Publications by authors named "Knud Erik Pedersen"

16 Publications

  • Page 1 of 1

Impact of chronic obstructive pulmonary disease on survival and symptoms of severe aortic valve stenosis.

Scand Cardiovasc J 2015 Feb 11;49(1):49-55. Epub 2015 Feb 11.

Department of Cardiology, Odense University Hospital , Denmark.

Background: As patients with severe aortic valve stenosis (AS) develop symptoms their survival decreases rapidly, if treated conservatively. Transcatheter aortic valve implantation (TAVI) has been introduced as a less invasive treatment alternative, especially in inoperable patients, who often have severe comorbidities, including chronic obstructive pulmonary disease (COPD).

Materials And Methods: Since the beginning of our TAVI program in March 2008, data on all 131 TAVI patients were prospectively and consecutively collected in this registry with complete follow-up. COPD was present in 37 patients. By January 2012 survival data were collected from the Danish Civil Registration System. Median follow-up duration was 559 days.

Results: Overall survival and survival from cardiac death was equivalent in both patients with and without COPD (p = 0.98 and p = 0.26) in the follow-up period. Further, patients with COPD had higher New York Heart Association (NYHA) class prior to intervention compared with those without (3.1 ± 0.5 vs. 2.9 ± 0.5, p = 0.02). In multivariate regression analysis COPD was associated with 30-day postoperative NYHA class (0.43; 95% confidence interval (CI): 0.10-0.75; p = 0.01), but not to NYHA class improvement from pre- to postintervention (0.25; 95% CI: - 0.12 to -0.63; p = 0.18).

Conclusions: In patients with symptomatic severe AS treated with TAVI, the presence of COPD neither affects overall survival nor survival from cardiac death. Patients with COPD had, however, both higher pre- and postoperative NYHA class compared with patients without COPD, but NYHA class improvement from pre- to postintervention was equivalent in both groups.
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http://dx.doi.org/10.3109/14017431.2015.1006671DOI Listing
February 2015

Influence of cardiogenic shock with or without the use of intra-aortic balloon pump on mortality in patients with ST-segment elevation myocardial infarction.

Int J Cardiol Heart Vasc 2015 Mar 30;6:19-24. Epub 2014 Dec 30.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: Cardiogenic shock is a serious complication of a ST-segment elevation myocardial infarction (STEMI). We compared short- and long-term mortality among (1) STEMI patients with and without cardiogenic shock and (2) STEMI patients with cardiogenic shock with and without the use of an intra-aortic balloon pump (IABP).

Methods: From January 1, 2002 to December 31, 2010, all patients presenting with STEMI and treated with primary percutaneous coronary intervention (PCI) were identified. The hazard ratio (HR) for death was estimated using a Cox regression model, controlling for potential confounding.

Results: The study cohort consisted of 4293 STEMI patients: 286 (6.7%) with and 4007 (93.3%) without cardiogenic shock. Compared with patients without cardiogenic shock, patients with cardiogenic shock were older, and more likely to have diabetes mellitus, multi-vessel disease, anterior myocardial infarction (MI) or bundle-branch block MI and a reduced creatinine clearance. Among patients with cardiogenic shock vs. without shock, 30-day cumulative mortality was 57.3% vs. 4.5% (p < 0.001), one-year cumulative mortality was 60.7% vs. 8.2% (p < 0.001) and five-year mortality was 65.0% vs. 18.9% (p < 0.001). STEMI with cardiogenic shock was associated with higher 30-day mortality (adjusted HR = 12.89 [95% CI: 9.72-16.66]), 1-year mortality (adjusted HR = 8.83 [95% CI: 7.06-11.05]) and five-year mortality (adjusted HR = 6.39 [95% CI: 5.22-7.80]). IABP was used in 71 (25%) patients with cardiogenic shock and was associated with improved 30-day outcome (adjusted HR = 0.48 [95% CI: 0.28-0.83]).

