Transcatheter aortic valve replacement (TAVR) with the Portico® valve (Abbott) was found to be safe and associated with low rates of stroke, death or paravalvular leakage at one-year follow-up, according to the real-world PORTICO I study in patients with symptomatic, severe aortic stenosis.
Transcatheter aortic valve replacement (TAVR) with the CoreValve® system (Medtronic) and surgical aortic valve replacement (SAVR) show similar 5-year survival and stroke rates in high-risk patients, as shown by the MCV-US-2009-01 study (NCT01240902). Most patients remained free from severe structural valve deterioration (SVD) and valve reinterventions (VR).
Anticoagulation, which is often provided for atrial fibrillation (AF), decreases the risk of bioprosthetic valve dysfunction (BVD) after transcatheter aortic valve replacement (TAVR), according to the results of the FRANCE-TAVI registry study. Male gender, chronic kidney disease (CKD), and atrial fibrillation (AF) have the highest impact on the 3-year mortality due to BVD after TAVR.
Real-life use of edoxaban (Lixiana®, Daiichi Sankyo) in Asian atrial fibrillation (AF) patients significantly lowered the risk of ischaemic stroke (IS), intracranial haemorrhage (ICH), hospitalisation for gastrointestinal (GI) bleeding, hospitalisation for major bleeding, and all-cause death when compared to warfarin. This was concluded by the Korean investigators in the Journal of the American College of Cardiology. The benefits were consistent in the various high-risk subgroups.
Febuxostat to decrease uric acid levels and aid the prevention of cerebral, cardiovascular and renal events in elderly hyperuricaemia patients as reported by the investigators of the FREED trial during the ESC 2018 Congress.
In Asian atrial fibrillation (AF) patients, low-dose rivaroxaban (Xarelto®, Bayer) has a similar effect on the risk of thromboembolism and bleeding but not on myocardial infarction (MI) when compared to the standard-dose, as shown in a retrospective population-based cohort study from Taiwan.
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The 65th Annual Scientific Session of the American College of Cardiology (ACC2016) has just been adjourned and many have returned home fully updated on the latest cardiology news. We summarised 8½ of the most eye-catching news that will change the practice of cardiologists around the world.
At a median follow-up of 9.8 years, the Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (STICH/STICHES study) showed that adding coronary-artery bypass grafting (CABG) to guideline-directed medical therapy improved survival outcome when compared to medical therapy alone.
1212 patients with left ventricular ejection fraction (LVEF) ≤35% and coronary artery disease were randomised 1:1 to receive guideline-directed medical therapy with or without CABG. Death from any cause, the primary endpoint, occurred in 58.9% of the 610 patients in the group adding CABG compared to 66.1% of the 602 patients who received medical treatment alone (HR=0.84; 95% CI, 0.73 to 0.97; P = 0.02) [1].
The GAUSS-3 study is a two-stage (Phase A and B) randomized clinical trial that was presented during ACC2016.
Phase A treated 491 adult patients with a previous history of intolerance to 2 or more statins and uncontrolled low-density lipoprotein cholesterol (LDL-C) levels. Phase A had a cross-over design for atorvastatin and placebo, and patients identified to have true statin intolerance were randomised to evolocumab or ezetimibe inPhase B.
Phase B randomised 218 patients selected in Phase A. Composite endpoint was the mean percentile change in LDL-C level from baseline to the mean of weeks 22 and 24 levels and from baseline to week 24 levels. Entry mean LDL-C level was 219.9 mg/dl. In the 73 ezetimibe-treated patients, mean of week 22 and 24 LDL-C was 16.7% (95% CI, −20.5% to −12.9%) lower from baseline (183.0 mg/dl). In the 145 evolocumab-treated patients, mean of week 22 and 24 LDL-C was 54.5% (95% CI, −57.2% to −51.8%) lower from baseline (103.6 mg/dl) (P < 0.001). LDL-C level at week 24 showed similar results, in ezetimibe-treated patients mean LDL-C was 181.5 mg/dL at 24 weeks (−16.7% – 95% CI, −20.8% to −12.5%) and in evolocumab-treated patients mean LDL-C was at 24 weeks (−52.8% – 95% CI, −55.8% to −49.8%); Muscle symptoms were slightly higher in the ezetimibe group 28.8% vs 20.7% in the evolocumab-group (log-rank P = 0.17).
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Results of the open-label, randomised controlled DANAMI 3-DEFER trial in patients with symptoms of acute myocardial infarction and ST-segment elevation of 0·1 mV (STEMI) or more were presented at ACC2016. All patients underwent immediate percutaneous coronary intervention (PCI) and were randomly assigned to either immediate stent implementation (n=612) versus postponed or deferred stent implantation after 48 hours (n=603).
At a median follow-up of 42 months, 109 (18%) patients in the standard PCI arm and 105 (17%) patients in the deferred stent implantation arm experienced a primary composite endpoint event, which was all-cause mortality, hospital admission for heart failure, recurrent infarction, and any unplanned revascularisation of the target vessel (HR 0·99; 95% CI, 0·76–1·29; p=0·92).
