Papers by Peter Clemmensen
The American journal of cardiology, Jan 15, 2018
Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STE... more Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DA...
Circulation, 2018
Background: The optimal timing of invasive coronary angiography (ICA) and revascularization in pa... more Background: The optimal timing of invasive coronary angiography (ICA) and revascularization in patients with non-ST-segment elevation acute coronary syndrome is not well defined. We tested the hypothesis that a strategy of very early ICA and possible revascularization within 12 hours of diagnosis is superior to an invasive strategy performed within 48 to 72 hours in terms of clinical outcomes. Methods: Patients admitted with clinical suspicion of non-ST-segment elevation acute coronary syndrome in the Capital Region of Copenhagen, Denmark, were screened for inclusion in the VERDICT trial (Very Early Versus Deferred Invasive Evaluation Using Computerized Tomography) ( ClinicalTrials.gov NCT02061891). Patients with ECG changes indicating new ischemia or elevated troponin, in whom ICA was clinically indicated and deemed logistically feasible within 12 hours, were randomized 1:1 to ICA within 12 hours or standard invasive care within 48 to 72 hours. The primary end point was a combinati...
American Heart Journal, 2018
Background The objective was to compare patients with ischemic heart disease (IHD) undergoing per... more 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 b .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 b .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 b .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.
Clinical biochemistry, 2018
Primary percutaneous coronary intervention (pPCI) is recommended in patients presenting with ST-e... more Primary percutaneous coronary intervention (pPCI) is recommended in patients presenting with ST-elevation myocardial infarction (STEMI) within <12 h of symptom onset. However, patients-reported symptom duration is not always reliable. Cardiac specific troponin T (cTnT) and the endogenous stress marker copeptin have different temporal release patterns for myocardial infarction MI. We hypothesized that copeptin/troponin-ratio is associated to the duration of coronary occlusion and therefore inversely proportional to myocardial salvage. Patients older than 18 years with first time STEMI referred to pPCI were eligible. cTnT and copeptin values were measured at admission. A cardiac magnetic resonance scanning (CMR) was done during the index admission for assessment of area at risk (AAR), and later 3 months to assess final infarct size (FIS). Myocardial salvage index (MSI) was calculated based on these measurements. A total of 468 patients were included. The median time from patient-re...
The American journal of cardiology, 2018
Bleeding events in relation to treatment of ST-segment elevation myocardial infarction (STEMI) ha... more Bleeding events in relation to treatment of ST-segment elevation myocardial infarction (STEMI) have previously been associated with mortality. In this study, we investigated the incidence and prognosis of, and variables associated with serious bleedings within 30 days after primary percutaneous coronary intervention in patients from The Third Danish Study of Optimal Acute Treatment of Patients with ST-Segment Elevation Myocardial Infarction (DANAMI-3) (n = 2,217). Hospital charts were read within 30 days postadmission to assess bleeding events using thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium criteria. TIMI minor/major bleeding (TMMB) occurred in 59 patients (2.7%). Variables associated with TMMB were female gender (hazard ratio [HR] 3.9, 95% confidence interval [CI] 2.2 to 6.7, p <0.0001), symptom-to-catheterization time >3 hours (HR 1.9, 95% CI 1.1 to 3.3, p = 0.02), use of glycoprotein IIb/IIIa inhibitor (HR 2.1, 95% CI 1.2 to 3.7,...
Circulation. Cardiovascular interventions, 2017
The impact of disease severity on the outcome after complete revascularization in patients with S... more The impact of disease severity on the outcome after complete revascularization in patients with ST-segment-elevation myocardial infarction and multivessel disease is uncertain. The objective of this post hoc study was to evaluate the impact of number of diseased vessel, lesion location, and severity of the noninfarct-related stenosis on the effect of fractional flow reserve-guided complete revascularization. In the DANAMI-3-PRIMULTI study (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization), we randomized 627 ST-segment-elevation myocardial infarction patients to fractional flow reserve-guided complete revascularization or infarct-related percutaneous coronary intervention only. In patients with 3-vessel disease, fractional flow reserve-guided complete revascularization reduced the primary end point (all-cause mortality, reinfarction, and ischemia-driven revascularization; hazard rat...
