Publications by authors named "Lars Romer Krusell"

30 Publications

  • Page 1 of 1

Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II).

Circ Cardiovasc Imaging 2018 03;11(3):e007107

From the Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (J.W., S.W., M.-B.V., B.K.A., E.N.H., C.F.M., L.N.A., J.K.S., S.D.K., M.M., A.K., C.J.T., L.R.K., L.J., J.F.L., H.E.B., E.H.C., N.R.H.); Med-X Research Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, China (S.T., Y.Z.); Department of Cardiology, Hospitalsenheden Vest, Regionshospitalet Herning, Denmark (L.N., M.B.); Department of Cardiology, Hospitalsenheden Midt, Regionshospitalet Silkeborg, Denmark (J.K.J.); and Department of Radiology, Leiden University Medical Center, The Netherlands (J.H.C.R.).

Background: Quantitative flow ratio (QFR) is a novel diagnostic modality for functional testing of coronary artery stenosis without the use of pressure wires and induction of hyperemia. QFR is based on computation of standard invasive coronary angiographic imaging. The purpose of WIFI II (Wire-Free Functional Imaging II) was to evaluate the feasibility and diagnostic performance of QFR in unselected consecutive patients.

Methods And Results: WIFI II was a predefined substudy to the Dan-NICAD study (Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease), referring 362 consecutive patients with suspected coronary artery disease on coronary computed tomographic angiography for diagnostic invasive coronary angiography. Fractional flow reserve (FFR) was measured in all segments with 30% to 90% diameter stenosis. Blinded observers calculated QFR (Medis Medical Imaging bv, The Netherlands) for comparison with FFR. FFR was measured in 292 lesions from 191 patients. Ten (5%) and 9 patients (5%) were excluded because of FFR and angiographic core laboratory criteria, respectively. QFR was successfully computed in 240 out of 255 lesions (94%) with a mean diameter stenosis of 50±12%. Mean difference between FFR and QFR was 0.01±0.08. QFR correctly classified 83% of the lesions using FFR with cutoff at 0.80 as reference standard. The area under the receiver operating characteristic curve was 0.86 (95% confidence interval, 0.81-0.91) with a sensitivity, specificity, negative predictive value, and positive predictive value of 77%, 86%, 75%, and 87%, respectively. A QFR-FFR hybrid approach based on the present results enables wire-free and adenosine-free procedures in 68% of cases.

Conclusions: Functional lesion evaluation by QFR assessment showed good agreement and diagnostic accuracy compared with FFR. Studies comparing clinical outcome after QFR- and FFR-based diagnostic strategies are required.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02264717.
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http://dx.doi.org/10.1161/CIRCIMAGING.117.007107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895131PMC
March 2018

High-pressure balloon fracturing of small dysfunctional Mitroflow bioprostheses facilitates transcatheter aortic valve-in-valve implantation.

EuroIntervention 2017 Oct;13(9):e1020-e1025

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

Aims: Transcatheter valve-in-valve (VIV) implantation is usually discouraged in small surgical tissue valves. We report our first ten cases of fracturing small dysfunctional Mitroflow bioprostheses by high-pressure balloon dilatation to increase the internal diameter of the surgical valve before VIV (BF-VIV).

Methods And Results: BF-VIV was performed in 10 patients (mean age 84±4 years) with failing Mitroflow valves size 19 mm (n=3, threshold of fracture 15 atm) and 21 mm (n=7, threshold of fracture 13 atm). An Edwards SAPIEN 3 or XT 20 mm or 23 mm transcatheter valve was implanted inside the fractured Mitroflow bioprosthesis. The procedure improved aortic valve area (0.7±0.3 vs. 1.1±0.3 cm2, p=0.001), reduced peak aortic valve gradient (66±27 vs. 29±7 mmHg, p=0.002), resolved aortic regurgitation and improved patients' NYHA functional class (p=0.005). One patient had a minor stroke with complete resolution of symptoms and another patient required a pacemaker due to AV block. All patients were still alive at the end of follow-up (438±255 days).

Conclusions: Initial experience with transcatheter BF-VIV suggests that this method is feasible and safe, and that it improves aortic valve haemodynamics and clinical functional capacity. BF-VIV is a promising alternative to repeat surgery in patients with small failing Mitroflow bioprostheses.
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http://dx.doi.org/10.4244/EIJ-D-17-00244DOI Listing
October 2017

Computed tomography derived fractional flow reserve testing in stable patients with typical angina pectoris: influence on downstream rate of invasive coronary angiography.

