In the past year, there have been some major events in the field of cardiovascular disease. I hope more, and of course there are disappointments. Some are still controversial, and some have reached consensus.Let us review together.Stable coronary heart disease patients, really do not put the stent?The results of the ISCHEMIA trial were published in the COURAGE study published in 2007, which showed that in patients with stable coronary heart disease, there was no additional benefit from revascularization compared with the best medical treatment (OMT).In this regard, there is some controversy in the medical community.The ISCHEMIA study published during the 2019 AHA Annual Meeting confirmed this result again.Studies have shown that interventional therapy based on this does not benefit patients with stable ischemic heart disease (SIHD) with moderate to severe myocardial ischemia compared with the best medication alone.The ISCHEMIA trial compared the efficacy of OMT with invasive treatment strategies in patients with moderate to severe SIHD.A total of 5,179 subjects from 320 centers in 37 countries and regions were randomly divided into two groups: the OMT group (2591 patients) and the intervention group (2588 patients).Patients in the intervention group underwent coronary intervention (PCI or CABG) based on the best medication.The primary endpoint was the composite event endpoint of cardiovascular death, myocardial infarction, resuscitation from cardiac arrest, and hospitalization for unstable angina pectoris or heart failure.3-year follow-up showed no significant difference in the incidence of major endpoint events between the two groups (intervention group vs. OMT group = 13.3% vs. 15.5%; adjusted HR = 0.93; 95% CI: 0.80-1.08; p = 0.34).Cardiovascular death and myocardial infarction also showed similar trends in the major secondary endpoints, with no significant differences at 4 years.Comprehensively considering the results of clinical trials such as RITA-2, ORBITA, ISCHEMIA, etc., it is believed that for patients with stable ischemic heart disease, the best drug treatment according to the current guidelines should be used as the main treatment method, and the crown should be more strictly controlledIndications for stent therapy.DAPA-HF Trial: Dagelegrin, a new breakthrough in the treatment of heart failure. The DAPA-HF Trial is a large, global, multicenter, randomized, double-blind, parallel group controlled trial that included 4,744 LVEF ≤40%, NYHA II-IVPatients with heart failure (HFrEF) with symptomatic chronic ejection fraction; were randomly assigned to the daglicatem group (10 mg, qd) or the placebo group, and were given the standard recommended heart failure treatment.The primary endpoint was the time from randomization to the first occurrence of cardiovascular death, hospitalization for heart failure, or emergency visits due to heart failure, with a median follow-up of 18.2 months.The study found that the addition of the SGLT2 inhibitor daglitazone on the basis of the best drug treatment can significantly reduce the incidence of the primary endpoint in patients with HfrEF (HR = 0.74, 95% CI: 0.65-0.85, P = 0.00001, NNT = 21).In addition, the data analysis of three DAPA-HF trials was announced at the 2019 AHA Annual Meeting: First, the benefits of patients in the diabetic and non-diabetic groups were consistent, and the benefits were not related to the level of glycated hemoglobin (HbA1C).This means that patients with heart failure can be treated with daglitazone regardless of whether they have diabetes, and it is safer.The second is that daglitazone treatment can improve the quality of life of patients with heart failure.The treatment of heart failure patients mainly includes two aspects-improving prognosis (reducing hospitalization rate and mortality) and improving quality of life.The study found that Dagliflozin can improve the quality of life of patients while treating heart failure, and is also a very beneficial treatment for patients.The third is that daglicatem can bring benefits to patients of different ages.Although older patients have more comorbidities and use of more drugs, the study found that there is no difference between these patients and young patients.This means that daglitazone can be applied to heart failure patients of all ages and is safe and effective.The DAPA-HF trial is a milestone, and daglitazone is no longer just a medicine for diabetes, but a cross-border medicine for heart failure.This is just the beginning, and other SGLT2 inhibitors are conducting similar trials.TAVR indication expands and can be used in low-risk patients. On August 16, the FDA expanded the indication for transcatheter aortic valve replacement (TAVR). TAVR can be used in patients with severe aortic stenosis who are at low risk for surgery.That is, the risk of death is low or the risk of major complications related to surgery is low.So far, the indications for TAVR have covered the entire