Percutaneous complete revascularization strategies using sirolimus-eluting biodegradable polymer-coated stents in patients presenting with acute coronary syndrome and multivessel disease: Rationale and design of the BIOVASC trial.

BACKGROUND: Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued. METHODS: The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure. CONCLUSIONS: The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).

Incidence, determinants and consequences of delirium in older patients after transcatheter aortic valve implantation.

BACKGROUND: delirium is an event leading to negative health outcomes and increased mortality in patients. The aim of this study is to investigate the incidence, determinants and consequences of post-operative delirium (POD) in older patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: The TAVI Care and Cure program is a prospective, observational registry in patients referred for TAVI at Erasmus University Medical Centre. The presence of delirium was evaluated by daily clinical assessment by a geriatrician pre- and up to 3 days post-TAVI. Mortality data were obtained from the Dutch Civil Registry. RESULTS: A total of 543 patients underwent TAVI between January 2014 and December 2017. Overall, the incidence of POD was 14% (75/543 patients) but declined from 18% in 2014 to 7% in 2017 (P = 0.009). Patients who developed POD were older (81.9 ± 5.8 versus 78.6 ± 8.3 years, P < 0.001), had higher prevalence of renal dysfunction and prior stroke (54% versus 40%, P = 0.02; 31% versus 18%, P = 0.01) and were more often frail (32% versus 25%, P = 0.02). From a procedural perspective, general anesthesia (odds ratios (OR), 2.31; 95% CI, 1.40-3.83; P = 0.001), non-transfemoral access (OR, 2.37; 95% CI, 1.20-4.70; P = 0.01) and longer procedural time (OR, 1.01; 95% CI, 1.01-1.02; P < 0.001) were significantly associated with POD. One-year survival rate was 68% among patients who had suffered a POD and was 85% in patients without a POD (hazard ratio's 1.8 (95% CI 1.01-3.10), P = 0.045). CONCLUSION: POD frequently occurs after TAVI and is associated with increased mortality. It might be speculated that patient selection and the minimalistic approach of TAVI may reduce the frequency of delirium.

Impact of frailty on health-related quality of life 1 year after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) brings symptom relief and improvement in health-related quality of life (HRQoL) in the majority of patients treated for symptomatic, severe aortic stenosis. However, there is a substantial group of patients that do not benefit from TAVI. The aim of this study is to investigate the impact of frailty on HRQoL 1 year after TAVI. METHODS: The TAVI Care & Cure Program is an ongoing, prospective, observational study including patients referred for TAVI to our institution. A comprehensive geriatric assessment was performed to evaluate existence of frailty using the Erasmus Frailty Score (EFS). HRQoL was assessed using the EQ-5D-5 L at baseline and 1 year after TAVI. RESULTS: 239 patients underwent TAVI and completed HRQoL assessment 1 year after TAVI. Seventy (29.3%) patients were classified as frail (EFS ≥ 3). In non-frail patients, the EQ-5D-5 L index did not change (0.71(± 0.22) to 0.68(± 0.33) points, P = 0.22); in frail patients, the EQ-5D-5 L index decreased from 0.55(±0.26) to 0.44 points (±0.33) (P = 0.022). Frailty was an independent predictor of deteriorated HRQoL 1 year after TAVI (OR 2.24, 95% CI 1.07-4.70, P = 0.003). In frail patients, the absence of peripheral artery disease (OR 0.17, 95% 0.05-0.50, P = 0.001) and renal dysfunction (OR 0.13, 95% CI 0.04-0.41, P = <0.001) at baseline was associated with improved HRQoL 1 year after TAVI. CONCLUSION: Frailty is associated with deterioration of HRQoL 1 year after TAVI. Notably, HRQoL did improve in frail patients with no peripheral arterial disease or renal impairment at baseline.

Fractional flow reserve guided percutaneous coronary intervention optimization directed by high-definition intravascular ultrasound versus standard of care: Rationale and study design of the prospective randomized FFR-REACT trial.