Eur Heart J Cardiovasc Imaging 2018 04;19(4):405-414

Department of Cardiology, Aarhus University Hospital-Skejby, 8200 Aarhus N, Denmark.

Aims: To assess the use of downstream coronary angiography (ICA) and short-term safety of frontline coronary CT angiography (CTA) with selective CT-derived fractional flow reserve (FFRCT) testing in stable patients with typical angina pectoris.

Methods And Results: Between 1 January 2016 and 30 June 2016 all patients (N = 774) referred to non-emergent ICA or coronary CTA at Aarhus University Hospital on a suspicion of CAD had frontline CTA performed. Downstream testing and treatment within 3 months and adverse events ≥90 days were registered. Patients were divided into two groups according to the presence of typical angina pectoris, which according to local practice would have resulted in referral to ICA, (low-intermediate-risk, n = 593 [76%]; high-risk, n = 181 [24%]) with mean pre-test probability of CAD of 31 ± 16% and 67 ± 16%, respectively. Coronary CTA was performed in 745 (96%) patients in whom FFRCT was prescribed in 212 (28%) patients. In the high- vs. low-intermediate-risk group, ICA was cancelled in 75% vs. 91%. Coronary revascularization was performed more frequently in high-risk than in low-intermediate-risk patients, 76% vs. 52% (P = 0.03). Mean follow-up time was 157 ± 50 days. Serious clinical events occurred in four patients, but not in any patients with cancelled ICA by coronary CTA with selective FFRCT testing.

Conclusion: Frontline coronary CTA with selective FFRCT testing in stable patients with typical angina pectoris in real-world practice is associated with a high rate of safe cancellation of planned ICAs.
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http://dx.doi.org/10.1093/ehjci/jex068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5915944PMC
April 2018

Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial.

Circ Cardiovasc Interv 2016 07;9(7)

From the Department of Cardiology, Odense University Hospital, Denmark (L.O.J., P.T., A.J., K.T.V., K.N.H., H.S.H.); Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (M. Maeng, L.R.K., C.J.T., A.K., S.D.K., H.E.B., J.F.L., E.H.C.); Department of Cardiology, Aalborg University Hospital, Denmark (J.R., B.R., A.B.V., H.-H.T., J.A., S.E.J.); and Department of Clinical Epidemiology, Aarhus University, Denmark (M. Madsen, K.B.).

Background: Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy.

Methods And Results: The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, -0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05).

Conclusions: The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003610DOI Listing
July 2016

Staged re-evaluation of non-culprit lesions in ST segment elevation myocardial infarction: a retrospective study.

Open Heart 2016;3(1):e000427. Epub 2016 Jun 24.

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

Objective: It remains unknown whether complete revascularisation is optimally performed in patients with ST segment elevation myocardial infarction (STEMI) during the index or at staged procedures. The aims of this study were to quantify the number of primary percutaneous coronary intervention (PCI) procedures in which non-culprit lesions needed further evaluation, to determine the consequence of the re-evaluation and to quantify adverse cardiac events during the waiting time for re-evaluation and intervention.

Methods: The study was observational and retrospective and included all patients with STEMI treated with primary PCI during 1 year at our centre.

Results: Among the 507 patients with STEMI, 374 were considered sufficiently treated with culprit lesion PCI only. Complete primary multivessel revascularisation was performed in 11 patients. Non-culprit lesion re-evaluation was planned for 122 patients (24%). Of these 122 patients, 3 patients died during their index admission. Follow-up data were not available for 3 patients. Among the 116 patients, 187 non-culprit lesions were re-evaluated and 77 patients (66.4%) underwent revascularisation with treatment of 119 lesions (63.3%). Re-evaluation was performed after a median of 30 days (25th centile: 9 days, 75th centile: 35 days). During the waiting time for re-evaluation, two patients underwent a new primary PCI due to stent thrombosis of the index culprit lesion.

