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Blog: A closer look at PRATO-ACS and TERISA
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Martha Gulati
SAN FRANCISCO — Just like day 1, day 2 of the ACC Scientific Sessions offered attendees the opportunity to hear about the latest results from several highly anticipated and important studies during the late-breaking clinical trials sessions. In this post, Martha Gulati, MD, MS, FACC, FAHA, sheds light on these findings.
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Sunday, March 11, 8:00 a.m.
I have been waiting for the late-breaking session on the PRATO-ACS trial ever since I heard this study would be released at the ACC Scientific Sessions. The trial examined the effect of rosuvastatin on contrast-induced acute kidney injury after non-ST elevation MI (NSTEMI). This study supports the use of rosuvastatin on admission in statin-naïve patients with NSTEMI preceding angiographic procedures, given its apparent preventive effects against contrast injury. The timing of administration of statins appears to be important and should be given early in admission and before the angiographic procedure.
Dr. Anna Toso from Italy presented the results. Statin-naïve patients who had sustained a NSTEMI and were to undergo early intervention with imaging were assigned to either placebo (n=252) or rosuvastatin 40 mg (n=252) on admission to the acute coronary unit. The findings of this study showed a significant decrease in acute kidney injury (contrast-induced nephropathy) in the rosuvastatin group compared with placebo (6.7% vs.15.1%, P=0.001). These results persisted in those with higher risks for acute kidney injury, such as elevated estimated creatinine clearance, in those with a high-risk clinical profile and those who underwent PCI.
What we do not know is if it is just this specific statin or if the same will hold true with other statins. We will have to wait from PRACTO-ACS2 results to know this because those investigations will compare rosuvastatin with atorvastatin.
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11:57 a.m.
Today, the TERISA study results were released. They demonstrated a significant reduction in angina with the use of ranolazine in addition to background anti-anginal therapy in type 2 diabetic patients with chronic angina, when compared with placebo. This was an important study given the diffuse nature of coronary disease in diabetic patients and the high prevalence of angina.
A total of 927 patients were randomized to ranolazine (500 mg twice a day, titrated to 1,000 mg twice a day) or placebo. Weekly angina episodes decreased from 4.3 per week in the placebo group to 3.8 per week in the treatment group (P=.008) from week 2 to week 8 of treatment. Use of sublingual nitrates decreased from 2.1 times per week in the placebo group to 1.7 times per week in the ranolazine group (P=.003). In those with a HbA1c level >7%, there was a greater effect seen with ranolazine. There were very few adverse events in the treatment group compared with placebo.
Often diabetics will have diffuse coronary artery disease that is not amenable to interventional therapy and have persistent angina symptoms. The effectiveness of ranolazine in diabetic patients with chronic angina in this study makes this a therapeutic option for this difficult-to-treat population.