Early-BAMI trial randomised 683 patients with ST-levation Myocardial Infarction (STEMI) patients presenting
342 patients (54.8% of total) were evaluated by magnetic resonance imaging (MRI) for the primary endpoint myocardial infarct size by MRI at 30 days. Infarct size (% of LV) by MRI was similar in the 336 patient who received metoprolol (15.3 ± 11.0%) and the 346 patients receiving placebo (14.9 ± 11.5% p=0.616). LVEF was 51.0 ± 10.9% and 51.6 ± 10.8% (P =0.68) respectively. There was a small but significant difference for the secondary endpoint ventricular arrhythmias. Malignant arrhythmias occurred in 3.6% of the metoprolol-treated patients vs 6.9% in placebo group (P = 0.050). The incidence of adverse events was not different between groups. No significant difference in toxicities was observed.
Results of the HOPE-3 Trial (ClinicalTrials.gov: NCT00468923), a study with a 2-by-2 factorial design, at a median follow-up of 5.6 years were reported at ACC2016. The study randomised 12,705 subjects with intermediate cardiovascular risk and without history of cardiovascular disease to receive:
The two co-primary composite endpoints of the study were:
The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization.
Baseline mean BP was 138.1/81.9 mm Hg. When comparing candesartan plus hydrochlorothiazide vs placebo first co-primary endpoint occurred in 260 (4.1%) vs. 279 (4.4%) respectively (HR=0.93; 95% CI, 0.79 to 1.10; P =0.40) and second co-primary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%) respectively (HR=0.95; 95% CI, 0.81 to 1.11; P =0.51). Decrease in BP was 6.0/3.0 mm Hg greater in candesartan plus hydrochlorothiazide vs placebo [5].
When comparing rosuvastatin vs placebo first co-primary endpoint occurred in 235 (3.7%) vs. 304 (4.8%) respectively (HR=0.76; 95% CI, 0.64 to 0.002; P=0.002) and second co-primary outcome occurred in 277 participants (4.4%) and 363 participants (5.7%) respectively (HR=0.75; 95% CI, 0.64 to 0.88; P <0.001). In the rosuvastatin group overall mean LDL-C level was 26.5% lower when compared to placebo. Adverse events were similar but 3.8% of rosuvastatin-treated patients vs. 3.1% placebo-receiving patients had cataract surgery (P=0.02). Muscle symptoms were higher with 5.8% of participants vs. 4.7% respectively (P =0.005) [6].
This study investigated the genetic component in 26,025 patients with severe (LDL-C ≥ 190 ml/dl) hypercholesterolaemia by gene sequencing. Three known genes that are currently known to cause familial hypercholesteraemia (FH) LDLR, APOB, PCSK9 and their genetic variants were sequenced. Coronary Arterial Disease (CAD) risk correlation with mutations was assessed in these patients as well.
In the population with LDL-C ≥190 mg/dl (N=1386), 24 patients (1.7%) carried one of the FH mutations. The risk of CAD was found to be highest in subjects with LDL-C ≥190 mg/dl with FH mutations when compared to the reference group of LDL cholesterol
The non-inferiority trial PARTNER 2 (ClinicalTrials.gov: NCT01314313) investigated transcatheter aortic-valve replacement (TAVR) with surgical replacement in 2032 intermediate-risk patients with severe aortic stenosis.
Before randomization, patients were stratified based on clinical and imaging findings to either the transfemoral-access cohort ( 76.3%) or the transthoracic-access cohort (23.7%). The primary endpoint of death from any cause or disabling stroke at 2 years was equally met in TAVR group and the surgery group (P=0.001 for noninferiority). Event rates were 19.3% and 21.1% for the TAVR group and surgery group respectively (HR TAVR: 0.89; 95% CI, 0.73 to 1.09; P = 0.25). TAVR resulted in less primary endpoints in the transfemoral-access cohort when compared to surgery (HR: 0.79; 95% CI, 0.62 to 1.00; P = 0.05) but was similar for TAVR vs surgery in the transthoracic-access cohort [8].
Another study, the CoreValve, reported the sustained benefit over time at 3 years time-point for self-expanding transcatheter aortic valve replacement (TAVR) versus open surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis at increased risk for surgery at the ACC2016.
750 eligible subjects were randomised 1:1 to either TAVR or SAVR and underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR (37.3%) versus SAVR (46.7%) (P = 0.006). Furthermore, when comparing TAVR with SAVR at three-years time-point, all stroke (12.6% versus 19.0%; respectively P = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% versus 47.9%; respectively P=0.025) were both lower. There was a trend towards lower all-cause mortality (32.9% versus 39.1%, respectively; P=0.068) but this was not statistically significant. At 3 years mean aortic valve gradient was better in TAVR patients when compared to SAVR (7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR, P < 0.001). Moderate and severe residual aortic regurgitation proved higher in TAVR patients compared to SAVR (6.8% versus 0.0% in SAVR; P < 0.001) [9].
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