Conclusions: Staged re-evaluation of non-culprit lesions observed in patients with STEMI was required in 24% of a primary PCI cohort. Intervention was performed in 66.4% of patients scheduled for re-evaluation. We observed no adverse events related to the non-culprit lesions during the waiting time for a staged re-evaluation or intervention.
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http://dx.doi.org/10.1136/openhrt-2016-000427DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4932309PMC
July 2016

Fracturing the Ring of Small Mitroflow Bioprostheses by High-Pressure Balloon Predilatation in Transcatheter Aortic Valve-in-Valve Implantation.

Circ Cardiovasc Interv 2015 Aug;8(8):e002667

From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark.

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.002667DOI Listing
August 2015

A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the DiabeDES IV randomized angiography trial).

Catheter Cardiovasc Interv 2015 Dec 6;86(7):1161-7. Epub 2015 May 6.

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

Objective: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.

Background: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.

Methods: We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.

Results: At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).

Conclusion: EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.
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http://dx.doi.org/10.1002/ccd.25875DOI Listing
December 2015

Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial.

Lancet 2015 Apr 16;385(9977):1527-35. Epub 2015 Jan 16.

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

Background: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.

Methods: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448.

Findings: Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.

Interpretation: The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.

Funding: Medtronic Cardiovascular and Biosensors Interventional Technologies.
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http://dx.doi.org/10.1016/S0140-6736(14)61794-3DOI Listing
April 2015

Co-registration of optical coherence tomography and X-ray angiography in percutaneous coronary intervention. the Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) fusion study.

Int J Cardiol 2015 Mar 27;182:272-8. Epub 2014 Dec 27.

Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. Electronic address:

Background: Intracoronary imaging provides accurate lesion delineation and precise measurements for sizing and positioning of coronary stents. During percutaneous coronary intervention (PCI), it may be challenging to identify corresponding segments between intracoronary imaging and angiography. Computer based online co-registration may aid the target segment identification.

Methods: The DOCTOR fusion study was a prospective, single arm, observational study including patients admitted for elective PCI. Optical coherence tomography (OCT) was acquired pre-stent implantation for sizing of stents. The operator subsequently indicated on the angiogram the target area as identified by OCT. Computer based co-registration was performed on-line immediately after pre-stent acquisition to assess feasibility. The cumulated numerical difference between operator based, and computer based co-registration was assessed as the "Operator Registration Error". The operator implanted the stent blind to the co-registrated angiogram. The difference between the co-registered stent border positions and the actual stent deployment border positions was the "Geographic Miss Distance".

Results: Twenty-two patients were included in the study. Two patients were excluded due to missing pre or post-OCT acquisitions. Online co-registration pre-stenting was successful in all analyzed cases. The mean "Operator Registration Error" was 5.4±3.5mm. The mean "Geographic Miss Distance" was 5.4±2.6mm. Without access to the computer-based co-registration, segments of the target lesion indicated on OCT were left uncovered by stent in 14 patients (70%).

Conclusion: Computer based online co-registration of OCT and angiography is feasible. Frequent inaccuracies in operator based registration indicate that computer aided co-registration may reduce errors in corresponding OCT findings to the angiogram.
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http://dx.doi.org/10.1016/j.ijcard.2014.12.088DOI Listing
March 2015

Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation: an observational study.

BMC Cardiovasc Disord 2014 Aug 13;14:100. Epub 2014 Aug 13.

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

Background: The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available.

Methods: We followed 4,154 patients treated with coronary drug-eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases.

Results: Discontinuation of clopidogrel within the first 3 months after stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (hazard ratio (HR) 2.06; 95% confidence interval (CI): 1.08-3.93). Discontinuation 3-6 months (HR 1.29; 95% CI: 0.70-2.41) and 6-12 months (HR 1.29; 95% CI: 0.54-3.07) after stent implantation were associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE rates were highest within the first 2 months after discontinuation.

Conclusions: Discontinuation of clopidogrel was associated with an increased rate of MACE among patients treated with drug-eluting stents. The increase was statistically significant within the first 3 months after drug-eluting stent implantation but not after 3 to 12 months.
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http://dx.doi.org/10.1186/1471-2261-14-100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4135343PMC
August 2014

Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial.

Lancet 2014 Jun 14;383(9934):2047-2056. Epub 2014 Mar 14.

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

Background: In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents.

Methods: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478.

