Publications by authors named "Jens Flensted Lassen"

171 Publications

Clinical outcome following late reperfusion with percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction.

Eur Heart J Acute Cardiovasc Care 2020 May 18. Epub 2020 May 18.

Department of Cardiology, Copenhagen University Hospital, Denmark.

Background: Up to 40% of patients with ST-segment elevation myocardial infarction (STEMI) present later than 12 hours after symptom onset. However, data on clinical outcomes in STEMI patients treated with primary percutaneous coronary intervention 12 or more hours after symptom onset are non-existent. We evaluated the association between primary percutaneous coronary intervention performed later than 12 hours after symptom onset and clinical outcomes in a large all-comer contemporary STEMI cohort.

Methods: All STEMI patients treated with primary percutaneous coronary intervention in eastern Denmark from November 2009 to November 2016 were included and stratified by timing of the percutaneous coronary intervention. The combined clinical endpoint of all-cause mortality and hospitalisation for heart failure was identified from nationwide Danish registries.

Results: We included 6674 patients: 6108 (92%) were treated less than 12 hours and 566 (8%) were treated 12 or more hours after symptom onset. During a median follow-up period of 3.8 (interquartile range 2.3-5.6) years, 30-day, one-year and long-term cumulative rates of the combined endpoint were 11%, 17% and 25% in patients treated 12 or fewer hours and 21%, 29% and 37% in patients treated more than 12 hours (P<0.001 for all) after symptom onset. Late presentation was independently associated with an increased risk of an adverse clinical outcome (hazard ratio 1.42, 95% confidence interval 1.22-1.66; P<0.001).

Conclusions: Increasing duration from symptom onset to primary percutaneous coronary intervention was associated with an increased risk of an adverse clinical outcome in patients with STEMI, especially when the delay exceeded 12 hours.
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http://dx.doi.org/10.1177/2048872619886312DOI Listing
May 2020

Coronary Artery Healing Process after Bioresorbable Scaffold in Patients with Non-ST-Segment Elevation Myocardial Infarction: Rationale, Design, and Methodology of the HONEST Study.

Cardiology 2021 Feb 1:1-11. Epub 2021 Feb 1.

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

Background: Bioresorbable scaffolds (BRSs) is a relatively new approach in treating coronary artery stenosis. The initial results of the first commercially available scaffolds consisting of a backbone of poly-L-lactide raised safety concerns related to delayed resorption and healing. The magnesium alloy-based scaffold degrades via bio-corrosion within months, whereas it often takes several years for polymer scaffolds to degrade. The aim of the study was to assess the healing stage by optical coherence tomography (OCT) after 6 months in patients with non-ST-segment elevation myocardial infarct (NSTEMI) randomized to OCT or angiography-guided percutaneous coronary intervention with implantation of a magnesium sirolimus-eluting Magmaris scaffold (Magmaris; Biotronik, Bülach, Switzerland).

Methods: We analyzed the healing process by comparing OCT at baseline and after 6 months. Five stages of healing were defined with stage 1 being the least healed and stage 5 demonstrating complete resorption and healing with no visible scaffold/remnant. The primary end point is a calculated healing score that is based on 5 subtypes of healing stage: (1) malapposed, (2) uncovered with no detection of smooth surface tissue on top of struts or remnants, (3) covered protruding, (4) covered embedded, and (5) complete healing with a smooth neointimal surface and no sign of struts or visible remnants assessed by OCT 6 months after the index procedure.

Results: The impact of OCT-guided compared to angiography-guided scaffold implantation will be illuminated.

Conclusion: The present study will provide new information on midterm healing properties of the magnesium BRS in patients with NSTEMI.
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http://dx.doi.org/10.1159/000512417DOI Listing
February 2021

Efficacy of Thin- Versus Thick-Strut Polymer-Free Biolimus-Eluting Stents: the Biofreedom QCA Randomized Trial.

EuroIntervention 2021 Jan 12. Epub 2021 Jan 12.

Department of Interventional Cardiology, Cardiovascular Institute, Hospital Clinic IDIBAPS, Barcelona, Spain.

Aims: To evaluate the efficacy of the new BioFreedom Ultra™ drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BioFreedom™ drug-coated stent with a stainless-steel platform (BF-SS) in an all-comers population undergoing percutaneous coronary interventions (PCI).