BACKGROUND: Post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is a significant predictor of major adverse cardiac events (MACE). The rationale for low post procedural FFR values often remains elusive based on angiographic findings alone, warranting further assessment using an FFR pullback or additional intravascular imaging. It is currently unknown if additional interventions intended to improve the PCI, decrease MACE rates. STUDY DESIGN: The FFR REACT trial is a prospective, single-center randomized controlled trial in which 290 patients with a post PCI FFR <0.90 will be randomized (1:1) to either standard of care (no additional intervention) or intravascular ultrasound (IVUS)-directed optimization of the FFR (treatment arm). Eligible patients are those treated with angiographically successful PCI for (un)stable angina or non-ST elevation myocardial infarction (MI). Assuming 45% of patients will have a post PCI FFR <0.90, approximately 640 patients undergoing PCI will need to be enrolled. Patients with a post PCI FFR ≥ 0.90 will be enrolled in a prospective registry. The primary end point is defined as a composite of cardiac death, target vessel MI and clinically driven target vessel revascularisation (target vessel failure) at 1 year. Secondary end points will consist of individual components of the primary end point, procedural success, stent thrombosis and correlations on clinical outcome, changes in post PCI Pd/Pa and FFR and IVUS derived dimensions. All patients will be followed for 3 years. CONCLUSION: The FFR-REACT trial is designed to explore the potential benefit of HD-IVUS-guided PCI optimization in patients with a post PCI FFR <0.90 (Dutch trial register: NTR6711).

Development and validation of a risk model for long-term mortality after percutaneous coronary intervention: The IDEA-BIO Study.

OBJECTIVES: We aimed to develop a model to predict long-term mortality after percutaneous coronary intervention (PCI), to aid in selecting patients with sufficient life expectancy to benefit from bioabsorbable scaffolds. BACKGROUND: Clinical trials are currently designed to demonstrate superiority of bioabsorbable scaffolds over metal devices up to 5 years after implantation. METHODS: From 2000 to 2011, 19.532 consecutive patients underwent PCI in a tertiary referral hospital. Patients were randomly (2:1) divided into a training (N = 13,090) and validation (N = 6,442) set. Cox regression was used to identify determinants of long-term mortality in the training set and used to develop a risk model. Model performance was studied in the training and validation dataset. RESULTS: Median age was 63 years (IQR 54-72) and 72% were men. Median follow-up was 3.6 years (interquartile range [IQR] 2.4-6.8). The ratio elective vs. non-elective PCIs was 42/58. During 88,620 patient-years of follow-up, 3,156 deaths occurred, implying an incidence rate of 35.6 per 1,000. Estimated 5-year mortality was 12.9%.Regression analysis revealed age, body mass index, diabetes mellitus, renal insufficiency, prior myocardial infarction, PCI indication, lesion location, number of diseased vessels and cardiogenic shock at presentation as determinants of mortality. The long-term risk model showed good discrimination in the training and validation sets (c-indices 0.76 and 0.74), whereas calibration was appropriate. CONCLUSIONS: A simple risk model, containing 9 baseline clinical and angiographic variables effectively predicts long-term mortality after PCI and may possibly be used to select suitable patients for bioabsorbable scaffolds.

Expanded clinical use of everolimus eluting bioresorbable vascular scaffolds for treatment of coronary artery disease.

BACKGROUND: Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice. METHODS: This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported. RESULTS: A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%. CONCLUSIONS: The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc.

First-Line Support by Intra-Aortic Balloon Pump in Non-Ischaemic Cardiogenic Shock in the Era of Modern Ventricular Assist Devices.

