Top 10 Study Results Relevant to Pharmacists from the 2016 ACC Scientific Session

MAY 19, 2016
This article was collaboratively written by Ayesha M. Khan, PharmD, BCPS, and Alexander Kantorovich, PharmD, BCPS. Dr. Kantorovich received his Doctor of Pharmacy degree from the University of Illinois at Chicago College of Pharmacy and completed a 2-year pharmacotherapy residency with an emphasis in cardiology and critical care at the Cleveland Clinic. He is currently an assistant professor at Chicago State University College of Pharmacy and maintains a practice site at Advocate Christ Medical Center in Oak Lawn, Illinois.

A number of trial results presented at ACC.16 could impact recommendations made by pharmacists working in inpatient and ambulatory care settings.
Here are the top 10 trial results relevant to pharmacists:

1. Rate Control Versus Rhythm Control for Atrial Fibrillation After Cardiac Surgery1
Atrial fibrillation (AF) is a common post-cardiac surgery manifestation that increases postsurgical complications, hospitalizations, and even mortality. Controversy exists concerning initial treatment of stable patients with AF post-cardiac surgery with either rate or rhythm control.
This prospective, randomized, multicenter, multinational study examined whether the use of heart rate-slowing agents (rate control) or amiodarone (rhythm control) reduced hospital days within 60 days of randomization. Other endpoints included mortality, adverse effects, and rates of permanent AF. A total of 523 patients were randomized between the 2 cohorts with no major differences between groups.

There were no significant differences between the rate and rhythm control groups in terms of median hospital days, mortality, non-serious adverse events, or serious adverse events. Nearly a quarter of patients in each cohort stopped therapy due to either ineffectiveness (rate control) or adverse effects (rhythm control).

Key Points for Pharmacists
  • There is no distinct benefit of either rate or rhythm control as initial treatment of stable patients with postoperative AF.
  • Patients treated with rhythm strategies converted to normal sinus rhythm quicker, but at the cost of higher rates of adverse drug events compared with rate control strategies.
  • In stable cardiac surgery patients with new-onset AF, rate control is likely an appropriate first-line treatment strategy, but patient-specific characteristics should be taken into account.
2. Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy2
Patients on dual antiplatelet therapy (DAPT) are at risk of gastrointestinal (GI) bleeding. The randomized, placebo-controlled, double-blind, double-dummy COGENT trial showed reductions in GI events in patients on DAPT who were given the proton pump inhibitor (PPI) omeprazole compared with placebo. However, patients in the COGENT trial received various aspirin doses, so it was unknown whether the benefit of PPIs is with low- or high-dose aspirin, or both.
This study evaluated patients in the original COGENT trial stratified by aspirin dose. Doses ≤100 mg were deemed low-dose and those >100 mg were considered high-dose. More than 3500 patients were evaluated, with differences between groups seen in age, gender, and percutaneous coronary intervention (PCI). The primary endpoint was a composite of upper GI clinical events, including overt upper GI bleeding.

There was a statistically significant reduction in upper GI clinical events in patients on omeprazole in both the low- and high-dose cohorts. There were no increases in major adverse cardiac events in patients on omeprazole compared with those who weren’t. 

Key Points for Pharmacists
  • In patients on low- or high-dose aspirin, omeprazole use reduced GI events, including overt GI bleeding.
  • This study didn’t evaluate adverse effects of omeprazole, which are known to be prevalent.
  • In patients on DAPT, regardless of aspirin dose, clinicians should consider agents to reduce the risk of GI events if patients have risk factors; however, routine use of these agents isn’t warranted based on the sole use of DAPT.

Ayesha Khan, PharmD, BCPS
Ayesha Khan, PharmD, BCPS
Ayesha M. Khan, PharmD, BCPS, is a clinical assistant professor of pharmacy practice at Chicago State University College of Pharmacy (CSU-COP) and maintains a practice site at Rush University Medical Center. She received her Doctor of Pharmacy from Midwestern University Chicago College of Pharmacy in 2012 and then completed a PGY-1 Pharmacy Practice Residency at The University of Toledo Medical Center in Toledo, Ohio.