Journal of Electrocardiology, 2017
Background: Elevated levels of N-terminal pro brain natriuretic peptide (NT-proBNP) are associate... more Background: Elevated levels of N-terminal pro brain natriuretic peptide (NT-proBNP) are associated with adverse cardiovascular outcome after ST elevation myocardial infarction (STEMI). We hypothesized that decreasing acuteness-score (based on the electrocardiographic score by Anderson-Wilkins acuteness score of myocardial ischemia) is associated with increasing NT-proBNP levels and the impact of decreasing acuteness-score on NT-proBNP levels is substantial in STEMI patients with severe ischemia. Methods: In 186 STEMI patients treated with primary percutaneous coronary intervention (pPCI), the severity of ischemia (according to Sclarovsky-Birnbaum severity grades of ischemia) and the acuteness-score were obtained from prehospital ECG. Patients were classified according to the presence of severe ischemia or non-severe ischemia and acute ischemia or non-acute ischemia. Plasma NT-proBNP (pmol/L) was obtained after pPCI within 24 hours of admission and was correlated with the acuteness-score. Results: NT-proBNP levels were median (25th-75th interquartile) 112 (51-219) pmol/L in patients with non-severe ischemia (71.5%) and 145 (79-339) in patients with severe ischemia (28.5%) (p = 0.074). NT-proBNP levels were highest in patients with severe and non-acute ischemia compared to those with severe and acute ischemia (182 (98-339) pmol/L vs 105 (28-324) pmol/L, p = 0.012). There was a negative correlation between acuteness-score and log(NT-proBNP) in patients with severe ischemia (r = 0.395, p = 0.003), which remained significant in multilinear regression analysis (β = −0.155, p = 0.007). No correlation was observed between the acutenessscore and log(NT-proBNP) in patients with non-severe ischemia (p = 0.529) or in the entire population (p = 0.187). Conclusion: In STEMI patients with severe ischemia, neurohormonal activation is inversely associated with ECG patterns of acute myocardial ischemia.
J Amer Coll Cardiol, 2011
The Lancet, 2016
Background Despite successful treatment of the culprit artery lesion by primary percutaneous coro... more Background Despite successful treatment of the culprit artery lesion by primary percutaneous coronary intervention (PCI) with stent implantation, thrombotic embolisation occurs in some cases, which impairs the prognosis of patients with ST-segment elevation myocardial infarction (STEMI). We aimed to assess the clinical outcomes of deferred stent implantation versus standard PCI in patients with STEMI. Methods We did this open-label, randomised controlled trial at four primary PCI centres in Denmark. Eligible patients (aged >18 years) had acute onset symptoms lasting 12 h or less, and ST-segment elevation of 0•1 mV or more in at least two or more contiguous electrocardiographic leads or newly developed left bundle branch block. Patients were randomly assigned (1:1), via an electronic web-based system with permuted block sizes of two to six, to receive either standard primary PCI with immediate stent implantation or deferred stent implantation 48 h after the index procedure if a stabilised fl ow could be obtained in the infarct-related artery. The primary endpoint was a composite of all-cause mortality, hospital admission for heart failure, recurrent infarction, and any unplanned revascularisation of the target vessel within 2 years' follow-up. Patients, investigators, and treating clinicians were not masked to treatment allocation. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01435408.
Journal of electrocardiology, Jan 21, 2016
System delay (time from first medical contact to primary percutaneous coronary intervention) is a... more System delay (time from first medical contact to primary percutaneous coronary intervention) is associated with heart failure and mortality in patients with ST segment elevation myocardial infarction (STEMI). We evaluated the impact of system delay on left ventricular function (LVF) according to the combination of ischemia severity (Sclarovsky-Birnbaum grades) and acuteness (Anderson-Wilkins scores) in the pre-hospital electrocardiogram (ECG). In a predefined secondary analysis of a prospective study, the severity and acuteness scores were performed on the pre-hospital ECG. Patients were assessed with respect to 4 classifications which were not mutually exclusive: severe ischemia (+SI) or non-severe ischemia (-SI) and acute ischemia (+AI) or non-acute ischemia (-AI). LVF was assessed by global longitudinal strain (GLS) within 48hours of admission. Adjusted linear regression investigated the association of system delay with GLS in each group. In total 262 patients were eligible for a...
