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BACKGROUND: Coronary artery disease is a major cause of morbidity and mortality worldwide, and is a consequence of acute thrombotic events involving activation of platelets and coagulation proteins. Factor Xa inhibitors and aspirin each reduce thrombotic events but have not yet been tested in combination or against each other in patients with stable coronary artery disease.METHODS: In this multicentre, double-blind, randomised, placebo-controlled, outpatient trial, patients with stable coronary artery disease or peripheral artery disease were recruited at 602 hospitals, clinics, or community centres in 33 countries. This paper reports on patients with coronary artery disease. Eligible patients with coronary artery disease had to have had a myocardial infarction in the past 20 years, multi-vessel coronary artery disease, history of stable or unstable angina, previous multi-vessel percutaneous coronary intervention, or previous multi-vessel coronary artery bypass graft surgery. After a 30-day run in period, patients were randomly assigned (1:1:1) to receive rivaroxaban (2·5 mg orally twice a day) plus aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day), or aspirin alone (100 mg orally once a day). Randomisation was computer generated. Each treatment group was double dummy, and the patients, investigators, and central study staff were masked to treatment allocation. The primary outcome of the COMPASS trial was the occurrence of myocardial infarction, stroke, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, 27 395 patients were enrolled to the COMPASS trial, of whom 24 824 patients had stable coronary artery disease from 558 centres. The combination of rivaroxaban plus aspirin reduced the primary outcome more than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio [HR] 0·74, 95% CI 0·65-0·86, pINTERPRETATION: In patients with stable coronary artery disease, addition of rivaroxaban to aspirin lowered major vascular events, but increased major bleeding. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease worldwide.FUNDING: Bayer AG.

Aim: To define the predictors of long-term mortality in patients with type 2 diabetes mellitus and recent acute coronary syndrome.Methods and results: A total of 7226 patients from a randomized trial, testing the effect on cardiovascular outcomes of the dual peroxisome proliferator-activated receptor agonist aleglitazar in patients with type 2 diabetes mellitus and recent acute coronary syndrome (AleCardio trial), were analysed. Median follow-up was 2 years. The independent mortality predictors were defined using Cox regression analysis. The predictive information provided by each variable was calculated as percent of total chi-square of the model. All-cause mortality was 4.0%, with cardiovascular death contributing for 73% of mortality. The mortality prediction model included N-terminal proB-type natriuretic peptide (adjusted hazard ratio = 1.68; 95% confidence interval = 1.51-1.88; 27% of prediction), lack of coronary revascularization (hazard ratio = 2.28; 95% confidence interval = 1.77-2.93; 18% of prediction), age (hazard ratio = 1.04; 95% confidence interval = 1.02-1.05; 15% of prediction), heart rate (hazard ratio = 1.02; 95% confidence interval = 1.01-1.03; 10% of prediction), glycated haemoglobin (hazard ratio = 1.11; 95% confidence interval = 1.03-1.19; 8% of prediction), haemoglobin (hazard ratio = 1.01; 95% confidence interval = 1.00-1.02; 8% of prediction), prior coronary artery bypass (hazard ratio = 1.61; 95% confidence interval = 1.11-2.32; 7% of prediction) and prior myocardial infarction (hazard ratio = 1.40; 95% confidence interval = 1.05-1.87; 6% of prediction).Conclusion: In patients with type 2 diabetes mellitus and recent acute coronary syndrome, mortality prediction is largely dominated by markers of cardiac, rather than metabolic, dysfunction.

To determine (1) the medium-term effect of rosiglitazone and glipizide on intra-stent neointima hyperplasia, (2) restenosis pattern as assessed by intra-vascular ultrasound (IVUS) and quantitative coronary angiography (QCA) in patients with T2DM and coronary artery disease. A total of 462 patients with T2DM were randomized to rosiglitazone or glipizide for up to 18 months in the APPROACH trial, and had evaluable baseline and follow-up IVUS examinations. There was no significant difference in the size of plaque behind stent between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (-5.6 mm(3) vs. 1.9 mm(3); P = 0.61) or with a drug-eluting stent (12.1 mm(3) vs. 5.5 mm(3); P = 0.09). Similarly, there was no significant difference in percentage intimal hyperplasia volume between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (24.1% vs. 19.8%; P = 0.38) or with a drug-eluting stent (9.8% vs. 8.3%; P = 0.57). QCA data (intra-stent late loss, intra-stent diameter stenosis or binary restenosis) were not different between the rosiglitazone and glipizide groups. This study suggests that both rosiglitazone and glipizide have a similar effect on neointimal growth at medium term follow-up, a finding that warrants investigation in dedicated randomized trials.

