There are three categories of great trials. One: The trial that affirms a good practice or theory. Two: The trial that refutes a bad practice or theory. Three: The trial that serves as a stepping-stone to future trials. On Sunday and Monday of the American Heart Association (AHA) 2017 Scientific Sessions, we saw trials in every category. I'll do a brief review with a few thoughts on where I'd like to see the data go from here.
The Trial We Did: Sudden Death in Young People With Diabetes
Dr Jesper Svane presented data from a Danish trial revealing that children and young people with diabetes are six to seven times more likely to die suddenly than their peers who don't have diabetes. Autopsies for those aged 35 or younger were mostly inconclusive, leading one to assume that the deaths were related to either arrhythmia or hypoglycemia. Older cohorts (aged 36–49) most often died of complications of CAD. The trial was both intriguing and terrifying, especially for any parents who will have to absorb these data on a personal level.
The Trial We Should Do: Consider a trial using simultaneous loop implant and insulin-pump data in young children with diabetes. There has been a long-standing concern regarding hypoglycemia-invoked arrhythmia. In addition, we practitioners should take a careful history regarding dizziness, palpitation, and syncope in at-risk patients. We should have a low threshold for offering event monitors, Holters, and loop implants in this population as well. Young people with diabetes need a 12-lead ECG. Hopefully this information will bolster a movement toward ECG screening in that population.
The Trial We Did: BRUISE CONTROL-1 and -2
BRUISE CONTROL-2 showed that it doesn't help or hurt to stop anticoagulation for 2 days prior to device implant with regard to stroke or pocket hematoma rates vs continued anticoagulation. The BRUISE CONTROL trials did not include patients with recent CVA, TIA, or mechanical valves. (I always bridge those higher-risk patients despite having no data to support it.) The presenters did not provide any descriptions on pocket preparation or implant technique, but I'd assume most everyone on anticoagulation got some Bovie love. BRUISE-CONTROL-2 was an excellent trial that supports a nonbridging approach as safe for most patients.
The Trial We Should Do: With thousands of phone calls from dentists every year regarding the anticoagulation issue and dental extractions, root canals, and fillings, it would be great to lay this issue to rest for the world of dentistry. My usual patients do well without interruption or with short interruptions, but we need proof because the inflammatory milieu in patients with a toothache might be dramatically different from that of someone who electively comes in for a new pacer implant or generator change.
The Trial We Did: DACAB
DACAB compared a combination of ticagrelor (Brilinta, AstraZeneca) and aspirin vs ticagrelor alone or aspirin alone for preservation of saphenous vein graft patency 12 months post-CABG.
This trial was spurred by a 10% to 25% rate of saphenous vein graft failure at 1 year. Ticagrelor with aspirin beat either drug alone. Patency rates were 88.7% with dual therapy vs 82.8% for ticagrelor alone and 76.5% for aspirin alone (P=0.0006). Those impressive statistics were bolstered by low rates of major bleeding.
The Trial We Should Do: Aspirin and ticagrelor vs aspirin and lifestyle–walking 30 minutes per day and following the Mediterranean diet.
Downstream benefits of walking include better glycemia control, improved lipid levels, lower blood pressure, and a reduced risk of stroke and heart attack, not to mention cancer. Plus, walking is way cheaper than pharmaceuticals.
The Trial We Did: PRESERVE
The PRESERVE trial compared both N-acetylcysteine and sodium bicarbonate with saline for the prevention of contrast-induced nephropathy and found no benefit for N-acetylcysteine.
Just when I thought we had killed N-acetylcysteine (two or three times now), it appears, dangling body parts and all, in yet another meeting presentation. It doesn't work, never has, and never will. This sentiment takes nothing away from the investigators and the effort it took them to collect and analyze the data. I'm grateful for their diligent efforts and that the outcome of their trial matched other trials.
The Trial We Should Do: Internal-medicine specialists have long scoffed at the attributes of lactated ringers (LRs) while surgeons continue to laud them. Balanced crystalloids have made resurgence in trials looking at emergency-department and ICU outcomes in pediatric patients with sepsis or adults with pancreatitis,. While there are well-placed concerns about hyperkalemia, we can monitor potassium levels, and most patients don't have hyperkalemia at baseline. The anti-inflammatory benefits of LR have been cited in several studies, so it's time to give this a whirl in the realm of contrast-nephropathy prevention.
The Trial We Did: TRICS-3
TRICS-3 studied liberal or restricted transfusion of blood products for CABG patients.
A restrictive strategy called for transfusion if hemoglobin dropped to less than 7.5 g/dL during an open chest procedure that could include revascularization and/or valve surgery. The liberal strategy used a transfusion threshold of <9.5 g/dL during the procedure or in the intensive-care unit and <8.5 g/dL for the rest of the hospital stay after discharge from the ICU. Mortality rates were similar for the two groups and the cost savings are estimated at $3 million for the restrictive strategy. Somewhat counterintuitively, older patients (>75 years) did better with the restrictive strategy; the jury is still out on younger cohorts.
The Trial We Should Do: We should include quality-of-life measures in the first 3 months postop for all CABG patients, but I'd especially like to drill down on why my younger patients seem to experience more breathlessness than the elderly. We should look at the number of ER and office visits required for shortness of air, weakness, or fatigue. We should look at the types of blood products being transfused (ie, leukocyte reduced and/or irradiated packed cells). We should study outcomes based on the age of the blood products. In addition, I'd like to see if diastology in the elderly favorably affects their tolerance of lower blood volumes.
In addition, I’d like to see if diastology in the elderly favorably affects their tolerance and perhaps even a preference for lower blood volumes.
Trial and error paves the way to success. By that measure, this was a pretty successful 2 days at AHA 2017.
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Melissa Walton-Shirley. Trials We Did, Trials We Should Do - Medscape - Nov 15, 2017.