OBJECTIVES: Little is known about circulatory support in cardiogenic shock (CS) from other causes than the acute coronary syndrome or after cardiotomy. We evaluated the effects of first-line intra-aortic balloon pump (IABP) support in this subpopulation of CS patients. METHODS: A retrospective study was performed in 27 patients with CS from end-stage cardiomyopathy supported firstly by IABP in the years 2011-2016. RESULTS: At 24 h, lactate decreased from 3.2 (2.1-6.8) to 1.8 (1.2-2.2) mmol/L (p < 0.001). Eighteen patients (67%) defined as IABP responders were successfully bridged to either recovery (n = 7), left ventricular assist device (n = 5), or heart transplantation (n = 6). IABP failed in 9 patients (non-responders, 33%) who either died (n = 7) or needed support by extracorporeal membrane oxygenation (n = 2). At 24 h of IABP support, urinary output was higher (2,660 [1,835-4,440] vs. 1,200 [649-2,385] mL; p = 0.02) and fluid balance more negative (-1,564 [-2,673 to -1,086] vs. -500 [-930 to +240] mL; p < 0.001) in responders than non-responders. Overall survival at 1 year was 63%. CONCLUSION: In most patients, first-line support by IABP in end-stage cardiomyopathy is associated with improvement in organ perfusion and clinical stabilisation for at least 24 h allowing time for decision making on next therapies.

Determinants of high cardiovascular risk in relation to plaque-composition of a non-culprit coronary segment visualized by near-infrared spectroscopy in patients undergoing percutaneous coronary intervention.

AIM: The aim of this study was to determine the relationship between clinical and blood characteristics of a vascular inflammatory milieu and coronary plaque composition visualized by near-infrared spectroscopy (NIRS) in percutaneous coronary intervention (PCI) patients. METHODS AND RESULTS: Between April 2009 and January 2011, we performed NIRS in 208 patients who underwent PCI or invasive diagnostic coronary exploration for various indications. Imaging was performed of one non-intervened coronary segment after the initial procedure. Univariate and multivariate linear regression analyses were applied to evaluate the relationship between the acquired NIRS-derived lipid core burden index (LCBI) and clinical and blood (lipids and hs-C-reactive protein) characteristics. Patients with a history of hypercholesterolaemia [median 48 (inter-quartile range 21-101) vs. 38 (13-70), P = 0.043] and multi-vessel disease [55 (24-104) vs. 32 (12-71), P = 0.012] had higher LCBI levels. Men had higher LCBI than women [48 (21-95) vs. 27 (9-59), P = 0.003]. Hypercholesterolaemia and gender remained significant in multivariate regression analysis, whereas also a history of non-cardiac vascular disease and beta-blockers were positively associated with LCBI. Altogether 23.2% of the variability in LCBI could be explained by clinical and blood characteristics. CONCLUSION: Clinical characteristics reflecting patients with a high cardiovascular risk profile explained 23.2% of the variability in LCBI, whereas blood biomarkers added little. Further research is warranted to evaluate whether NIRS has the potential to provide additional prognostic information about patients' cardiovascular risk.

Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study.

AIMS: We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The present investigation is a prospective, single-arm, single-centre study, reporting data after the BVS implantation in STEMI patients. Quantitative coronary angiography and optical coherence tomography (OCT) data were evaluated. Clinical outcomes are reported at the 30-day follow-up. The intent-to-treat population comprises a total of 49 patients. The procedural success was 97.9%. Pre-procedure TIMI-flow was 0 in 50.0% of the patients; after the BVS implantation, a TIMI-flow III was achieved in 91.7% of patients and the post-procedure percentage diameter stenosis was 14.7 ± 8.2%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography analysis performed in 31 patients showed that the post-procedure mean lumen area was 8.02 ± 1.92 mm(2), minimum lumen area 5.95 ± 1.61 mm(2), mean incomplete scaffold apposition area 0.118 ± 0.162 mm(2), mean intraluminal defect area 0.013 ± 0.017 mm(2), and mean percentage malapposed struts per patient 2.80 ± 3.90%. Scaffolds with >5% malapposed struts were 7. At the 30-day follow-up, target-lesion failure rate was 0%. Non-target-vessel revascularization and target-vessel myocardial infarction (MI) were reported. A non-target-vessel non-Q-wave MI occurred. No cases of cardiac death or scaffold thrombosis were observed. CONCLUSION: In the present series, the BVS implantation in patients presenting with acute MI appeared feasible, with high rate of final TIMI-flow III and good scaffold apposition. Larger studies are currently needed to confirm these preliminary data.

Circulating chemokines in relation to coronary plaque characteristics on radiofrequency intravascular ultrasound and cardiovascular outcome.