Methods And Results: This was a prospective, multi-center, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiographic at 9-month follow-up. Clinical evaluation was performed at 1 year. A total of 200 patients were randomized (1:1) to either the BF-CoCr or the BF-SS stent at 8 centers in Spain and Denmark. Baseline clinical and lesion characteristics were similar among the groups. Mean age was 66 years and 23% were females. The mean number of stents implanted per patient was 1.5. At 9-month follow-up, mean in-stent LLL was 0.34±0.49mm in BF-CoCr versus 0.29±0.37mm in the BF-SS, p=0.005 for non-inferiority. At 1-year, target lesion failure was similar between groups (7.3% in Bf-CoCr vs 9.3% in the BF-SS group; p=0.60).

Conclusions: The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at 9 months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.
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http://dx.doi.org/10.4244/EIJ-D-20-01162DOI Listing
January 2021

Percutaneous Coronary Intervention For Bifurcation Coronary Lesions.The 15th Consensus Document from the European Bifurcation Club.

EuroIntervention 2020 Oct 20. Epub 2020 Oct 20.

Insitute of Cardiology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.

The 15th European Bifurcation Club (EBC) meeting was held in Barcelona in October 2019 and it facilitated a renewed consensus on coronary bifurcation lesions (CBL) and unprotected left main (LM) percutaneous interventions. Bifurcation stenting techniques continue to be refined, developed and tested. It remains evident that provisional approach with optional side-branch treatment utilising T, T and small protrusion (TAP) or culotte continue to provide flexible options for the majority of CBL patients. Debate persists regarding the optimal treatment of side branches, including assessment of clinical significance and thresholds for bail-out treatment. In more complex CBL, especially when involving the LM, adoption of dedicated 2-stent techniques should be considered. Operators using such techniques have to be fully familiar with their procedural steps and should acknowledge associated limitations and challenges. When using 2-stent techniques, failure to perform a final kissing inflation is regarded as a technical failure, since it may jeopardize clinical outcome. The development of novel technical tools and drug regimens deserve attention. In particular, intra-coronary imaging, bifurcation simulation, drug-eluting balloon technology and tailored anti-platelet therapy are identified as promising tools to enhance clinical outcomes. In conclusion, the evolution of a broad spectrum of bifurcation PCI components have resulted from studies extending from bench testing to randomised controlled trials. However, further advances are still needed to achieve the ambitious goal of optimizing the clinical outcomes for every patient undergoing PCI on a CBL.
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http://dx.doi.org/10.4244/EIJ-D-20-00169DOI Listing
October 2020

Applications of computational simulation in bifurcation stenting: past, present and future.

EuroIntervention 2020 Oct 9;16(9):e698-e700. Epub 2020 Oct 9.

Department of Cardiology B, Odense University Hospital and University of Southern Denmark, Odense, Denmark.

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http://dx.doi.org/10.4244/EIJV16I9A128DOI Listing
October 2020

The association between self-reported health status and adverse events: a comparison among coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI).

Qual Life Res 2020 Nov 28;29(11):3017-3029. Epub 2020 Aug 28.

Department of Cardiology, Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense C, Denmark.

Purpose: While several studies have investigated clinical outcomes following coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI), studies investigating self-reported health and the association with adverse outcomes are limited. Thus, the aim was to investigate differences in health-related quality of life (HRQoL), anxiety and depression at discharge and the association with a composite endpoint of the first event of acute cardiac readmission, revascularisation or 1-year mortality among patients undergoing CABG vs. PCI.

Methods: Data from the national cohort study, DenHeart, were used, including measures of HRQoL; EuroQoL-5D-5L (EQ-5D Index Score and VAS) and HeartQoL (Global, Physical and Emotional), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and register-based follow-up. A total of 7000 patients were included (CABG n = 652, PCI n = 6348) (median age 65, 75% men). Cox Proportional Hazard models were performed among a propensity-matched population of responders (n = 520).

