Gender differences in risk factor management and pharmacological treatment among CHD patients: Belgian results of the EUROASPIRE IV and EUROASPIRE V surveys.

AIMS: The aim of this study was to provide an up-to-date overview of gender differences or similarities in risk factor control and medical management in the Belgian CHD population. METHODS: All analyses are based on the ESC EORP EUROASPIRE IV and EUROASPIRE V (European Survey Of Cardiovascular Disease Prevention And Diabetes) surveys. Patients between 18 and 80 years old, hospitalised for a first or recurrent coronary event, were included in the survey. RESULTS: Data were available for 10,519 patients, of which 23.9% were women. Women had a worse risk factor profile compared to men. Women were more physical inactive (OR = 1.31, 95% CI = 1.19-1.44), had a higher prevalence of obesity (OR = 1.37, 95% CI = 1.25-1.50) and had a worse LDL-C control (OR = 1.52, 95% CI = 1.36-1.70). Moreover, women were less likely to use ACE-I/ARBs (OR = 0.84, 95% CI = 0.76-0.94) and statins (OR = 0.79, 95% CI = 0.70-0.90). In addition, little gender differences were found in patients' risk factor awareness, except on cholesterol awareness. Women were more aware about their total cholesterol levels (OR = 1.37, 95% CI = 1.21-1.56). CONCLUSION: Despite little to no gender differences in the management of CHD patients, women still have a worse risk factor profile, both in Belgian and in other European high-income countries.

Prevalence and Disease Spectrum of Extracoronary Arterial Abnormalities in Spontaneous Coronary Artery Dissection.

Importance: Spontaneous coronary artery dissection (SCAD) has been associated with fibromuscular dysplasia (FMD) and other extracoronary arterial abnormalities. However, the prevalence, severity, and clinical relevance of these abnormalities remain unclear. Objective: To assess the prevalence and spectrum of FMD and other extracoronary arterial abnormalities in patients with SCAD vs controls. Design, Setting, and Participants: This case series included 173 patients with angiographically confirmed SCAD enrolled between January 1, 2015, and December 31, 2019. Imaging of extracoronary arterial beds was performed by magnetic resonance angiography (MRA). Forty-one healthy individuals were recruited to serve as controls for blinded interpretation of MRA findings. Patients were recruited from the UK national SCAD registry, which enrolls throughout the UK by referral from the primary care physician or patient self-referral through an online portal. Participants attended the national SCAD referral center for assessment and MRA. Exposures: Both patients with SCAD and healthy controls underwent head-to-pelvis MRA (median time between SCAD event and MRA, 1 [IQR, 1-3] year). Main Outcome and Measures: The diagnosis of FMD, arterial dissections, and aneurysms was established according to the International FMD Consensus. Arterial tortuosity was assessed both qualitatively (presence or absence of an S curve) and quantitatively (number of curves ≥45%; tortuosity index). Results: Of the 173 patients with SCAD, 167 were women (96.5%); mean (SD) age at diagnosis was 44.5 (7.9) years. The prevalence of FMD was 31.8% (55 patients); 16 patients (29.1% of patients with FMD) had involvement of multiple vascular beds. Thirteen patients (7.5%) had extracoronary aneurysms and 3 patients (1.7%) had dissections. The prevalence and degree of arterial tortuosity were similar in patients and controls. In 43 patients imaged with both computed tomographic angiography and MRA, the identification of clinically significant remote arteriopathies was similar. Over a median 5-year follow-up, there were 2 noncardiovascular-associated deaths and 35 recurrent myocardial infarctions, but there were no primary extracoronary vascular events. Conclusions and Relevance: In this case series with blinded analysis of patients with SCAD, severe multivessel FMD, aneurysms, and dissections were infrequent. The findings of this study suggest that, although brain-to-pelvis imaging allows detection of remote arteriopathies that may require follow-up, extracoronary vascular events appear to be rare.

Reduction of Lipid-Core Burden Index in Nonculprit Lesions at Follow-Up after ST-Elevation Myocardial Infarction: A Randomized Study of Bioresorbable Vascular Scaffold versus Optimal Medical Therapy.

