|REVIEW ARTICLE - CARDIOLOGY IN REVIEW
|Year : 2015 | Volume
| Issue : 3 | Page : 244-246
Cardiology in review: 2015
Sunil Kumar Verma
Department of Cardiology, CNC, AIIMS, New Delhi, India
|Date of Web Publication||23-Feb-2016|
Sunil Kumar Verma
Department of Cardiology, CNC, AIIMS, Suite No. 24, 7th Floor, Ansari Nagar, New Delhi - 110 029
Source of Support: None, Conflict of Interest: None
In 2015, the SPRINT Research Group showed the advantage of intensively controlling systemic blood pressure. Are the leads of pacemaker going to be their vestigial remnant? - A rapidly advancing technology is showing success with Micra and Nanostim. Similarly, ABSORB III showed favorable results for bioresorbable scaffolds for noncomplex coronary lesions. Once again, the trial of routine aspiration thrombectomy with percutaneous coronary intervention (PCI) versus PCI alone in patients with ST-elevation myocardial infarction (STEMI) trial failed to show the benefit of manual thrombus aspiration in acute STEMI. The Food and Drug Administration (FDA) Class 1 recalled rotawires because wire fracture affected rotablation. Proton pump inhibitors demonstrated reduction in the gastrointestinal bleeding in postmyocardial infarction patients on antithrombotics and concomitant nonsteroidal anti-inflammatory drugs use. The antidotes for newer oral anticoagulants are significant achievements of this year (REVERSE AD, ANNEXA-A, and ANNEXA-R). The FDA approval of proprotein convertase subtilisin-Kexin type 9 drugs for cholesterol lowering is a remarkable development. Selexipag is now approved for treatment of pulmonary hypertension. Different approaches of atrial fibrillation ablation were compared in substrate and trigger ablation for reduction of atrial fibrillation trail part II. High-sensitivity cardiac troponin I assays are a new hope for decision making in suspected acute coronary syndrome.
Keywords: 2015, annual, cardiology, review, summary
|How to cite this article:|
Verma SK. Cardiology in review: 2015. J Pract Cardiovasc Sci 2015;1:244-6
| Introduction|| |
2015 was remarkable with the introduction of a number of new drugs and a number of therapeutic advances. These are discussed in this review.
| Systemic Hypertension|| |
Targeting a systolic blood pressure to <120 mm Hg (intensive treatment arm), as compared with <140 mm Hg (standard treatment arm) in nondiabetic patients at high risk of cardiovascular events, was evaluated by the SPRINT Research Group.  The intensive treatment group had lower rates of fatal and nonfatal major cardiovascular event and death from any cause. It was surprising to see such dramatic results with just 3.26 years of follow-up, but this probably is the true reflection of the importance of intensively controlling the blood pressure. However, the benefit of intensively controlling blood pressure was diluted by a significant increase in serious adverse events (hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure).
| Cardiac Pacemakers|| |
Major contribution to the evolving technology in the field of cardiac pacemaker came from the two studies of LEADLESS transcatheter intracardiac pacemaker published this year. Two different trial groups showed their 6 months follow-up data. The sizes and design of both LEADLESS trial  (Nanostim, St. Jude Medical, St. Paul, Minnesota) and Micra device (Medtronic) study  were similar. The short-term feasibility and safety of these tiny intracardiac devices were demonstrated in both studies. Other than a long-term efficacy and safety, dual chamber and septal pacing technology, magnetic resonance imaging compatibility, cost including insurance- and cremation-related issues seem major hurdles. In future, these devices can definitively circumvent problems related to pacing in infants and children and pacemaker implantation in patients on anticoagulants and antiplatelets. Cardiac surgeons can also use this device per operatively in patients undergoing cardiac surgery with need for subsequent permanent pacemaker implantation.
| Coronary Artery Disease|| |
The hypothesis of bioresorbable scaffolds moved one more step forward with the results of a trial of ABSORB III.  Totally, 1322 patients with an everolimus-eluting bioresorbable vascular (ABSORB) scaffold were compared with 686 patients with an everolimus-eluting cobalt-chromium (Xience) stent in noncomplex obstructive coronary artery disease. ABSORB, as compared with Xience, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. Device thrombosis within 1 year occurred in 1.5% of patients in the ABSORB group and 0.7% of patients in the Xience group (P = 0.13). There was no significant difference between the ABSORB group and the Xience group in rates of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization.
