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To evaluate the impact of acute kidney injury on transition to chronic kidney disease (CKD) after cardiac surgery and to determine frequency of incident CKD in these patients. A systematic review and meta-analysis of observational studies. Electronic databases Medline and Embase were systematically searched from 1974 to February 6, 2023. Eligible studies were original observational studies on adult cardiac surgery patients, written in the English language, and with clear kidney disease definitions. Exclusion criteria were studies with previously transplanted populations, populations with preoperative kidney impairment, ventricular assist device procedures, endovascular procedures, a kidney follow-up period of <90 days, and studies not presenting necessary data for effect size calculations. Patients developing postoperative acute kidney injury after cardiac surgery were compared with patients who did not develop acute kidney injury. The search identified 4,329 unique studies, 87 underwent full-text review, and 12 were included for analysis. Mean acute kidney injury occurrence across studies was 16% (minimum-maximum: 8-50), while mean occurrence of CKD was 24% (minimum-maximum: 3-35), with high variability depending on definitions and follow-up time. Acute kidney injury was associated with increased odds of CKD in all individual studies. The pooled odds ratio across studies was 5.67 (95% confidence interval, 3.34-9.64; p < 0.0001). Acute kidney injury after cardiac surgery was associated with a more than 5-fold increased odds of developing CKD. New-onset CKD occurred in almost 1 in 4 patients in the years after surgery. [ABSTRACT FROM AUTHOR]

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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. [ABSTRACT FROM AUTHOR]

Abstract 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) Central Illustration [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The potential interactions between prehospital (pre-H) ticagrelor administration and thrombus aspiration (TA) in patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) have never been studied. Therefore, we evaluated the potential benefit of TA and pre-H ticagrelor treatment in patients enrolled in the ATLANTIC trial (NCT01347580).Methods: This analysis included 1,630 patients who underwent primary PCI. Multivariate analysis was used to explore the potential association of TA and pre-H treatment to clinical outcomes. Potential interactions between TA and pre-H ticagrelor were also explored.Results: A total of 941 (57.7%) patients underwent TA. In adjusted multivariate logistic model, pre-H ticagrelor treatment was significantly associated with less frequent new MI or definite stent *thrombosis (ST) (odds ratio [OR] 0.43, 95% CI 0.20-0.92, P=.031), or definite ST (OR 0.26, 95% CI 0.07-0.91, P=.036) at 30 days. Patients treated with TA had higher frequency of Thrombolysis in Myocardial Infarction (TIMI) flow 0-1 compared with no-TA group (80.7% vs 51.9%, P<.0001). TA when also adjusted for TIMI flow 0-1 showed significant association only for higher bailout use of glycoprotein IIb/IIIa inhibitors (OR 1.72, 95% CI 1.18-2.50, P=.004) and more frequent 30-day TIMI major bleeding (OR 2.92, 95% CI 1.10-7.76, P=.032). No significant interactions between TA and pre-H ticagrelor were present for the explored end points.Conclusions: TA when left to physicians' discretion was used in high-risk patients, was associated with bailout use of glycoprotein IIb/IIIa inhibitors and TIMI major bleeding, and had no impact on 30-day clinical outcomes. Conversely, pre-H ticagrelor treatment predicted lower 30-day rates of ST or new MI without interaction with TA. [ABSTRACT FROM AUTHOR]

Background: Among patients with STEMI in the ATLANTIC study, pre-hospital administration of ticagrelor improved post-PCI ST-segment resolution and 30-day stent thrombosis. We investigated whether this clinical benefit with pre-hospital ticagrelor differs by ischemic duration.Methods: In a post hoc analysis we compared absence of ST-segment resolution post-PCI and stent thrombosis at 30 days between randomized treatment groups (pre- versus in-hospital ticagrelor) stratified by symptom onset to first medical contact (FMC) duration [≤1 hour (n = 773), >1 to ≤3 hours (n = 772), and >3 hours (n = 311)], examining the interaction between randomized treatment strategy and duration of symptom onset to FMC for each outcome.Results: Patients presenting later after symptom onset were older, more likely to be female, and have higher baseline risk. Patients with symptom onset to FMC >3 hours had the greatest improvement in post-PCI ST-segment elevation resolution with pre- versus in-hospital ticagrelor (absolute risk difference: ≤1 hour, 2.9% vs. >1 to ≤3 hours, 3.6% vs. >3 hours, 12.2%; adjusted p for interaction = 0.13), while patients with shorter duration of ischemia had greater improvement in stent thrombosis at 30 days with pre- versus in-hospital ticagrelor (absolute risk difference: ≤1 hour, 1.3% vs. >1 hour to ≤3 hours, 0.7% vs. >3 hours, 0.4%; adjusted p for interaction = 0.55). Symptom onset to active ticagrelor administration was independently associated with stent thrombosis at 30 days (adjusted OR 1.89 per 100 minute delay, 95%CI 1.20-2.97, P < .01), but not post-PCI ST-segment resolution (P = .41).Conclusions: The effect of pre-hospital ticagrelor to reduce stent thrombosis was most evident when given early within 3 hours after symptom onset, with delay in ticagrelor administration after symptom onset associated with higher rate of stent thrombosis. These findings re-emphasize the need for early ticagrelor administration in primary PCI treated STEMI patients. [ABSTRACT FROM AUTHOR]