BACKGROUND: Non-flow-limiting nonculprit lesions (NCL) that contain a large lipid-rich necrotic core (nonculprit lipid-rich plaques (NC-LRP)) are most likely to cause recurrent acute coronary syndrome after ST-elevation myocardial infarction (STEMI). Near-infrared spectroscopy (NIRS) detects LRPs using the maximum 4 mm lipid-core burden index (maxLCBI4 mm). Few data are available regarding NIRS-guided therapy of these NC-LRPs, which are a potential target for preventive stenting. Bioresorbable vascular scaffold (BVS) provides local drug delivery and could facilitate plaque passivation after resorption. This study sought to assess the safety of BVS implantation in NC-LRPs and its efficacy in reducing maxLCBI4 mm at 2-year follow-up after STEMI. METHODS AND RESULTS: In total, 33 non-flow-limiting NCLs from 29 STEMI patients were included in this study. Of these, 15 were LRPs and were randomly assigned to either the BVS + optimal medical therapy (OMT) arm (group 1; N = 7) or the OMT arm (group 2; N = 8). At baseline, there were no differences in plaque characteristics between groups (fractional flow reserve: 0.85 ± 0.04 vs. 0.89 ± 0.06; diameter stenosis (DS): 43.4 ± 8 vs. 40.1 ± 10.7%; plaque burden 54.98 ± 5.8 vs. 49.76 ± 8.31%; and maxLCBI4 mm 402 [348; 564] vs. 373 [298; 516]; p=NS for all comparisons between groups 1 and 2, respectively). Seven BVSs were implanted 3 ± 1 days after STEMI in six patients, without complications. At angiographic follow-up (712 [657; 740] days), a significant and similar reduction of maxLCBI4 mm was observed in both groups, with a median change of 306 [257; 377] in group 1 vs. 300 [278; 346] in group 2 (p=0.44). DS was significantly lower in group 1 vs. group 2 (19.8 ± 7 vs. 41.7 ± 13%, p=0.003), while plaque burden remained unchanged in both groups. Overall survival was 100%, target lesion failure was 13%, and stent thrombosis was 0%. CONCLUSIONS: BVS + OMT and OMT appear as similarly safe and effective in reducing maxLCBI4mm in NC-LRPs at 2-year follow-up after STEMI.

The European/International Fibromuscular Dysplasia Registry and Initiative (FEIRI)-clinical phenotypes and their predictors based on a cohort of 1000 patients.

AIMS: Since December 2015, the European/International Fibromuscular Dysplasia (FMD) Registry enrolled 1022 patients from 22 countries. We present their characteristics according to disease subtype, age and gender, as well as predictors of widespread disease, aneurysms and dissections. METHODS AND RESULTS: All patients diagnosed with FMD (string-of-beads or focal stenosis in at least one vascular bed) based on computed tomography angiography, magnetic resonance angiography, and/or catheter-based angiography were eligible. Patients were predominantly women (82%) and Caucasians (88%). Age at diagnosis was 46 ± 16 years (12% ≥65 years old), 86% were hypertensive, 72% had multifocal, and 57% multivessel FMD. Compared to patients with multifocal FMD, patients with focal FMD were younger, more often men, had less often multivessel FMD but more revascularizations. Compared to women with FMD, men were younger, had more often focal FMD and arterial dissections. Compared to younger patients with FMD, patients ≥65 years old had more often multifocal FMD, lower estimated glomerular filtration rate and more atherosclerotic lesions. Independent predictors of multivessel FMD were age at FMD diagnosis, stroke, multifocal subtype, presence of aneurysm or dissection, and family history of FMD. Predictors of aneurysms were multivessel and multifocal FMD. Predictors of dissections were age at FMD diagnosis, male gender, stroke, and multivessel FMD. CONCLUSIONS: The European/International FMD Registry allowed large-scale characterization of distinct profiles of patients with FMD and, more importantly, identification of a unique set of independent predictors of widespread disease, aneurysms and dissections, paving the way for targeted screening, management, and follow-up of FMD.

Usefulness of a Gentle and Short Hemostasis Using the Transradial Band Device after Transradial Access for Percutaneous Coronary Angiography and Interventions to Reduce the Radial Artery Occlusion Rate (from the Prospective and Randomized CRASOC I, II, and III Studies).