Open heart, 2015
Left atrial (LA) volume is a strong prognostic predictor in patients following ST-segment elevati... more Left atrial (LA) volume is a strong prognostic predictor in patients following ST-segment elevation myocardial infarction (STEMI). However, the change in LA volume over time (LA remodelling) following STEMI has been scarcely studied. We sought to identify predictors for LA remodelling and to evaluate the prognostic importance of LA remodelling. This is a subgroup analysis from a randomised clinical trial that evaluated the cardioprotective effect of exenatide treatment. A total of 160 patients with STEMI underwent a cardiovascular MR (CMR) 2 days after primary angioplasty and a second scan 3 months later. LA remodelling was defined as changes in LA volume or function from baseline to 3 months follow-up. Major adverse cardiac events were registered after a median of 5.2 years. Adverse LA minimum volume (LAmin) remodelling was correlated to the presence of hypertension, larger infarct size by CMR, higher peak troponin T, larger area at risk and adverse left ventricular (LV) remodellin...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 25, 2014
Aims: The currently stated optimal catchment population for a pPCI centre is 300,000-1,100,000, r... more Aims: The currently stated optimal catchment population for a pPCI centre is 300,000-1,100,000, resulting in 200-800 procedures/year. pPCI centres are increasing in number even within small geographic areas. We describe the organisation and quality of care after merging two high-volume centres, creating one mega centre serving 2.5 million inhabitants, and performing ~1000 procedures/year. Methods and results: In this descriptive cohort study, we linked individual-level data from the national Central Population Register holding survival status with our in-hospital dedicated PCI database of baseline, organisational and procedural characteristics. Quality measures were treatment delays and 30-day all-cause mortality. In the three-year study period, 2,066 consecutive pPCIs were performed. After the fusion of the two centres, pPCI procedures increased by 102%, while door-to-balloon remained stable at 32 minutes. Up to 75.1% of patients were directly transferred by pre-hospital triage, of...
European heart journal. Acute cardiovascular care, 2012
Reperfusion delay in ST-segment elevation myocardial infarction (STEMI) predicts adverse outcome.... more Reperfusion delay in ST-segment elevation myocardial infarction (STEMI) predicts adverse outcome. We evaluated time from alarm call (system delay) and time from first medical contact (PCI-related delay), where fibrinolysis could be initiated, to balloon inflation in a pre-hospital organization with tele-transmitted electrocardiograms, field triage and direct transfer to a 24/7 primary percutaneous coronary intervention (PPCI) center. This was a single center cohort study with long-term follow-up in 472 patients. The PPCI center registry was linked by person identification number to emergency medical services (EMS) and National Board of Health databases in the period of 2005-2008. Patients were stratified according to transfer distances to PPCI into zone 1 (0-25 km), zone 2 (65-100 km) and zone 3 (101-185 km) and according to referral by pre-hospital triage. System delay was 86 minutes (interquartile range (IQR) 72-113) in zone 1, 133 (116-180) in zone 2 and 173 (145-215) in zone 3 (...
