|
 
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| REVIEW ARTICLE |
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| Year : 2018 | Volume
: 4
| Issue : 1 | Page : 15-20 |
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Cardiology update 2018: The first quarter
Sunil Kumar Verma1, FA Farooqui1, Sridharan Umapathy1, H Gupta2
1 Department of Cardiology, CTC, AIIMS, Lucknow, Uttar Pradesh, India
2 Department of Medicine, KGMU, Lucknow, Uttar Pradesh, India
| Date of Web Publication | 4-May-2018 |
Correspondence Address:
Dr. Sunil Kumar Verma
Suite No. 24, 7th Floor, Department of Cardiology, CTC, AIIMS, Ansari Nagar, New Delhi - 110 029
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/jpcs.jpcs_14_18
Trials addressing the PCSK9 inhibitors, wearable cardioverter defibrillator, genotype-guided antiplatelet therapy, his bundle pacing, and therapies for HFpEF were discussed in American College of Cardiology 2018. TASMINH4 evaluated the need for self-monitoring and telemonitoring of blood pressure in the management of patients with poorly controlled blood pressure. In heart failure, issues regarding temporal trends and patterns of incidence, NT-proBNP, HeartMate pump, immunosuppression (sirolimus versus calcineurin) in heart transplant recipients, and aspirin use were evaluated in various trials. Drug-eluting balloon, MiStent, Resolute Onyx 2.0 drug-eluting stent, Omega-3 fatty acids, safety of drugs used in the treatment of gout (febuxostat versus allopurinol), and preventive strategies for those at risk for renal complications were tested in patients with coronary artery disease. Smokers were compared with nonsmokers presenting with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention in terms of clinical, angiographic, and outcomes. Association of influenza infection with acute myocardial infarction was also tested. A good number of trials tested different antiplatelets in different manners. Keywords: Cardiology review, 2018, update
How to cite this article:
Verma SK, Farooqui F A, Umapathy S, Gupta H. Cardiology update 2018: The first quarter. J Pract Cardiovasc Sci 2018;4:15-20 |
How to cite this URL:
Verma SK, Farooqui F A, Umapathy S, Gupta H. Cardiology update 2018: The first quarter. J Pract Cardiovasc Sci [serial online] 2018 [cited 2023 May 29];4:15-20. Available from: https://www.j-pcs.org/text.asp?2018/4/1/15/231928 |
We start this review with a glimpse of some of the most awaited trials to be presented at ACC 2018.
| American College of Cardiology 2018 | |  |
ODYSSEY-CV Outcomes trial is a randomized controlled trial evaluating the effect of the PCSK9 inhibitor, alirocumab on major cardiovascular events in patients who had an acute coronary syndrome (ACS) within the prior year. The FOURIER trial had previously showed that the PCSK9 inhibitor evolocumab reduced nonfatal cardiac events but not mortality.[1] The high cost of the drug and low absolute difference in event rates have limited its use in clinical practice. The ODYSSEY-CV Outcomes trial has a longer follow-up period and lower low-density lipoprotein targets and may yield different results.
The VEST trial explores the idea of the wearable cardioverter defibrillator (WCD) in postmyocardial infarction (MI) period in patients with an ejection fraction (EF) ≤35%. The WCD was approved by the US Food and Drug Administration in 2001. Although the DINAMIT trial [2] failed to demonstrate an overall survival benefit with early implantable cardioverter defibrillator (ICD) implantation in the immediate post-MI period, arrhythmic death was significantly lower in the ICD group. Whether a WCD would be effective in the immediate post-MI period before a definitive decision can be made regarding an ICD remains an unanswered question which this trial attempts to answer.
Loss of function mutations in CYP2C19 has been shown to be associated with poorer outcomes in patients receiving clopidogrel following percutaneous coronary intervention (PCI).[3],[4] However, randomized controlled trials evaluating genotype-guided antiplatelet therapy are lacking. The ADAPT-PCI and PHARMCLO trials are attempting to clarify the role of point-of-care genotype assays for CYP2C19 in patients undergoing PCI.