The study sought to evaluate the benefit of the reduction in intensity and duration of the hemostasis obtained with the transradial (TR) Band compression device on the radial artery occlusion (RAO) rate. RAO is the most frequent complication of TR access for cardiac catheterization and limits future use of this safe route. Its occurrence must be minimized. Between 2009 and 2016, 3,616 TR accesses were randomized to TR Band hemostasis during 3 consecutive protocols: CRASOC I (Compression of Radial ArterieS without Occlusion): 13 versus 10 cc of air into the TR Band and for 4 hours of continuous compression; CRASOC II: 10 cc of air for 3 hours versus 2 hours of compression; and CRASOC III: 10 cc of air for 2 hours versus 1.5 hours of compression and virtual 4F introducer as default sheath (both arms). Radial artery patency was assessed by plethysmography at 24 hours, using Doppler for doubtful or negative plethysmography. The primary end point, 24 hours of RAO, was markedly reduced when hemostasis was soft (10 cc of air) and short (1.5 hours) and resulted in a 2.3% rate of RAO versus 9.4% for 13 cc, 4 hours. Hemostasis was obtained in 89% of patients with only 10 cc of air and in 97% of patients with less than the recommended 13 cc. About 8% of patients required more than the 1.5 hours of hemostasis time. In conclusion, short and soft hemostasis with the TR Band device leads to a low RAO rate.

The STIB score: a simple clinical test to predict clopidogrel resistance.

BACKGROUND: High platelet reactivity (HPR) to clopidogrel is associated with an increased risk of ischaemic complications during and after coronary interventions and concerns up to 50% of patients undergoing PCI. AIM OF THE STUDY: The aim of the study was to identify patients with HPR to clopidogrel using bedside clinical information obtained in the Stent Thrombosis In Belgium (STIB) trial. METHODS: Data on platelet reactivity using the VerifyNow® point-of-care assay were obtained in 844 patients undergoing PCI for stable coronary artery disease 12 to 24 hours after a 600-mg loading dose of clopidogrel was given. Demographic, clinical and baseline routine biological tests were obtained and compared with P2Y12 reaction units (PRU). Patients with PRU>230 (HPR) were considered as non-responders to clopidogrel. RESULTS: HPR was observed in 424/844 pts. Age, weight, body mass index (BMI), HPR to aspirin, diabetes, renal failure (MDRD<60 ml/min), haemoglobin (Hb), haematocrit, fibrinogen, glycaemia and glycated haemoglobin were associated with HPR to clopidogrel. In multivariate analysis, only Hb (OR: 0.77), BMI (OR: 1.06) and diabetes (OR: 1.62) emerged as independent risk factors. Hb<13.9 g/dl, BMI>28 kg/m2 and presence of diabetes were equally associated to predict HPR and can be added to derive a simple score to predict clopidogrel resistance. Although 38.5% of patients without a single clinical predictor still have HPR, 2/3 patients with 2 or 3 risk factors are resistant to clopidogrel. CONCLUSIONS: STIB HPR score allows identification of patients with a high probability of resistance to clopidogrel based on diabetes, Hb<13.9 g/dl and BMI>28 kg/m2. This bedside clinical test could be useful for the identification of patients in whom another P2Y12 inhibitor should be recommended before and after PCI.

Long-term effect of molsidomine, a direct nitric oxide donor, as an add-on treatment, on endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: results of the MEDCOR trial.

OBJECTIVE: The MEDCOR trial is a double-blind, randomized study aiming at demonstrating the superiority of molsidomine (direct NO donor) over placebo, used as add-on treatments, on improving endothelial function (EF) after 12 months, in stable angina patients undergoing percutaneous coronary intervention. METHODS: EF was assessed by peripheral vasodilator response (i.e. Endoscore) using arterial tonometry and by several biomarkers, in terms of changes versus baseline after a one-year treatment. RESULTS: The change in Endoscore was +75 ± 130% in placebo group and +39 ± 145% in molsidomine group (p = 0.143). There was a decrease in sICAM-1 with molsidomine (-6%) and an increase with placebo (+6%). The MPO activity/antigen ratio slightly increased with placebo (+9%) and strongly decreased with molsidomine (-42%) (p = 0.020). CONCLUSION: The MEDCOR trial was not able to demonstrate significant differences between molsidomine and placebo for all parameters, except the MPO activity/antigen ratio which significantly decreased with molsidomine (p = 0.020 versus placebo).

