Twenty-four RCTs were included in the meta-analysis (n= 6,803 patients). The methods of randomisation were described as appropriate in 14 trials that used computer-generated randomisation sequence. Sample-size calculation was reported in 15 trials. All the trials performed intention-to-treat analysis and reported the number of patients lost to follow-up. Crossover occurred in 21 trials, with rates ranging from 2.5 to 29.7%.
There was significant reduction in a composite of death or myocardial infarction in patients undergoing percutaneous coronary intervention who received direct stenting compared with conventional pre-dilation stenting (OR 0.76, 95% CI 0.60 to 0.96; I2=12%; 24 trials; n=6,803 patients). No statistically significant difference was found between direct and conventional stenting for rate of death (p=0.26).
Patients treated with direct stenting were less likely to experience an episode of myocardial infarction (OR 0.77, 95% CI 0.59 to 0.99; I2=16%; 24 studies; n=6,803 patients) than those treated with conventional stenting, but similar rates of target-vessel revascularisation were found between the two groups (24 studies; I2=0%).
Sensitivity analyses did not change any of these findings. The meta-regression analyses did not demonstrate any relationship between crossover rates and the death odds ratios in the two groups.
The funnel plots and Begg's tests did not indicate evidence of publication bias.