A high-sensitivity cardiac troponin I assay was tested in 6304 consecutively enrolled patients suspected of presenting with suspected acute coronary syndrome.  A threshold value of <5 ng/L of this high-sensitivity cardiac troponin I assay can identify patients at low risk of cardiac events and are suitable for immediate discharge from the hospital.
A study from Denmark  involving more than 100,000 of patients of acute MI followed up over 14 years to evaluate the effect of proton pump inhibitors (PPIs) on gastrointestinal bleeding. Patients were taking antithrombotic and were treated with nonsteroidal anti-inflammatory drugs. Concurrent use of PPIs was independently associated with a decreased risk of gastrointestinal bleeding in post-MI patients taking antithrombotics and nonsteroidal anti-inflammatory drug (NSAID), regardless of antithrombotic regimen, type of NSAID, and type of PPI used.
In the mid-November this year, Food and Drug Administration (FDA) issued Class 1 human device recall RotaWire Elite and sireClip Torquer, GuideWire and GuideWire Manipulation Device, Floppy. , The devices are part of Rotablator rotational atherectomy system. The recall comes following three reports of rotawire fracture with device use. One fracture occurred during device preparation, and other two fractures occurred during procedure while the tip of device was spinning at rate of 190,000 rotations/min resulting in Burr migration into pericardium. One of these patients was not able to survive even after coronary stent graft placement and subsequent surgery.
| ST-elevation Myocardial Infarction|| |
Trial of routine aspiration thrombectomy with percutaneous coronary intervention (PCI) versus PCI alone in patients with ST-elevation MI (STEMI)  demonstrated no benefit rather than harm with manual thrombus aspiration. In 10,732 patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent MI, cardiogenic shock, or New York Heart Association Class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days.
| Newer Oral Anticoagulants|| |
With the increasing worldwide acceptability of newer oral anticoagulants, a remarkable advancement in this field was demonstrated by the successful clinical use of an antidote for dabigatran reversal. In REVERSE AD clinical trial,  two groups of patients (one, those who had serious bleeding [n = 51] and second, those who required an urgent procedure [n = 39]) were given 5 mg intravenous idarucizumab in patients on dabigatran. Dilute thrombin time or ecarin clotting time was the laboratory parameter assessed. The primary endpoint of maximum percentage of reversal of anticoagulant effect of dabigatran by idarucizumab was achieved in 88-98% of patients within minutes on the basis of above two laboratory results. The key secondary endpoint of restoration of hemostasis was achieved in about 92% of patients. One patient suffered a thrombotic event within 72 h after idarucizumab administration in whom anticoagulants had not been reinitiated. Idarucizumab was approved by FDA in October 2015.
ANNEXA-A and ANNEXA-R studies  evaluated the ability of andexanet alfa to reverse the anticoagulant activity of apixaban and rivaroxaban, respectively, in older healthy participants. Both these newer oral anticoagulants are direct factor Xa inhibitors. Andexanet alfa is a recombinant human factor Xa decoy protein. Andexanet neutralizes the anticoagulant effect of both direct and indirect factor Xa inhibitors. Anti-Xa activity, measurement of thrombin generation, and reduction in the levels of the anticoagulants are proposed parameters to assess effects of andexanet. In both these trials, andexanet proved successful reversal of anticoagulant activity of apixaban and rivaroxaban within minutes after bolus intravenous administration and for the duration of infusion. No clinical, toxic effect was evident which was presumed to be related to the transient increase in the level of D-dimer and prothrombin fragments 1 and 2.