Platelet reactivity and cardiovascular events after percutaneous coronary intervention in patients with stable coronary artery disease: the Stent Thrombosis In Belgium (STIB) trial.

AIMS: The Stent Thrombosis In Belgium (STIB) trial aimed to determine whether assessing platelet reactivity (PR) in patients with stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI) could predict the risk of ischaemic complications and adverse clinical events up to 30 days post PCI. METHODS AND RESULTS: PR before intervention was determined in 891 patients undergoing PCI for stable angina pectoris. Twelve to 24 hours before PCI, all patients received a 600 mg clopidogrel dose followed by 75 mg daily, and 500 mg of aspirin followed by 80-100 mg daily. Residual PR was assessed by VerifyNow point-of-care aspirin and P2Y12 assay before PCI. "Non-responders" to antiplatelet therapy were defined as aspirin reaction unit (ARU) >550 and as P2Y12 reaction unit (PRU) >230. The endpoint of the study was the composite of periprocedural myonecrosis, stent thrombosis, non-fatal myocardial infarction (MI), stroke and death at 30 days in patients with or without high PR. The endpoint was observed in 180 patients: four deaths, one stroke, 11 Q-wave MI, three non-Q-wave MI and 161 periprocedural myonecroses. At multivariate analysis, the endpoint was predicted by total stent length (OR: 1.020), GFR <60 ml/min (OR: 1.87), history of PCI (OR: 0.58), white blood cell count (OR: 1.95) and diabetes (OR: 1.83). No significant association was found between residual PR and the primary endpoint or any of its components. CONCLUSIONS: PR measured before PCI in stable patients undergoing elective PCI who are preloaded with 500 mg of aspirin and 600 mg of clopidogrel is not predictive of periprocedural myocardial injury or adverse ischaemic complications up to 30 days.

Double-blind parallel placebo-controlled study to evaluate the effect of molsidomine on the endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: the MEDCOR Trial.

The effects of molsidomine (a direct nitric oxide donor) on the endothelial dysfunction have never been evaluated using reactive hyperemia peripheral arterial tonometry (RH-PAT). The objective of the MEDCOR double-blind trial will be to demonstrate the superiority of molsidomine (Coruno® 16 mg, once daily) over placebo, on improving the endothelial function (Endoscore by RH-PAT) after 12 months of treatment in stable angina patients undergoing elective percutaneous coronary intervention (PCI). Study design will take care of the real-life situation, in which patients are being offered PCI and stent placement (drug-eluting or bare metal), but also gold standard medical therapy (beta-blockers, statins, angiotensin-converting enzyme inhibitors (ACEIs), and/or calcium antagonists). Demonstrating clinical and statistical superiority of the study drug over placebo will be a real challenge. Therefore, a sequential approach has been designed with a pilot phase aiming at recruiting 50 patients. Upon evaluation of the results by an independent data steering committee, a larger sample size phase will eventually be considered.

Full conversion from transfemoral to transradial approach for percutaneous coronary interventions results in a similar success rate and a rapid reduction of in-hospital cardiac and vascular major events.