Objectives The aim of this landmark exploratory analysis, ATLANTIC-H 24 , was to evaluate the effects of pre-hospital ticagrelor during the first 24 h after primary percutaneous coronary intervention (PCI) in the ATLANTIC (Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial infarction to open the Coronary artery) study. Background The ATLANTIC trial in patients with ongoing ST-segment elevation myocardial infarction showed that pre-hospital ticagrelor was safe but did not improve pre-PCI coronary reperfusion compared with in-hospital ticagrelor. We hypothesized that the effect of pre-hospital ticagrelor may not have manifested until after PCI due to the rapid transfer time (31 min). Methods The ATLANTIC-H 24 analysis included 1,629 patients who underwent PCI, evaluating platelet reactivity, Thrombolysis In Myocardial Infarction flow grade 3, ≥70% ST-segment elevation resolution, and clinical endpoints over the first 24 h. Results Following PCI, largest between-group differences in platelet reactivity occurred at 1 to 6 h; coronary reperfusion rates numerically favored pre-hospital ticagrelor, and the degree of ST-segment elevation resolution was significantly greater in the pre-hospital group (median, 75.0% vs. 71.4%; p = 0.049). At 24 h, the composite ischemic endpoint was lower with pre-hospital ticagrelor (10.4% vs. 13.7%; p = 0.039), as were individual endpoints of definite stent thrombosis (p = 0.0078) and myocardial infarction (p = 0.031). All endpoints except death (1.1% vs. 0.2%; p = 0.048) favored pre-hospital ticagrelor, with no differences in bleeding events. Conclusions The effects of pre-hospital ticagrelor became apparent after PCI, with numerical differences in platelet reactivity and immediate post-PCI reperfusion, associated with reductions in ischemic endpoints, over the first 24 h, whereas there was a small excess of mortality. (Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial infarction to open the Coronary artery [ATLANTIC, NCT01347580 ]) [ABSTRACT FROM AUTHOR]

Background: Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population.Design: The multicenter SORT OUT VII trial (NCT01879358) randomly assigned 2,530 patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at 3 sites in Western Denmark. Patients were eligible, if they were ≥18 years old; had chronic stable coronary artery disease or acute coronary syndromes; and ≥1 coronary lesion with >50% diameter stenosis, requiring treatment with a DES. 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. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of 3.0%.Conclusion: The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event. [ABSTRACT FROM AUTHOR]

Background In patients with ST-segment elevation myocardial infarction (STEMI), timely reperfusion with primary percutaneous coronary intervention (PCI) is the preferred treatment. In primary PCI patients with multivessel disease, it is unclear whether culprit vessel PCI only is the preferred treatment. We compared mortality among (1) STEMI patients with single-vessel disease and those with multivessel disease and (2) multivessel disease patients with and without additional revascularization of nonculprit lesions within 2 months after the index PCI. Methods From January 2002 to June 2009, all patients presenting with STEMI and treated with primary PCI were identified from the Western Denmark Heart Registry, which covers a population of 3.0 million. The hazard ratio (HR) for death was estimated using a Cox regression model, controlling for potential confounding. Results The study cohort consisted of 8,822 patients: 4,770 (54.1%) had single-vessel disease and 4,052 (45.9%) had multivessel disease. Overall, 1-year cumulative mortality was 7.6%, and 7-year cumulative mortality was 24.0%. Multivessel disease was associated with higher 7-year mortality (adjusted HR 1.45 [95% CI 1.30-1.62], P < .001). Among patients with multivessel disease, lack of additional revascularization beyond the culprit lesion was associated with higher 7-year mortality (adjusted HR 1.50 [95% CI 1.25-1.80], P < .001). In patients with multivessel disease who underwent additional revascularization, 7-year mortality (adjusted HR 1.01 [95% CI 0.84-1.22], P = .89) was similar compared to patients with single-vessel disease. Conclusion In STEMI patients, multivessel disease was associated with a higher mortality compared to single-vessel disease. In multivessel disease patients, additional revascularization was associated with a higher survival compared with culprit vessel PCI only. [ABSTRACT FROM AUTHOR]

Objectives The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. Background In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES. Methods We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis). Results At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70). Conclusions At 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877). [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Coronary CT angiography (CTA) is an established noninvasive method for visualization of coronary artery disease. However, coronary CTA lacks physiological information; thus, it does not permit differentiation of ischemia-causing lesions. Recent advances in computational fluid dynamic techniques applied to standard coronary CTA images allow for computation of fractional flow reserve (FFR), a measure of lesion-specific ischemia. The diagnostic performance of computed FFR (FFRCT) compared with invasively measured FFR is not yet fully established. Methods/Design: HeartFlowNXT (HeartFlow analysis of coronary blood flow using coronary CT angiography: NeXt sTeps) is a prospective, international, multicenter study designed to evaluate the diagnostic performance of FFRCT for the detection and exclusion of flow-limiting obstructive coronary stenoses, as defined by invasively measured FFR as the reference standard. FFR values ≤0.80 will be considered to be ischemia causing. All subjects (N = 270; 10 investigative sites) will undergo coronary CTA (single- or dual-source CT scanners with a minimum of 64 slices) and invasive coronary angiography with FFR. Patients with insufficient quality of coronary CTA will be excluded. Blinded core laboratory interpretation will be performed for FFRCT, invasive coronary angiography, and FFR. Stenosis severity by coronary CTA will be evaluated by the investigative site in addition to a blinded core laboratory interpretation. The primary objective of the study is to determine the diagnostic performance of FFRCT compared with coronary CTA alone to noninvasively determine the presence of hemodynamically significant coronary lesions. The secondary end point comprises assessment of diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of FFRCT. [Copyright &y& Elsevier]