Various anatomical sites have been evaluated for cardiac pacing. Right ventricular pacing has been previously demonstrated to be a far from ideal site for cardiac pacing.[5],[6],[7] It has been associated with dyssynchronous ventricular contraction. His bundle pacing (HBP) has been explored as a novel pacing strategy in preliminary studies and has been shown to be a feasible pacing strategy.[8] An interesting study titled “Permanent HBP Is Associated with Reduction in Mortality and Morbidity Compared to Right Ventricular Pacing: Results From the Geisinger HBP Registry” attempts to shed light on this matter.
Heart failure (HF) with preserved EF continues to intrigue investigators around the world. Various therapies have been evaluated in this population without evidence of conclusive benefit.[9],[10],[11],[12],[13],[14] The impact of inhaled sodium inorganic nitrate on the peak VO2 after 4 weeks of treatment is being evaluated in the INDIE-HFpEF trial. An improvement in exercise capacity with inhaled nitrates would provide much needed impetus toward the development of newer treatment targets for this condition.
A journal scan of the best articles and studies of the last 4 months reveals these publications.
| Hypertension | | |
The TASMINH4, an unmasked randomized controlled trial, evaluated the titration of antihypertensive medications by general practitioner in patients with poorly controlled blood pressure based on the self-monitoring/telemonitoring/usual care.[15] About 400 patients were studied in each group. The study showed that self-monitoring, with or without telemonitoring, led to significantly lower blood pressures than titration guided by clinical readings.
| Heart Failure | | |
The ICON-RELOADED investigators evaluated the diagnostic performance of NT-proBNP in contemporary population.[16] The ICON study had previously suggested optimal cutoffs of 450, 900, and 1800 pg/mL for NT-proBNP (<50, 50–75, and >75 years, respectively). These values were validated in the current study. In addition, an NT-proBNP <300 pg/mL was found to have a sensitivity and specificity of 94% and 98%, respectively, in ruling out the presence of acute HF.
In MOMENTUM 3 trial involving 366 patients with advanced HF, a fully magnetically levitated centrifugal flow pump (HeartMate 3) was superior to a mechanical-bearing axial-flow pump (HeartMate II) with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.[17]
In heart transplant recipients, early conversion to sirolimus (<2 years) immunosuppression was associated with attenuated coronary allograft vasculopathy (CAV) progression and with lower long-term mortality and fewer CAV-related events compared with continued calcineurin inhibitor use over a mean follow-up period of 8.9 years.[18]
In a recent study, no association was detected between low-dose aspirin use and the composite outcome of all-cause mortality, admission for MI, and admission for stroke in patients with HF with no history of atrial fibrillation. Aspirin use was associated with an increased risk of readmission for HF.[19]
Temporal trends and patterns in heart failure incidence
A population-based study of 4 million individuals in a cohort representative of UK population in terms of age and sex from 2002 to 2014 showed that despite a moderate decline in the standardized incidence of HF, the burden of HF in the UK is increasing.[20]
| Coronary Artery Disease and Atherosclerosis | | |
A recent meta-analysis involving ten trials demonstrated that omega-3 fatty acids had no significant association with fatal or nonfatal coronary heart disease or any major vascular events. It provides no support for current recommendations for the use of such supplements in people with a history of coronary heart disease.[21]
In DARE trial involving patients with ISR, treatment with paclitaxel-eluting balloon was noninferior compared with drug-eluting stent (DES) (everolimus-eluting stent) in terms of 6-month minimal luminal diameter. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a drug eluting balloon (DEB) is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.[22]
The Food and Drug Administration has approved the Resolute Onyx 2.0-mm DES, a zotarolimus-eluting stent, tested in the RESOLUTE 2.0 study [23] which enrolled 101 patients. 12-month follow-up results showed no stent thrombosis or cardiac death and a target lesion failure rate of 5%. This stent needs to be further evaluated in larger studies with a longer follow-up.
The CARES trial compared febuxostat with allopurinol among patients with gout and cardiovascular disease.[24] Febuxostat was found to be noninferior to allopurinol at preventing cardiovascular events. However, all-cause mortality was shown to be higher with febuxostat. The mechanism of this observation of increased mortality seems unrelated to cardiovascular causes.
About 5000 patients who were at high risk for renal complications and scheduled for coronary angiography were randomized in a 2 × 2 factorial design to receive intravenous 1.26% sodium bicarbonate or intravenous 0.9% sodium chloride and 5 days of oral acetylcysteine or oral placebo in a modified intention to treat analysis.[25] The results showed that there was no benefit of intravenous sodium bicarbonate over intravenous sodium chloride or of oral acetylcysteine over placebo for the prevention of death, need for dialysis or persistent decline in renal functions at 90 days or for the prevention of contrast-induced acute kidney injury.