Journal of the American College of Cardiology, 2010
The purpose of this study was to evaluate the long-term effects of distal protection during percu... more The purpose of this study was to evaluate the long-term effects of distal protection during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Background The use of distal filter protection during primary PCI increases procedure complexity and may influence lesion treatment and stent implantation. Methods The STEMI patients were assigned to distal protection (DP) (n ϭ 312) or conventional treatment (CT) (n ϭ 314). Clinical follow-up was performed after 1, 6, and 15 months, and angiographic follow-up after 8 months. All target lesion revascularizations (TLRs) were clinically driven. We report the pre-specified end points of stent thrombosis according to the criteria of the Academic Research Consortium, TLR, and reinfarction after 15 months. Results The total number of stent thrombosis was 11 in the DP group and 4 in the CT group (p ϭ 0.06). The rate of definite stent thrombosis was significantly increased in the DP group as compared with the CT group, with 9 cases versus 1 (p ϭ 0.01). Clinically driven TLRs (31 patients vs. 18 patients, p ϭ 0.05) and clinically driven target vessel revascularizations (37 patients vs. 22 patients, p ϭ 0.04) were more frequent in the DP group. Conclusions In primary PCI for STEMI, the routine use of DP increased the incidence of stent thrombosis and clinically driven target lesion/vessel revascularization during 15 months of follow-up. (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction Trial [DEDICATION]; NCT00192868) (
Journal of Electrocardiology, 2014
Background and Aim: The reduction of left ventricular ejection fraction (LVEF) following STsegmen... more Background and Aim: The reduction of left ventricular ejection fraction (LVEF) following STsegment elevation myocardial infarction (STEMI) is a result of infarcted myocardium and may involve dysfunctional but viable myocardium. An index that may quantitatively determine whether LVEF is reduced beyond the expected value when considering only infarct size (IS) has previously been presented based on cardiac magnetic resonance (CMR). The purpose of this study was to introduce the index based on the electrocardiogram (ECG) and compare indices based on ECG and CMR. Method and Results: In 55 patients ECG and CMR were obtained 3 months after STEMI treated with primary percutaneous coronary intervention. Significant, however moderate inverse relationships were found between measured LVEF and IS. Based on IS and LVEF an IS estimated LVEF was derived and an MI-LVEF mismatch index was calculated as the difference between measured LVEF and IS estimated LVEF. In 41 (74.5%) of the patients there was agreement between the ECG and CMR indices in regards to categorizing indices as N 10 or ≤ 10 and generally no significant difference was detected, mean difference of 1.26 percentage points (p = 0.53). Conclusion: The study found an overall good agreement between MI-LVEF mismatch indices based on ECG and CMR. The MI-LVEF mismatch index may serve as a tool to identify patients with potentially reversible dysfunctional but viable myocardium, but future studies including both ECG and CMR are needed.
Journal of Electrocardiology, 2012
Background and Purpose: Recent studies have shown that the Selvester QRS score is significantly c... more Background and Purpose: Recent studies have shown that the Selvester QRS score is significantly correlated with delayed enhancement-magnetic resonance imaging (DE-MRI) measured myocardial infarct (MI) size in reperfused ST elevation MI (STEMI). This study further tests the hypothesis that Selvester QRS score correlates well with MI size determined by DE-MRI in reperfused STEMI. Methods and Results: The relationship was evaluated retrospectively in 55 first-time STEMI patients 3 months after receiving primary percutaneous coronary intervention. Selvester QRS score and DE-MRI MI size were significantly correlated, r = 0.41 (P b .01). The difference between the Selvester QRS score and DE-MRI was 5.8% MI of the left ventricle (95% confidence interval, 2.9%-8.6%). Furthermore, increasing difference between Selvester QRS score and DE-MRI was observed with increasing MI size. Conclusion: Selvester QRS score correlated only moderately with DE-MRI MI size. Selvester QRS score overestimated MI size.
Diabetes, 2014
Hyperglycemia upon hospital admission in patients with ST-segment elevation myocardial infarction... more Hyperglycemia upon hospital admission in patients with ST-segment elevation myocardial infarction (STEMI) occurs frequently and is associated with adverse outcomes. It is, however, unsettled as to whether an elevated blood glucose level is the cause or consequence of increased myocardial damage. In addition, whether the cardioprotective effect of exenatide, a glucose-lowering drug, is dependent on hyperglycemia remains unknown. The objectives of this substudy were to evaluate the association between hyperglycemia and infarct size, myocardial salvage, and area at risk, and to assess the interaction between exenatide and hyperglycemia. A total of 210 STEMI patients were randomized to receive intravenous exenatide or placebo before percutaneous coronary intervention. Hyperglycemia was associated with larger area at risk and infarct size compared with patients with normoglycemia, but the salvage index and infarct size adjusting for area at risk did not differ between the groups. Treatme...