Objectives: This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. Background: The randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) trial evaluated the outcome after DES compared with BMS implantation in patients with STEMI undergoing primary percutaneous coronary intervention. Methods: Patients with a high-grade stenosis/occlusion of a native coronary artery presenting with symptoms <12 h and ST-segment elevation were enrolled after giving informed consent. Patients were randomly assigned to receive a DES or a BMS in the infarct-related lesion. Patients were followed for at least 5 years, and clinical endpoints were evaluated from population registries and hospital charts. The main endpoint was the occurrence of the first major adverse cardiac event (MACE), defined as cardiac death, nonfatal recurrent myocardial infarction, and target lesion revascularization. Results: Complete clinical status was available in 623 patients (99.5%) at 5 years follow-up. The combined MACE rate was insignificantly lower in the DES group (16.9% vs. 23%), mainly driven by a lower need of repeat revascularization (p = 0.07). Whereas the number of deaths from all causes tended to be higher in the DES group (16.3% vs. 12.1%, p = 0.17), cardiac mortality was significantly higher (7.7% vs. 3.2%, p = 0.02). The 5-year stent thrombosis rates were generally low and similar between the DES and the BMS groups. No cardiac deaths occurring within 1 month could be clearly ascribed to stent thrombosis, whereas stent thrombosis was involved in 78% of later-occurring deaths. Conclusions: The 5-year MACE rate was insignificantly different, but the cardiac mortality was higher after DES versus BMS implantation in patients with STEMI. Stent thrombosis was the main cause of late cardiac deaths. [Copyright &y& Elsevier]

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) [ABSTRACT FROM AUTHOR]

Abstract: Background: In patients with ST elevation myocardial infarction (STEMI), spontaneous ST resolution (spontSTR) is a marker of successful microvascular reperfusion. The significance of increase in ST elevation during reperfusion therapy (the ST peak phenomenon), however, is controversial. Aims: The purpose of the study was to evaluate whether preprocedural and periprocedural ST changes predict final infarct size (IS) in STEMI patients treated with primary percutaneous coronary intervention (primary PCI). Methods: Twelve-lead electrocardiograms (ECGs) were acquired in the prehospital phase and on admission in 200 STEMI patients transferred for primary PCI. Continuous ST monitoring was performed during and 90 minutes after primary PCI. The exact timing of interventional procedures and the resulting thrombolysis in myocardial infarction (TIMI) flow were registered. A 1-month single-photon emission computerized tomography was performed to evaluate IS. Patients were stratified into groups according to preprocedural and periprocedural ST changes as follows: patients with spontSTR before primary PCI and without (A) or with (B) ST peak during primary PCI and patients with persistent ST elevation before primary PCI and without (C) or with (D) ST peak during primary PCI. Findings: Groups A (n = 45), B (n = 10), C (n = 109), and D (n = 36) differed with regard to IS (median, 2%, 3%, 13% vs 22% of the left ventricle; P < .0001). In multivariable analysis adjusting for baseline characteristics, preprocedural and periprocedural ECG findings and routine angiography findings, spontSTR was associated with smaller IS (B = −8.6%; P < .001), whereas the ST peak phenomenon was associated with larger IS (B = +5.0%; P = .006). There was no difference in TIMI flow grades in relation to coronary interventions among patients with and without ST peak during primary PCI. Conclusions: In STEMI patients, spontSTR before primary PCI and the ST peak phenomenon during primary PCI predict minor vs extensive IS independent of angiographic patency grades. Further studies are needed to clarify whether the ST peak phenomenon is “a marker of injury before reperfusion” or “a marker of reperfusion-induced injury.” [Copyright &y& Elsevier]

Abstract: In patients with ST-elevation myocardial infarction, fast initiation of reperfusion therapy is mandatory. It is well established that prehospital diagnosis results in earlier initiation of fibrinolysis, but there is limited evidence concerning the value of prehospital evaluation in patients treated with primary percutaneous coronary intervention (PCI). The present paper proposes various prehospital strategies that may be of relevance in treating the latter patients: (1) a substantial reduction in treatment delay may be achieved by prehospital diagnosis, especially if combined with rerouting of patients directly to interventional hospital; (2) use of telemedicine may allow a widespread implementation of a prehospital diagnostic program; (3) a rerouting strategy may result in prolonged transportation. In this setting, continuous real-time 1-lead ECG transmission from ambulance to hospital may allow physicians to support ambulance personnel in the treatment of arrhythmias during transportation; and (4) equipment used for prehospital ECG acquisition and transmission has built-in features for continuous ST-segment monitoring. It is hypothesized that continuous ST-segment monitoring performed in the prehospital phase and during primary PCI may provide important prognostic information, with the potential of triaging future pharmacological and interventional treatment at time of PCI. [Copyright &y& Elsevier]

