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| 2. |
- 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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| 3. |
- 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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| 4. |
- Buccheri, Sergio, et al.
(författare)
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Clinical outcomes with unselected use of an ultrathin-strut sirolimus-eluting stent : a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
- 2021
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Ingår i: EuroIntervention. - : European Society of Cardiology. - 1774-024X .- 1969-6213. ; 16:17, s. 1413-1421
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The aim of this study was to assess the real-world clinical performance of a sirolimus-eluting ultrathin-strut drug-eluting stent (DES) (Orsiro) in a large nationwide cohort of patients undergoing percu-taneous coronary intervention (PCI).Methods and results: From the Swedish Coronary Angiography and Angioplasty Registry, the two-year outcomes of 4,561 patients implanted with Orsiro (Orsiro group) and 69,570 receiving other newer-gen-eration DES (n-DES group) were analysed. The rate of definite stent thrombosis was low in both groups (0.67% and 0.83% for Orsiro and n-DES, respectively; adjusted hazard ratio [HR] 0.90, 95% confidence interval [CI]: 0.55-1.46, p-value 0.66). Restenosis was also infrequent (1.5% vs 2.0% with Orsiro and n-DES, adjusted HR 0.81, 95% CI: 0.63-1.03, p-value=0.09). The risk of target lesion revascularisation by PCI was lower in the Orsiro group (1.6% vs 2.3%, adjusted HR 0.75, 95% CI: 0.60-0.94, p-value=0.013). All-cause mortality and myocardial infarction did not show a statistically significant difference between the two groups (mortality of 7.5% in both groups, adjusted HR 0.99, 95% CI: 0.72-1.35, p-value=0.94; 6.0% vs 5.2% for myocardial infarction, adjusted HR 1.19, 95% CI: 1.00-1.43, p-value=0.06).Conclusions: In a nationwide scenario, the use of a sirolimus-eluting ultrathin-strut DES portended favourable clinical outcomes.
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| 5. |
- El Farissi, Mohamed, et al.
(författare)
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A randomised trial of selective intracoronary hypothermia during primary PCI
- 2024
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Ingår i: EuroIntervention. - : European Society of Cardiology. - 1774-024X .- 1969-6213. ; 20:12
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking.AIMS: We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI.METHODS: In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months.RESULTS: Selective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53).CONCLUSIONS: Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI. (ClinicalTrials.gov: NCT03447834).
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| 6. |
- Erlinge, David, et al.
(författare)
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A pooled analysis of the effect of endovascular cooling on infarct size in patients with ST-elevation myocardial infarction.
- 2013
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Ingår i: EuroIntervention. - 1969-6213. ; 8:12, s. 1435-1440
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Forskningsöversikt (refereegranskat)abstract
- Aims: Prior evaluations of endovascular cooling during primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) have suggested variability in treatment effect related to core temperature at the time of reperfusion, to infarct location and time from symptom onset to reperfusion. Recent results from a randomised feasibility study suggest rapid induction of hypothermia in primary PCI results in a significant reduction in infarct size (IS). Methods and results: Outcomes from two randomised trials of hypothermia in primary PCI were pooled to examine IS as a percentage of left ventricular myocardium assessed by SPECT or magnetic resonance imaging. Compared with controls (n=103), hypothermia (n=94) was associated with a significant 24% relative reduction (RR) in IS (10.7±1.3% vs. 14.1±1.6%, mean±SEM, p=0.049). Among hypothermia-treated patients for whom core temperature <35 C° was achieved before reperfusion, IS was reduced by 37% (8.8±1.7% vs. 14.1±1.6%, p=0.01), a benefit observed for both anterior (14.9±2.9% vs. 22.2±2.7%, RR 33%; p=0.03) and inferior infarcts (4.5±1.4% vs. 7.7±1.3%, RR 42%; p=0.04). Conclusions: In a pooled analysis of randomised trials evaluating adjunctive hypothermia in primary PCI, achievement of core body temperature <35°C before reperfusion may reduce infarct size with a similar efficacy for both anterior and inferior MI.
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| 7. |
- 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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| 8. |
- Grimfjärd, Per, et al.
(författare)
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Outcome of percutaneous coronary intervention with the Absorb bioresorbable scaffold : Data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
- 2017
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Ingår i: EuroIntervention. - 1774-024X .- 1969-6213. ; 13:11, s. 1304-1311
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Tidskriftsartikel (refereegranskat)abstract
- Aims: Randomised trials indicate higher rates of stent thrombosis (ST) and target lesion failure (TLF) after percutaneous coronary intervention (PCI) with the Absorb bioresorbable scaffold (BRS) compared with modern drug-eluting stents (DES). We aimed to investigate the outcome of all Swedish patients treated with the Absorb BRS. Methods and results: The Absorb BRS (n=810) was compared with commonly used modern DES (n=67,909). The main outcome measure was definite ST; mean follow-up was two years. Despite being implanted in a younger, lower-risk population compared with modern DES, the Absorb BRS was associated with a higher crude incidence of definite ST at stent level: 1.5 vs. 0.6%, hazard ratio (HR) 2.38 (95% confidence interval [CI]: 1.34-4.23), adjusted HR 4.34 (95% CI: 2.37-7.94); p<0.001. The patient level adjusted HR was 4.44 (95% CI: 2.25-8.77). Rates of in-stent restenosis were similar for BRS and DES. Non-compliance with dual antiplatelet therapy (DAPT) guidelines was noted in six out of 12 BRS ST events. Three very late ST events occurred with the Absorb BRS. Conclusions: In this real-world observational study, the Absorb BRS was associated with a significantly higher risk of definite ST compared with modern DES. Non-compliance with DAPT guideline recommendations was common among Absorb definite ST events.
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| 9. |
- 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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