A comparison of MiStent (sirolimus-eluting bioabsorbable polymer stent) with everolimus-eluting durable polymer stent (Xience) in randomized, single-blind, multicenter Phase II study (DISSOLVE III) showed noninferiority of MiStent for a device-oriented composite clinical end point at 12 months in an all-comer population.[26]
| Myocardial Infarction and Acute Coronary Syndrome | | |
A clinical trial compared the smokers with nonsmokers presenting with acute ST-segment elevation MI (STEMI) and undergoing primary PCI in terms of clinical and angiographic profiles along with 6-month outcomes.[27] The study demonstrated that smokers in comparison to nonsmokers have STEMI about a decade earlier, have a higher thrombus burden with lesser nonculprit vessel involvement, and most importantly have similar 6-month outcomes that questions the well-known hypothesis of “Smoker's Paradox.”
A recent study evaluated the association between laboratory-confirmed influenza infection and hospitalization for acute MI. Increased incidence of an admission for acute MI during the risk interval of 7 days (20 admissions per week) occurred compared to control interval (3.3 admissions per week). Incidence ratios for acute MI within 7 days after detection of influenza B, influenza A, respiratory syncytial virus, and other viruses were 10.11 (95% confidence interval [CI], 4.37–23.38), 5.17 (95% CI, 3.02–8.84), 3.51 (95% CI, 1.11–11.12), and 2.77 (95% CI, 1.23–6.24), respectively.[28]
In MATRIX trial involving patients with ACS undergoing PCI, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin, irrespective of planned glycoprotein IIb/IIIa inhibitor (GPI) use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs.[29]
A study from Canada [30] investigated the impact of the direct transfer to PCI-capable hospitals on survival to hospital discharge for patients with out-of-hospital cardiac arrest particularly in the absence of prehospital return of spontaneous circulation. They found that there was an association between being transported to a PCI-capable center and survival to discharge. If the delay is expected to be of <14 min, it could be reasonable to redirect out-of-hospital cardiac arrest patients to a PCI-capable center.
| Antiplatelet Therapy | | |
The TOPIC trial evaluated the long-term implications of switching antiplatelet therapy from the newer ADP antagonists to clopidogrel at 1-month post-PCI in ACS patients.[31] It was concluded that switching to clopidogrel at 1-month post-PCI significantly reduced bleeding without an increase in ischemic events. These findings are at odds with the current treatment guidelines. The impact of this study on the current treatment practice remains to be seen.
The PRAGUE 18 trail is the first randomized head-to-head comparison of prasugrel and ticagrelor.[32] One-year follow-up data showed no significant difference in efficacy between the two drugs.[33] In addition, thrombolysis in MI (TIMI) major bleeding and ischemic stroke was similar with both drugs. The investigators concluded that in the setting of acute MI, the use of either agent seems acceptable.
The role of ticagrelor in patients with STEMI treated with thrombolysis was evaluated in the TREAT trial.[34] Ticagrelor was compared to clopidogrel in this randomized trial. Ticagrelor was noninferior to clopidogrel for major bleeding in this subset of patients. This trial however was not powered for efficacy.
In the SMART-DATE study, 6-month DAPT was compared to 12 months or longer DAPT in patients with ACS undergoing PCI with current-generation DES. MI occurred more frequently in the 6-month DAPT group (24 [1·8%] patients vs. 10 [0·8%]; HR 2·41 CI [1·15–5·05]; P = 0·02) with no difference in the primary composite end point.[35]
The management of antiplatelet therapy in ACS patients with thrombocytopenia was discussed in a review by McCarthy et al.[36] Thrombocytopenia (platelet count <150 × 109/L) is present in approximately 5% of ACS patients.[20],[21] This population has been underrepresented in most clinical trials of antiplatelet therapy in ACS.[22],[23] Clopidogrel has lower rates of bleeding compared to prasugrel/ticagrelor and may be preferred in patients with thrombocytopenia. The injectable agent cangrelor may also be a useful alternative in this subset of patients given its short half-life. In addition to selection of an appropriate antiplatelet agent, other strategies may be employed to reduce the risk of bleeding. Radial approach may be preferred to femoral approach in these patients. In patients with a platelet count <50 × 109/L who have undergone PCI, the duration of DAPT may be reduced to 1 month. GP IIb/IIIa inhibitors should be avoided in cases of severe thrombocytopenia. In addition, a proton pump inhibitor must be used in all cases unless contraindicated.