Although kidney insufficiency has been shown to be associated with increased risk of myocardial injury, benefit of coronary angiography (CAG) and revascularization remains uncertain, with implications on management strategies and outcomes. We aimed to compare rates of CAG and revascularization and subsequent risk of cardiovascular and kidney outcomes in hospitalized patients with myocardial injury and kidney dysfunction. Retrospective cohort study encompassing hospitalized patients with myocardial injury i.e. elevated troponin I or T and an eGFR ≤60 ml/min/1.73 m2 identified between 2011 and 2021 in Danish national registers. 30-day odds for CAG were computed across granular eGFR-categories based on multiple logistic regression. Standardized one-year risks of cardiovascular and kidney outcomes including mortality were determined based on hazards obtained in multiple Cox regression. A total of 52,798 patients with myocardial injury were identified. CAG was performed in 14.3 % (n = 7549). 30-day odds ratios for CAG were 0.64 [0.60–0.68], 0.38 [0.34–0.42], 0.18 [0.14–0.22], and 0.35 [0.30–0.40] in patients with eGFR 31–45 ml/min/1.73 m2, eGFR 15–30 ml/min/1.73 m2 for eGFR<15 ml/min/1.73 m2 and chronic dialysis, respectively (eGFR 46-60 ml/min/1.73 m2 as reference). Median follow-up was 4.1 years. One-year mortality risk differences associated with CAG and revascularization (no CAG as reference) were −7.8 [−7.0; −8.7] and −9.1 [−8.4; −9.9] for eGFR 46-60 ml/min/1.73 m2; −7.0 [−5.7;-8–3] and −8.0 [−6.6; −9.5] for eGFR 31-45 ml/min/1.73 m2; −5.4 [−3.0; −7.2] and −5.2 [−2.2; −8.3] for eGFR 15-30 ml/min/1.73 m2; −8.8 [−3.1; −13.7] and −5.4 [3.1; −13.4] for eGFR<15 ml/min/1.73 m2; and −4.9 [−0.1; −9.7] and −4.2 [1.5; −9.2] for chronic dialysis, respectively. Probability of CAG following myocardial injury declined with progressive kidney dysfunction. Overall, CAG was associated with lower mortality irrespective of kidney function and subsequent revascularization. • Myocardial injury i.e. elevated cardiac troponins is common in hospitalized patients • Implications of elevated troponin remain uncertain in patients with kidney insufficiency beyond overt myocardial infarction • Probability of coronary angiography and revascularization declines with progressive kidney dysfunction • Revascularization benefit is curtailed with increasing kidney dysfunction [ABSTRACT FROM AUTHOR]

Background: The purpose of a bioresorbable scaffold (BRS) is to provide radial support during coronary healing. In this study, coronary artery healing after optical coherence tomography (OCT)- versus angiography-guided magnesium BRS (MBRS) implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) is compared.Methods: 75 patients were randomized 1:1 to OCT- or angiography-guided implantation of a MBRS with protocolled pre- and post-dilation. In the OCT-guided group, prespecified criteria indicating additional intervention were (1) scaffold under-expansion, (2) strut malapposition, (3) edge dissection, and (4) residual stenosis at distal or proximal reference segments. The primary endpoint was OCT-derived healing stage at 6 months.Results: At 6 months, there was no difference in average healing stage between OCT- and angiography-guided intervention (4.6 [interquartile range (IQR): 4.5-4.7] versus 4.5 [IQR: 4.3-4.7]; p = 0.54). The MBRSs were completely resolved in 77.0% [IQR: 68.5-85.5] versus 76.5% [IQR: 67.9-85.5]; (p = 0.97). Minimal lumen area (MLA) was reduced at 6 months in both the OCT- (32.3%; p < 0.01) and the angiography-guided group (21.3%; p < 0.01), however OCT-guided implantation was associated with a greater reduction of total lumen volume (-27.1 ± 32.5 mm3 versus -5.0 ± 32.9 mm3; p < 0.01) and MLA (-2.3 ± 1.6 mm2 vs. -1.4 ± 1.4 mm2; p = 0.02).Conclusions: In NSTEMI patients, OCT-guidance with protocolled pre- and post-dilation of MBRS implantation showed similar healing pattern at 6 months compared to angiography-guidance alone.Clinical Trial Registration: The Coronary Artery Healing Process after Optical Coherence Tomography Guided Percutaneous Coronary Intervention with Magmaris Bioresorbable Scaffold in Patients with Non-ST-Segment-Elevation Myocardial Infarction: (HONEST) trial is registered with ClinicalTrials.gov, NCT03016624. [ABSTRACT FROM AUTHOR]

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). 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). 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. • Participants in the DANAMI-3 trial were not representative to the background population with STEMI. • Participants in the DANAMI-3 trial were not representative to the per protocol target population. • Sampling bias and unreported screening had occurred. • Screening logs may not be suitable for addressing issues of external validity. [ABSTRACT FROM AUTHOR]