Conclusion: Patients with STEMI and cardiogenic shock had substantial short- and long-term mortality that may be improved with IABP implantation. More studies on use of IABP in such patients are warranted.
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http://dx.doi.org/10.1016/j.ijcha.2014.12.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5497164PMC
March 2015

Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV).

Circulation 2012 Mar 3;125(10):1246-55. Epub 2012 Feb 3.

Department of Cardiology, Odense University Hospital, Denmark.

Background: Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent.

Methods And Results: The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) trial was a randomized multicenter, single-blind, all-comer, 2-arm, noninferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were assigned to receive the everolimus-eluting stent and 1384 patients to the sirolimus-eluting stent. At the 9-month follow-up, 68 patients (4.9%) treated with the everolimus-eluting stent compared with 72 patients (5.2%) treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio, 0.94; 95% confidence interval, 0.67-1.31; P for noninferiority=0.01). At the 18-month follow-up, this differential remained: 99 patients (7.2%) treated with the everolimus-eluting stent versus 105 (7.6%) treated with the sirolimus-eluting stent (hazard ratio, 0.94; 95% confidence interval, 0.71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0.9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88).

Conclusion: The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552877.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.111.063644DOI Listing
March 2012

Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial.

EuroIntervention 2011 Jul;7(3):323-31

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Aims: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients.

Methods And Results: In the DiabeDES III trial, 127 patients were randomised to SES or ZES stent implantation. Angiographic 10-month follow-up data were available in 105 patients, including 48 SES and 57 ZES treated patients. Angiographic endpoints were in-stent late lumen loss and minimal lumen diameter. IVUS endpoints included NIH volume and in-stent percent volume obstruction. Baseline clinical characteristics and lesion parameters were similar in the two groups. At 10-month follow-up, angiographic in-stent late lumen loss (0.14±0.37 mm vs. 0.74±0.45 mm, p<0.001) was reduced and minimum lumen diameter was higher (2.36±0.53 mm vs. 1.96±0.65, p<0.001) in the SES group as compared to the ZES group. As compared to the ZES group, NIH volume was significantly reduced in the SES group (median [interquartile range]: 0.0 mm3 [0.0 to 1.2] vs. 16.5 mm3 [6.2 to 31.1], p<0.001). In-stent% volume obstruction was significantly reduced in SES as compared to ZES (median [interquartile range]: 0.0% [0.0-0.7] vs. 13.0% [6.7-20.8], p<0.001).

Conclusions: In diabetic patients, the SES reduced angiographic late lumen loss and inhibited NIH more effectively than ZES.
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http://dx.doi.org/10.4244/EIJV7I3A56DOI Listing
July 2011

Rationale and design of a randomized clinical comparison of everolimus-eluting (Xience v/Promus) and sirolimus-eluting (cypher select+) coronary stents in unselected patients with coronary heart disease.

Cardiology 2010 3;116(2):73-8. Epub 2010 Jun 3.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: The sirolimus-eluting stent has demonstrated the least amount of late lumen loss among previously released drug-eluting stents, but its safety and efficacy has not been compared head-to-head with the everolimus-eluting stent.

Method: The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non-inferiority design, power calculations estimated a needed enrolment of 2,678 patients. The primary endpoint is a composite of cardiac death, myocardial infarction, and stent thrombosis or target vessel revascularization after 9 months. Data on clinical events and mortality for all randomized patients will be obtained from national databases at 9 months. No clinical follow-up examination is scheduled.

Conclusion: The SORT OUT IV trial will directly compare clinically relevant differences in efficacy and safety in two drug-eluting stents: a first-generation sirolimus-eluting stent versus a second-generation everolimus-eluting stent. The study makes use of clinical endpoints routinely collected in computerized healthcare registries, allowing complete follow-up of a large, well-defined population without scheduled angiographic examinations.
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http://dx.doi.org/10.1159/000315136DOI Listing
October 2010

Clinical outcome after primary percutaneous coronary intervention with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction.

Circ Cardiovasc Interv 2008 Dec;1(3):176-84

Department of Cardiology, Odense University Hospital, Sdr. Boulevard 29, Odense, Denmark.