AIMS: The transradial approach (TRA) for percutaneous coronary intervention (PCI) recently emerged as a safer vascular access with a similar rate of MACE but a lower success rate requiring crossover to another approach when compared to the transfemoral approach (TFA). METHODS AND RESULTS: In our hospital the introduction of the TRA in November 2003 resulted in a progressive decline of TFA use. Over the five years of conversion to TRA, from 2002 (100% TFA) to 2007 (98% TRA), major adverse cardiac events (MACE) and all in-hospital vascular and bleeding events, related or not to vascular access, were prospectively collected to assess performances of each approach in the specific setting of PCI (percutaneous coronary interventions). Data of 1,928 TFA and 1,672 TRA for a total of 3,600 consecutive PCI procedures are reported. PCI success rate was unchanged by TRA (96.1% versus 95.3% for TFA, NS). TRA was associated with a reduction in the rate of post-PCI myocardial infarction (2.3% versus 3.6% for TFA, p=0.023) and with a significant reduction of MACE (3.8% versus 5.2% for TFA, p=0.041). TRA use was also associated with a marked reduction of blood transfusion and surgery for post-PCI bleeding (0.2% versus 1.5% for TFA, p<0.001), despite more frequent prescription of downstream glycoprotein IIb/IIIa inhibitors (23.7% versus 7.4% for TFA, p<0.001). Thus, TRA resulted in a rapid and significant reduction of all major in-hospital adverse events, cardiac as well as non-cardiac, pooled in a "Net Adverse Clinical Event (NACE) index" of non-desirable events: death, myocardial infarction, stroke, urgent CABG surgery, surgery for bleeding and vascular events and blood transfusion. Such events occurred in 4.1% of TRA (n=69) as compared to 7% of TFA (n=134) (p<0.001), accounting for a 41% relative reduction of this NACE index by TRA. By multivariate analysis, TRA was related to a better in-hospital outcome (OR 0.64, 95% confidence interval [CI] 0.47-0.87; p=0.005). CONCLUSIONS: TRA for PCI provides the same success rate as TFA but significantly reduces post hoc related complications.

Recovery after balloon aortic valvuloplasty in patients with aortic stenosis and impaired left ventricular function: predictors and prognostic implications.

AIMS: The aim of this study was to evaluate predictors of recovery after balloon aortic valvuloplasty (BAV) among patients with aortic stenosis and depressed left ventricular ejection fraction (LVEF). Predictors for recovery after BAV are not clearly defined. B-type natriuretic peptide (BNP) predicts outcome after surgical and transcatheter aortic valve replacement. METHODS AND RESULTS: Among 151 consecutive patients treated in our institution by BAV, a total of 59 with poor LVEF underwent an echocardiography at 1 month. In these 59 patients, LVEF significantly improved in 22 patients (group 1) from 27 ± 5% to 45 ± 6% (P<.0001) and remained unchanged in 37 patients (group 2) from 29 ± 8% to 30 ± 11% (P=NS). BNP plasma levels at 24 hours only decreased in group 1 from 2170 ± 967 pg/mL to 1208 ± 662 pg/mL (P=.001). By multivariate analysis, BNP reduction >300 pg/mL was the strongest independent predictor of LVEF improvement at 30 days (hazard ratio, 5.459; 95% confidence interval, 1.580-18.860; P=.007). Kaplan-Meier analysis showed that 1-year survival after BAV was significantly higher in patients of group 1 than in group 2 (95 ± 4% vs 51 ± 8%, respectively; P=.02). CONCLUSIONS: BAV in patients with poor left ventricular function resulted in LVEF improvement at 30 days in 37% of cases, which was detected by a reduction of BNP levels already seen at 24 hours. Survival at 1 year was significantly higher in patients with such an improved LVEF after BAV.

Impact of frailty scores on outcome of octogenarian patients undergoing transcatheter aortic valve implantation.

BACKGROUND: For selected patients with symptomatic aortic stenosis, transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement (AVR). In addition to co-morbidities, frailty has to be taken into account in the decision-making process. Criteria for patient selection, according to current guidelines, include EuroSCORE and STS score but frailty is not easy to quantify. ISAR (Identification of Seniors At Risk) detects seniors at risk for adverse health outcome after an emergency visit and SHERPA (Score Hospitalier d'Evaluation du Risque de Perte d'Autonomie) assesses the risk of functional decline after hospitalization. OBJECTIVES: The aim of the present study was to evaluate the impact of ISAR and SHERPA scores in the prediction of patient outcome afterTAVI. METHODS AND RESULTS: A prospective cohort of 30 consecutive octogenarian patients (16 males, 86 +/- 3 y, EuroSCORE 34 +/- 12%) underwent a transfemoral TAVI and a complete geriatric assessment in our institution. Survival at one year was 73%. The ISAR score was similar between both groups (3.1 +/- 1 vs. 3.6 +/- 1; P = 0.10) but the SHERPA score was significantly higher in non-survivors (7.8 +/- 1.6) than among survivors (4.9 +/- 2.4; P = 0.001). With multivariate analysis, SHERPA score and BMI were independent predictors of 1-year mortality. Kaplan-Meier analysis showed that 1-year survival was significantly lower in patients with than in those without a SHERPA score > 7 (40 vs. 89%; P = 0.004). CONCLUSIONS: The result of this study showed that SHERPA score predicts 1-year survival after transfemoral TAVI and could be considered as a useful frailty score in patient selection.

