AMSTERDAM, The Netherlands —In patients with ST-segment myocardial infarction (STEMI) receiving percutaneous coronary intervention (PCI), early administration of intracoronary adenosine is associated with improved functional recovery and improvements in infarct mass in patients with ischemic times below 200 minutes, researchers reported in a featured research presentation on September 2, 2013, at the European Society of Cardiology Congress.

For the multicenter PROMISE trial, investigators led by David Garcia-Dorado, MD, of Hospital Universitari Vall d'Hebron (Barcelona, Spain), enrolled 201 STEMI patients with TIMI flow grade 0/1 who were undergoing PCI. Patients were randomized to receive 4 mg adenosine or saline given over 2 minutes distal to the lesion. Stenting and thrombus aspiration were performed as needed. Median ischemic time was 200 minutes

No Differences Seen in Overall Population

Adenosine treatment was not associated with serious adverse events, and there were no differences between the placebo and adenosine groups in 6-month mortality or MACE rates.

Magnetic resonance imaging was performed at 2-7 days and at 6 months after reperfusion.

Compared with placebo, infarct mass was not significantly smaller with adenosine (20.8% vs. 22.5%; P = 0.40), nor was relative microvascular obstruction mass (2.75% vs. 2.90%; P = 0.85). LVEF increased significantly in the adenosine group (3.32%; P = 0.006) but not in the placebo group (1.49%; P = 0.25). 

In the prespecified subanalysis of patients with ischemic time less than 200 minutes, however, infarct mass was significantly lower in the adenosine group (19.4% vs. 25.7%; P = 0.43). Adenosine administration also was associated with a trend towards smaller relative microvascular obstruction mass (1.91% vs. 2.94%; P = 0.29) and improved LVEF recovery (3.6% vs. 0.43%).

In patients with proximal left anterior descending artery involvement, 6-month differences were more pronounced with adenosine for both microvascular obstruction mass (1.80% vs. 5.53%; P = 0.059) and increase of LVEF (6.8%; P = 0.01 vs. 0.46%; P = 0.897).

Symptom Onset Time Matters

Dr. Garcia-Dorado concluded that PROMISE does not support routine use of adenosine in STEMI patients receiving primary PCI.

“However, our results,” he added, “indicate that this safe and inexpensive treatment may limit infarct size in patients receiving PCI early after symptom onset and may improve recovery of LVEF during the months following STEMI. Considered together with previous studies, the PROMISE results support the use of intracoronary adenosine in patients receiving PCI within 3 hours of symptom onset.”

Session co-moderator Philippe Gabriel Steg, MD, of Hôpital Bichat-Claude Bernard (Paris, France), noted that the P value of the prespecified subset is less important than that of the interaction between ischemic time and the primary outcome.

Dr. Garcia-Dorado agreed, noting that there was a significant interaction.

Study Details

Patients had a mean age of 59 years, and 13.7% were women. There were no differences in prevalence of risk factors, comorbidities, or treatment, or in the proportion of anterior infarction (48%) between groups.

 

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Source:
Garcia-Dorado D. Primary results of the PROMISE trial: Myocardial protection with intracoronary adenosine given before reperfusion in patients with STEMI. Presented at: European Society of Cardiology Congress; September 2, 2013; Amsterdam, The Netherlands.

 

 

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