Aims In the TRITON-TIMI 38 trial, greater platelet inhibition with prasugrel reduced the first occurrence of the primary endpoint (cardiovascular death, MI, or stroke) compared with clopidogrel in patients with an acute coronary syndrome (ACS) undergoing planned percutaneous coronary intervention. We hypothesized that prasugrel would reduce not only first events but also recurrent primary endpoint events and therefore total events compared with clopidogrel. Methods and results Poisson regression analysis was performed to compare the number of occurrences of the primary endpoint between prasugrel and clopidogrel in TRITON-TIMI 38. Landmark analytic methods were used to evaluate the risk of a recurrent primary endpoint event following an initial non-fatal endpoint event. Among patients with an initial non-fatal event, second events were significantly reduced with prasugrel compared to clopidogrel (10.8 vs. 15.4%, HR 0.65, 95% CI 0.46–0.92; P = 0.016), as was CV death following the non-fatal event (3.7 vs. 7.1%, HR 0.46, 95% CI 0.25–0.82; P = 0.008). Overall there was a reduction of 195 total primary efficacy events with prasugrel vs. clopidogrel (rate ratio 0.79, 95% CI 0.71–0.87; P < 0.001). Recurrent bleeding events occurred infrequently (TIMI major non-CABG bleeds: four with prasugrel and two with clopidogrel). Study drug discontinuation was frequent following the initial major bleeding event (42% of patients discontinued study drug). Conclusion While standard statistical analytic techniques for clinical trials censor patients who experience a component of the primary composite endpoint, total cardiovascular events remain important to both patients and clinicians. Prasugrel, a more potent anti-platelet agent, reduced both first and subsequent cardiovascular events compared with clopidogrel in patients with ACS.

Background— Analysis of right ventricular (RV) regional dysfunction by cardiac magnetic resonance (CMR) imaging in arrhythmogenic RV cardiomyopathy (ARVC) may be inadequate because of the complex contraction pattern of the RV. Aim of this study was to determine the use of RV strain and dyssynchrony assessment in ARVC using feature-tracking CMR analysis. Methods and Results— Thirty-two consecutive patients with ARVC referred to CMR imaging were included. Thirty-two patients with idiopathic RV outflow tract arrhythmias and 32 control subjects, matched for age and sex to the ARVC group, were included for comparison purpose. CMR imaging was performed to assess biventricular function; feature-tracking analysis was applied to the cine CMR images to assess regional and global longitudinal, circumferential, and radial RV strains and RV dyssynchrony (defined as the SD of the time-to-peak strain of the RV segments). RV global longitudinal strain (−17±5% versus −26±6% versus −29±6%; P P =0.001), and global radial strain (18 [12–26]% versus 22 [15–32]% versus 27 [20–39]%; P =0.015) were significantly lower and SD of the time-to-peak RV strain in all 3 directions were significantly higher among patients with ARVC compared with patients with RV outflow tract arrhythmias and controls. RV global longitudinal strain >−23.2%, SD of the time-to-peak RV longitudinal strain >113.1 ms, and SD of the time-to-peak RV circumferential strain >177.1 ms allowed correct identification of 88%, 75%, and 63% of ARVC patients with no or only minor CMR criteria for ARVC diagnosis. Conclusions— Strain analysis by feature-tracking CMR helps to objectively quantify global and regional RV dysfunction and RV dyssynchrony in patients with ARVC and provides incremental value over conventional cine CMR imaging.

