Year : 2020 | Volume
: 6 | Issue : 1 | Page : 12--15
Cardiology update 2020 first quarter
Department of Cardiology, AIIMS, New Delhi, India
Department of Cardiology, Cardio Neuro Center, AIIMS, Room No. 32, 7thFloor, New Delhi
This review covers the end of 2019 and the beginning of 2020 and includes treatment of asymptomatic aortic stenosis, role of antisense oligonucleotides, rivaroxaban in transcatheter aortic valve implantation (TAVI), complete revascularization after myocardial infarction (MI) proving superior, study of colchicine in MI, and update of NOBLE trial showing that percutaneous coronary intervention in left main interventions is inferior to coronary artery bypass graft. There were also a number of trials highlighting various aspects of the outcomes of TAVI implants.
|How to cite this article:|
Yadav S. Cardiology update 2020 first quarter.J Pract Cardiovasc Sci 2020;6:12-15
|How to cite this URL:|
Yadav S. Cardiology update 2020 first quarter. J Pract Cardiovasc Sci [serial online] 2020 [cited 2021 Oct 25 ];6:12-15
Available from: https://www.j-pcs.org/text.asp?2020/6/1/12/282801
Lipoprotein(A) Reduction in Persons With Cardiovascular Disease(Akcea-Apo(A)-Lrx Study)
Lipoprotein(a) levels are genetically determined and, when elevated, are a risk factor for cardiovascular disease and aortic stenosis. There are no approved pharmacologic therapies to lower lipoprotein(a) levels.
A total of 286 patients with established cardiovascular disease and screening lipoprotein(a) levels of at least 60 mg/dL (150 nmol/l) were studied. Patients received the hepatocyte-directed antisense oligonucleotide AKCEA-APO(a)-LRx, referred to here as APO(a)-LRx (20, 40, or 60 mg every 4 weeks; 20 mg every 2 weeks; or 20 mg every week), or saline placebo subcutaneously for 6–12 months.
APO(a)-LRx reduced lipoprotein(a) levels in a dose-dependent manner in patients who had elevated lipoprotein(a) levels and established cardiovascular disease.
Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis (Recovery Study)
This trial compared early surgery with conservative care in asymptomatic patients with very severe aortic stenosis. The trial showed a lower incidence of the primary end point of operative mortality or death from cardiovascular causes during the follow-up period among patients who underwent early surgery than among those who received conservative care. Moreover, early surgery was associated with a lower incidence of death from any cause among such patients.
A Controlled Trial of Rivaroxaban After Transcatheter Aortic-Valve Replacement (Galileo Study)
It was a randomized, controlled trial to evaluate the efficacy and safety of rivaroxaban-based antithrombotic therapy as compared with antiplatelet-based therapy after successful transcatheter aortic valve replacement in patients without an established indication for anticoagulation. A dose of rivaroxaban of 10 mg daily (lower than the approved dose for stroke prevention in patients with atrial fibrillation) was selected to provide a level of anticoagulation to prevent valve surface thromboembolism while mitigating bleeding complications.
It was observed that the rivaroxaban group had higher rates of death or thromboembolic complications and higher rates of bleeding complications in the intention-to-treat analysis (rates that were attenuated in the on-treatment analysis).
Reduced Leaflet Motion After Transcatheter Aortic-Valve Replacement (Galileo-Four-Dimensional Study)
This substudy of the main GALILEO trial used four-dimensional computed tomography (CT) imaging at 90 days after randomization to evaluate a subgroup of the bioprosthetic aortic valves that were implanted during the trial. The main findings were as follows: the overall percentages of patients with significantly reduced leaflet motion (Grade 3 or higher) and leaflet thickening were 6.6% and 22.6%, respectively; both findings were less frequent with the rivaroxaban-based strategy than with the antiplatelet-based strategy, and echocardiography was not useful in identifying patients with these valvular abnormalities.
In conclusion, in patients without an established indication for long-term anticoagulation after successful transcatheter aortic-valve replacement (TAVR), a treatment strategy that included anticoagulation with rivaroxaban at a dose of 10 mg once daily was more effective than an antiplatelet-based strategy in preventing subclinical reduced leaflet motion at 90 days. However, we cannot recommend routine imaging for the detection of reduced leaflet motion or the routine use of anticoagulation after TAVR with the aim of preventing leaflet-motion abnormalities, given the unfavorable clinical outcomes with rivaroxaban in the main GALILEO trial.