Findings: We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17.0%] vs sirolimus-eluting stents 182/1170 [15.6%]; odds ratio [OR] 1.10, 95% CI 0.88-1.37; p=0.40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170 [3.9%]; OR 2.13, 95% CI 1.48-3.07; p<0.0001) compared with those at follow-up between 1 and 5 years (104 [9.0%] vs 136 [11.6%]; OR 0.78, 95% CI 0.59-1.02; p=0.071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1.1%]) than the sirolimus-eluting stent (4/1170 [0.3%]; OR 3.34, 95% CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1%] vs sirolimus-eluting stent 21/1170 [1.8%], OR 0.05, 95% CI 0.01-0.36; p=0.003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period.

Interpretation: The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation.

Funding: Cordis and Medtronic.
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http://dx.doi.org/10.1016/S0140-6736(14)60405-0DOI Listing
June 2014

Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial.

Lancet 2013 Feb 30;381(9867):661-9. Epub 2013 Jan 30.

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

Background: Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer-coated sirolimus-eluting stent in a population-based setting.

Methods: This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites across western Denmark. Eligible patients were aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion (>50% diameter stenosis). We randomly assigned patients (1:1) using an independently managed computer-generated allocation sequence to receive either a biolimus-eluting biodegradable polymer stent (Nobori, Terumo, Tokyo, Japan) or a sirolimus-eluting permanent polymer stent (Cypher Select Plus, Cordis, Johnson & Johnson, Warren, NJ, USA). The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation) at 9 months, analysed by intention to treat (non-inferiority margin of 0·02). This trial is registered with ClinicalTrials.gov, number NCT01254981.

Findings: From July, 2009, to January, 2011, we assigned 1229 patients (1532 lesions) to receive the biolimus-eluting stent and 1239 (1555 lesions) to receive the sirolimus-eluting stent. One patient was lost to follow-up because of emigration. Intention-to-treat analysis showed that 50 (4·1%) patients who were assigned the biolimus-eluting stent and 39 (3·1%) who were assigned the sirolimus-eluting stent met the primary endpoint (risk difference 0·9% [upper limit of one-sided 95% CI 2·1%]; p(non-inferiority)=0·06). Significantly more patients in the biolimus-eluting stent group had definite stent thrombosis at 12 months than did those in the sirolimus-eluting stent group (9 [0·7%] vs 2 [0·2%], risk difference 0·6% [95% CI 0·0-1·1]; p=0·034). Per-protocol analysis showed that 45 (3·8%) of 1193 patients who received a biolimus-eluting stent and 39 (3·2%) of 1208 who received a sirolimus-eluting stent met the primary endpoint (risk difference 0·5% [upper limit of one-sided 95% CI 1·8%]; p(non-inferiority)=0·03).

Interpretation: At 1 year follow-up, the biodegradable polymer biolimus-eluting Nobori stent did not improve clinical results compared with a first-generation sirolimus-eluting stent. We will need to obtain long-term data before we can make recommendations for the role of this biolimus-eluting stent in routine clinical practice.

Funding: Terumo and Cordis (Johnson & Johnson).
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http://dx.doi.org/10.1016/S0140-6736(12)61962-XDOI Listing
February 2013

2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial.

J Am Coll Cardiol 2012 Sep 5;60(13):1140-7. Epub 2012 Sep 5.

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

Objectives: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES).

Background: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months.

Methods: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES.

Results: At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80).

Conclusions: At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes.
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http://dx.doi.org/10.1016/j.jacc.2012.07.004DOI Listing
September 2012

3-Year clinical outcomes in the randomized SORT OUT III superiority trial comparing zotarolimus- and sirolimus-eluting coronary stents.

JACC Cardiovasc Interv 2012 Aug;5(8):812-8

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

Objectives: This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice.

Background: The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear.

Methods: The authors randomized 2,332 patients to ZES (n = 1,162) or SES (n = 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis.

Results: At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p = 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p = 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p = 0.0005).

Conclusions: Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drug-eluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478).
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http://dx.doi.org/10.1016/j.jcin.2012.04.008DOI Listing
August 2012

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

Influence of pre-infarction angina, collateral flow, and pre-procedural TIMI flow on myocardial salvage index by cardiac magnetic resonance in patients with ST-segment elevation myocardial infarction.

Eur Heart J Cardiovasc Imaging 2012 May 29;13(5):433-43. Epub 2011 Dec 29.

Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.

Background: In patients with ST-segment elevation myocardial infarction (STEMI) pre-infarction angina, pre-procedural TIMI flow and collateral flow to the myocardium supplied by the infarct related artery are suggested to be cardioprotective. We evaluated the effect of these factors on myocardial salvage index (MSI) and infarct size adjusting for area at risk in patients with STEMI treated with primary percutaneous coronary intervention.

Methods And Results: Cardiac magnetic resonance (CMR) was used to measure myocardial area at risk within 1-7 days and final infarct size 90 ± 21 days after the STEMI in 200 patients. MSI was calculated as (area-at-risk infarct size) / area-at-risk. Patients with pre-infarction angina had a median MSI of 0.80 (IQR 0.67 to 0.86) versus 0.72 (0.61 to 0.80) in those without pre-infarction angina, P = 0.004). In a regression analysis of the infarct size plotted against the area-at-risk there was a strong trend that the line for the pre-infarction angina group was below the one for the non-angina group (P = 0.05). Patients with pre-procedural TIMI flow 0/1, 2 and 3 had a median MSI of (0.69 (IQR 0.59 to 0.76), 0.78 (0.68 to 0.86) and 0.85 (0.77 to 0.91), respectively (P<0.001). Collateral flow did not change MSI (P = 0.45) nor area-at-risk (P = 0.40) and no significant difference in infarct size adjusted for area at risk (P = 0.25) was observed.

Conclusions: Pre-infarction angina increases MSI in patients with STEMI supporting the theory that pre-infarction angina leads to ischemic preconditioning. As opposed to the presence of angiographically visible collateral flow to the infarct area pre-procedural TIMI flow is strongly associated with MSI.
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http://dx.doi.org/10.1093/ejechocard/jer296DOI Listing
May 2012

Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction.

Eur Heart J 2012 Jun 14;33(12):1491-9. Epub 2011 Sep 14.

Department of Cardiology, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.

Aims: Exenatide, a glucagon-like-peptide-1 analogue, increases myocardial salvage in experimental settings with coronary occlusion and subsequent reperfusion. We evaluated the cardioprotective effect of exenatide at the time of reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI).

Methods And Results: A total of 172 patients with STEMI and Thrombolysis in Myocardial Infarction flow 0/1 were randomly assigned to exenatide or placebo (saline) intravenously. Study treatment was commenced 15 min before intervention and maintained for 6 h after the procedure. The primary endpoint was salvage index calculated from myocardial area at risk (AAR), measured in the acute phase, and final infarct size measured 90 ± 21 days after pPCI by cardiac magnetic resonance (CMR). In 105 patients evaluated with CMR, a significantly larger salvage index was found in the exenatide group than in the placebo group (0.71 ± 0.13 vs. 0.62 ± 0.16; P= 0.003). Infarct size in relation to AAR was also smaller in the exenatide group (0.30 ± 0.15 vs. 0.39 ± 0.15; P= 0.003). In a regression analysis, there was a significant correlation between the infarct size and the AAR for both treatment groups and an analysis of covariance showed that datapoints in the exenatide group lay significantly lower than for the placebo group (P= 0.011). There was a trend towards smaller absolute infarct size in the exenatide group (13 ± 9 vs. 17 ± 14 g; P= 0.11). No difference was observed in left ventricular function or 30-day clinical events. No adverse effects of exenatide were observed.

Conclusion: In patients with STEMI undergoing pPCI, administration of exenatide at the time of reperfusion increases myocardial salvage.
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http://dx.doi.org/10.1093/eurheartj/ehr309DOI Listing
June 2012

Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial.

Lancet 2010 Mar 16;375(9720):1090-9. Epub 2010 Mar 16.

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

Background: In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery disease who were receiving routine clinical care with no direct follow-up.

Methods: We did a single-blind, all-comer superiority trial in adult patients with chronic stable coronary artery disease or acute coronary syndromes, and at least one target lesion. Patients were treated at one of five percutaneous coronary intervention centres between January, 2006, and August, 2007. Computer-generated block randomisation and a telephone allocation service were used to randomly assign patients to receive the zotarolimus-eluting or the sirolimus-eluting stent. Data for follow-up were obtained from national Danish administrative and health-care registries. The primary endpoint was a composite of major adverse cardiac events within 9 months: cardiac death, myocardial infarction, and target vessel revascularisation. Intention-to-treat analyses were done at 9-month and 18-month follow-up. This trial is registered with ClinicalTrials.gov, number NCT00660478.