Background: The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis, myocardial infarction, and death after the implantation of DES or BMS in primary PCI patients in Western Denmark.

Methods And Results: A total of 3756 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI and stent implantation, recorded in the Western Denmark Heart Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjusted RR=6.74; 95% CI=1.23 to 37.00; P=0.03). The 2-year incidence of myocardial infarction was similar in the 2 groups, 5.2% in the DES group versus 6.3% in the BMS group (P=0.28; adjusted RR=1.13; 95% CI=0.81 to 1.59; P=0.47). All-cause 2-year mortality was 7.8% in the DES group and 11.4% in BMS group (P<0.004; adjusted RR=0.79; 95% CI=0.60 to 1.04; P=0.09). The 2-year incidence of target lesion revascularization was 7.2% in the DES group and 8.7% in the BMS group (P=0.09; adjusted RR=0.70; 95% CI=0.52 to 0.92; P=0.012).

Conclusions: In ST-segment elevation myocardial infarction patients treated with primary PCI, target lesion revascularization was reduced by 30% in patients treated with a DES. The risk of very late definite stent thrombosis was low but increased in patients treated with DES. DES was not associated with increased risk of myocardial infarction or death, when compared with BMS.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.108.794578DOI Listing
December 2008

Outcome in high risk patients with unprotected left main coronary artery stenosis treated with percutaneous coronary intervention.

Catheter Cardiovasc Interv 2010 Jan;75(1):101-8

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Objective: We examined mortality, risk of myocardial infarction (MI), and target lesion revascularization (TLR) in high-risk patients with unprotected left main (LM) percutaneous coronary intervention (PCI) in Western Denmark.

Background: PCI of left main coronary artery lesions may be an alternative to coronary artery bypass grafting in high-risk surgical patients.

Methods: From January 2005 to May 2007, all patients who had unprotected LM PCI with stent implantation were identified in the Western Denmark Heart Registry. The indications for PCI were: (1) ST segment elevation MI (STEMI), (2) non-STEMI (NSTEMI) or unstable angina, and (3) stable angina. All patients were followed up for 18 months.

Results: A total of 344 patients were treated with LM PCI (STEMI: 71, NSTEMI/unstable angina: 157, and stable angina: 116). In STEMI patients, the median logistic EuroSCORE was 22.5 (interquartile range 12.5-39.5), in non-STEMI (NSTEMI)/unstable angina patients 13.8 (4.8-23.9), and in stable angina patients 4.8 (2.2-10.4). Mortality after 18 months 38.0, 18.5, and 11.2% (P < 0.001) in patients with STEMI, NSTEMI/unstable angina, and stable angina, respectively. MI after 18 months was 9.9, 6.4, and 6.0% (P = ns), respectively. Four subacute and one late definite stent thrombosis were seen. TLR occurred in 5.6, 4.5, and 6.9% (P = ns) of patients, respectively.

Conclusion: After PCI, patients with STEMI and LM culprit lesion have a high-mortality risk, whereas long-term outcome for patients with NSTEMI and stable angina pectoris is comparable with other high surgical risk patients with unprotected left main lesion. Further, TLR rates and risk of stent thrombosis were low.
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http://dx.doi.org/10.1002/ccd.22205DOI Listing
January 2010

Comparison of intravascular ultrasound and angiographic assessment of coronary reference segment size in patients with type 2 diabetes mellitus.

Am J Cardiol 2008 Mar 14;101(5):590-5. Epub 2008 Jan 14.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