Results: HRQoL was significantly better among patients undergoing PCI vs. CABG, but with no differences in time to readmission or revascularisation. HRQoL, anxiety and depression were significantly associated with the risk of the composite endpoint among the PCI group (Hazard Ratio, HR (95% confidence intervals, CI) [EQ-5D index score 3.07 (1.67-5.67), EQ-5D VAS 0.97 (0.96-0.99), HeartQol Global 0.61 (0.38-0.95), HeartQol Emotional 0.56 (0.39-0.80), HADS-D ≥ 8 3.12 (1.61-6.01), HADS-A ≥ 8 2.08 (1.14-3.80)].

Conclusion: Patients undergoing PCI reported better HRQoL at discharge compared with patients undergoing CABG, whereas readmission rates were similar. Self-reported health was associated with the risk of adverse events among patients undergoing PCI, but not among patients undergoing CABG.

Clinical Trial Registration: NCT01926145.
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http://dx.doi.org/10.1007/s11136-020-02573-8DOI Listing
November 2020

[Treatment of out-of-hospital cardiac arrest with mechanical cardiopulmonary resuscitation].

Ugeskr Laeger 2020 Aug;182(33)

This review provides a summary of treatment of cardiac arrest with mechanical cardiopulmonary resuscitation (CPR). CPR provides chest compressions according to guidelines in the treatment of out-of-hospital cardiac arrest. This is useful in situations where CPR cannot be safely delivered (e.g. during transportation and prolonged CPR). Randomized controlled trials have not shown improved patient outcomes after treatment with mechanical CPR compared to manual CPR. Mechanical CPR can, like manual CPR, cause injuries, and some may be life-threatening. Mechanical CPR is therefore recommended as an adjunct to manual CPR in special circumstances but not used routinely.
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August 2020

Ultrasound-assisted thrombolysis for acute intermediate-high-risk pulmonary embolism.

Dan Med J 2020 Jul 1;67(7). Epub 2020 Jul 1.

Introduction: Eustachian tube dysfunction (ETD) may result in hearing loss, chronic otitis and cholesteatoma. With advances in treatment options, the identification of patients with obstructive ETD is becoming increasingly important. The objective of this study was to validate a Danish translation of the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7).

Methods: All participants underwent tympanometry, otomicroscopy and completed the ETDQ-7. We included 34 ears from patients with obstructive ETD who had abnormal tympanometry curves but no history of cholesteatoma or adhesive otitis. As a control group, 48 otherwise healthy ears with a normal tympanometry curve were included from patients with known sensorineural hearing loss or normal hearing.

Results: A Cronbach's alpha of 0.77 indicated a good internal consistency reliability of the questionnaire. The mean ETDQ-7 score in the obstructive ETD group was 31 versus 13.5 in the control group (p = 0.00). A receiver operating characteristics analysis produced an area under the curve of 94%, showing excellent discriminatory abilities between the groups.

Conclusions: The ETDQ-7 has previously been validated in English, German, Dutch and Portuguese, demonstrating good clinical relevance. The Danish translation of the ETDQ-7 has produced similar results and may be valuable in diagnosing obstructive ETD and in monitoring the effect of balloon dilation of the Eustachian tube.

Funding: none. The study was approved by the Danish Data Protection Agency (VD-2018-33, I-Suite 6229).
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July 2020

European Bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions.

Catheter Cardiovasc Interv 2020 Nov 24;96(5):1067-1079. Epub 2020 Jun 24.

Medical Faculty, Department of Cardiology, Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia.

Background: Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison.

Methods: The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice.

Results: An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques ("provisional" and "inverted provisional") and (b) 2-stent techniques ("T/TAP," "culotte," and "DK-crush").

Conclusions: The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice.
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http://dx.doi.org/10.1002/ccd.29071DOI Listing
November 2020

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.

Circulation 2020 06 21;141(25):2052-2063. Epub 2020 May 21.

Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).

Background: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.

Methods: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021.

Results: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; =0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; <0.0001).

Conclusions: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.040241DOI Listing
June 2020

Clinical outcome following late reperfusion with percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction.

Eur Heart J Acute Cardiovasc Care 2020 May 18:2048872619886312. Epub 2020 May 18.

Department of Cardiology, Copenhagen University Hospital, Denmark.