OBJECTIVE: To investigate relations of several circulating chemokines with extent and phenotype of coronary atherosclerosis and with 1-year clinical outcome. METHODS: Intravascular ultrasound virtual histology (IVUS-VH) imaging of a coronary artery was performed in 581 patients. Monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory protein-1α (MIP-1α), MIP-1ß and regulated upon activation normal T cell expressed and secreted (RANTES) were measured in plasma. RESULTS: Higher MCP-1, MIP-1α and lower RANTES were associated with coronary plaque burden. Higher MCP-1, MIP-1α and lower RANTES were associated with the presence of IVUS-VH-derived thin-cap fibroatheroma lesions. RANTES was associated with major adverse cardiac events. CONCLUSIONS: RANTES is a promising biomarker that is inversely associated with coronary plaque burden and vulnerability, as well as with death and acute coronary syndrome.

Device infection in patients undergoing pacemaker or defibrillator surgery: risk stratification using the PADIT score.

BACKGROUND: The use of an antibacterial envelope is cost-effective for patients at high risk of developing cardiac implantable electronic device (CIED) infection. The identification of these high-risk patients may be facilitated using a clinical risk score. The aim of the current study is to evaluate the PADIT score for identifying high-risk patients in patients undergoing a CIED procedure in a tertiary academic center. METHODS: This was a retrospective single-center study of consecutive patients undergoing a CIED procedure between January 2016 and November 2021. Patients who received an antibacterial envelope were excluded from this study. The primary endpoint was hospitalization for a CIED infection in the first year after the procedure. RESULTS: A total of 2333 CIED procedures were performed in the study period (mean age 61.6 ± 16.3 years, male sex 64.5%, previous CIED infection 1.7%, immunocompromised 5.4%). The median PADIT score was 4 (interquartile range, 2-6). CIED infection occurred in 10 patients (0.43%). The PADIT score had good discrimination in predicting major CIED infection (C-statistic 0.70; 95% confidence interval [CI] 0.54 to 0.86, P = 0.03). Using an optimal PADIT score cut-off value of 7, the risk of CIED infection was higher in the patients with a PADIT score of ≥ 7 in comparison to those with a lower PADIT score (1.23% vs. 0.26%, P = 0.02; odds ratio 4.8, 95% CI 1.4 to 16.6, P = 0.01). CONCLUSIONS: The PADIT score is a clinically useful score for identifying patients at high risk of developing CIED infection. The use of an antibacterial envelope in these high-risk patients may be cost-effective.

Effects of menstruation on the onset of acute coronary syndrome in premenopausal women: A case series.

Background: The incidence of cardiovascular disease (CVD) among women is lower before the menopause, which may be due to the atheroprotective effects of female sex hormones, including estrogens. This study explored whether women experienced acute coronary syndrome (ACS) more often during menstruation, when the levels of female sex hormones are low. Methods: All premenopausal women referred to the local cardiac rehabilitation program after ACS between August 2010 and September 2018 were contacted by telephone to gather information about their menstrual cycle, contraceptive use and whether ACS occurred during menstruation. Information on cardiovascular risk factors was collected using the clinical electronic health record. Results: Of the 22 women fulfilling the inclusion criteria and having a regular menstrual cycle, 22.7% reported that they were diagnosed with ACS at the time of menstruation. Conclusions: The percentage of women who were menstruating whilst having their cardiovascular event is higher than the percentage expected if the event was unrelated to the menstrual cycle. To gain more insight into the effect of female sex hormones on ACS, it is suggested that information on the menstrual cycle is routinely collected from women admitted to hospital with the condition.

Cardiac rehabilitation designed for patients with obesity: OPTICARE XL RCT results on health-related quality of life and psychosocial well-being.

