.
  • Ponticelli, Francesco, et al. (författare)
  • Safety and efficacy of coronary sinus narrowing in chronic refractory angina: Insights from the RESOURCE study.
  • 2021
  • Ingår i: International journal of cardiology. - : Elsevier BV. - 1874-1754 .- 0167-5273. ; 337, s. 29-37
  • Tidskriftsartikel (refereegranskat)abstract
    • Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy.The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke.At a median follow-up of 502days (IQR 225-1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively.CSR implantation is safe and reduces angina in patients with refractory angina.
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  • Ramunddal, Truls, et al. (författare)
  • Chronic Total Occlusions in Sweden - A Report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
  • 2014
  • Ingår i: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 9:8
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction: Evidence for the current guidelines for the treatment of patients with chronic total occlusions (CTO) in coronary arteries is limited. In this study we identified all CTO patients registered in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and studied the prevalence, patient characteristics and treatment decisions for CTO in Sweden. Methods and Results: Between January 2005 and January 2012, 276,931 procedures (coronary angiography or percutaneous coronary intervention) were performed in 215,836 patients registered in SCAAR. We identified all patients who had 100% luminal diameter stenosis known or assumed to be >= 3 months old. After exclusion of patients with previous coronary artery bypass graft (CABG) surgery or coronary occlusions due to acute coronary syndrome, we identified 16,818 CTO patients. A CTO was present in 10.9% of all coronary angiographies and in 16.0% of patients with coronary artery disease. The majority of CTO patients were treated conservatively and PCI of CTO accounted for only 5.8% of all PCI procedures. CTO patients with diabetes and multivessel disease were more likely to be referred to CABG. Conclusion: CTO is a common finding in Swedish patients undergoing coronary angiography but the number of CTO procedures in Sweden is low. Patients with CTO are a high-risk subgroup of patients with coronary artery disease. SCAAR has the largest register of CTO patients and therefore may be valuable for studies of clinical importance of CTO and optimal treatment for CTO patients.
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16.
  • Rawshani, Araz, 1986, et al. (författare)
  • Characteristics, survival and neurological outcome in out-of-hospital cardiac arrest: A nationwide study of 56,203 cases with emphasis on cardiovascular comorbidities.
  • 2022
  • Ingår i: Resuscitation plus. - : Elsevier BV. - 2666-5204. ; 11
  • Tidskriftsartikel (refereegranskat)abstract
    • We studied clinical characteristics, survival and neurological outcomes in patients with pre-existing cardiovascular (CV) conditions who experienced an out-of-hospital cardiac arrest (OHCA).We studied all cases of OHCA in the Swedish Registry for Cardiopulmonary Resuscitation (2010-2020). Patients were grouped according to the following pre-existing CV conditions prior: hypertension (HT), heart failure (HF) with HT, HF with ischemic heart disease (IHD), HF without HT or IHD, IHD, myocardial infarction (MI) and diabetes mellitus (DM), with groups being mutually exclusive. We studied 30-day survival and neurological outcomes using logistic and Cox regression.A total of 56,203 patients were included. The lowest rates of shockable rhythm occurred in cases with HT (19%), HF and HT (18%) and DM (18%). Median time to OHCA from diagnosis of HT was 2.0years in cases aged 0-40years at diagnosis of HT, 4.4years in those aged 41-60 at diagnosis, 5.0years in those aged 61-70years, 5.6years in those aged 71-80years and 6.0years in those aged 81years or older. The lowest survival was noted for patients with HF and HT. Age and sex adjusted OR for CPC score 1 did not differ in any group.The combination of HT and HF has the lowest survival of all cardiovascular comorbidities. Early onset of hypertension is a predictor for early cardiac arrest.
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17.
  • Redfors, Björn, et al. (författare)
  • Angiographic findings and survival in patients undergoing coronary angiography due to sudden cardiac arrest in western Sweden.