During percutaneous coronary intervention, the reference segment is assessed angiographically. This report described the discrepancy between angiographic and intravascular ultrasound (IVUS) assessment of reference segment size in patients with type 2 diabetes mellitus. Preintervention IVUS was used to study 62 de novo lesions in 41 patients with type 2 diabetes mellitus. The lesion site was the image slice with the smallest lumen cross-sectional area (CSA). The proximal and distal reference segments were the most normal-looking segments within 5 mm proximal and distal to the lesion. Plaque burden was measured as plaque CSA/external elastic membrane (EEM) CSA. Using IVUS, the reference lumen diameter was 2.80 +/- 0.42 mm and the reference EEM diameter was 4.17 +/- 0.56 mm. The angiographic reference diameter was 2.63 +/- 0.36 mm. Mean difference between the IVUS EEM diameter and angiographic reference diameter was 1.56 +/- 0.55 mm. The mean difference between the IVUS reference lumen diameter and angiographic reference lumen diameter was 0.18 +/- 0.44 mm. Plaque burden in the reference segment correlated inversely with the difference between IVUS and quantitative coronary angiographic reference lumen diameter (slope = -0.12, 95% confidence interval -0.17 to -0.07, p <0.001), but it was not related to the absolute angiographic reference lumen diameter. Thus, reference segment diameters in type 2 diabetic patients were larger using IVUS than angiography, especially in the setting of larger plaque burden. In conclusion, these findings combined with inadequate remodeling may explain the angiographic appearance of small arteries in diabetic patients.
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http://dx.doi.org/10.1016/j.amjcard.2007.10.020DOI Listing
March 2008

Influence of a pressure gradient distal to implanted bare-metal stent on in-stent restenosis after percutaneous coronary intervention.

Circulation 2007 Dec 19;116(24):2802-8. Epub 2007 Nov 19.

Department of Cardiology, Catheterization Laboratory, Odense University Hospital, Sdr Blvd 29, 5000 Odense C, Denmark.

Background: Fractional flow reserve predicts cardiac events after coronary stent implantation. The aim of the present study was to assess the 9-month angiographic in-stent restenosis rate in the setting of optimal stenting and a persisting gradient distal to the stent as assessed by a pressure wire pullback recording in the entire length of the artery.

Methods And Results: In 98 patients with angina pectoris, 1 de novo coronary lesion was treated with a bare-metal stent. After stent implantation, pressure wire measurements (P(d)=mean hyperemic coronary pressure and P(a)=mean aortic pressure) were performed in the target vessel: (1) P(d)/P(a) as distal to the artery as possible (fractional flow reserve per definition); (2) P(d)/P(a) just distal to the stent; (3) P(d)/P(a) just proximal to the stent; and (4) P(d)/P(a) at the ostium. Residual abnormal P(d)/P(a) was defined as a pressure drop between P(d)/P(a) measured at points 1 and 2. Fractional flow reserve distal to the artery after stenting was significantly lower (0.88+/-0.21 versus 0.97+/-0.05; P<0.001), and angiographic in-stent binary restenosis rate was significantly higher (44.0% versus 8.1%; P<0.001) in vessels with a residual abnormal P(d)/P(a). Residual abnormal P(d)/P(a) (odds ratio, 4.39; 95% confidence interval, 1.10 to 18.16; P=0.034), reference vessel size (odds ratio, 0.17; 95% confidence interval, 0.04 to 0.69; P=0.013), and stent length (odds ratio, 1.11; 95% confidence interval, 1.03 to 1.21; P=0.009) were predictors of angiographic in-stent restenosis after 9 months.

Conclusions: A residual abnormal P(d)/P(a) distal to a bare-metal stent was an independent predictor of in-stent restenosis after implantation of a coronary bare-metal stent.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.107.704064DOI Listing
December 2007

Intravascular ultrasound assessment of remodelling and reference segment plaque burden in type-2 diabetic patients.

Eur Heart J 2007 Jul 31;28(14):1759-64. Epub 2007 May 31.

Catheterization Laboratory, Department of Cardiology, Odense University Hospital, Odense C, Denmark.

Aims: Intravascular ultrasound (IVUS) assesses arterial remodelling by comparing the lesion external elastic membrane (EEM) with the reference segments; however, reference segments are rarely disease-free. The aim was to assess lesion and reference segment remodelling and plaque burden in patients with type-2 diabetes mellitus.