Cardiology, 2013
Objectives: We hypothesized that prehopsital ECG scores can identify ST-segment elevation myocard... more Objectives: We hypothesized that prehopsital ECG scores can identify ST-segment elevation myocardial infarction (STEMI) patients in whom time delay is particularly important for myocardial salvage. Methods: We evaluated the Anderson-Wilkins (AW) score (which designates the acuteness of ischemia) and grade 3 ischemia (GI3) (which identifies severe ischemia) in the prehospital ECG and compared them to the myocardial salvage index (MSI) assessed by cardiac magnetic resonance. Results: In 150 patients, system delay (alarm to balloon inflation) (β = -0.304, p < 0.001) and AW score (β = 0.364, p < 0.001) correlated with MSI. AW scores ≥3 (p < 0.001) and GI3 (p = 0.002) predicted the MSI. We formed 4 subgroups combining AW scores (<3 or ≥3) and grades of ischemia (Conclusion: In patients with STEMI, the novel prehospital salvage score identifies subgroups in which myocardial salvage is particularly time dependent.
The American Journal of Cardiology, 2011
It is unknown whether high-sensitivity C-reactive protein (hs-CRP) predicts outcome depending on ... more It is unknown whether high-sensitivity C-reactive protein (hs-CRP) predicts outcome depending on implanted stent type. We investigated the prognostic value of hs-CRP in relation to type of stent implanted in patients with ST-segment elevation myocardial infarction (STEMI). Immediately before primary percutaneous coronary intervention (pPCI), 301 patients had blood drawn. Patients were categorized according to hs-CRP levels and combination of hs-CRP (<2 vs >2 mg/L) and stent type (bare metal stent [BMS] vs drug-eluting stent [DES]). Hs-CRP >2 mg/L (median, hazard ratio 2.7, 95% confidence interval 1.3 to 5.6, p ؍ 0.007) and the combined variable of hs-CRP >2 mg/L and BMS (hazard ratio 2.4, 95% confidence interval 1.2 to 4.5, p ؍ 0.006) independently predicted the composite end point of death and MI at 36-month follow-up. There was a significant interaction (p ؍ 0.006) for hs-CRP and stent type. Survival analysis demonstrated significant differences for occurrence of death and MI: 4.8% in BMS ؉ CRP <2 mg/L, 11.9% in DES ؉ CRP <2 mg/L, 17.6% in DES ؉ CRP >2 mg/L, and 27.9% in BMS ؉ CRP >2 mg/L. None of the 14 stent thromboses occurred in patients with BMS ؉ CRP <2 mg/L. In conclusion, preprocedure hs-CRP predicts outcome after pPCI in patients with STEMI. Our hypothesis-generating data indicate that BMS implantation should be preferred when hs-CRP is <2 mg/L and DES when hs-CRP is >2 mg/L to decrease long-term adverse outcomes including stent thrombosis in patients with STEMI treated with pPCI. These findings need confirmation in larger randomized clinical trials.
American Heart Journal, 2010
Background Ischemic postconditioning (IPost) during primary percutaneous coronary intervention (P... more Background Ischemic postconditioning (IPost) during primary percutaneous coronary intervention (PPCI) is suggested to reduce myocardial damage. However, the association with ST-segment resolution (STR) and clinical outcome is not determined. The primary aim of this study was to evaluate the association of IPost with STR and clinical outcome. Secondly, we sought to determine the relationship between STR and cardiac magnetic resonance (CMR) parameters in these patients. Methods One hundred eighteen patients referred for PPCI were randomly assigned to either conventional PPCI or PPCI with IPost. In a single electrocardiographic lead, STR was determined. Treatment modalities were compared as regards STR, ST-segment elevation, and the number of patients achieving complete-STR (≥70%), incomplete-STR (30%-70%), and no-STR (b30%). Patients were evaluated for clinical outcome after 15 months. Furthermore, patients with and without complete-STR were compared as regards CMR parameters. Results There was a tendency toward a better outcome with IPost for the number of patients achieving complete-STR (55% vs 63%; P = .09), ST-segment elevation (1.41 vs 1.12 mm; P = .07), and New York Heart Association class (P = .06). No difference in other cardiac events was observed. Furthermore, data determine that patients with complete-STR have smaller infarct size (12.9% vs 21.1%; P b .01) and a better ejection fraction (55.7% vs 47.7%; P b .01). Conclusions Patients treated with IPost are suggested to have improved STR and New York Heart Association classification. Infarct size and the functional CMR parameters were better in the patients with complete-STR; as to this, single-lead STR remains an important predictor for successful treatment in patients treated with IPost.
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Papers by Peter Clemmensen