Background: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown.Objectives: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial.Methods: Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis.Results: At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72).Conclusions: At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877). [ABSTRACT FROM AUTHOR]

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 ± 2.6 mm. 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. [ABSTRACT FROM AUTHOR]

System delay (delay from emergency medical service call to reperfusion with primary percutaneous coronary intervention [PPCI]) is acknowledged as a performance measure in ST-elevation myocardial infarction (STEMI), as shorter system delay is associated with lower mortality. It is unknown whether system delay also impacts ability to stay in the labor market. Therefore, the aim of the study was to evaluate whether system delay is associated with duration of absence from work or time to retirement from work among patients with STEMI treated with PPCI. We conducted a population-based cohort study including patients ≤67 years of age who were admitted with STEMI from January 1,1999, to December 1,2011 and treated with PPCI. Data were derived from Danish population-based registries. Only patients who were full- or part-time employed before their STEMI admission were included. Association between system delay and time to return to the labor market was analyzed using a competing-risk regression analysis. Association between system delay and time to retirement from work was analyzed using a Cox regression model. A total of 4,061 patients were included. Ninety-three percent returned to the labor market during 4 years of follow-up, and 41% retired during 8 years of follow-up. After adjustment, system delay >120 minutes was associated with reduced resumption of work (subhazard ratio 0.86,95% confidence interval 0.81 to 0.92) and earlier retirement from work (hazard ratio 1.21, 95% confidence interval 1.08 to 1.36). In conclusion, system delay was associated with reduced work resumption and earlier retirement. This highlights the value of system delay as a performance measure in treating patients with STEMI. [ABSTRACT FROM AUTHOR]

Improvement of prehospital triage is essential to ensure rapid management of patients with acute myocardial infarction (AMI). This study evaluates the feasibility of prehospital quantitative point-of-care cardiac troponin T (POC-cTnT) analysis, its ability to identify patients with AMI, and its capacity to predict mortality. The study was performed in the Central Denmark Region from May 2010 to May 2011. As a supplement to electrocardiography, a prehospital POC-cTnT measurement was performed by a paramedic in patients with suspected AMI. AMI was diagnosed according to the universal definition of myocardial infarction using the ninety-ninth percentile upper reference level as diagnostic cut point. The paramedics performed POC-cTnT measurements in 985 subjects with a symptom duration of 70 minutes (95% CI, 35 to 180); of whom, 200 (20%) had an AMI. The prehospital sample was obtained 88 minutes (range, 58 to 131) before the sample made on admission to the hospital. The sensitivity for detection of patients with an AMI was 39% (95% CI, 32% to 46%) and the diagnostic accuracy of the POC-cTnT values was 0.67 (95% CI, 0.64 to 0.71). Adjusted survival analysis showed a strong significant association between elevated prehospital POC-cTnT level above the detection level of 50 ng/L and mortality in patients with a suspected AMI irrespective of whether an AMI was diagnosed. In conclusion, large-scale quantitative prehospital POC-cTnT testing by paramedics is feasible. An elevated prehospital POC-cTnT value contains diagnostic information and is highly predictive of mortality in patients with a suspected AMI. [ABSTRACT FROM AUTHOR]

Abstract: Background: This prospective multicenter registry used intravascular ultrasound (IVUS) in patients with definite stent thrombosis (ST) to compare rates of incomplete stent apposition (ISA), stent fracture and stent expansion in patients treated with drug-eluting (DES) versus bare metal (BMS) stents. ST is a rare, but potential life threatening event after coronary stent implantation. The etiology seems to be multifactorial. Methods: 124 patients with definite ST were assessed by IVUS during the acute ST event. The study was conducted in 15 high-volume percutaneous coronary intervention -centers in the Nordic–Baltic countries. Results: In early or late ST there were no differences in ISA between DES and BMS. In very late ST, ISA was a more frequent finding in DES than in BMS (52% vs.16%; p=0.005) and the maximum ISA area was larger in DES compared to BMS (1.1±2.3mm2 vs. 0.1±0.5mm2; p=0.004). Further, ISA was more prevalent in sirolimus-eluting than in paclitaxel-eluting stents (58% vs. 37%; p=0.02). Stent fractures were found both in DES (16%) and BMS (24%); p=0.28, and not related to time of stent thrombosis occurrence. For stents with nominal diameters ≥2.75mm, 38% of the DES and 22% of the BMS had a minimum stent area of less than 5mm2; p=0.14. Conclusions: Very late stent thrombosis was more prevalent and associated with more extensive ISA in DES than in BMS treated patients. Stent fracture was a common finding in ST after DES and BMS implantation. [Copyright &y& Elsevier]

Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients. [Copyright &y& Elsevier]

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. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877) [ABSTRACT FROM AUTHOR]