Findings: 1162 patients (1619 lesions) were assigned to receive the zotarolimus-eluting stent, and 1170 patients (1611 lesions) to receive the sirolimus-eluting stent. 67 patients (72 lesions) had stent failure, and six patients were lost to follow-up. All randomly assigned patients were included in analyses at 9-month follow-up; 2200 patients (94%) had completed 18-month follow-up by the time of our assessment. At 9 months, the primary endpoint had occurred in a higher proportion of patients treated with the zotarolimus-eluting stent than in those treated with the sirolimus-eluting stent (72 [6%] vs 34 [3%]; HR 2.15, 95% CI 1.43-3.23; p=0.0002). At 18-month follow-up, this difference was sustained (113 [10%] vs 53 [5%]; 2.19, 1.58-3.04; p<0.0001). For patients receiving the zotarolimus-eluting stent and those receiving the sirolimus-eluting stent, all cause-mortality was similar at 9-month follow-up (25 [2%] vs 18 [2%]; 1.40, 0.76-2.56; p=0.28), but was significantly different at 18-month follow-up (51 [4%] vs 32 [3%]; 1.61, 1.03-2.50; p=0.035).

Interpretation: The sirolimus-eluting stent is superior to the zotarolimus-eluting stent for patients receiving routine clinical care.

Funding: Cordis and Medtronic.
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http://dx.doi.org/10.1016/S0140-6736(10)60208-5DOI Listing
March 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

Scintigraphic evaluation of routine filterwire distal protection in percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: a randomized controlled trial.

J Nucl Cardiol 2009 Sep-Oct;16(5):784-91. Epub 2009 Jun 12.

Department of Cardiology B, Aarhus University Hospital, Skejby, 8200, Aarhus N, Denmark.

Aim: Distal embolization during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) may result in reduced myocardial perfusion, infarct extension and impaired prognosis. In a prospective randomized trial, we assessed the effect of routine filterwire distal protection on scintigraphic estimated infarct size.

Methods And Results: The effect of routine filterwire distal protection was evaluated in 344 patients with STEMI <12 hours undergoing primary PCI. Patients were randomized to distal protection with a filterwire or standard PCI. The primary endpoint was myocardial infarct size measured by Sestamibi SPECT after 30 days (%). Secondary endpoints included myocardial salvage, ST-segment resolution (STR), myocardial biomarker release and major adverse cardiac and cerebral events. Baseline characteristics including area at risk (estimated by Sestamibi SPECT) were similar. Final infarct size was not statistically different in the distal protection and the control groups (median [IQR], 6% [1-19] and 5% [1-14], P = .23). Also, secondary endpoints were similar in the two treatment groups.

Conclusion: Distal protection with a filterwire performed as routine therapy in primary PCI for STEMI did not reduce myocardial infarct size. The study does not support routine use of distal protection in primary PCI.
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http://dx.doi.org/10.1007/s12350-009-9105-xDOI Listing
December 2009

2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry).

J Am Coll Cardiol 2009 Feb;53(8):658-64

Department of Cardiology, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark.

Objectives: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS).

Background: Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death.

Methods: A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding.

Results: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups.

Conclusions: During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.
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http://dx.doi.org/10.1016/j.jacc.2008.09.058DOI Listing
February 2009

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

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

Target lesion revascularisation in patients treated with a sirolimus-eluting or paclitaxel-eluting stent.

Heart 2007 Jun 28;93(6):694-7. Epub 2006 Dec 28.

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

Objective: To identify risk factors for clinical-driven target lesion revascularisation (TLR) in patients treated with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in a real-world scenario.

Design: From 1 January 2003 to 18 May 2005, all patients treated with a Cypher or Taxus stent were consecutively registered and followed for 9 months. Re-intervention was driven by clinical symptoms.

Setting: Western Denmark Heart Registry.

Patients: 4432 patients with 6102 lesions treated with a Cypher (n = 3791 lesions) or Taxus (n = 2311 lesions) stent.

Interventions: Percutaneous coronary intervention.