Objectives: The aim of our study is to evaluate the safety and efficacy of DES implantation in an unselected, “real world,” high-risk population. Background: Several clinical trials showed that drug-eluting stents (DESs) implantation is safe and effective in selected population. In spite of these encouraging results, there are some concerns about “real world” utilization of these stents. Methods: One thousand four hundred and fifty-five off-label patients have been included in our registry. Primary end-points were: long-term clinical incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombosis (ST). We detected the difference between uniDES vs. multiDES implantation in terms of MACCE, death, nonfatal-MI, the composite of death/nonfatal-MI and target lesion revascularization (TLR) and the difference between DES type in term of MACCE. Results: At 36 months follow-up we found: cardiac death occurred in 20 patients (1.6%); 33 patients (2.6%) had a nonfatal MI and 81 patients (6.3%) had a TLR. We observed one (0.1%) acute, 9 subacute (0.6%), 6 late (0.6%), and 1 (0.5%) very late definite ST. No difference were found in terms of overall MACCE, MI, death and composite of death/nonfatal-MI between uni- and multiDES implantation but multiDES group had a higher incidence of TLR. No difference between DES type in term of MACCE was detected. Conclusions: DES utilization shows their safety and efficacy in off-label patients with complex clinical and angiographic profile in terms of long-term incidence of MACCE. MultiDES implantation is associated with a higher risk of long-term TLR. No difference between DES type was found. © 2011 Wiley Periodicals, Inc.

Objective: The aim of this study was to determine the occurrence of patient-prosthesis mismatch (P-PM) after aortic valve replacement (AVR) with a small-size Cryolife O'Brien (CLOB) bioprosthesis and to evaluate its clinical and hemodynamic implications. Methods: Sixty-two patients (mean age 70.9 ± 5.2 years, 77.8% females), receiving a labeled 21–23 mm CLOB between 1993 and 2000, were retrospectively studied. Effective orifice area (EOA) was calculated by the continuity equation and then indexed to the patient's body surface area (BSA) to obtain the indexed EOA (EOAI). Based on previous observations a mismatch was defined as EOAI ≤ 0.85 cm2/m2. Results: Twelve patients (20%) at discharge, two (3.3%) at 6 months and none at late controls had an EOAI ≤ 0.85 cm2/m2. At ANOVA determinants of mismatch were female sex (p < 0.001), age (p = 0.01), and patient's annulus index (PAI, p < 0.001). Patients with mismatch had higher mean gradients (MG, p = 0.01, and p < 0.001 at discharge and 6 months, respectively) and EOAI correlated with MG at discharge (r2= 0.72, p < 0.001) and 6-month (r2= 0.40, p = 0.001) studies. At 1 year no difference in MG was detected between patients with or without mismatch (p = ns) and EOAI did not correlate with MG (r2= 0.01, p = ns). Midwall fractional shortening did not differ in patients with or without mismatch (p = ns). Patients with an EOAI ≥ 0.8 cm/m2 showed an earlier concentric remodeling up to 1 year; no difference was demonstrated at later studies between groups. Survival and clinical status results were not affected by an EOAI ≤ 0.85 cm2/m2. Conclusions: After AVR with CLOB mismatch occurred early postoperatively in a small number of patients without clinical repercussions. EOAI, significantly increasing over time, was adequate to BSA in all patients at late controls. (J Card Surg 2004;19:91-97)

Background: The St Jude Medical Regent™ is a new-generation mechanical heart valve that represents a design evolution of the St Jude Hemodynamic Plus Series (HP). The purpose of this study was to evaluate early “in vivo” hemodynamic performance of the Regent™ valve in patients with aortic stenosis. Methods: Between March 2000 and December 2001, 32 patients (mean age59.9 ± 5.9, 56.3%male) with pure aortic stenosis received a Regent™ mechanical prosthesis in the aortic position. Hemodynamic performance was assessed by Doppler echocardiography at discharge, two months, six months, and one year by calculating peak transprosthetic velocity (Vmax), mean (MG) and peak (PG) transprosthetic gradients, effective orifice area index (EOAI), left ventricular mass index (LVMI), and degree of aortic regurgitation. Results: A significant reduction in mean and peak transaortic gradients(p < 0.001)and a significant increase in EOAI(p < 0.001)over time followed valve replacement, and a bivariate analysis of variance (ANOVA) failed to demonstrate statistical differences by valve size over time(p = ns).A significant reduction in left ventricular hypertrophy occurred over time(p < 0.001)in all valve sizes (p = ns between groups): baseline LVMI was221 ± 57 g/cm2; it decreased by30 g/cm2 (p < 0.001)at discharge. LVMI decreased from191 ± 54 g/cm2to161 ± 41 g/cm2 (p < 0.001)from discharge to two months. Further reductions were not significant. At the six-month follow-up no patient in our cohort exhibited moderate or severe aortic regurgitation at Doppler echocardiography. Conclusions: Early results with the St Jude Medical Regent™ valve have been satisfactory. Further assessments are necessary to confirm these results.(J Card Surg 2003;18:125-132)