Patients with diabetes mellitus (DM) have a worse outcome after percutaneous coronary intervention (PCI) than nondiabetic patients. The purpose of this study was to compare rates of stent thrombosis, myocardial infarction (MI), target lesion revascularization (TLR), and death in diabetic and nondiabetic patients treated with primary PCI for ST-segment elevation MI (STEMI) in Western Denmark. From January 2002 through June 2005, 3,655 consecutive patients with STEMI treated with primary PCI and stent implantation (316 patients with DM, 8.6%; 3,339 patients without DM, 91.4%) were recorded in the Western Denmark Heart Registry. All patients were followed for 3 years. Cox regression analysis was used to compute hazard ratios (HRs), controlling for potential confounding. Three-year rates of definite stent thrombosis were 1.6% in the DM group and 1.5% in the non-DM group (adjusted HR 1.15, 95% confidence interval [CI] 0.50 to 2.67). The rate of MI was 12.3% in the DM group versus 5.6% in the non-DM group (adjusted HR 2.56, 95% CI 1.81 to 3.61). Rates of TLR were 12.1% in the DM group and 8.7% in the non-DM group (adjusted HR 1.55, 95% CI 1.14 to 2.11). All-cause mortality was 23.7% in patients with DM versus 12.7% in patients without DM (adjusted HR 2.03, 95% CI 1.59 to 2.59). In conclusion, stent thrombosis rate was similar in patients with and without DM and STEMI treated with primary PCI, whereas the presence of DM increased the risk of MI, TLR, and death. [Copyright &y& Elsevier]

Patients ≥80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients ≥80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (≥80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and “ventricular arrhythmia or congestive heart failure” in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients ≥80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time. [ABSTRACT FROM AUTHOR]

Prehospital electrocardiographic (ECG) diagnosis has improved triage and outcome in patients with acute ST-elevation myocardial infarction. However, many patients with acute myocardial infarction (AMI) present with equivocal ECG patterns making prehospital ECG diagnosis difficult. We aimed to investigate the feasibility and ability of prehospital troponin T (TnT) testing to improve diagnosis in patients with chest pain transported by ambulance. From June 2008 through September 2009, patients from the central Denmark region with suspected AMI and transported by ambulance were eligible for prehospital TnT testing with a qualitative point-of-care test (cutpoint 0.10 ng/ml). Quantitative TnT was measured at hospital arrival and after 8 and 24 hours (cutpoint 0.03 ng/ml). A prehospital electrocardiogram was recorded in all patients. Prehospital TnT testing was attempted in 958 patients with a 97% success rate. In 258 patients, in-hospital TnT values were increased (≥0.03 ng/ml) during admission. The prehospital test identified 26% and the first in-hospital test detected 81% of patients with increased TnT measurements during admission. A diagnosis of AMI was established in 208 of 258 patients with increased TnT. The prehospital test identified 30% of these patients, whereas the first in-hospital test detected 79%. Median times from symptom onset to blood sampling were 83 minutes (46 to 167) for the prehospital sample and 165 minutes (110 to 276) for the admission sample. In conclusion, prehospital TnT testing is feasible with a high success rate. This study indicates that prehospital implementation of quantitative tests, with lower detection limits, could identify most patients with AMI irrespective of ECG changes. [Copyright &y& Elsevier]

Abstract: Aim of the study: Quality of cardiopulmonary resuscitation (CPR) is a critical determinant of outcome following out-of-hospital cardiac arrest. The aim of our study was to evaluate the quality of CPR provided by emergency medical service providers (Basic Life Support (BLS) capability) and emergency medical service providers assisted by paramedics, nurse anesthetists or physician-manned ambulances (Advanced Life Support (ALS) capability) in a nationwide, unselected cohort of out-of-hospital cardiac arrest cases. Methods: We conducted a prospective, observational study of out-of-hospital cardiac arrest with non-traumatic etiology (>18 years of age) occurring from the 1st to the 31st of January 2009 and treated by the primary Danish emergency medical service operator, covering approximately 85% of the population. One hundred and ninety-one cases were eligible for analysis. Follow-up was up to one year or death. Quality of CPR was evaluated using measurements of transthoracic impedance. Results: The majority of patients were treated by ambulances with ALS capability (54%). Interruptions in CPR related to loading of the patient into the emergency medical service vehicle were substantial, but independent of whether patients were managed by ALS or BLS capable units (222s versus 224s, P =0.76) as were duration of interruptions during rhythm analysis alone (20s versus 22s, P =0.33) and defibrillation (24s versus 26s, P =0.07). Conclusions: Nationwide, routine monitoring of transthoracic impedance is feasible. CPR is hampered by extended interruptions, particularly during loading of the patient into the emergency medical service vehicle, rhythm analysis and defibrillation. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). Background: The evidence of long-term efficacy and safety after implantation of DES in patients with complex lesions is scarce. Methods: We randomly assigned 626 patients with STEMI referred within 12 h to have a DES or a BMS implanted in the infarct-related lesion with or without distal protection during primary percutaneous coronary intervention. Results: At 3 years, target lesion revascularization was 6.1% in the DES group compared with 16.3% in the BMS group (p < 0.001), and the rate of major adverse cardiac events was 11.5% versus 18.2%, respectively (p = 0.02). Whereas all-cause mortality did not differ significantly, the rate of cardiac death was higher in the DES group, 6.1% versus 1.9% for the BMS group (p = 0.01). The occurrence of reinfarction, stroke, and stent thrombosis was similar. Conclusions: Implantation of DES in patients with STEMI reduces the long-term rate of major adverse cardiac events compared with BMS, but patients with DES had a higher risk of cardiac death not attributed to myocardial infarction or stent thrombosis. (Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction [DEDICATION]; NCT00192868) [ABSTRACT FROM AUTHOR]