Main Outcome Measures: TLR, defined as either new percutaneous coronary intervention or coronary artery bypass graft operation of the target lesion, within 9 months from the index procedure.

Results: TLR within 9 months was performed in 2.5% of lesions treated with the Cypher stent and in 3.3% of lesions treated with the Taxus stent (OR 1.36, 95% CI 1.00 to 1.84). After adjustment by multivariate logistic regression, Taxus stent implantation was an independent predictor of TLR (OR 1.43, 95% CI 1.05 to 1.95). Implantation of >1 stent per lesion (OR 1.62, 95% CI 1.13 to 2.33) and reference diameter <2.8 mm (OR 1.42, 95% CI 1.00 to 2.02) were also identified as independent predictors of TLR.

Conclusions: These data from the registry reflect a real-world clinical scenario with operator-driven use of drug-eluting stents and symptom-driven re-intervention. In this setting, use of the Taxus stent, implantation of multiple stents per lesion and stent implantation in small vessels were independent predictors of TLR.
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http://dx.doi.org/10.1136/hrt.2006.100594DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1955176PMC
June 2007

Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial.

Circulation 2006 Jul 26;114(1):40-7. Epub 2006 Jun 26.

Department of Cardiology B, Aarhus University Hospital, Skejby, 8200 Aarhus N, Denmark.

Background: Distal embolization during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction may result in reduced myocardial perfusion, infarct extension, and impaired prognosis.

Methods And Results: In a prospective randomized trial, we studied the effect of routine thrombectomy in 215 patients with ST-segment-elevation myocardial infarction lasting <12 hours undergoing primary PCI. Patients were randomized to thrombectomy pretreatment or standard PCI. The primary end point was myocardial salvage measured by sestamibi SPECT, calculated as the difference between area at risk and final infarct size determined after 30 days (percent). Secondary end points included final infarct size, ST-segment resolution, and troponin T release. Baseline variables, including ST-segment elevation and area at risk, were similar. Salvage was not statistically different in the thrombectomy and control groups (median, 13% [interquartile range, 9% to 21%] and 18% [interquartile range, 7% to 25%]; P=0.12), but 24 patients in the thrombectomy group and 12 patients in the control group did not have an early SPECT scan, mainly because of poor general or cardiac condition (P=0.04). In the thrombectomy group, final infarct size was increased (median, 15%; [interquartile range, 4% to 25%] versus 8% [interquartile range, 2% to 18%]; P=0.004).

Conclusions: Thrombectomy performed as routine therapy in primary PCI for ST-elevation myocardial infarction does not increase myocardial salvage. The study suggests a possible deleterious effect of thrombectomy, resulting in an increased final infarct size, and does not support the use of thrombectomy in unselected primary PCI patients.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.105.595660DOI Listing
July 2006

Outcome of unprotected left main percutaneous coronary intervention in surgical low-risk, surgical high-risk, and acute myocardial infarction patients.

EuroIntervention 2006 Feb;1(4):403-8

Department of cardiology, Aarhus University Hospital (Skejby), Aarhus, Denmark.

Aim: Percutaneous coronary intervention (PCI) of left main (LM) coronary artery stenosis may become an alternative to the standard therapy, coronary artery bypass graft surgery (CABG). The purpose of the present study was to describe the outcome after LM PCI in three cohorts of patients: patients with low surgical risk, patients with high surgical risk or patients considered inoperable, and patients with acute ST elevation MI.

Methods And Results: 104 consecutive patients who had LM PCI at the Department of Cardiology, Skejby University hospital between 1999 and 2004 were investigated. The patients were divided into three groups according to PCI indication and operability: surgical low risk patients and suitable lesions for PCI (n=27), poor CABG candidates (age > 80 years, severe comorbidity or inoperability) (n=50), and patients presenting with AMI (n=27). In the three groups mean ages+/-SD were: 60+/-14, 76+/-9, and 68+/-12 years, respectively. At thirty days follow-up the cumulative incidence of major adverse cardiac events (MACE); cardiac death, MI, or target lesion revascularization (95% CI) were 4 (1-24)%, 16 (8-30)%, and 41 (25-61)%, respectively. At 6 months the cumulative incidence of MACE were 4 (1-24)%, 27 (17-43)%, and 41 (25-62)%.