  • 2015
  • Ingår i: Resuscitation. - : Elsevier BV. - 0300-9572 .- 1873-1570. ; 90:May 2015, s. 13-20
  • Tidskriftsartikel (refereegranskat)abstract
    • AIM: Sudden cardiac arrest (SCA) accounts for more than half of all deaths from coronary heart disease. Time to return of spontaneous circulation is the most important determinant of outcome but successful resuscitation also requires percutaneous coronary intervention in selected patients. However, proper selection of patients is difficult. We describe data on angiographic finding and survival from a prospectively followed SCA patient cohort.METHODS: We merged the RIKS-HIA registry (Register of Information and Knowledge about Swedish Heart Intensive Care Admissions) and SCAAR (Swedish Coronary Angiography and Angioplasty Registry) for patients hospitalized in cardiac care units in Western Sweden between January 2005 and March 2013. We performed propensity score-adjusted logistic and Cox proportional-hazards regression analyses on complete-case data as well as on imputed data sets.RESULTS: 638 consecutive patients underwent coronary angiography due to SCA. Severity of coronary artery disease was similar among SCA patients and patients undergoing coronary angiography due to suspected coronary artery disease (n=37,142). An acute occlusion was reported in the majority of SCA patients and was present in 37% of patients who did not have ST-elevation on the post resuscitation ECG. 31% of SCA patients died within 30 days. Long-term risk of death among patients who survived the first 30 days was higher in patients with SCA compared to patients with acute coronary syndromes (P<0.001).CONCLUSIONS: Coronary artery disease and acute coronary occlusions are common among patients who undergo coronary angiography after sudden cardiac arrest. These patients have a substantial mortality risk both short- and long-term.
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18.
  • Redfors, Björn, et al. (författare)
  • Prognosis is similar for patients who undergo primary PCI during regular-hours and off-hours: A report from SCAAR.
  • 2018
  • Ingår i: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. - : Wiley. - 1522-726X. ; 91:7, s. 1240-1249
  • Tidskriftsartikel (refereegranskat)abstract
    • Timely percutaneous coronary intervention (PCI) improves prognosis in ST-elevation myocardial infarction (STEMI). However, recent reports indicate that patients with STEMI who present during non-regular working hours (off-hours) have a worse prognosis. The aim of this study was to compare outcome between patients with STEMI who underwent primary PCI during off-hours and regular hours.We retrieved data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) for all patients who underwent primary PCI in Region Västra Götaland due to STEMI between January 2004 and May 2013. We modeled unadjusted and adjusted Cox proportional-hazards regression and logistic regression models for the outcomes death, cardiogenic shock, stent thrombosis and in-stent restenosis. A propensity score-adjusted Cox proportional-hazards model, which adjusted for traditional cardiovascular risk factors was predefined as the primary statistical model. Death at any time during the study period was pre-specified as primary end-point.During the study period 4.611 (65%) patients underwent primary PCI due to STEMI during off-hours and 2,525 (35%) during regular hours. The risk of dying was similar among the groups for the primary endpoint death at any time during the study period (HR 1.00, 95% CI 0.89-1.12, P=0.991) and for secondary end-point death within 30 days (HR 1.03; 95% CI 0.85-1.25, P=0.735). The risks of developing cardiogenic shock, stent thrombosis, or in-stent restenosis were similar between the groups.In our region, short- and long-term prognosis for patients with STEMI who undergo primary PCI is similar for patients presenting during off-hours and regular hours.
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19.
  • Reinsfelt, Björn, et al. (författare)
  • Transcranial Doppler microembolic signals and serum marker evidence of brain injury during transcatheter aortic valve implantation.
  • 2012
  • Ingår i: Acta anaesthesiologica Scandinavica. - : Wiley. - 1399-6576 .- 0001-5172. ; 56:2, s. 240-24
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Recent studies have shown that transcatheter aortic valve implantation (TAVI) is associated with new foci of restricted diffusion on cerebral magnetic resonance imaging suggestive of cerebral microembolism. The aim of the present investigation was to quantify the cerebral embolic load and to evaluate during which phase of the TAVI procedure microembolism occurs. We also evaluated the association between the cerebral embolic load and post-procedural release of S100B, a serological marker of cerebral injury. METHODS: In 21 patients, we described the extent and intra-procedural distribution of microemboli during the TAVI procedure using the transcranial Doppler technique. S100B, a marker of astroglial injury, was measured for 24h after the procedure, and the area under the curve (AUC(24h) ) relating S100B to time was calculated. RESULTS: During the TAVI procedure, a mean of 282±169 emboli was detected, 37% occurred during manipulation of the aortic arch/root/valve by guide wires and catheters, 22% occurred immediately after balloon dilatation of the native valve and 41% occurred during frame expansion of the valve prosthesis. S100B increased in all patients with a peak at 1h after the procedure and returned to baseline after 4h. There was a positive correlation between the total amount of cerebral microemboli and the AUC(24h) for S100B (r=0.68, P<0.001). None of the patients developed neurological impairment. CONCLUSION: TAVI is associated with a substantial amount of cerebral microemboli. The microembolic load correlates to the degree of post-procedural release of a marker of cerebral injury.