| Atrial Fibrillation and Novel Oral Anticoagulants | | |
The CASTLE AF trial showed that catheter ablation for atrial fibrillation in patients with HF (EF <35%) was associated with a significantly lower rate of a composite end point of death from any cause or hospitalization for worsening HF than medical therapy over a median follow-up of 37.8 months.[37]
Whether digoxin use was independently associated with increased mortality in patients with atrial fibrillation was studied in the ARISTOTLE trial.[38] The risk of death was independently related to serum digoxin concentration. Patients with a serum digoxin level ≥1.2 ng/mL had a 56% increased hazard of mortality. Initiating digoxin was independently associated with higher mortality in patients with atrial fibrillation, regardless of HF.
A recent publication looks at registry data of the WATCHMAN and LARIAT LA appendage closure devices.[39] The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with the WATCHMAN device compared to the LARIAT device. In addition, the reported postmarketing complications with the WATCHMAN device have been shown to be higher than the premarketing data, raising a word of caution. This study also highlights the importance of postmarketing surveillance with newer technologies.
Among the novel oral anticoagulants (NOACs), a recent article reviews the various trials and meta-analyses which have been done to compare them.[40] It highlights variations in methodology of these various trials and therefore questions the robustness of meta-analyses stemming from these trials. What is clearly shown is that NOACs have a favorable benefit risk profile, similar trends in reduced risk of stroke and embolism and reduced intracranial hemorrhage, and a trend toward lower rates of major bleeding.
| Transcathter Aortic Valve Replacement | | |
The TOPAS study reported clinical outcomes in 287 patients with low-flow, low-gradient AS who underwent transcathter aortic valve replacement (TAVR). TAVR was associated with good periprocedural outcomes in these patients. However, approximately one-third recipients died at 2-year follow-up, with pulmonary disease, anemia, and residual paravalvular leaks being associated with poorer outcomes. Left ventricular EF (LVEF) improved following TAVR, but dobutamine stress echo failed to predict clinical outcomes or LVEF changes over time.[41]
| Sudden Cardiac Death | | |
The incidence of sudden cardiac death during participation in sports activities was evaluated during 18.5 million person-years of observation by the Rescu investigators in Canada.[42] The incidence of sudden cardiac arrest during competitive sports was 0.76 cases per 100,000 athlete years, with 43.8% of the athletes surviving until they were discharged from the hospital. Unlike previous studies, hypertrophic cardiomyopathy was uncommon as a cause of sudden cardiac death among competitive athletes in this study. Most deaths in competitive athletes were sure to primary arrhythmic causes. On the other hand, among noncompetitive athletes, the predominant cause of death was ischemic followed closely by structural heart disease. Routine preparticipation screening among competitive athletes needs to be reconsidered given the rarity of structural heart disease as a cause of sudden cardiac death in this population.
| Structural Heart Disease | | |
In DEFENSE PFO trial involving 120 patients with cryptogenic stroke and high-risk PFO characteristics (atrial septal aneurysm, hypermobility [phasic septal excursion into either atrium ≥10 mm], PFO size ≥2 mm), PFO closure resulted in a lower rate of the primary endpoint (composite of stroke, vascular death, TIMI major bleed) as well as stroke recurrence compared to medical therapy over a follow-up of 2 years.[43]
| Venous Thromboembolism | | |
Nearly 1000 patients with cancer who had acute symptomatic or incidental venous thromboembolism were randomized in an open label, noninferiority trial to receive either low molecular weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily or subcutaneous dalteparin at a dose of 200 IU/kg of body weight once daily for 1 month followed by dalteparin at the dose of 150 IU/kg once daily.[44] The results showed that oral edoxaban was noninferior to subcutaneous dalteparin for the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower, but the rate of major bleeding was higher with edoxaban than with dalteparin.
In a randomized trial, 3424 patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism.[45]
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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