ObjectivesThis study evaluated the occurrence of prosthesis-patient mismatch (PPM) after Cryolife O’Brien (CLOB) suprannular stentless valve replacement in patients with a small aortic root and its repercussions on the patient’s hemodynamic status and left ventricular mass regression.BackgroundThe correct management of the small aortic annulus is still controversial. Small aortic prostheses can lead to a PPM, which results in high gradients with important repercussions on the hemodynamic status.MethodsSeventy-two patients (mean age: 72.5 ± 6.2 years, 73.6% women) with a small aortic root (≤21 mm intraoperatively measured aortic annulus) had a CLOB valve implanted in the aortic position between November 1993 and July 2001 at our institution. Mean prosthesis size was 22.0 ± 0.8 mm. Patients underwent echocardiography preoperatively, at discharge, six months, one year and yearly thereafter.ResultsThe incidence of PPM at discharge was 22.2% (16/72); 18.7% were severe (effective orifice area index [EOAI] ≤0.65 cm/m2), 43.7% were moderate (EOAI = 0.66 to 0.75 cm/m2) and 37.6% were mild (0.76 to 0.85 cm/m2). At multivariable analysis, gender (p < 0.001), age (p = 0.015), body surface area (p < 0.001) and patient’s annulus index (p < 0.001) were significant factors influencing the occurrence of “transient” PPM. At one year the incidence of PPM was 0%.ConclusionsSuprannular CLOB valve yielded excellent hemodynamic results in patients with small aortic roots. This study demonstrates that PPM can be completely avoided when using the CLOB valve. The superior hemodynamics of this stentless valve are likely to be related to its suprannular design.

Chylopericardium is a rare complication of cardiac surgical procedures. We describe a 41-year-old woman who underwent orthotopic heart transplantation and developed chylopericardium early in the post-operative period. Because of unsuccessful conservative treatment (pericardiocentesis, pericardial drainage, low-fat diet with medium-chain triglycerides, and total parenteral nutrition), surgical intervention was indicated and the patient successfully underwent right-sided thoracoscopic duct ligation and partial pericardiectomy (pericardial window).

Mortality, morbidity, complication rates, and echo hemodynamic results using the Cryolife O'Brien stentless aortic bioprosthesis over a 5-year period are reported.The stentless valve was implanted in 97 conscecutive patients, 54 male and 43 female, mean age 70.9 +/- 6.5 years. All patients underwent preoperative, discharge (early study), 6-month (intermediate study), and late (18.3 +/- 10.4 months) echocardiography.The actuarial 5-year survival rate was 93.9% +/- 3%. Aortic regurgitation was absent in 95.5%, mild in 3.4%, and moderate in 1.1%. Peak and mean systolic gradients were significantly lower at discharge (p0.001) and at the 6-month follow-up (p0.001) but did not significantly fall further at the late study (p = NS). The effective orifice area index at discharge (p0.001) and at 6 months (p0.001) differed significantly from preoperative values, but variations at late study were not significant (p = NS). Left ventricular mass index decreased early postoperatively (p0.001) and at 6-month assessment (p0.001) with a further significant reduction at late echocardiography (p = 0.04).The 5-year results of this stentless valve showed a low rate of valve-related complications with excellent hemodynamic performance in all valve sizes.