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20.
  • Råmunddal, Truls, 1973, et al. (författare)
  • International Randomized Trial on the Effect of Revascularization or Optimal Medical Therapy of Chronic Total Coronary Occlusions with Myocardial Ischemia - ISCHEMIA-CTO Trial - Rationale and Design.
  • 2022
  • Ingår i: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703.
  • Tidskriftsartikel (refereegranskat)abstract
    • Chronic total occlusions (CTO) are frequent among patients with coronary artery disease. Revascularization with percutaneous coronary intervention (PCI) is safe and feasible in experienced hands. However, randomized data are needed to demonstrate symptomatic as well as prognostic effect of CTO-PCI compared to optimal medical therapy alone.This trial aims to evaluate the effect of CTO PCI in patients with a CTO lesion and target vessel diameter ≥ 2.5 mm, and myocardial ischemia in the relevant territory. First, all patients are subjected to optimal medical therapy (OMT) for at least for 3 months and non-CTO lesions are managed according to guidelines. Subsequently, prior to randomization myocardial ischemia and quality of life (Seattle Questionnaire (SAQ)) is assessed. Patients are divided into two cohorts based on their SAQ score and randomized to either OMT alone or OMT and CTO-PCI. Cohort A is defined as Low- or asymptomatic patients with a quality-of-life score > 60 and/or CCS class < 2, and more than 10 % ischemia in the left ventricle (LV). Cohort B is symptomatic patients with a quality-of-life score < 60 or CCS class angina > 1 and at least ischemia in 5% of the LV. The primary end-point in cohort A is a composite of major adverse cardiac and cerebral events, hospitalization for heart failure and malignant ventricular arrhythmias. The primary endpoint in cohort B is difference in quality of life 6 months after randomization.This trial is designed to investigate if CTO-PCI improves QoL and MACCE. Both positive and negative outcome of the trial will affect future guidelines and recommendations on how to treat patients with CTO.
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21.
  • Råmunddal, Truls, et al. (författare)
  • Prognostic Impact of Chronic Total Occlusions : A Report From SCAAR (Swedish Coronary Angiography and Angioplasty Registry)
  • 2016
  • Ingår i: JACC: Cardiovascular Interventions. - : Elsevier BV. - 1936-8798. ; 9:15, s. 1535-1544
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives The aim of this study was to determine the prognostic impact of chronic total occlusion (CTO) on long-term mortality in a large prospective cohort. Background CTO is present in many patients with coronary artery disease and is difficult to treat with percutaneous coronary intervention. Methods The study population consisted of all consecutive patients who underwent coronary angiography in Sweden between January 1, 2005 and January 1, 2012, who were registered in SCAAR (Swedish Coronary Angiography and Angioplasty Registry). The patient population was heterogeneous with regard to indication for angiography (stable angina, ST-segment elevation myocardial infarction [STEMI], unstable angina or non-STEMI, and other) and treatment options. The long-term mortality rates of patients with and without CTO were compared by using shared frailty Cox proportional hazards regression adjusted for confounders. Tests were conducted for interactions between CTO and several pre-specified characteristics: indication for angiography and percutaneous coronary intervention (stable angina, STEMI, unstable angina or non-STEMI, and other), severity of coronary artery disease (1-, 2-, and 3-vessel and/or left main coronary artery disease), age, sex, and diabetes. Results During the study period, 14,441 patients with CTO and 75,431 patients without CTO were registered in SCAAR. CTO was associated with higher mortality (hazard ratio: 1.29; 95% confidence interval: 1.22 to 1.37; p < 0.001). In subgroup analyses, the risk attributable to CTO was lowest in patients with stable angina and highest in those with STEMI. In addition, CTO was associated with highest risk in patients under 60 years of age and with lowest risk in octogenarians. There was no interaction between CTO and either diabetes or sex, suggesting an equally adverse effect in both groups. Conclusions In this large prospective observational study of patients with coronary artery disease, CTO was associated with increased mortality. This association was most prominent in younger patients and in those with acute coronary syndromes.