Efficacy and Safety of Low-Dose Colchicine After Myocardial Infarction (Colcot Study)
Inflammation appears to play an important role in atherosclerosis. Inhibition of interleukin-1β by the injectable monoclonal antibody canakinumab not only led to a 15% lower risk of cardiovascular events than was observed with placebo in the Canakinumab Anti-inflammatory Thrombosis Outcomes Study, but also led to a slightly higher incidence of fatal infections. In contrast, methotrexate did not affect cardiovascular outcomes or plasma markers of inflammation in the Cardiovascular Inflammation Reduction Trial.
In this study, the risk of the primary composite efficacy end point of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction (MI), stroke, or urgent hospitalization for angina leading to coronary revascularization, as assessed in a time-to-event analysis, was significantly lower among the patients who were randomly assigned to receive 0.5 mg of colchicine once daily than among those who received placebo. This result was due predominantly to a lower incidence of strokes and urgent hospitalizations for angina, leading to coronary revascularization.
Percutaneous Coronary Angioplasty Versus Coronary Artery Bypass Grafting in the Treatment of Unprotected Left Main Stenosis: Updated 5-Year Outcomes of Noble Trial
This was an investigator-initiated, randomized, multicentric trial comparing percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) for revascularization of patients with left main coronary artery disease (CAD) using contemporary treatment techniques. The trial has reached the predefined number of endpoints for adequate power. The results show that PCI is associated with inferior clinical outcomes compared with CABG after 5 years. Of note, mortality was similar after the two procedures, but patients treated with PCI had higher rates of nonprocedural MI and repeat revascularization. Stroke rates were not found to be different for PCI and CABG. They found no interaction for any of the tested subgroups. Of concern, the subgroup of patients with a SYNTAX score of <23 did not benefit from PCI in terms of the composite endpoint of major adverse cardiac or cerebrovascular events. In comparison with the 5-year PCI results of the EXCEL trial, mortality in the NOBLE trial was numerically lower, whereas rates of nonprocedural MI and repeat revascularization were similar. These findings indicate that the quality of PCI in NOBLE was at least similar to that of EXCEL, and the difference in primary outcome is likely to relate to the definitions of endpoints.
Complete Versus Lesion-Only Revascularization in St-Segment Elevation Myocardial Infarction and Multivessel Disease (The Cvlprit Trial Long-Term Follow-Up)
Complete Versus Lesion-Only PRImary PCI trial was a randomized trial of complete inpatient revascularization versus infarct-related artery revascularization only at the index admission.
Long-term follow-up of this trial shows that the significantly lower rate of major adverse cardiovascular events (MACE) in the complete revascularization group, previously seen at 12 months, is sustained to a median of 5.6 years. A significant difference in composite all-cause death/MI favoring the complete revascularization was also observed.
A Community-Based Intervention for Managing Hypertension in Rural South Asia (Cobra-Bps Study)
The burden of hypertension is escalating, and control rates are poor in low- and middle-income countries. Cardiovascular mortality is high in rural areas.
In rural communities in Bangladesh, Pakistan, and Sri Lanka, a multicomponent intervention that was centered on proactive home visits by trained government community health workers who were linked with the existing public health-care infrastructure led to a greater reduction in blood pressure than usual care among adults with hypertension.
Polymer-Based or Polymer-Free Stents in Patients at High Bleeding Risk (Onyx One Study)
Polymer-free, drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo PCI and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based, drug-eluting stents, as compared with polymer-free, drug-coated stents, in such patients are limited.
Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, the use of polymer-based zotarolimus-eluting stents was noninferior to the use of polymer-free, drug-coated stents with regard to the safety and effectiveness composite outcomes.
Safety and Efficacy of Femoral Access Versus Radial Access in St-Segment Elevation Myocardial Infarction (The Safari-St-Segment Elevation Myocardial Infarction Randomized Clinical Trial)
Among patients with ST-segment elevation MI (STEMI) referred for primary PCI, a survival benefit associated with radial access compared with femoral access remains controversial.
This multicentric, open-label, randomized clinical trial was conducted at five PCI centers in Canada. In total, 2292 patients with STEMI referred for primary PCI were enrolled.
No significant differences were found for survival or other clinical endpoints at 30 days after the use of radial access versus femoral access in patients with STEMI referred for primary PCI. However, small absolute differences in endpoints cannot be definitively refuted given the premature termination of the trial.