Background: Up to 40% of patients with ST-segment elevation myocardial infarction (STEMI) present later than 12 hours after symptom onset. However, data on clinical outcomes in STEMI patients treated with primary percutaneous coronary intervention 12 or more hours after symptom onset are non-existent. We evaluated the association between primary percutaneous coronary intervention performed later than 12 hours after symptom onset and clinical outcomes in a large all-comer contemporary STEMI cohort.

Methods: All STEMI patients treated with primary percutaneous coronary intervention in eastern Denmark from November 2009 to November 2016 were included and stratified by timing of the percutaneous coronary intervention. The combined clinical endpoint of all-cause mortality and hospitalisation for heart failure was identified from nationwide Danish registries.

Results: We included 6674 patients: 6108 (92%) were treated less than 12 hours and 566 (8%) were treated 12 or more hours after symptom onset. During a median follow-up period of 3.8 (interquartile range 2.3-5.6) years, 30-day, one-year and long-term cumulative rates of the combined endpoint were 11%, 17% and 25% in patients treated 12 or fewer hours and 21%, 29% and 37% in patients treated more than 12 hours (<0.001 for all) after symptom onset. Late presentation was independently associated with an increased risk of an adverse clinical outcome (hazard ratio 1.42, 95% confidence interval 1.22-1.66; <0.001).

Conclusions: Increasing duration from symptom onset to primary percutaneous coronary intervention was associated with an increased risk of an adverse clinical outcome in patients with STEMI, especially when the delay exceeded 12 hours.
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http://dx.doi.org/10.1177/2048872619886312DOI Listing
May 2020

Clinical outcomes three-year after revascularization with biodegradable polymer stents: ultrathin-strut sirolimus-eluting stent versus biolimus-eluting stent: from the Scandinavian organization for randomized trials with clinical outcome VII trial.

Coron Artery Dis 2020 09;31(6):485-492

Department of Cardiology, Odense University Hospital, Odense.

Background: Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis.

Methods: The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization.

Results: A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups.

Conclusion: At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.
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http://dx.doi.org/10.1097/MCA.0000000000000875DOI Listing
September 2020

Asia Pacific consensus document on coronary bifurcation interventions.

EuroIntervention 2020 Oct 9;16(9):e706-e714. Epub 2020 Oct 9.

National University Heart Center Singapore and National University of Singapore, Singapore.

Coronary bifurcation intervention is common but complex. Progress in this field has been made in recent years with considerable contribution from the Asia Pacific (APAC) region. However, the standard of practice varies across the APAC region due to differences in culture, socioeconomic state and healthcare set-up. Practice may also differ from the rest of the world. Hence, a panel of experts was invited to discuss topics relevant to bifurcation intervention in order to make a concerted effort to achieve consensus that is applicable within the region and in line with available evidence.
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http://dx.doi.org/10.4244/EIJ-D-19-00977DOI Listing
October 2020

Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.

Lancet 2019 10 6;394(10207):1415-1424. Epub 2019 Sep 6.

The Hatter Cardiovascular Institute, University College London, London, UK. Electronic address:

Background: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months.

Methods: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed.

Findings: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed.

Interpretation: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.

Funding: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.
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http://dx.doi.org/10.1016/S0140-6736(19)32039-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6891239PMC
October 2019

Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction.

Heart 2020 01 17;106(1):24-32. Epub 2019 Jul 17.

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Objective: The Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction - Ischaemic Postconditioning (DANAMI-3-iPOST) did not show improved clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning. However, the use of thrombectomy was frequent and thrombectomy may in itself diminish the effect of ischaemic postconditioning. We evaluated the effect of ischaemic postconditioning in patients included in DANAMI-3-iPOST stratified by the use of thrombectomy.

Methods: Patients with STEMI were randomised to conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI. The primary endpoint was a combination of all-cause mortality and hospitalisation for heart failure.

Results: From March 2011 until February 2014, 1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months. There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004). In patients not treated with thrombectomy (n=520), the primary endpoint occurred in 33 patients (10%) who underwent ischaemic postconditioning (n=326) and in 35 patients (18%) who underwent conventional treatment (n=194) (adjusted hazard ratio (HR) 0.55 (95%confidence interval (CI) 0.34 to 0.89), p=0.016). In patients treated with thrombectomy (n=714), there was no significant difference between patients treated with ischaemic postconditioning (n=291) and conventional PCI (n=423) on the primary endpoint (adjusted HR 1.18 (95% CI 0.62 to 2.28), p=0.62).