Patients with diabetes mellitus have worse outcomes after percutaneous coronary intervention than patients without diabetes mellitus. We compared the risk of stent thrombosis, myocardial infarction, death, and target lesion revascularization in diabetic and nondiabetic patients after implantation of drug-eluting stents or bare metal stents. In the Western Denmark Heart Registry, 12,347 consecutive patients (1,575 with and 10,772 without diabetes) were identified and followed up for 2 years. The 2-year risk of definite stent thrombosis was 0.52% in patients with diabetes mellitus and 0.71% in nondiabetic patients (adjusted relative risk [RR] 0.74, 95% confidence interval [CI] 0.41 to 1.34, p = 0.321). The 2-year risk of myocardial infarction was greater in the diabetic patients (6.9%) than in the nondiabetic patients (3.6%; adjusted RR 1.96, 95% CI 1.58 to 2.43; p <0.001). The all-cause 2-year mortality rate was almost twice as great for the diabetic patients compared to the nondiabetic patients (12.4% vs 6.7%; adjusted RR 1.91, 95% CI 1.63 to 2.23; p <0.001). The 2-year risk of target lesion revascularization was 8.5% in the diabetic patients and 6.8% in the nondiabetic patients (adjusted RR 1.28, 95% CI 1.10 to 1.49; p <0.001). In conclusion, 2 years after drug-eluting stent or bare metal stent implantation, diabetic patients had a greater risk than nondiabetic patients of myocardial infarction and death. Drug-eluting stent treatment reduced the risk of target lesion revascularization compared to bare metal stent treatment, regardless of diabetes status. [Copyright &y& Elsevier]

Abstract: Purpose: Lengthy resuscitations in the catheterisation laboratory carry extremely high rates of mortality because it is essentially impossible to perform effective chest compressions during percutaneous coronary intervention (PCI). The purpose of this study was to evaluate the use of a mechanical chest compression device, LUCAS™, in the catheterisation laboratory, in patients who suffered circulatory arrest requiring prolonged resuscitation. Materials and methods: The study population was comprised of patients who arrived alive to the catheterisation laboratory and then required mechanical chest compression at some time during the angiogram, PCI or pericardiocentesis between 2004 and 2008 at the Lund University Hospital. This is a retrospective registry analysis. Results: During the study period, a total of 3058 patients were treated with PCI for ST-elevation myocardial infarction (STEMI) of whom 118 were in cardiogenic shock and 81 required defibrillations. LUCAS™ was used in 43 patients (33 STEMI, 7 non-ST-elevation myocardial infarction (NSTEMI), 2 elective PCIs and 1 patient with tamponade). Five patients had tamponade due to myocardial rupture prior to PCI that was revealed at the start of the PCI, and all five died. Of the remaining 38 patients, 1 patient underwent a successful pericardiocentesis and 36 were treated with PCI. Eleven of these patients were discharged alive in good neurological condition. Conclusion: The use of mechanical chest compressions in the catheterisation laboratory allows for continued PCI or pericardiocentesis despite ongoing cardiac or circulatory arrest with artificially sustained circulation. It is unlikely that few, if any, of the patients would have survived without the use of mechanical chest compressions in the catheterisation laboratory. [Copyright &y& Elsevier]

Objectives: 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 = 312) or conventional treatment (CT) (n = 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 = 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 = 0.01). Clinically driven TLRs (31 patients vs. 18 patients, p = 0.05) and clinically driven target vessel revascularizations (37 patients vs. 22 patients, p = 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). [ABSTRACT FROM AUTHOR]

Accelerated idioventricular rhythm (AIVR) has been considered a marker of successful reperfusion in fibrinolytic-treated patients. Evidence is limited regarding its significance in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention (PPCI). The purpose of the present study was to determine the prevalence and associated outcomes of arrhythmias and conduction disturbances occurring during PPCI. In 503 patients with ST-elevation myocardial infarction, the arrhythmias and conduction disturbances occurring from arrival at the catheterization laboratory to 90 minutes after PPCI were registered. Continuous ST-monitoring was performed to determine the interval from the first wire to complete ST resolution. The area at risk was evaluated in the acute phase and the final infarct size (FIS) after 1 month using myocardial perfusion imaging. Mortality was registered at a median follow-up of 2.9 years. The most common arrhythmias observed during PPCI were AIVR (42%), sinus bradycardia (28%), and nonsustained ventricular tachycardia (26%). The arrhythmias associated with the FIS included AIVR (unstandardized regression coefficient [B] = 5.27, p <0.001), sustained ventricular tachycardia (B = 15.7, p <0.001), and sinus bradycardia (B = −4.12, p = 0.001). Right bundle branch block was the only conduction disturbance associated with FIS (B = 7.17, p = 0.001). Patients with AIVR less often achieved spontaneous ST resolution before PPCI (13% vs 36%, p <0.001), less often had Thrombolysis In Myocardial Infarction flow 3 on admission (3% vs 33%, p <0.001), had a larger area at risk (35% vs 23% of the left ventricle, p <0.001), had a longer time to complete ST resolution (39 vs 21 minutes, p <0.001), had a larger FIS (13% vs 5% of the left ventricle, p <0.001) but had similar mortality (8.6% and 6.5%, p = 0.39) compared to patients without AIVR. In conclusion, AIVR is the most frequent arrhythmia occurring during PPCI in patients with ST-elevation myocardial infarction. However, it is not a marker of successful reperfusion but is associated with extensive myocardial damage and delayed microvascular reperfusion. [Copyright &y& Elsevier]

