| 1. |
- Bondesson, Per, et al.
(författare)
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Comparison of two drug-eluting balloons : a report from the SCAAR registry
- 2012
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Ingår i: EuroIntervention. - : Europa Edition. - 1774-024X .- 1969-6213. ; 8:4, s. 444-449
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Tidskriftsartikel (refereegranskat)abstract
- Aims: Recently, drug-eluting balloons have received a guideline class IIa recommendation in the treatment of in-stent restenosis after bare metal stent implantation. It is not known if different balloons perform equally. Using a large real world registry, restenosis frequency was reported for two drug-eluting balloons. less thanbrgreater than less thanbrgreater thanMethods and results: From April 2009 until September 2011, 1,129 patients were treated with paclitaxel-eluting balloons in Sweden. Mean follow-up was 328 +/- 210 days. Nine hundred and nineteen patients were treated with a balloon using a contrast agent as a drug-carrier and 217 with a balloon without a contrast agent as a drug-carrier. The indications were predominantly de novo (45.4%) or in-stent restenotic (51.8%) lesions. The overall incidence of restenosis at six months was 3.4% with the paclitaxel balloon using a contrast agent as carrier, compared with 12.5% with the paclitaxel-eluting balloon without a carrier (risk ratio: 0.42; 95% confidence interval [CI] [0.26-0.68]). After adjusting for indications, lesion types and procedural factors, the risk ratio was 0.39; 95% CI (0.24-0.65). less thanbrgreater than less thanbrgreater thanConclusions: This observational study from a large real world population shows a major difference between two paclitaxel-eluting balloons. The findings suggest that there are no class effects for drug-eluting balloons and factors other than the drug may be important for the clinical effect.
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| 2. |
- Buccheri, Sergio, et al.
(författare)
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Bioabsorbable polymer everolimus-eluting stents in patients with acute myocardial infarction : A report from the Swedish Coronary Angiography and Angioplasty Registry
- 2018
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Ingår i: EuroIntervention. - 1774-024X .- 1969-6213. ; 14:5, s. 562-569
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The clinical performance of the SYNERGY drug-eluting stent (DES) in patients with acute myocardial infarction (MI) has not been investigated in detail. We sought to report on the outcomes after SYNERGY DES (Boston Scientific, Marlborough, MA, USA) implantation in patients with MI undergoing percutaneous revascularisation (PCI). Methods and results: We included all consecutive patients with MI undergoing PCI with the SYNERGY DES and newer-generation DES (n-DES group) in Sweden. From March 2013 to September 2016, a total of 36,292 patients, of whom 39.7% presented with ST-elevation MI, were included. As compared to patients in the n-DES group (n=31,403), patients in the SYNERGY group (n=4,889) were older and presented more often with left main or three-vessel disease involvement, as well as with restenotic lesions (p<0.001 for all parameters). The Kaplan-Meier estimates of ST at two years in the SYNERGY and n-DES groups were 0.69% and 0.81%, respectively (adjusted HR 1.00, 95% CI: 0.69-1.46; p=0.99). Clinically relevant restenosis was encountered in 1.48% and 1.25% of patients in the SYNERGY and n-DES groups, respectively (adjusted HR 1.05, 95% CI: 0.81-1.37; p=0.72). No differences in the risk of all-cause death and recurrent MI were found between the two groups after adjustment (adjusted HR 1.12, 95% CI: 0.98-1.28; p=0.10, and adjusted HR 0.95, 95% CI: 0.82-1.10; p=0.49, respectively). Conclusions: In a large and unselected cohort of patients with MI undergoing percutaneous revascularisation with the SYNERGY DES, stent performance and clinical outcomes did not differ compared with other n-DES up to two years.
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| 3. |
- Byrne, Robert A., et al.
(författare)
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Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention : executive summary
- 2018
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Ingår i: EuroIntervention. - : EUROPA EDITION. - 1774-024X .- 1969-6213. ; 13:13, s. 1574-1586
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Tidskriftsartikel (refereegranskat)abstract
- A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device - the Absorb bioresorbable vascular scaffold - has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE-mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.
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| 4. |
- Damman, Peter, et al.
(författare)
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Invasive strategies and outcomes for non-ST-segment elevation acute coronary syndromes : a twelve-year experience from SWEDEHEART.
- 2016
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Ingår i: EuroIntervention. - 1774-024X .- 1969-6213. ; 12:9, s. 1108-1116
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: Despite recommendations in recent guidelines for a routine invasive strategy for non-ST-segment elevation acute coronary syndrome (NSTE-ACS), long-term data on the implementation of treatment strategies in clinical practice are not available. Our aim was to provide long-term data on the implementation of a routine invasive strategy in NSTE-ACS in clinical practice.METHODS AND RESULTS: In the SWEDEHEART registry, data from 204,092 consecutive NSTE-ACS patients admitted between 1996 and 2007 were recorded. The use of the routine invasive strategy, retrospectively defined as coronary angiography (and subsequent revascularisation) within three days after admission, increased from 3.8% in the period 1996-1998 to 37.4% in the period 2005-2007. The largest absolute increase in the use of this strategy was observed in low-risk patients, while a similar relative increase was observed in all risk categories. The use of the selective invasive strategy, defined as coronary angiography later than three days after admission or none at all, decreased from 96.2% in the period 1996-1998 to 62.5% in the period 2005-2007. In the total population, there was a gradual decrease in three-year all-cause mortality, from 29.1% in the period 1996-1998 to 23.9% in the period 2005-2007.CONCLUSIONS: There has been an increase in the use of a routine invasive strategy in NSTE-ACS patients over the course of 12 years in Sweden. There was a decrease in three-year mortality over the same time course.