Conclusions: In this post-hoc study of DANAMI-3-iPOST, ischaemic postconditioning, in addition to primary PCI, was associated with reduced risk of all-cause mortality and hospitalisation for heart failure in patients with STEMI not treated with thrombectomy.

Trial Registration Number: NCT01435408.
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http://dx.doi.org/10.1136/heartjnl-2019-314952DOI Listing
January 2020

Percutaneous coronary intervention for obstructive bifurcation lesions: the 14th consensus document from the European Bifurcation Club.

EuroIntervention 2019 May;15(1):90-98

Department of Cardiology, Radcliffe Department of Medicine, John Radcliffe Hospital, Oxford University Hospitals, Oxford, United Kingdom.

The European Bifurcation Club recommends an approach to a bifurcation stenosis which involves careful assessment, planning and a sequential provisional approach. In the minority of lesions where two stents are required, careful deployment and optimal expansion are essential to achieve a long-term result.
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http://dx.doi.org/10.4244/EIJ-D-19-00144DOI Listing
May 2019

Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI.

Int J Cardiol 2019 08 1;289:1-5. Epub 2019 May 1.

Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Denmark; University of Lund, Sweden.

Aims: To assess the impact of sampling bias due to reported as well as unreported exclusion of the target population in a multi-center randomized controlled trial (RCT) of ST-elevation myocardial infarction (STEMI).

Methods And Results: We compared clinical characteristics and mortality between participants in the DANAMI-3 trial to contemporary non-participants with STEMI using unselected registries. A total of 179 DANAMI-3 participants (8%) and 617 contemporary non-participants (22%) had died (Log-Rank: P < 0.001) after a median follow-up of 1333 days (range: 1-2021 days). In an unadjusted Cox regression model all groups of non-participants had a higher hazard ratio to predict mortality compared to participants: eligible excluded (n = 144) (hazard ratio: 3.41 (95% CI: (2.69-4.32)), ineligible excluded (n = 472) (hazard ratio: 3.42 (95% CI: (2.44-4.80), eligible non-screened (n = 154) (hazard ratio: 3.37 (95% CI: (2.36-4.82)), ineligible non-screened (n = 154) (hazard ratio: 6.48 (95% CI: (4.77-8.80).

Conclusion: Sampling bias had occurred due to both reported and unreported exclusion of eligible patients and the difference in mortality between participants and non-participants could not be explained only by the trial exclusion criteria. Thus, screening logs may not be suited to address the risks of sampling bias.
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http://dx.doi.org/10.1016/j.ijcard.2019.04.064DOI Listing
August 2019

Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the randomized SORT OUT IX trial.

Am Heart J 2019 07 14;213:1-7. Epub 2019 Mar 14.

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

Background: In patients with increased bleeding risk during dual antiplatelet therapy, the biolimus A9-coated BioFreedom, a stainless steel drug-coated stent devoid of polymer, has shown superiority compared to a bare-metal stent. The aim of this study was to investigate whether the polymer-free biolimus A9-coated BioFreedom is noninferior to a modern thin-strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.

Methods: The multicenter SORT OUT IX trial (NCT02623140) randomly assigned all-comers patients to treatment with the BioFreedom drug-coated stent or the biodegradable polymer Orsiro stent in 4 Danish University Hospitals. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection based on Danish registries will be used and continue through 5 years. Assuming an event rate of 4.2% in each stent group, 1,563 patients in each treatment arm will provide 90% power to detect noninferiority of the drug-coated BioFreedom stent with a noninferiority margin of 2.1%.

Results: A total of 3,150 patients have been randomized and enrolled in the study.

Conclusions: The SORT OUT IX trial will determine whether the drug-coated BioFreedom stent is noninferior to a modern biodegradable polymer Orsiro stent.
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http://dx.doi.org/10.1016/j.ahj.2019.02.017DOI Listing
July 2019

Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study.

Open Heart 2019;6(1):e000941. Epub 2019 Feb 28.

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

Objectives: We aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS).

Background: The Fantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favourable mid-term clinical and angiographic outcomes.