Conclusions: PCI of LM coronary artery stenosis can be performed with good outcome in patients with low surgical risk and with acceptable outcome in surgical high risk patients or patients considered inoperable. Patients with AMI and culprit lesion in the LM have a high mortality in the acute phase, but mid-term prognosis is good if the patient is successfully treated with PCI. This follow-up study underlines the importance of risk stratification in the heterogeneous group of patients undergoing LM PCI.
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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

[Beta-radiation as adjuvant treatment of in-stent restenosis in coronary vessels].

Ugeskr Laeger 2005 Aug;167(33):3033-6

Arhus Universitetshospital, Skejby Sygehus, Hjertemedicinsk Afdeling B, Arhus N.

Introduction: The purpose of this study was to describe our initial "real-world" experience with vascular b-radiation for in-stent restenosis using a simple angioplasty approach without stent implantation.

Materials And Methods: Thirty-five consecutive patients with in-stent restenosis were treated with balloon angioplasty (n = 28), cutting balloon angioplasty (n = 3), or angioplasty plus stent implantation (only in case of significant dissection: n = 4), followed by catheter-based beta-radiation. Angiographic follow-up was performed after 6 to 10 months.

Results: One patient experienced a left main stem occlusion immediately after beta-radiation, which necessitated an acute coronary bypass operation. No other complications related to the radiation procedure were observed. In-stent restenosis recurred in 6 of the 34 patients (18%).

Discussion: Our results indicate that catheter-based radiation can be safely introduced at centres without previous experience with this treatment modality. Furthermore, the in-stent restenosis recurrence rates after catheter-based radiation which have been obtained in randomised trials can be reproduced in consecutive patients.
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August 2005

In-laboratory femoral sheath removal after heparin reversal by protamine after percutaneous coronary intervention.

EuroIntervention 2005 May;1(1):66-9

Department of cardiology, Aarhus University Hospital (Skejby), Aarhus, Denmark.

Objective: To evaluate the safety of heparin neutralisation by protamine immediately after PCI.

Design: Retrospective analysis of prospectively registered data.

Setting: A Danish mono-centre study.

Patients: All angina pectoris patients treated with PCI between January 1999 and December 2002. The cohort was divided into two groups. Group I (n=1.129 procedures) were patients admitted January 1999 to December 1999, and group II n=4.193 procedures) were admitted January 1, 2000 to December 31, 2002.

Interventions: In group I, the femoral sheath was removed 4 hours after the PCI procedure. In group II, circulating heparin was neutralised by protamine sulphate, and the femoral sheath removed immediately after the procedure.

Main Outcome Measures: Rates of puncture site complications, stent thrombosis, non-fatal myocardial infarction and death during admission.

Results: The rates of stent thrombosis, non-fatal myocardial infarction and in-hospital mortality were similar in the two groups. The rate of puncture site complications were 4,7% in group 1 and 2,6% in group 2 (p<0,001).

Conclusions: Circulating heparin can be safely neutralised by protamine sulphate immediately after PCI.
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May 2005

Long genuine coronary artery lesions treated with stiff tubular or flexible coiled stents. A randomized angiographic follow-up study.

Scand Cardiovasc J 2002 Mar;36(2):91-4

Department of Cardiology, Skejby Sygehus, Aarhus University Hospitals, Aarhus, Denmark.

Objective: To investigate effects of stent flexibility on 6 months' clinical and angiographic outcome in long stented lesions.

Design: A total of 44 genuine coronary artery lesions (lesion length >20 mm and < or =30 mm) were randomized to implantation with a 30 mm long flexible coiled stainless steel stent (Freedom Force, Global Therapeutics) (n = 23) or a 30 mm long stiff tubular stainless steel stent (Crown, Johnson & Johnson) (n = 21).

Results: Target vessel revascularization was performed in 10 patients (45%) in the Freedom Force stent group, and in 7 patients (33%) in the Crown stent group (ns). No significant differences concerning minimum lumen diameter (MLD), early gain, late loss or binary restenosis rate were seen. In the Freedom Force stent group all restenoses were located within the stent. In the Crown stent group three (27%) of the restenoses were located at the edge of the stent (ns).

Conclusion: In a limited number of patients no significant differences could be detected in clinical or angiographic parameters between patients treated with long tubular or long coiled stents.
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http://dx.doi.org/10.1080/140174302753675366DOI Listing
March 2002