Methods And Results: We used pre-intervention IVUS to study 62 de novo lesions in 43 patients with type-2 diabetes mellitus. The lesion site was the image slice with the smallest lumen cross-sectional area (CSA). The proximal and distal reference segments were the most normal-looking segments within 5 mm proximal and distal to the lesion. Plaque burden was measured as plaque CSA/EEM CSA. The remodelling index was defined as lesion EEM CSA/mean reference EEM CSA. Reference segment plaque burden measured 0.54 +/- 0.09. The majority of lesions (83.9%) had negative remodelling (lesion EEM < reference). Similarly, the slope of the regression line relating EEM to plaque CSA within the lesion was less than the reference substantiating negative remodelling. The reference segment plaque burden correlated inversely with the difference between IVUS lumen and quantitative coronary angiographic artery size [slope = -0.12 (95% CI -0.17 to -0.07); P < 0.001] in all patients with type-2 diabetes mellitus.

Conclusion: Lesions in type-2 diabetic patients are different from previous reports in non-diabetics. Lesions in type-2 diabetics are characterized by a large reference segment plaque burden and negative lesion site remodelling. These IVUS findings may explain the angiographic appearance of small arteries in diabetic patients.
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http://dx.doi.org/10.1093/eurheartj/ehm175DOI Listing
July 2007

Recruitable collateral blood flow index predicts coronary instent restenosis after percutaneous coronary intervention.

Eur Heart J 2007 Aug 24;28(15):1820-6. Epub 2007 Apr 24.

Department of Cardiology, Catheterization Laboratory, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Denmark.

Aims: Collateral flow may influence long-term results after percutaneous coronary intervention (PCI) because of haemodynamic forces compete with the antegrade flow through the dilated lesion. The aim of the study was to assess the influence of recruitable collateral blood flow on restenosis in patients undergoing PCI with bare metal stents and using optimal antithrombotic treatment.

Methods And Results: In 95 patients, 95 de novo lesions were treated with PCI and a bare metal stent. Fractional flow reserve (FFR) at maximum hyperaemia induced by intravenous adenosine was determined. The pressure-derived collateral flow index (CFI) was determined as (P(w)-P(cvp))/(P(a)-P(cvp)), where P(w) represents coronary wedge pressure, P(cvp) central venous pressure, and P(a) mean aortic blood pressure. Both were measured during transient coronary occlusion by a balloon inflation of 30 s. Pre-interventional FFR (0.65 +/- 0.20) correlated inversely with the CFI (0.18 +/- 0.11), r =- 0.356, P < 0.001. After 9 months, binary angiographic restenosis (>/=50% diameter stenosis) was seen in 29.1%. Compared to patients with poorly developed collaterals (CFI < 0.25), patients with well-developed collaterals (CFI >/= 0.25) had a lower pre-interventional FFR (0.50 +/- 0.14 vs. 0.72 +/- 0.18, P < 0.001), a higher CFI (0.33 +/- 0.08 vs. 0.13 +/- 0.07, P < 0.001), and a higher binary restenosis rate (54.2% vs. 19.4, P = 0.003). CFI*100 was an independent predictor of restenosis after 9 months (odds ratio 1.07, 95% CI 1.02-1.12, P = 0.016).

Conclusion: Recruitable collateral blood flow measured during balloon inflation predicts angiographic instent restenosis in PCI patients treated with bare metal stents.
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http://dx.doi.org/10.1093/eurheartj/ehm067DOI Listing
August 2007

Effect of simvastatin on coronary lesion site remodeling: a serial intravascular ultrasound study.

Cardiology 2006 18;106(4):256-63. Epub 2006 May 18.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: Direct evidence of coronary artery remodeling can be derived only from serial changes in the external elastic membrane (EEM) and plaque area. The aim of the study was to assess the effect of simvastatin on coronary remodeling in serial intravascular ultrasound (IVUS) studies.

Methods: In 39 male patients ECG-triggered transducer pullback IVUS was performed at baseline, after 3 months on a lipid-lowering diet (control period), and after another 12 months of simvastatin 40 mg/day. The lesion site was the image slice with maximum plaque burden at 3 months.