Methods And Results: FANTOM II was a prospective, single arm study with implantation of the Fantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8±1.7 mm and 5.7±1.4 mm at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm and 5.6±1.4 mm in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm at baseline to 7.2±1.4 mm at 6 months (p=0.12), and from 7.4±1.5 mm to 7.3±1.4 mm at 9 months. Strut malapposition was median 0.8 (IQR 0.0;3.5)% and 1.8 (IQR 0.3;6.0)% at baseline and was 0.0 (IQR 0.0;0.0)% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)% at 6 months and 98.9 (IQR 98.3;100.0)% at 9 months.

Conclusions: The novel Fantom BRS had favourable healing patterns at 6-month and 9-month follow-up as malapposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil.
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http://dx.doi.org/10.1136/openhrt-2018-000941DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6443130PMC
February 2021

Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial).

JACC Cardiovasc Interv 2019 04;12(7):624-633

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

Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES).

Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation.

Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%.

Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001).

Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).
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http://dx.doi.org/10.1016/j.jcin.2018.12.036DOI Listing
April 2019

Joint consensus on the use of OCT in coronary bifurcation lesions by the European and Japanese bifurcation clubs.

EuroIntervention 2019 Feb 8;14(15):e1568-e1577. Epub 2019 Feb 8.

ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands.

Coronary artery bifurcation lesions comprise approximately 15-20% of all percutaneous coronary interventions (PCI) and constitute a complex lesion subgroup. Intravascular optical coherence tomography (OCT) is a promising adjunctive tool for guiding coronary bifurcation with its unrivalled high resolution. Compared to angiography, intravascular OCT has a clear advantage in that it depicts ostial lesion(s) in bifurcation without the misleading two-dimensional appearance of conventional angiography such as overlap and foreshortening. In addition, OCT has the ability to reconstruct a bifurcation in three dimensions and to assess the side branch ostium from 3D reconstruction of the main vessel pullback, which can be applied to ensure the optimal recrossing position of the wire after main vessel stenting. Recently, online co-registration of OCT and angiography became widely available, helping the operator to position a stent in precise landing zones, reducing the risk of geographic miss. Despite these technological advances, the currently available clinical data are based mainly on observational studies with a small number of patients; there is little evidence from randomised trials. The joint working group of the European Bifurcation Club and the Japanese Bifurcation Club reviewed all the available literature regarding OCT use in bifurcation lesions and here provides recommendations on OCT guiding of coronary interventions in bifurcation lesions.
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http://dx.doi.org/10.4244/EIJ-D-18-00391DOI Listing
February 2019

A nationwide investigation of CPR courses, books, and skill retention.

Resuscitation 2019 01 29;134:110-121. Epub 2018 Oct 29.

Emergency Medical Services Copenhagen, University of Copenhagen, Telegrafvej 5, 2750 Copenhagen, Denmark; Danish Resuscitation Council, c/o Emergency Medical Services, Telegrafvej 5, 2750 Copenhagen, Denmark.

Introduction: Survival from Out-of-Hospital Cardiac Arrest is highly associated with bystander cardiopulmonary resuscitation. The quality of bystander CPR is influenced by citizens attending Basic Life Support (BLS) courses and the quality of these courses. The purpose of the study was to investigate content, quality and compliance with the European Resuscitation Council (ERC) guidelines in national Danish BLS courses and the skill retention.

Methods: Books from 16 different course providers were analyzed for compliance with guidelines using the principle of mutually exclusive and collectively exhaustive questioning. Observation of 56 BLS courses were conducted using an evaluation sheet, with a five-point Likert scale including theoretical, technical, and non-technical skills. BLS skills of participants were assessed with a follow-up test 4-6 months after a course using a modified Cardiff Test.

Results: Analysis of the books, showed compliance with ERC guidelines of 69% on the examined items. Courses using ERC educational structure and having maximum six participants per instructor were associated with high quality in the course observations and a better follow-up test. Especially, the use of automated external defibrillator showed significant odds ratio (OR) of 21.8 (95% CI 4.1-114.7) to 31.3 (95% CI 3.7-265.1) of achieving high quality on courses with similar results in the follow-up test.

Conclusion: National BLS courses had significant variation in the content of books, and compliance to ERC guidelines during courses and in skills retention 4-6 months after the courses. This study can be used to further improve and standardize BLS courses.
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http://dx.doi.org/10.1016/j.resuscitation.2018.10.029DOI Listing
January 2019

Morphine and Ticagrelor Interaction in Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction: ATLANTIC-Morphine.