The different mechanisms of periprocedural myocardial infarction and their impact on in-hospital outcome.

BACKGROUND: CK-MB levels exceeding 3 times the upper limit of normal (ULN) following percutaneous coronary intervention (PCI), defining periprocedural myocardial infarction (PMI), are associated with worse outcomes. This study assessed the incidence and mechanisms of PMI and their impact on in-hospital stay. METHODS AND RESULTS: Over a 12-year period (1996-2007), 272 cases of PMI (overall incidence, 3.5%) were analyzed among 310 consecutive cases of periprocedural myocardial necrosis (PMN; CK-MB > ULN). Mean numbers of treated segments and stents per procedure were 1.87 ± 0.99 and 1.43 ± 1.01, respectively. Mean stent length per procedure was 29.50 ± 19.30 mm. Following analysis of angiogram, procedural data, delay between PCI and necrosis, and mechanisms of PMN were classified as follows: cryptogenic (by exclusion, 41.5%), immediate failure, side-branch occlusion (14.0% each), stent thrombosis (10.6%), prolonged ischemia (9.2%), delayed failure (8.1%), post coronary artery bypass graft (1.5%), and non-target lesion related MI (1.1%). Significantly more stents were used in stent thrombosis, prolonged ischemia during PCI, and cryptogenic cases. In-hospital mortality was 8.1% for PMN and 8.8% for periprocedural MI, decreasing from non-target lesion related MI (25.0%) to mechanisms linked to stent thrombosis (20.7%), immediate failure (17.5%), delayed failure (7.7%), cryptogenic causes (6.1%), and prolonged ischemia (3.4%). Multivariate analysis confirms that in-hospital mortality is influenced by stent thrombosis, age, ejection fraction, and extent of coronary artery disease. CONCLUSIONS: The precise mechanism of PMI was determined in about 60% of our series. Stent thrombosis and immediate failure had the poorest in-hospital outcomes.

Low rate of conversion to transfemoral approach when attempting both radial arteries for coronary angiography and percutaneous coronary intervention: a study of 1,826 consecutive procedures.

AIMS: Despite a proven safety profile, the transradial approach (TRA) for coronary procedures is regarded by many as complicated and the second-choice arterial access, with a high conversion rate to transfemoral access (TFA). This study reports causes of failure and the contemporary success rate of TRA when both radial arteries are attempted first before converting to TFA. METHODS: This prospective, single-center study included 1,826 consecutive patients referred for cardiac catheterization, which was performed by two trained operators between January 2005 and June 2007. Procedural data were reported in a specific database. RESULTS: The procedural success rate through TRA (attempting one or both radial arteries) was 98.8%. One hundred and thirty-five radial attempts failed. Inability to puncture or to wire the artery accounted for 52.6% of failures, inability to reach coronary or graft ostia accounted for 20.7% and the remaining failures were related to the inability to reach a contralateral mammary graft. By multivariate analysis, the best predictors for failures were peripheral artery disease (PAD) (odds ratio [OR] 1.8, 95% confidence interval [CI] 1.1-2.8; p = 0.016), bedside clinical assessment of either a "small radial artery" size (OR 2.6, 95% CI 1.4 to 5.0; p = 0.003) or a "difficult access" (OR 2.5, 95% CI 1.3-4.9; p = 0.006). The number of failed attempts regresses annually by about 40% (OR 0.6, 95% CI 0.4-0.8; p < 0.001), thus demonstrating a continuous learning curve. Although rare, hematoma combined with swelling (3.8%) arises more frequently in females (OR 2.4, 95% CI 1.4-3.9; p = 0.001) and elderly patients (OR 1.9, 95% CI 1.0- 3.7; p = 0.040). CONCLUSION: The TRA can be safely proposed for all patients, with a low conversion rate to TFA when an attempt on both radial arteries is considered first.