As the end of the year approaches, experts in various disciplines are beginning to take stock of this year’s clinical research. Let’s review with American clinical electrophysiologist John Mandrola what significant discoveries and advances have been made in the field of cardiology research.
1, the application of PCSK9 inhibitors
This year, the FDA approved the listing of injectable monoclonal antibodies evolocumab and alirocumab on the basis that both drugs can substantially reduce LDL-C, but there is no evidence that the effect translates into heart disease, stroke- or death-related benefits, and their long-term safety is unknown, as the longest clinical trial follow-up time is less than 2 years; Mandrola says he is not implying that such drugs are unsafe, only that their safety is unclear.
Because there are no prognostic trial data, researchers do not know the cost-effectiveness of these drugs, so their use may be a “game changer. If the FOURIER trial turns out to be negative, our previous investment will be wasted. Tip: Patients with familial hypercholesterolemia who are not well treated with statins may try these drugs.
2. The SPRINT study, which still requires trade-offs
Although blood pressure control is important, there is no ideal target value for lowering blood pressure. the SPRINT study compared the effects of 120 mmHg versus 140 mmHg in elderly high-risk patients. The results found a significant increase in cardiac events in the standard blood pressure lowering group, so the trial was terminated early. Of course there was a price to pay for the intensive BP lowering: more medications and more vertigo, acute kidney injury and electrolyte imbalance in this group. Although the SPRINT study was a positive trial, the practical application of the results will be limited, and the burden of medication may be a major problem, as a hypothetical study found that many patients would prefer to “die early” rather than take a lot of medication every day.
3, the return of coffee and fat
The impact of food on human health is the most basic, the 1970s trial data recommend that people consume no more than 30% fat and no more than 10% saturated fat, which once influenced the latest U.S. guidelines recommendations. In this 570-page report, many recommendations remain unchanged, such as more intake of fruits, vegetables, whole grains, nuts, and fatty fish, and less intake of sugars and trans fats, but the change is to allow for proper caffeine intake, while no longer restricting cholesterol diets. in 2015, many scholars found that refined sugar promotes certain diseases, so the government also began taking steps to limit its use.
4. The resurgence of atrial fibrillation treatment
First, the STAR-AF 2 trial found that additional ablation did not improve the prognosis of patients with atrial fibrillation compared to pulmonary vein isolation, second, the LEGACY trial and the CARDIO-FIT trial showed that weight loss and fitness were effective in improving arrhythmias, and finally, the ARREST-AF substrate study found that risk factor management could affect prognosis by improving the electrophysiological and structural characteristics of human atria. structural features to influence prognosis. Therefore, an important change in 2015 is that the academic community is beginning to focus on risk factor management, which is difficult to do, but extremely important for patients with AF.
5. SGLT-2 inhibitors are making their mark
Silvio Inzucchi from Yale University presented the results of the EMPA-REG prognosis trial at this year’s European Diabetes Annual Meeting, where they found a reduced risk of death in patients with type 2 diabetes combined with cardiovascular disease treated with engramine (SGLT-2 inhibitor). Many scholars have called this a landmark trial because it was the first diabetes drug to reduce mortality. However, the mechanism by which this class of drugs reduces the risk of death is unclear, and the FDA has indicated that this class of drugs may increase the risk of ketoacidosis and fractures.
6, the birth of NOAC reversal agent
Currently more than 70,000 patients have been selected for NOAC and warfarin controlled trials, and the results of the studies have shown that NOAC can reduce patient deaths, but the risk of bleeding from such drugs has been a concern for doctors. In October, the FDA approved the marketing of idarucizumab, a dabigatran reversal agent; a study published in the New England Journal of Medicine also found that andexanet alfa can safely reverse the anticoagulant effect of apixaban and rivaroxaban in elderly volunteers, so its approval is also imminent.
7. Wireless pacemakers
The only weakness of cardiac pacing devices is the wire problem, and this year a wireless revolution in the field of cardiac pacing has erupted, with the NanoStim LP wireless pacemaker and the Micra TPS device both showing good therapeutic efficacy and both having passed the European CE mark and, of course, possible FDA approval. Some scholars argue that this evidence is not important because of the small percentage of single-chamber ventricular pacemakers, but this is, after all, one of the main reasons for the failure of cardiac pacing therapy. Some pacemakers can be implanted through the femoral sheath, which means that cardiologists can all complete the operation, perhaps making the application of single-chamber ventricular pacemakers increase; secondly, wireless pacemakers may be used in conjunction with subcutaneous ICD transmitters as wireless ICDs in the next 5 years.
8. International breakthroughs in the field of cerebrovascular disease
Five clinical trials found significant benefits in acute stroke patients treated with endovascular therapy (or combined with tPA), with fewer than 10 patients requiring prevention of major long-term disability risks. Similar studies have not found a benefit in the past, and the differences in the new study are faster treatment, application of a new retrievable stent, and subjects with large vessel obstruction. similar experience has been gained with the Watchman study, and the MR CLEAN trial included 500 patients out of 16,800,000, Werner Hacke (University Hospital Heidelberg) said in an editorial. The device was only reimbursed in clinical trials. Although the initiative is difficult to implement in other national health systems, the benefits of the treatment may far outweigh the investment.
9. Say “no” to anticoagulation bridging
The rationale behind perioperative bridging for anticoagulated patients is that a reduction in thrombotic events can offset the high risk of bleeding. However, the authors do not share this view, and the data show that the risk of discontinuing anticoagulants before and after surgery is negligible, and many nonrandomized observational trials have not found a benefit from bridging therapy. Two studies this year (an observational study and a randomized clinical trial [BRIDGE]) found that bridging therapy increased the risk of bleeding and did not reduce thrombotic events. In the observational trial, bridging therapy increased patients’ risk of bleeding by 17-fold; the BRIDGE trial excluded patients with high-risk mechanical valves and patients with prior stroke, so it is not clear whether such patients need bridging therapy, but most still do not need bridging anticoagulation.
10. ABIM cognitive maintenance
Many scholars have summarized this year’s cardiology research progress during the American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) process, and many comments have been received. However, an analysis published this year in Circulation showed that concomitant certification was not a good predictor of prognosis for PCI. Late in the year, ABIM began allowing specialists to recertify in their specialty and relaxed the MOC requirements, claiming it would reform the assessment within 10 years.