Am J Cardiovasc Drugs 2019 Apr;19(2):173-183

Sorbonne Université, ACTION Study Group, Hôpital Pitié-Salpêtrière (AP-HP), 47 boul de l'Hôpital, 75013, Paris, France.

Background: Morphine adversely impacts the action of oral adenosine diphosphate (ADP)-receptor blockers in ST-segment elevation myocardial infarction (STEMI) patients, and is possibly associated with differing patient characteristics. This retrospective analysis investigated whether interaction between morphine use and pre-percutaneous coronary intervention (pre-PCI) ST-segment elevation resolution in STEMI patients in the ATLANTIC study was associated with differences in patient characteristics and management.

Methods: ATLANTIC was an international, multicenter, randomized study of treatment in the acute ambulance/hospital setting where STEMI patients received ticagrelor 180 mg ± morphine. Patient characteristics, cardiovascular history, risk factors, management, and outcomes were recorded.

Results: Opioids (97.6% morphine) were used in 921 out of 1862 patients (49.5%). There were no significant differences in age, sex or cardiovascular history, but more morphine-treated patients had anterior myocardial infarction and left-main disease. Time from chest pain to electrocardiogram and ticagrelor loading was shorter with morphine (both p = 0.01) but not total ischemic time. Morphine-treated patients more frequently received glycoprotein IIb/IIIa inhibitors (p = 0.002), thromboaspiration and stent implantation (both p < 0.001). No significant difference between the two groups was found regarding pre-PCI ≥ 70% ST-segment elevation resolution, death, myocardial infarction, stroke, urgent revascularization and definitive acute stent thrombosis. More morphine-treated patients had an absence of pre-PCI Thrombolysis in Myocardial Infarction (TIMI) 3 flow (85.8% vs. 79.7%; p = 0.001) and more had TIMI major bleeding (1.1% vs. 0.1%; p = 0.02).

Conclusions: Morphine-treatment was associated with increased GP IIb/IIIa inhibitor use, less pre-PCI TIMI 3 flow, and more bleeding. Judicious morphine use is advised with non-opioid analgesics preferred for non-severe acute pain.

Trial Registration: clinicaltrials.gov identifier: NCT01347580.
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http://dx.doi.org/10.1007/s40256-018-0305-0DOI Listing
April 2019

Pre-hospital administration of ticagrelor in diabetic patients with ST-elevation myocardial infarction undergoing primary angioplasty: A sub-analysis of the ATLANTIC trial.

Catheter Cardiovasc Interv 2019 06 9;93(7):E369-E377. Epub 2018 Oct 9.

Sorbonne Université, ACTION Study Group, Hospital Pitie-Salpetriere (AP-HP), Paris, France.

Objective: We investigated, in the contemporary era of ST-elevation myocardial infarction (STEMI) treatment, the influence of diabetes mellitus (DM) on cardiovascular outcomes, and whether pre-hospital administration of ticagrelor may affect these outcomes in a subgroup of STEMI patients with DM.

Background: DM patients have high platelet reactivity and a prothrombotic condition which highlight the importance of an effective antithrombotic regimen in this high-risk population.

Methods: In toal 1,630 STEMI patients enrolled in the ATLANTIC trial who underwent primary percutaneous coronary intervention (PCI) were included. Multivariate analysis was used to explore the association of DM with outcomes and potential treatment-by-diabetes interaction was tested.

Results: A total of 214/1,630 (13.1%) patients had DM. DM was an independent predictor of poor myocardial reperfusion as reflected by less frequent ST-segment elevation resolution (≥70%) after PCI (OR 0.59, 95% CI 0.43-0.82, P < 0.01) and was an independent predictor of the composite 30-day outcomes of death/new myocardial infarction (MI)/urgent revascularization/definite stent thrombosis (ST) (OR 2.80, 95% CI 1.62-4.85, P < 0.01), new MI or definite acute ST (OR 2.46, 95% CI 1.08-5.61, P = 0.03), and definite ST (OR 10.00, 95% CI 3.54-28.22, P < 0.01). No significant interaction between pre-hospital ticagrelor vs in-hospital ticagrelor administration and DM was present for the clinical, electrocardiographic and angiographic outcomes as well as for thrombolysis in myocardial infarction major bleeding.