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22.
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23.
  • Råmunddal, Truls, 1973, et al. (författare)
  • Safety and Feasibility Using a Fluid-Filled Wire to Avoid Hydrostatic Errors in Physiological Intracoronary Measurements.
  • 2024
  • Ingår i: Cardiology research and practice. - 2090-8016. ; 2024
  • Tidskriftsartikel (refereegranskat)abstract
    • Using a fluid-filled wire with a pressure sensor outside the patient compared to a conventional pressure wire may avoid the systematic error introduced by the hydrostatic pressure within the coronary circulation.To assess the safety and effectiveness of the novel fluid-filled wire, Wirecath (Cavis Technologies, Uppsala, Sweden), as well as its ability to avoid the hydrostatic pressure error.The Wirecath pressure wire was used in 45 eligible patients who underwent invasive coronary angiography and had a clinical indication for invasive coronary pressure measurement at Sahlgrenska University Hospital, Gothenburg, Sweden. In 29 patients, a simultaneous measurement was performed with a conventional coronary pressure wire (PressureWire X, Abbott Medical, Plymouth, MN, USA), and in 19 patients, the vertical height difference between the tip of the guide catheter and the wire measure point was measured in a 90-degree lateral angiographic projection. No adverse events caused by the pressure wires were reported. The mean Pd/Pa and mean FFR using the fluid-filled wire and the sensor-tipped wire differed significantly; however, after correcting for the hydrostatic effect, the sensor-tipped wire pressure correlated well with the fluid-filled wire pressure (R=0.74 vs. R=0.89 at rest and R=0.89 vs. R=0.98 at hyperemia).Hydrostatic errors in physiologic measurements can be avoided by using the fluid-filled Wirecath wire, which was safe to use in the present study. This trial is registered with NCT04776577 and NCT04802681.
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24.
  • Sabbah, Muhammad, et al. (författare)
  • Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation - the third Nordic Aortic Valve Intervention Trial - NOTION-3.
  • 2022
  • Ingår i: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703.
  • Tidskriftsartikel (refereegranskat)abstract
    • Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes.The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least one significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary endpoint is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI.NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI.
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25.
  • Sabbah, Muhammad, et al. (författare)
  • Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation – the third nordic aortic valve intervention trial – NOTION-3
  • 2023
  • Ingår i: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 255, s. 39-51
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes. Study design: The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least 1 significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary end point is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI. NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI.
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26.
  • Völz, Sebastian, 1980, et al. (författare)
  • Long-term mortality in patients with ischaemic heart failure revascularized with coronary artery bypass grafting or percutaneous coronary intervention : insights from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
  • 2021
  • Ingår i: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 42:27, s. 2657-2664
  • Tidskriftsartikel (refereegranskat)abstract
    • AIMS: To compare coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for treatment of patients with heart failure due to ischaemic heart disease.METHODS AND RESULTS: We analysed all-cause mortality following CABG or PCI in patients with heart failure with reduced ejection fraction and multivessel disease (coronary artery stenosis >50% in ≥2 vessels or left main) who underwent coronary angiography between 2000 and 2018 in Sweden. We used a propensity score-adjusted logistic and Cox proportional-hazards regressions and instrumental variable model to adjust for known and unknown confounders. Multilevel modelling was used to adjust for the clustering of observations in a hierarchical database. In total, 2509 patients (82.9% men) were included; 35.8% had diabetes and 34.7% had a previous myocardial infarction. The mean age was 68.1 ± 9.4 years (47.8% were >70 years old), and 64.9% had three-vessel or left main disease. Primary designated therapy was PCI in 56.2% and CABG in 43.8%. Median follow-up time was 3.9 years (range 1 day to 10 years). There were 1010 deaths. Risk of death was lower after CABG than after PCI [odds ratio (OR) 0.62; 95% confidence interval (CI) 0.41-0.96; P = 0.031]. The risk of death increased linearly with quintiles of hospitals in which PCI was the preferred method for revascularization (OR 1.27, 95% CI 1.17-1.38, Ptrend < 0.001).CONCLUSION: In patients with ischaemic heart failure, long-term survival was greater after CABG than after PCI.
