Intravenous nicorandil did not improve 12-month outcomes after primary PCI for STEMI

Design

Multicentre, randomised, double-blind, placebo-controlled, 49 hospitals in China

Population

1,503 adults aged 18 to 80 with STEMI within 12 hours, undergoing primary PCI

Primary outcome

Cardiovascular death, non-fatal MI, target-vessel revascularisation or unplanned heart failure admission at 12 months

Effect

13.1% vs 13.1%; rate ratio 0.869 (95% CI 0.650 to 1.162; P = 0.34)

CLEAN randomised 1,503 adults aged 18 to 80 with STEMI within 12 hours of symptom onset, at 49 hospitals in China, to intravenous nicorandil (a 6 mg bolus before reperfusion, then 6 mg per hour for 48 hours) or placebo. Oral nicorandil was not allowed during follow-up.

The primary composite was cardiovascular death, non-fatal myocardial infarction, target-vessel revascularisation or unplanned heart failure admission within 12 months. It occurred in 98 patients (13.1%) given nicorandil and 99 (13.1%) given placebo (rate ratio 0.869, 95% CI 0.650 to 1.162; P = 0.34). Adverse events were similar.

Among secondary outcomes, cardiovascular death (1.9% vs 3.6%) and target-vessel revascularisation (1.1% vs 3.0%) were lower with nicorandil. These were nominal findings in a trial whose primary outcome was neutral, so they generate a hypothesis and do not justify use. The authors concluded the results do not support routine intravenous nicorandil in unselected STEMI.

• Do not add intravenous nicorandil to primary PCI as routine on the strength of this trial.
• The 12-month composite was identical at 13.1% in both arms.
• Treat the lower cardiovascular death and revascularisation rates as hypothesis-generating only.
• Adverse events did not differ, so the result is neutral rather than harmful.

Why it matters

It adds a large double-blind trial to a question where earlier randomised evidence on long-term outcomes was inconclusive.

Don't overread it

The lower cardiovascular death rate was a nominal secondary finding and cannot be taken as a benefit.

The statistics, in plain English

A confidence interval of 0.650 to 1.162 spans 1, so the data are compatible with a benefit, no effect or a small harm. Secondary outcomes were not the basis for the trial's sample size, and with several secondary comparisons one or two can reach nominal significance by chance.

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