Patients with diabetes have an increased risk of in-stent restenosis after coronary stent implantation. Serial intravascular ultrasound was used to study chronic arterial responses and edge effects after implantation of Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) or Taxus (Boston Scientific, Maple Grove, Minnesota) stents in diabetic patients. Seventy-four diabetic patients were randomly assigned to Cypher or Taxus stent implantation. Intravascular ultrasound of 5-mm long segments immediately proximal and distal to the stent was performed after the procedure and at the 8-month follow-up. The increase in peri-stent external elastic membrane (EEM) volume was more pronounced in the Taxus group (292.4 ± 132.6 to 309.5 ± 146.8 mm3) than in the Cypher group (274.4 ± 137.2 to 275.4 ± 140.1 mm3; p = 0.005). Peri-stent plaque volume increased in the Taxus group (152.5 ± 73.7 to 166.1 ± 85.1 mm3), but was unchanged in the Cypher group (153.5 ± 75.5 to 151.5 ± 75.8 mm3; p = 0.002). In proximal and distal reference segments, mean lumen area decreased within the entire 5-mm edge segment (proximal and distal) because of plaque progression (distal, 5.5 ± 3.6 to 5.8 ± 3.7 mm2; p = 0.097; proximal, 8.1 ± 2.7 to 8.7 ± 2.9 mm2; p = 0.006) without remodeling (change in EEM) in the Taxus group. Conversely, there were no significant changes in reference-segment EEM or plaque areas in the Cypher group. In conclusion, in diabetic patients, Taxus stent implantation was associated with increased (1) peri-stent EEM volume and peri-stent plaque, and (2) stent edge plaque progression accompanied by lumen reduction without remodeling. These findings were not seen in Cypher stents. [Copyright &y& Elsevier]

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. [Copyright &y& Elsevier]

The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent. [ABSTRACT FROM AUTHOR]

The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 ± 0.54 vs 0.44 ± 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent. [Copyright &y& Elsevier]

Patients with diabetes have a higher risk for in-stent restenosis after coronary stent implantation. Drug-eluting stents (DES) are highly effective in reducing in-stent restenosis. Once neointimal hyperplasia is suppressed with DES, the impact of stent underexpansion becomes magnified. The aim of this study was to evaluate DES expansion in patients with diabetes. Ninety-five patients with diabetes were randomized to Cypher Select (n = 48) or Taxus Express-2 (n = 47) stent implantation. Intravascular ultrasound was performed after stent implantation. Stent expansion was defined as the ratio of measured to predicted minimum stent diameter. There was a trend for lower stent expansion in the Cypher Select stent group (0.74 ± 0.08 vs 0.78 ± 0.11 in the Taxus Express-2 stent group, p = 0.061). Cypher Select stents achieved a final minimal stent cross-sectional area of 5.5 ± 1. 8 mm2, compared with 6.4 ± 1.9 mm2 for Taxus Express-2 stents (p = 0.015). For stents with nominal diameters ≥2.75 mm (Cypher Select n = 40, Taxus Express-2 n = 38), 42.5% of the Cypher Select stents and 10.5% of the Taxus Express-2 stents did not achieve a final minimum stent area of 5 mm2 (p = 0.002). Insulin treatment (relative risk 0.31, 95% confidence interval 0.10 to 0.95, p = 0.041) and stent type (relative risk 0.15, 95% CI 0.04 to 0.53, p = 0.003) were independent predictors of not achieving a minimum stent area >5.0 mm2. In conclusion, an important percentage of DES in patients with diabetes fail to achieve the manufacturers'' predicted final minimal stent diameter. Cypher Select stent and insulin treatment were independent predictors of not achieving a minimum stent area >5.0 mm2. [Copyright &y& Elsevier]

Objectives: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). Background: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. Methods: From January 2002 through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from the national databases. The Academic Research Consortium definition of ST was used. Results: The DES were implanted in 3,548 patients (5,422 lesions) and BMS were implanted in 8,847 patients (11,730 lesions). Definite, probable, or possible ST was found in 190 (2.15%) patients in the BMS group and in 64 (1.80%) patients in the DES. The risk of definite ST was similar in the 2 groups (DES: 0.65%; BMS: 0.61%). Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES (hazard ratio [HR] 10.93, 95% confidence interval [CI] 1.27 to 93.76). Also, the risk of MI between 12 and 15 months after implantation was higher in the DES group (HR 4.00, 95% CI 2.06 to 7.79). Mortality was similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES (HR 0.57, 95% CI 0.48 to 0.67). Conclusions: The minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents. [Copyright &y& Elsevier]