Purpose We studied the effectiveness of a new cardiac rehabilitation (CR) program developed for patients with obesity compared with standard CR on HRQOL and psychosocial well-being.Materials and methods OPTICARE XL was a multicentre RCT in patients with cardiac disease and obesity (Netherlands Trial Register: NL5589). Patients were randomized to OPTICARE XL CR (n = 102) or standard CR (n = 99). The one-year OPTICARE XL CR group program included endurance and resistance exercises, behavioural coaching, and after-care. Standard CR consisted of a 6- to 12-week endurance exercise group program, and cardiovascular lifestyle education. Primary endpoint was HRQOL (MacNew) at six months post CR. Second, we assessed anxiety and depression (both HADS), fatigue (FSS), and participation in society (USER-P).Results In both groups, improvements in HRQOL were observed six months post CR. Mean HRQOL improved from 4.92 to 5.40 in standard CR [mean change (95% CI): 0.48 (0.28, 0.67)] and from 4.96 to 5.45 in OPTICARE XL CR (mean change (95% CI): 0.49 (0.29, 0.70), without between-group differences. Psychosocial well-being improvements within both groups were obtained at six months post CR, regardless of allocated program.Conclusions OPTICARE XL CR did not have added value in improving HRQOL and psychosocial well-being in patients with obesity.Implications for rehabilitationMore than a third of cardiac patients suffers from obesity, and standard cardiac rehabilitation (CR) programs are suboptimal in this increasing patient population.The OPTICARE XL CR program is a state-of-the art, one-year CR program designed for patients with obesity including aerobic and strength exercises, behavioural coaching towards a healthy diet and an active lifestyle, and after-care.Improvements in HRQOL and psychosocial well-being were comparable between patients with obesity allocated to standard CR and OPTICARE XL CR.Therefore, there was no additional benefit of OPTICARE XL CR.

Effects of a Dedicated Cardiac Rehabilitation Program for Patients With Obesity on Body Weight, Physical Activity, Sedentary Behavior, and Physical Fitness: The OPTICARE XL Randomized Controlled Trial.

OBJECTIVE: Previously published results of the OPTICARE XL open label randomized controlled trial showed no added value of OPTICARE XL CR, a dedicated cardiac rehabilitation (CR) program for patients with obesity, with respect to health-related quality of life (primary outcome). This clinical trial studied the effects of OPTICARE XL CR on several secondary outcomes, which included body weight, physical activity, sedentary behavior, and physical fitness. METHODS: Patients with coronary artery disease or atrial fibrillation and body mass index ≥ 30 were randomized to OPTICARE XL CR (n = 102) or standard CR (n = 99). OPTICARE XL CR was a 1-year group intervention, specifically designed for patients with obesity that included aerobic and strength exercise, behavioral coaching, and an aftercare program. Standard CR consisted of a 6- to 12-week group aerobic exercise program, supplemented with cardiovascular lifestyle education. Study end points included body weight, physical activity, sedentary behavior (accelerometer), and physical fitness (6-Minute Walk Test and handgrip strength), which were evaluated 6 months after the end of CR (primary endpoint) and 3 months after the start of CR. RESULTS: Six months after completion of either program, improvements in body weight, physical activity, sedentary behavior, and physical fitness were similar between the groups. Three months after CR start, patients randomized to OPTICARE XL CR showed greater weight loss (mean change = -3.6 vs -1.8 kg) and a larger improvement in physical activity (+880 vs +481 steps per day) than patients randomized to standard CR. CONCLUSION: Patients allocated to OPTICARE XL CR lost significantly more body weight and showed promising results with respect to physical activity 3 months after the start of CR; however, these short-term results were not expanded or sustained in the longer term. IMPACT: Patients with obesity do not benefit from standard CR programs. The new OPTICARE XL CR program showed its effects in the short term on weight loss and physical activity, and, therefore, redesign of the aftercare phase is recommended.

Validation of Segmental Post-PCI Physiological Gradients With IVUS-Detected Focal Lesions and Stent Underexpansion.