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27.
  • Völz, Sebastian, 1980, et al. (författare)
  • Prognostic impact of percutaneous coronary intervention in octogenarians with non-ST elevation myocardial infarction: A report from SWEDEHEART.
  • 2020
  • Ingår i: European heart journal. Acute cardiovascular care. - : Oxford University Press (OUP). - 2048-8734 .- 2048-8726. ; 9:5, s. 480-487
  • Tidskriftsartikel (refereegranskat)abstract
    • Percutaneous coronary intervention (PCI) improves outcomes in non-ST elevation acute coronary syndromes (NSTE-ACSs). Octogenarians, however, were underrepresented in the pivotal trials. This study aimed to assess the effect of PCI in patients ≥80 years old.We used data from the SWEDEHEART registry for all hospital admissions at eight cardiac care centres within Västra Götaland County. Consecutive patients ≥80 years old admitted for NSTE-ACS between January 2000 and December 2011 were included. We performed instrumental variable analysis with propensity score. The primary endpoint was all-cause mortality at 30 days and one year after index hospitalization. During the study period 5200 patients fulfilled the inclusion criteria. In total, 586 (11.2%) patients underwent PCI, the remaining 4613 patients were treated conservatively. Total mortality at 30 days was 19.4% (1007 events) and 39.4% (1876 events) at one year. Thirty-day mortality was 20.7% in conservatively treated patients and 8.5% in the PCI group (adjusted odds ratio 0.34; 95% confidence interval 0.12-0.97, p = 0.044). One-year mortality was 42.1% in the conservatively treated group and 16.3% in the PCI group (adjusted odds ratio 0.97; 95% confidence interval 0.36-2.51, p = 0.847).PCI in octogenarians with NSTE-ACS was associated with a lower risk of mortality at 30 days. However, this survival benefit was not sustained during the entire study-period of one-year.
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28.
  • Völz, Sebastian, 1980, et al. (författare)
  • Ticagrelor is Not Superior to Clopidogrel in Patients With Acute Coronary Syndromes Undergoing PCI: A Report from Swedish Coronary Angiography and Angioplasty Registry.
  • 2020
  • Ingår i: Journal of the American Heart Association. - 2047-9980. ; 9:14
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Ticagrelor reduces ischaemic end points in acute coronary syndromes. However, outcomes of ticagrelor versus clopidogrel in real-world patients with acute coronary syndromes treated with percutaneous coronary intervention (PCI) remain unclear. We sought to examine whether treatment with ticagrelor is superior to clopidogrel in unselected patients with acute coronary syndromes treated with PCI. Methods and Results We used data from SCAAR (Swedish Coronary Angiography and Angioplasty Registry) for PCI performed in Västra Götaland County, Sweden. The database contains information about all PCI performed at 5 hospitals (∼20% of all data in SCAAR). All procedures between January 2005 and January 2015 for unstable angina/non‒ST-segment‒elevation myocardial infarction and ST-segment‒elevation myocardial infarction were included. We used instrumental variable 2-stage least squares regression to adjust for confounders. The primary combined end point was mortality or stent thrombosis at 30days, secondary end points were mortality at 30days and 1-year, stent thrombosis at 30days, in-hospital bleeding, in-hospital neurologic complications and long-term mortality. A total of 15097 patients were included in the study of which 2929 (19.4%) were treated with ticagrelor. Treatment with ticagrelor was not associated with a lower risk for the primary end point (adjusted odds ratio [aOR], 1.20; 95% CI, 0.87-1.61; P=0.250). Estimated risk of death at 30 days (aOR, 1.18; 95% CI, 0.88-1.64; P=0.287) and at 1-year (aOR, 1.28; 95% CI, 0.86-1.64; P=0.556) was not different between the groups. The risk of in-hospital bleeding was higher with ticagrelor (aOR, 2.88; 95% CI, 1.53-5.44; P=0.001). Conclusions In this observational study, treatment with ticagrelor was not superior to clopidogrel in patients with acute coronary syndromes treated with PCI.
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