| Lipidology|| |
Alirocumab  and evolocumab  on the basis of their ability to lower low-density lipoprotein (LDL) cholesterol levels were tested in clinical trials. Both are fully humanized monoclonal antibodies that inactivate proprotein convertase subtilisin-Kexin type 9 resulting in lowering of blood cholesterol levels. Over 78 weeks, alirocumab when added to statin therapy at the maximum tolerated dose caused 39-62% reduction in LDL cholesterol levels, as compared with placebo. During approximately 1 year of follow-up, evolocumab along with standard therapy reduced the level of LDL cholesterol by 61% as compared to standard therapy alone. However, both these trials for their respective molecules were unable to generate sufficient data at the present point of time to provide cardiovascular event reduction. Both these drugs got the FDA approval.
| Cardiomyopathy|| |
EPOCH-H study  provided a demographic, clinical, and genetic profile of Indian hypertrophic cardiomyopathy (HCM) patients. It is more prevalent in males and 18% of cases were familial. Clinically nonobstructive form of HCM is predominant, and familial cases have an early onset of disease with worst prognosis as compared to sporadic cases. More advanced genetic techniques need to be used to identify causal candidate genes as hotspot sequencing of MYH7 only explains 6% of the genetic basis of HCM.
| Atrial Fibrillation|| |
Substrate and trigger ablation for reduction of atrial fibrillation trial part II investigators  demonstrated that over 18 months follow-up, there is no additional success of catheter ablation for persistent AF when pulmonary vein isolation was compared with two contemporary techniques (pulmonary vein isolation plus ablation of additional electrograms showing fractionated electrical activity and pulmonary vein isolation plus additional linear ablations across left atrial roof and mitral valve isthmus).
| Pulmonary Arterial Hypertension|| |
Selexipag got the USA FDA approval in December this year.  Selexipag is a prostaglandin IP-receptor (IP-receptor) agonist. It is highly selective for IP -receptor. It is used in 200-800 μg twice daily. The phase III of GRIPHON trial  The GRIPHON trial evaluated the long-term effect of selexipag on morbidity and mortality (M/M) in patients with pulmonary arterial hypertension. Totally, 1156 patients were randomized to placebo or selexipag, and the intervention reduced the risk of M/M events by 40%.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
SPRINT Research Group, Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, et al.
A randomized trial of intensive versus standard blood-pressure control. N Engl J Med 2015;373:2103-16.
Reddy VY, Exner DV, Cantillon DJ, Doshi R, Bunch TJ, Tomassoni GF, et al.
Percutaneous implantation of an entirely intracardiac leadless pacemaker. N Engl J Med 2015;373:1125-35.
Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, et al
. A leadless intracardiac transcatheter pacing system. N Engl J Med 2015. [Epub ahead of print].
Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, et al.
Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med 2015;373:1905-15.
Shah AS, Anand A, Sandoval Y, Lee KK, Smith SW, Adamson PD, et al.
High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: A cohort study. Lancet 2015;386:2481-8.
Schjerning Olsen AM, Lindhardsen J, Gislason GH, McGettigan P, Hlatky MA, Fosbøl E, et al.
Impact of proton pump inhibitor treatment on gastrointestinal bleeding associated with non-steroidal anti-inflammatory drug use among post-myocardial infarction patients taking antithrombotics: Nationwide study. BMJ 2015;351:h5096.
Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, et al
. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015;372:1389-98.
Pollack CV Jr., Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, et al.
Idarucizumab for dabigatran reversal. N Engl J Med 2015;373:511-20.
Siegal DM, Curnutte JT, Connolly SJ, Lu G, Conley PB, Wiens BL, et al.
Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med 2015;373:2413-24.
Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, et al.
Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015;372:1489-99.
Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, et al.
Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med 2015;372:1500-9.
Biswas A, Das S, Kapoor M, Seth S, Balram Bhargava, Rao VR. Epidemiology of cardiomyopathy - A clinical and genetic study of hypertrophic cardiomyopathy: The EPOCH-H study. J Pract Cardiovasc Sci 2015;1:143-9.
Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, et al.
Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med 2015;372:1812-22.
FDA News Release. FDA Approves New Orphan Drug to Treat Pulmonary Arterial Hypertension. 22 December, 2015. FDA Website. [Last accessed on 2016 Jan 31].
McLaughlin, Channick R, Chin K, Frey A, Gaine S, et al
. Effect of selexipag on morbidity/mortality in pulmonary arterial hypertension: Results of the griphon study. J Am Coll Cardiol 2015;65:61538-8.