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| 5. |
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| 6. |
- Fokkema, Marieke L., et al.
(författare)
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Outcome after percutaneous coronary intervention for different indications : long-term results from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
- 2016
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Ingår i: EuroIntervention. - Toulouse, France : Europa Edition. - 1774-024X .- 1969-6213. ; 12:3, s. 303-311
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The aim of this study was to evaluate clinical outcome for different indications for PCI in an unselected, nationwide PCI population at short- and long-term follow-up.Methods and results: We evaluated clinical outcome up to six years after PCI in all patients undergoing a PCI procedure for different indications in Sweden between 2006 and 2010. A total of 70,479 patients were treated for stable coronary artery disease (CAD) (21.0%), unstable angina (11.0%), non-ST-elevation myocardial infarction (NSTEMI) (36.6%) and ST-elevation myocardial infarction (STEMI) (31.4%). Mortality was higher in STEMI patients at one year after PCI (9.6%) compared to NSTEMI (4.7%), unstable angina (2.2%) and stable CAD (2.0%). At one year after PCI until the end of follow-up, the adjusted mortality risk (one to six years after PCI) and the risk of myocardial infarction were comparable between NSTEMI and STEMI patients and lower in patients with unstable angina and stable CAD. The adjusted risk of stent thrombosis and heart failure was highest in STEMI patients.Conclusions: The risk of short-term mortality, heart failure and stent thrombosis is highest for STEMI patients after PCI. Therapies to reduce stent thrombosis and heart failure appear to be most important in decreasing mortality in patients with STEMI or NSTEMI undergoing PCI.
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| 7. |
- Grimfjärd, Per, et al.
(författare)
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Unfractionated heparin versus bivalirudin in patients undergoing primary percutaneous coronary intervention : a SWEDEHEART study
- 2017
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Ingår i: EuroIntervention. - 1774-024X .- 1969-6213. ; 12:16, s. 2009-2017
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The aim of the stud was to compare outcomes in unfractionated heparin (UM) and bivalirudintreated patients undergoing primary percutaneous coronary intervention (PPCI). Methods and results: This observational study contained 20,612 PPCT patients treated with either GM monotherapv or bivalirudin with or without concomitant UFE. Patients with oral anticoagulant or glycoprotein IIb/IIIa inhibitor (GPI) treatment were excluded. The primary outcome measure was definite early stent thrombosis (Si) that occurred at low and similar rates in UNA only and bivalirudin-treated patients: 0.9% vs. 0.8% (adjusted hazard ratio [HR] 1.08, 95% confidence interval [CI]: 0.7-1.65). All-cause death at 30 days occurred in 6.9% vs. 5.4% of patients (adjusted HR 1.23, 95% Cl: 1.05-1.44) and within 365 days in 12.1% vs. 8.9% (adjusted HR 1.34, 95% CI: 1.19-1.52) in the two groups, respectively. The incidence of major bleeding within 30 days was 0.8% vs. 0.6% (adjusted HR 1.54, 95% CI: 0.97-2.45). The incidence of reinfarction within 365 days and stroke within 30 days was similar between groups. Conclusions: In this large, nationwide observational study we found low and similar rates of early ST in UFH only and bivalirudin-treated patients undergoing primary PCI. Mortality was higher in IJFH compared with bivalirudin-treated patients.
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| 8. |
- Harnek, Jan, et al.
(författare)
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Very long-term outcome of coronary covered stents : a report from the SCAAR registry
- 2019
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Ingår i: EuroIntervention. - 1774-024X .- 1969-6213. ; 14:16, s. 1660-1667
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: To elucidate the short and long-term outcome of patients treated with covered stents compared to all other stented patients. Covered stents are mostly used for coronary perforations with high risk of early adverse events, but their long-term outcome are unknown.METHODS AND RESULTS: The Swedish national registries from 2005 - 2017 disclosed 265 patients receiving 366 covered stents. Their outcomes were compared to all other 197 948 stented patients receiving 320 784 stents. Compared to regular stents, significant differences (p<0.001) between covered stents in short and long-term in respect to in-stent restenosis (ISR); target lesion revascularization (TLR); re-infarction (MI), Re-PCI and mortality, were all higher. The higher mortality was concentrated within the first month, as a landmark analysis at that time-point adjusted for age and procedural indication demonstrated no future difference in mortality, HR 1.02 (0.78-1.33) p=0.877. Stent thrombosis (ST) within one year were reported higher in covered stents than in other stents. However, no ST was reported in equine pericardial covered stents.CONCLUSIONS: This observational study including the entire Swedish population shows patients receiving a covered stents have a significantly higher risk of all adverse events. Reassuring, long-term the mortality appears to be similar to other stented patients.
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| 9. |
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| 10. |
- Witt, Nils, et al.
(författare)
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Sweden : coronary and structural heart interventions from 2010 to 2015
- 2017
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Ingår i: EuroIntervention. - 1774-024X .- 1969-6213. ; 13:Z, s. Z70-Z74
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Tidskriftsartikel (refereegranskat)abstract
- Sparsely populated and with wide non-urbanised areas, Sweden faces specific challenges in providing publicly financed, high-quality and equal healthcare to all parts of the country. As a result, a decentralised organisation for acute coronary care has been developed with coronary care units and catheterisation laboratories in several small- and medium-sized city areas. In contrast, highly specialised non-emergent interventional procedures are centralised to a few high-volume centres, mainly located at university hospitals in large city areas. Nationwide quality registries with nearly complete coverage facilitate healthcare quality improvement and form a basis for clinical research. In this report, we present an overview of demographics, healthcare organisation, quality registries and procedural data for coronary and structural heart interventions in Sweden over the past six years.
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