BACKGROUND: Segmental postpercutaneous coronary intervention (PCI) pressure gradients may detect residual disease and potential targets for optimization. However, universal definitions of relevant segmental gradients are lacking. OBJECTIVES: This study sought to evaluate the diagnostic performance of post-PCI fractional flow reserve (FFR), distal coronary pressure-to-aortic pressure ratio (Pd/Pa), and diastolic pressure ratio (dPR) gradients to detect residual focal lesions and stent underexpansion as observed by intravascular ultrasound (IVUS). METHODS: Patients from the IVUS-guided optimization arm of the FFR REACT (FFR-guided PCI Optimization Directed by High-Definition IVUS Versus Standard of Care) trial with complete IVUS and FFR pullback data were included. Patients with angiographically successful PCI and post-PCI FFR <0.90 underwent FFR, Pd/Pa, and IVUS pullbacks. dPR was calculated offline using dedicated software. Segmental pressure gradients (distal, in stent, and proximal) in segments ≥5 mm were evaluated against IVUS-detected residual disease (distal or proximal focal lesions and stent underexpansion). RESULTS: A total of 139 vessels were included (mean post-PCI FFR: 0.83 ± 0.05, range 0.56-0.89). Focal distal and proximal lesions were detected by IVUS in 23 (17.4%) of 132 and 14 (12.6%) of 111 vessels, respectively, whereas stent underexpansion was present in 86 (61.9%) vessels. Diagnostic ability of segmental FFR gradients to predict IVUS-detected distal and proximal lesions was moderate-to-good (area under the curve [AUC]: 0.69 and 0.84, respectively) and poor to moderate for segmental Pd/Pa and dPR gradients (AUC ranging from 0.58 to 0.69). In-stent gradients had no discriminative ability to detect stent underexpansion (FFR AUC: 0.52; Pd/Pa AUC: 0.54; dPR AUC: 0.55). CONCLUSIONS: In patients with post-PCI FFR <0.90, segmental post-PCI pressure gradients have moderate discriminative ability to identify IVUS-detected focal lesions but no discriminative ability to identify IVUS-detected stent underexpansion.

Evaluating the 'all-comers' design: a comparison of participants in two 'all-comers' PCI trials with non-participants.

AIMS: We aimed to asses the generalizability of two 'all-comers' randomized clinical trials (AC-RCTs) in patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: Recently two large AC-RCT's comparing drug-eluting stents were performed in our institution (LEADERS and RESOLUTE-III). During the inclusion period of these trials 1242 consecutive PCI patients were treated of whom 579 (48%) were actually included. The most important reasons for non-participation were inability to provide informed consent (33.5%), refused to participate (19%), or patient met one of the other exclusion criteria (26.9%). Trial participants more frequently had stable angina (42.5 vs. 34.4%) and less frequently acute myocardial infarction as indication for PCI (31.4 vs. 42.4%) than non-participants. Hypertension (52.8 vs. 49.1%) and hypercholesterolaemia (56.3 vs. 49.1%) were seen more frequently in trial participants; heart failure was less common (2.1 vs. 4.4%). A significant difference in 30-day mortality was observed between AC-RCT participants and non-participants [0.7 vs. 4.5% events; adjusted hazard ratio (aHR) 0.18 and 95% confidence interval (CI) 0.06-0.52]. One-year mortality was also lower (3.1 vs. 6.9% events; aHR: 0.51 and 95% CI: 0.29-0.91, but 1-year mortality in 48 h survivors was similar (3.1 vs. 4.2% events; aHR: 0.74 and 95% CI: 0.41-1.34). CONCLUSION: Applying the all-comers design did not result in inclusion of all consecutive patients, as only half of the target population was enrolled. It should be noted, however, that this design included more patients than observed in classical RCTs. AC-RCT participants and non-participants were different in terms of baseline characteristics and outcome.

Gender Differences in Patients With Stable Chest Pain.