risk range, including patients who are not suitable for surgery, high-risk and intermediate-risk patients, and low-risk patients.Approved transcatheter valves include Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO.Evidence for expanded indications comes from two clinical trials of TAVR in low-risk patients published in March this year.The PARTNER 3 trial showed that TAVR using the SAPIEN 3 system significantly reduced the incidence of the primary endpoint (the composite endpoint of death, stroke, and rehospitalization at 1 year).The Evolut trial using a self-expanding valve (CoreValve / Evolut R / Evolut PRO) showed that the primary endpoint of TAVR treatment (the composite endpoint for any cause of death and disabling stroke at 24 months) was non-inferior to surgerySexually, the incidence of disabling stroke and hospitalization for heart failure was significantly reduced at 1 year.AUGUSTUS: Apixaban + P2Y12 inhibitors to achieve a win-win situation of efficacy and safety. For patients with AF and acute coronary syndrome (ACS) or receiving PCI, the antithrombotic therapy is challenging.there is controversy.AUGUSTUS trial results show that for patients with atrial fibrillation who recently had ACS or received PCI, the dual antithrombotic regimen of apixaban + P2Y12 inhibitor compared with the triple therapy of warfarin + dual antiplatelet therapy.Significantly reduced, no significant difference in the incidence of ischemic events.The primary safety endpoint showed a 31% reduction in risk for patients treated with apixaban compared with patients taking warfarin (10.5% vs 14.7%; HR, 0.69; 95% CI, 0.58 to 0.81; P <0.001 non-inferiority and superiority); compared with patients taking aspirin, the placebo group had a 47% reduction in risk (16.1% vs 9.0%; HR, 1.89; 95% CI, 1.59 to 2.24; P <0.001).This trial once again proved that the combination of a new oral anticoagulant (NOAC) + P2Y12 inhibitor can significantly reduce the risk of bleeding without increasing thrombotic events.TWILIGHT-ACS results announced, clinical benefits of antiplatelet monotherapy reaffirmed, new data from the TWILIGHT study published at the 2019 AHA Annual Meeting shows that in patients with acute coronary syndrome undergoing PCI, ticagrelor monotherapyCompared with dual antiplatelet therapy (DAPT), the risk of bleeding is reduced, while the risk of ischemic events is not increased.The TWILIGHT study is an international multicenter, prospective, randomized, double-blind, placebo-controlled trial designed to assess the safety and clinical benefit of ticagrelimab after short-term DAPT after PCI.The study included adult patients who received DES for PCI and who had at least one clinical risk factor and one angiographic feature risk factor. Patients received at least 3 months of ticagrelor (90 mg, each2 times a day) combined with aspirin (81-100 mg) and then randomized: one group continued to receive ticagrelor combined with low-dose aspirin dual antiplatelet therapy, and the other group received ticagrelor combined with placebo.The duration of treatment is 12 months.The primary endpoint was the clinically relevant bleeding event endpoint, which was BARC type 2, 3, or 5 clinically relevant bleeding.Secondary ischemic composite endpoints included all-cause death, non-fatal myocardial infarction, and non-fatal stroke.One year after randomization, the incidence of clinically relevant hemorrhage of BARC type 2, 3, or 5 in the ticagrelor monotherapy group and the DAPT group was 3.6% and 7.6%, respectively (HR = 0.47; 95% CI, 0.36-0.61, P <0.001).The TWILIGHT-ACS study reconfirmed the clinical benefit of ticagrelor monotherapy in patients with non-ST-segment elevation acute coronary syndromes.ISAR-REACT 5 study: Prasigrel vs. ticagrelor ISAR-REACT 5 trial results published at the 2019 ESC Annual Meeting show that for patients with ACS hospitalization and planned coronary angiography, both STEMI and NSTE-ACSCompared with ticagrelor, the primary end point of death, myocardial infarction, or stroke was significantly reduced in the prasugrel group at one year without major bleeding.The ISAR-REACT 5 trial is a multicenter, randomized, open-label trial that compares Prasugrel and Tigrelor for the first time.The trial recruited 4,018 patients with ACS to undergo an invasive evaluation at 23 centers in Germany and Italy to assess the effect of ticagrelor or prasugrel antiplatelet therapy on patient outcomes.The primary endpoint was the incidence of death, myocardial infarction, or stroke at 1 year.The primary endpoint was 9.3% in the ticagrelor group and 6.9% in the prasugrel group (HR = 1.36; 95% CI, 1.09-1.7; P = 0.006).Comparison of the components of the primary endpoint was similar.The trial results support the personalized prasugrel strategy as first-line antiplatelet therapy in patients with ACS.STOP-DAPT 2: What is the net clinical benefit of stopping aspirin 1 month after a new generation of drug stents?The duration of DAPT after