Results: Absolute changes in the EEM area correlated significantly with changes in plaque area during the control period [B = 0.966, r = 0.792 (95% CI 0.71-1.22); p < 0.001] and during simvastatin treatment [B = 0.945, r = 0.822 (95% CI 0.73-1.16); p < 0.001], but there was no significant difference in the slope (delta EEM/delta plaque) between the two time intervals. After 12 months of simvastatin, there was a significant reduction in the lesion EEM area of 4.6% (p = 0.006) and in the lesion plaque area of 5.9% (p < 0.001), but there was no change in reference measurements. As a result, the remodeling index was reduced by simvastatin from 1.01 +/- 0.12 to 0.95 +/- 0.09 (p < 0.001).

Conclusion: Simvastatin decreases the remodeling index by reducing lesion, but not reference plaque and EEM area. However, simvastatin does not affect direct evidence of remodeling (delta EEM/delta plaque) obtained using serial IVUS studies.
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http://dx.doi.org/10.1159/000093367DOI Listing
February 2007

Short- and long-term influence of diet and simvastatin on brachial artery endothelial function.

Int J Cardiol 2006 Feb;107(1):101-6

Department of Cardiology, Catheterization Laboratory, Odense University Hospital, Sdr. Boulevard 29, DK-5000, Odense, Denmark.

Background: Endothelium-dependent dilation (EDD) has often been studied in patients with hypercholesterolemia without overt coronary atherosclerosis where an improvement after statin treatment has been documented within few weeks. The aim of the study was to assess the short-term effect of diet as well as short- and long-term effect of simvastatin on EDD in patients with hypercholesterolemia and ischemic heart disease.

Methods: In 43 male patients with hypercholesterolemia and ischemic heart disease, EDD of the brachial artery was measured at baseline, after 3 months on a lipid-lowering diet, and after another 1, 3 and 12 months on simvastatin at 40 mg/day.

Results: Three months changes in EDD were neither influenced by diet nor short-term simvastatin therapy (4.9% vs. 4.9% vs. 4.8%, p=ns). Twelve months simvastatin treatment, however, significantly improved EDD by 32.7% (4.9% vs. 6.5%, p=0.007). By regression analysis an individual adjusted increase in EDD during the simvastatin treatment period was seen (coefficient 0.132 a month, p=0.002). A significant reduction in total cholesterol of 31.0% (6.1+/-0.8 vs. 4.2+/-0.7, p<0.001) and LDL cholesterol of 42.6% (4.0+/-0.8 vs. 2.2+/-0.6, p<0.001) was observed.

Conclusion: EDD is improved after long-term simvastatin therapy; however, neither did 3 months diet or 3 months simvastatin therapy has influence on the EDD.
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http://dx.doi.org/10.1016/j.ijcard.2005.02.041DOI Listing
February 2006

Randomized comparison of deliverability and in-hospital complications in implantation of BxSonic(R), Express(R), and Flexmaster(R) coronary stents.

EuroIntervention 2005 Nov;1(3):273-6

Department of Cardiology, Skejby Hospital, University of Aarhus, Denmark.

Aims: To compare deliverability and in-hospital complications in implantation of BxSonic(R), Express(R), and Flexmaster(R) coronary stents in a randomized multicenter trial in five Danish interventional centres.

Methods And Results: Patients with planned stenting of at least one stenotic lesion in a native coronary artery were included in the study. There were 494 (664) patients (treated lesions) in the BxSonic(R), 499 (657) in the Express(R) and 500 (658) in the Flexmaster(R) groups. The groups were well matched with regard to age, sex, diabetes, smoking, hypercholesterolemia, hypertension, indication for PCI and coronary artery lesion complexity. The study stents were implanted with or without predilatation according to ordinary -clinical practice.Rates of successful stent implantation and in-hospital stent thrombosis, re-intervention, non-fatal myocardial infarction or death. The BxSonic(R), Express(R) and Flexmaster(R) stents were successfully implanted in 92,2%, 89,3% and 91,6% of all lesions (ns). There were no in-hospital deaths and the rates of in-hospital complications were similar in the three stent groups.