Age-Related Differences in the Noninvasive Evaluation for Possible Coronary Artery Disease Promise Trial
Insights from the study and make prospective multicenter imaging study for evaluation of chest pain trial
The noninvasive evaluation of stable symptoms in patients without a history of CAD seeks to confirm the diagnosis and provides prognostic information about future risk. In this study of the PROspective Multicenter Imaging Study for Evaluation of chest pain trial, age was associated with an increased prevalence of CAD, as evidenced by a higher proportion of positive functional test results, obstructive disease on coronary computed tomography angiography (CTA), and higher Coronary Artery Calcium (CAC) score, with no interaction between the test type and diagnostic yield. However, they found a significant interaction between age group and noninvasive test type for the prediction of future cardiovascular death or MI events.
Specifically, coronary CTA and CAC score better stratified prognosis for patients younger than 65 years, while functional testing was a better determinant of future risk for older adults (≥65 years).
Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement (Partner 2 Study)
There are scant data on long-term clinical outcomes and bioprosthetic valve function after TAVR as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.
Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement.
Balloon-Expandable Versus Self-Expanding Transcatheter Aortic-Valve Replacement: a Propensity-Matched Comparison from the France-Transcatheter Aortic Valve Implantation Registry
No randomized study powered to compare balloon-expandable (BE) with self-expanding (SE) transcatheter heart valves (THVs) on individual endpoints after TAVR has been conducted to date.
In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% confidence interval (CI), 1.46–1.91]; P < 0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% vs. 8.3%; relative risk, 1.90 [95% CI, 1.63–2.22]; P < 0.0001) and in-hospital mortality (5.6% vs. 4.2%; relative risk, 1.34 [95% CI, 1.07–1.66]; P = 0.01).
The present study suggests that the use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with the use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
|1||Tsimikas S, Karwatowska-Prokopczuk E, Gouni-Berthold I, Tardif JC, Baum SJ, Steinhagen-Thiessen E, et al. Lipoprotein(a) reduction in persons with cardiovascular disease. N Engl J Med 2020;382:244-55.|
|2||Kang DH, Park SJ, Lee SA, Lee S, Kim DH, Kim HK, et al. Early surgery or conservative care for asymptomatic aortic stenosis. N Engl J Med 2020;382:111-9.|
|3||Dangas GD, Tijssen JG, Wöhrle J, Søndergaard L, Gilard M, Möllmann H, et al. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med 2020;382:120-9.|
|4||De Backer O, Dangas GD, Jilaihawi H, Leipsic JA, Terkelsen CJ, Makkar R, et al. Reduced leaflet motion after transcatheter aortic-valve replacement. N Engl J Med 2020;382:130-9.|
|5||Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med 2019;381:2497-505.|
|6||Holm NR, Mäkikallio T, Lindsay MM, Spence MS, Erglis A, Menown IB, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: Updated 5-year outcomes from the randomised, non-inferiority NOBLE trial. Lancet 2020;395:191-9.|
|7||Gershlick AH, Banning AS, Parker E, Wang D, Budgeon CA, Kelly DJ, et al. Long-term follow-up of complete versus lesion-only revascularization in STEMI and multivessel disease: The CvLPRIT trial. J Am Coll Cardiol 2019;74:3083-94.|
|8||Jafar TH, Gandhi M, de Silva HA, Jehan I, Naheed A, Finkelstein EA, et al. A community-based intervention for managing hypertension in rural South Asia. N Engl J Med 2020;382:717-26.|
|9||Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, et al. Polymer-based or polymer-free stents in patients at high bleeding risk. N Engl J Med 2020;382;1208-18.|
|10||Le May M, Wells G, So D, Chong AY, Dick A, Froeschl M, et al. Safety and efficacy of femoral access vs. radial access in ST-segment elevation myocardial infarction: The SAFARI-STEMI randomized clinical trial. JAMA Cardiol 2020;5:126-34.|
|11||Lowenstern A, Alexander KP, Hill CL, Alhanti B, Pellikka PA, Nanna MG, et al. Age-related differences in the noninvasive evaluation for possible coronary artery disease: Insights from the prospective multicenter imaging study for evaluation of chest pain (PROMISE) Trial. JAMA Cardiol 2010;5:193-201. [doi: 10.1001/jamacardio. 2019.4973].|
|12||Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med 2020;382:799-809.|
|13||Van Belle E, Vincent F, Labreuche J, Auffret V, Debry N, Lefèvre T, et al. Balloon-expandable versus self-expanding transcatheter aortic valve replacement: A propensity-matched comparison from the FRANCE-TAVI registry. Circulation 2020;141:243-59.|