coronary drug-eluting stents has been controversial.A shorter DAPT helps reduce bleeding events and may be an attractive option.So does shortening the DAPT course affect the ischemic event?What is the net clinical benefit?The STOPDAPT-2 trial is an open-label, prospective, multicenter, randomized, controlled trial initiated by a physician. It compares two successful CoCr-EES eluting stents (CoCr-EES) after implantation.Efficacy and safety of antithrombotic therapy: (1) 1 month of aspirin + P2Y12 inhibitor dual antibody treatment, followed by clopidogrel monotherapy to 12 months; (2) standard 12 month dual antibody treatment.The primary endpoint (net clinical benefit) was 2.4% in the experimental group, 3.7% in the standard protocol group, HR 0.64 (95% CI 0.42-0.98), non-inferiority P <0.001, and superiority P = 0.04.The results of the STOP DAPT2 study show that the application of the short-term DAPT protocol for only one month after the application of the latest generation of drug-coated stents is not inferior to or even better than the 12-month DAPT at the combined endpoint of bleeding and ischemia.In the ischemic and bleeding secondary endpoint events, the DAPT 1-month group also performed well.The application of short-term DAPT for 1 month does not increase the incidence of ischemia while reducing the occurrence of bleeding. The publication of the results will further affect clinical practice.The PARAGON-HF study has not reached the primary end point, but still cannot completely deny ARNI. Previous multiple studies have confirmed the therapeutic effect of sacurbactra / valsartan in patients with HFREF and acute decompensated heart failure, and its ejection fraction.How does it behave in patients with reserved heart failure (HFpEF)?At the 2019 ESC Annual Meeting, the results of the PARAGON-HF trial were officially announced, and sacurbactra / valsartan failed to reduce cardiovascular deaths and hospitalization rates for total heart failure in patients with HFpEF.In this regard, Professor Dong Yugang of the First Affiliated Hospital of Sun Yat-sen University said that even if ARNI obtained a negative result in HFpEF, it could not be completely denied.Because heart failure is a syndrome, and the etiology of this syndrome is different, especially the etiology of HFpEF is more widespread.Although patients present with heart failure in the clinic, it is difficult to use a method to improve their prognosis because of its diverse and diverse pathogenesis.As shown in the subgroup analysis, for some types of population (such as hypertension, coronary heart disease, or diabetes), shakubatrivalsartan may improve patient prognosis.The future need to explore whether ARNI has a role in a certain type of patients.RACE 7 ACWAS: Patients who have recently had atrial fibrillation do not need to rush to a recent episode of symptomatic atrial fibrillation. Sinus rhythm is usually restored immediately with medication or electrical cardioversion.However, is it necessary to restore sinus rhythm immediately?Because AF usually ends on its own.An alternative is to wait, which includes giving heart rate-controlling medications and delaying cardioversion only if necessary to avoid hospitalization and overtreatment.Dr. Harry Crijns of the Maastricht University Medical Center in the Netherlands presented the results of the RACE 7 ACWAS study at the 2019 EHRA Annual Meeting.This multicenter, randomized, developmental, non-inferiority trial evaluates the efficacy of delayed cardioversion and early cardioversion in patients with recent-onset AF.The results showed that delayed cardioversion was not inferior to early cardioversion.At 4 weeks, 91% of the patients in the delayed cardioversion group (193 patients) recovered sinus rhythm, and 94% of the patients in the early cardioversion group (201 patients) recovered sinus rhythm (difference between groups -2.9%, 95% CI? 8.2-2.2, non-inferiority P = 0.005).FDA approves Vascepa, a high-purity fish oil preparation, to reduce the risk of cardiovascular eventsVascular disease or diabetes to reduce the risk of cardiovascular events.. Vascepa capsule is a single-molecule prescription product composed of omega-3 fatty acids in the form of ethyl ester (commonly called EPA), which can reduce triglyceride levels and can be used as an adjuvant therapy after the maximum tolerated dose of statinThe approval was based mainly on the results of the REDUCE-IT study.REDUCE-IT research shows that high-dose EPA can bring significant benefits to people with cardiovascular disease or diabetes who have elevated triglyceride levels.In the intention-to-treat population, in addition to the effects of statins, omega-3 fatty acids can further reduce the relative risk of first occurrence of MACE by 25% (HR, 0.75; 95% CI: 0.68-0.83; p <0.001).The above content is only authorized by 39Health.com for exclusive use, please do not reprint without authorization of the copyright party.
Events in Cardiology 2019