Conclusions: DM remains independently associated with poor myocardial reperfusion and worse 30-day clinical outcomes. No significant interaction was found between pre-hospital vs in-hospital ticagrelor administration and DM status. Further approaches for the treatment of DM patients are needed.

Clinical Trial Registration: clinicaltrials.gov identifier: NCT01347580.
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http://dx.doi.org/10.1002/ccd.27921DOI Listing
June 2019

Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up: the FANTOM II study.

EuroIntervention 2018 Dec 7;14(11):e1215-e1223. Epub 2018 Dec 7.

Department of Cardiology, Erasmus MC, Rotterdam, the Netherlands.

Aims: FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings.

Methods And Results: A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25% at six months, and 3.40±4.11% at nine months).

Conclusions: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.
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http://dx.doi.org/10.4244/EIJ-D-18-00491DOI Listing
December 2018

Use of renal replacement therapy after out-of-hospital cardiac arrest in Denmark 2005-2013.

Scand Cardiovasc J 2018 Oct 5;52(5):238-243. Epub 2018 Sep 5.

a Department of Cardiology, The Heart Centre , Copenhagen University Hospital Rigshospitalet , København , Denmark.

Objectives: Renal replacement therapy (RRT) is used to treat acute kidney injury as part of multi organ failure. Use and prognostic implications after out-of-hospital cardiac arrest (OHCA) is not well known. This study aims to assess incidence and use of RRT and whether RRT post-arrest was associated with 30-day mortality in Denmark in the years 2005-2013.

Methods: The Danish Cardiac Arrest Registry holds information on all OHCA patients in Denmark from 2005 to 2013. We identified 3,012 one-day survivors of OHCA ≥18 years, with presumed cardiac aetiology of arrest, admitted to ICU without previous RRT. Change in use of RRT during the study period was assessed using competing risk analysis. Mortality was assessed with Cox regression.

Results: On average, RRT was performed in 6% of the patient population with an average annual 1% increase, HR: 1.01, CI: 0.95-1.07, p = .69. Hazard of RRT was lower in patients receiving bystander cardiopulmonary resuscitation (CPR) (p < .001), patients with a shockable primary rhythm (p = .009) and elderly patients (p = .03). Socioeconomic factors did not influence hazard of RRT, but patients admitted to tertiary centres had higher hazard of RRT (p = .009). Use of RRT was associated with increased mortality in multivariate Cox regression (HR: 1.28, CI: 1.06-1.55, p = .01).

Conclusion: Use of RRT as part of post resuscitation care following OHCA did not increase from 2005 to 2013; use was more common in tertiary centres and in patients with negative prehospital predictors (no bystander CPR, non-shockable rhythm). RRT was associated with increased mortality.
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http://dx.doi.org/10.1080/14017431.2018.1503707DOI Listing
October 2018

Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study.

Am Heart J 2018 10 10;204:128-138. Epub 2018 Aug 10.

Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; University of Lund, Lund, Sweden.

Background: The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI.

Methods: In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was all-cause mortality.

Results: A total of 10,317 (30%) patients were included in 10 relevant RCTs (trial participants), and a total of 23,644 (70%) contemporary patients did not participate (nonparticipants). In all the included RCTs, nonparticipants had higher hazard ratios for mortality compared to trial participants (P < .001). Among all patients treated with PCI, the pooled estimates showed a significantly higher mortality rate for nonparticipants compared to trial participants (hazard ratio: 2.03, 95% CI: 1.88-2.19) (P < .001). When patients were stratified according to indication for PCI, the pooled estimates showed a significantly lower mortality rate for trial participants compared to nonparticipants in all strata (P for all < .001).

Conclusions: Trial participants in recently performed RCTs including patients undergoing PCI were not representative of the general population of patients with IHD treated with PCI according to clinical characteristics and mortality. The difference in mortality was found irrespective of the indication for PCI. Thus, results from RCTs including patients undergoing PCI should be extrapolated with caution to the general patient population.
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http://dx.doi.org/10.1016/j.ahj.2018.05.018DOI Listing
October 2018