This study sought to investigate gender differences in clinical presentation, presence, and extent of coronary artery disease (CAD), and all-cause mortality in patients with stable chest pain who underwent coronary computed tomography angiography (CCTA). Patients who visited the fast-track outpatient clinic of the Erasmus Medical Center and underwent CCTA were analyzed. Clinical characteristics of chest pain, CAD on CCTA, coronary artery calcium scores, and survival were collected retrospectively and compared between men and women. Logistic regression was used to identify independent risk factors for the presence of CAD and Cox regression for all-cause mortality. In 1,835 included patients, 966 (52.6%) were female. Men and women were similar in age (55 vs 56 years). Compared with men, women had a lower frequency of typical pain (22.8% vs 31.1%, p <0.001), lower prevalence of significant CAD (22.2% vs 38.1%, p <0.001), and lower coronary artery calcium scores (p <0.001). CAD was more prevalent in men than in women with typical pain (67.4% vs 35.9%, p <0.001) and also with nontypical pain (24.9% vs 18.1%, p = 0.002). After adjustment for baseline characteristic, male sex was associated with all-cause mortality (adjusted hazard ratio 1.87, 95% confidence interval 1.25 to 2.80, p = 0.002). The additional risk of mortality because of CAD was similar between men and women. Stratifying by typical and nontypical pain, women again had a better prognosis. Our study identifies gender-related differences in characteristics, CCTA-findings, and outcomes for women compared with men presenting for CCTA with chest pain. Women have less CAD and a better prognosis than men, the clinical implications of which require further study.

Impact of undiagnosed obstructive sleep apnea on atrial fibrillation recurrence following catheter ablation (OSA-AF study).

Background: Sleep-disordered breathing (SDB) may hamper the outcome of catheter ablation of atrial fibrillation (AF). However, SDB is underdiagnosed in clinical practice and the relevancy of undiagnosed SDB on the outcome of catheter ablation is unclear. Objective: To evaluate if undiagnosed SDB has an impact on AF recurrence after catheter ablation. Methods: In this single-center cohort study we enrolled patients who had a catheter ablation of AF 12 to 18 months prior to enrolment. Patients with diagnosed SDB at the time of catheter ablation were excluded. Enrolled patients underwent screening using WatchPAT (WP). SDB was defined as an apnea-hypopnea index (AHI) ≥ 15. Results: A total of 164 patients were screened for eligibility. After exclusion of patients with previously diagnosed SDB (n = 30), 104 of 134 eligible patients were enrolled and underwent SDB screening. The median AHI was 11.5 (interquartile range 6.8-21.9) and 39 patients (38%) had SDB which was undiagnosed during the first year after ablation. AF recurrence in the first year after catheter ablation occurred in 40 patients (38%). The risk of AF recurrence was higher in the group with undiagnosed SDB in comparison to those without SDB (51% versus 31%, P = 0.04). Interestingly, the prevalence of AF recurrence was similar between patients with previously diagnosed and undiagnosed SDB (51% versus 50%, P = 0.92). Conclusion: A significant proportion of patients undergoing catheter ablation of AF have undiagnosed SDB which is associated with a twofold higher risk of AF recurrence. SDB screening may improve patient counselling regarding the efficacy of catheter ablation.

Clinical Outcomes with Targeted Temperature Management (TTM) in Comatose Out-of-Hospital Cardiac Arrest Patients-A Retrospective Cohort Study.

Purpose: we evaluated the effects of the shift of a targeted temperature management (TTM) strategy from 33 °C to 36 °C in comatose out-of-hospital cardiac arrest (OHCA) patients admitted to the Intensive Care Unit (ICU). Methods: we performed a retrospective study of all comatose (GCS < 8) OHCA patients treated with TTM from 2010 to 2018 (n = 798) from a single-center academic hospital. We analyzed 90-day mortality, and neurological outcome (CPC score) at ICU discharge and ICU length of stay, as primary and secondary outcomes, respectively. Results: we included 798 OHCA patients (583 in the TTM33 group and 215 in the TTM36 group). We found no association between the TTM strategy (TTM33 and TTM36) and 90-day mortality (hazard ratio (HR)] 0.877, 95% CI 0.677−1.135, with TTM36 as reference). Also, no association was found between TTM strategy and favorable neurological outcome at ICU discharge (odds ratio (OR) 1.330, 95% CI 0.941−1.879). Patients in the TTM33 group had on average a longer ICU LOS (beta 1.180, 95% CI 0.222−2.138). Conclusion: no differences in clinical outcomes­both 90-day mortality and favorable neurological outcome at ICU discharge­were found between targeted temperature at 33 °C and 36 °C. These results may help to corroborate previous trial findings and assist in implementation of TTM.