Trial Tidbits: AHA 2019

The 2019 American Heart Association Scientific Sessions took place in Philadelphia, PA from November 16-18, 2019. Here’s a handy guide to some of the big trials you might have missed.

ISCHEMIA TRIAL

Participants

• 5,179 patients with stable heart disease and evidence of reduced cardiac blood flow.

Trial Design

• Half of participants received heart medications (such as statins).
• The other half received heart medications and underwent procedures to unclog arteries – either angioplasty or a bypass procedure.
• Patients were followed for 3.3 years.

Study Endpoints

• How many patients in each group had a heart attack, cardiac-related death, a hospitalization for chest pain or heart failure, or were resuscitated after a cardiac arrest.

Key Study Findings

• The invasive procedures were no better than medications at preventing cardiac outcomes such as myocardial infarction (MI).
• The procedures were better at relieving angina than medications.

The Bottom Line

• An early invasive procedure may not decrease the chance of MI or protect against death, but it can relieve angina.
• If patients have little or no chest pain, they can try medications first before having a procedure.
• Either way, patients and clinicians should have a conversation about the risks and benefits of each treatment option.

COLCOT TRIAL

Participants

• 4,745 patients who had an MI in the past 30 days.

Trial Design

• Half of patients took low-dose (0.5 mg/day) colchicine, an anti-inflammatory medication.
• Half of patients took a placebo.
• Patients were followed for a median of 22.6 months.

Study Endpoints

• How many patients in each group had cardiac death, another MI, a stroke, hospitalization for chest pain requiring procedure, or were resuscitated after cardiac arrest.

Key Study Findings

• Patients who took colchicine and received standard medical care had a lower risk of cardiac events vs. those who took a placebo pill.
• The reduced risk was mostly due to lower rates of stroke and angina.
• There was no major difference in rates of MI or cardiovascular death between the two groups.

The Bottom Line

• The results confirm that managing inflammation can reduce cardiac risk.
• The results only apply to patients who recently had an MI, so more research is needed in other high-risk patient groups.

ORION-10 TRIAL

Participants

• 1,561 patients with atherosclerotic cardiovascular disease taking cholesterol-lowering medication.

Trial Design

• Half of patients took 300 mg of a new agent called inclisiran.
• Half of patients took a placebo.
• Patients were followed for 18 months.

Study Endpoints

• Whether inclisiran lowered cholesterol levels, specifically low-density lipoprotein (LDL) cholesterol, compared to a placebo. (Both the inclisiran and the placebo doses were given as an injection on day 1 and day 30, and every 6 months after that for 18 months.)

Key Study Findings

• At the end of the study (day 510), LDL levels were 58% lower in the patients who received inclisiran vs. those who received a placebo.
• There were no serious side effects in either group.
• A small percentage of patients in both groups reported reactions or pain from the injections.

The Bottom Line

• Inclisiran is a promising new cholesterol-lowering agent, but more research is needed to determine if it’s safe to use long term and if it has effects on other heart-health measures like triglycerides.
• Inclisiran isn’t being pitched as a replacement for current cholesterol-lowering drugs (like statins). It’s intended to be used as add-on therapy for high-risk patients or for patients with genetic cholesterol disorders.

TREAT STROKE TO TARGET TRIAL

Participants

• 2,860 patients who had an atherothrombotic ischemic stroke in the past 3 months or a transient ischemic attack (TIA) in the past 15 days.  

Trial Design

• Half of patients had an LDL cholesterol target of <70 mg/dl.
• The other half had a target of <90-110 mg/dl.
• All patients were taking cholesterol-lowering medications.
• Patients were followed for 5.3 years.

Study Endpoints

• Whether lower cholesterol levels resulted in fewer heart-related events.
  • Events included nonfatal ischemic stroke or heart attack, new symptoms requiring intervention, or sudden cardiac death.

Key Study Findings

• There were fewer major heart-related events with an LDL target of <70 mg/dl than with a more moderate target of <90-110 mg/dl.
• The onset of diabetes and hemorrhagic stroke are both key concerns with aggressive LDL lowering. Fortunately, the lower LDL target didn’t increase the hemorrhagic stroke or diabetes risk in this study.

The Bottom Line

• Lowering cholesterol in patients who’ve had an ischemic stroke or TIA may reduce the risk of major heart-related events.
• The trial was stopped early due to a lack of funding, so the results should be interpreted with caution. More research is needed.