Conclusion: We found similar deliverability and in-hospital complication rates of the BxSonic(R), Express(R) and Flexmaster(R) stents.
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November 2005

Low variation and high reproducibility in plaque volume with intravascular ultrasound.

Int J Cardiol 2004 Dec;97(3):463-9

Catherization Laboratorium, Department of Cardiology, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense, Denmark.

Background: Intravascular ultrasound (IVUS) has several advantages compared to angiography when evaluating coronary atherosclerosis in the vessel wall.

Methods: The accuracy, reproducibility, and short-time spontaneous variation in volume of vessel, plaque and lumen were studied by electrocardiographic-gated three-dimensional (3D) IVUS in 20 male patients with ischaemic heart disease (IHD).

Results: The study lesions were angiographically insignificant, with a length of the analysed segment on 11.4+/-5.9 mm. At baseline the mean minimal lumen diameter was 2.41+/-0.59 mm, minimal lumen area 4.82+/-2.38 mm2, and maximal plaque burden 65.61+/-9.57%. Mean reference diameter was 3.1+/-0.6 mm. No significant changes were observed in volumes of total vessel, lumen or plaque. The coefficient of variation (CV) for two volume measurements at baseline was: vessel 0.8%, plaque 1.3%, and lumen 1.4%. For measurements recorded at baseline and after 12.6+/-1.5 weeks, CV was respectively 3.5%, 3.3% and 6.6%. Reproducibility and interobserver and intraobserver variation showed very high correlations. A linear correlation was present in percent changes over 12.6+/-1.5 weeks between vessel volume and lumen volume (r=0.804; p<0.001) and between percent changes in plaque volume and vessel volume (r=0.581; p=0.007). No correlation was found between changes in plaque volume and lumen volume (r=0.015; p=0.950).

Conclusion: ECG-gated 3D IVUS is a highly reproducible method when applied on coronary artery atherosclerosis. CV for lumen volume over 12.6+/-1.5 weeks is twice that of plaque volume indicating the superiority of the 3D IVUS compared to coronary angiography (CAG).
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http://dx.doi.org/10.1016/j.ijcard.2003.10.036DOI Listing
December 2004

Regression of coronary atherosclerosis by simvastatin: a serial intravascular ultrasound study.

Circulation 2004 Jul 6;110(3):265-70. Epub 2004 Jul 6.

Department of Cardiology, Catheterization Laboratorium, Odense University Hospital, Odense, Denmark.

Background: Angiography of the coronary arteries reflects only changes in luminal dimensions. With intravascular ultrasound, cross-sectional images can be obtained and area measurements can be added to calculate volumes of the external elastic membrane (EEM), plaque plus media (P+M), and lumen. The aim of this study was to investigate the effect of lipid lowering by simvastatin on coronary atherosclerotic P+M as changes in volumes of EEM, P+M, and lumen.

Methods And Results: In 40 male patients with hypercholesterolemia, ischemic heart disease, and a nonsignificant coronary artery lesion in a not previously revascularized coronary artery, serial intravascular ultrasound studies with an ECG-triggered pullback were performed at baseline, after 3 months on a lipid-lowering diet, and after another 12 months on simvastatin 40 mg/d. Mean length of the analyzed atherosclerotic segments was 5.9+/-3.3 mm. After 12 months on simvastatin, a significant reduction in P+M volume of 6.3% (P=0.002) was observed, whereas only a nonsignificant reduction in EEM volume of 1.8% was seen without any concomitant change in lumen volume. A significant reduction in total cholesterol of 31.0% (6.1+/-0.8 versus 4.2+/-0.7 mmol/L, P<0.001) and LDL cholesterol of 42.6% (4.0+/-0.8 versus 2.2+/-0.6 mmol/L, P<0.001) was obtained.

Conclusions: Lipid-lowering therapy with simvastatin for 12 months is associated with a significant P+M regression in coronary arteries measured as reduction in P+M and EEM volumes without any concomitant change in lumen volume.
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http://dx.doi.org/10.1161/01.CIR.0000135215.75876.41DOI Listing
July 2004