According to a recent study based on the REVELATION Trial, conducted by Nicola S. Vos et al. and published in JACC, Paclitaxel-coated balloon angioplasty was documented to be non-inferior to the routine drug-eluting stenting (DES) in ST-segment elevation myocardial infarction (STEMI) patients.
The REVELATION Trial, a single-centered, prospective, randomized controlled trial, compared the fractional flow reserve at 9 months between drug-coated balloon (DCB) angioplasty and drug-eluting stenting (DES) in STEMI patients. A total of 120 patients were randomized in a 1:1 fashion to either DCB or DES treatment group. The randomization criteria involved a new culprit lesion in a native coronary artery with the absence of severe calcification and ≤ 50% residual stenosis after thrombus aspiration (in case of visible thrombus) and mandatory pre-dilatation. According to the current STEMI guidelines of the European Society of Cardiology, all patients received 1-year dual-antiplatelet therapy (DAPT) because of STEMI and peri-procedural bivalirudin. Coronary revascularization was performed according to the European Society of Cardiology guidelines for “Myocardial Revascularization”. A successful primary percutaneous coronary intervention (PPCI) was defined as a diameter stenosis < 30% (by visual estimation) and TIMI flow grade ≥ 2 for DCB angioplasty and a diameter stenosis < 20% and TIMI flow grade ≥ 2 for stent use. Primary endpoint was the functional assessment of the infarct-related lesion by fractional flow reserve (FFR) at 9 months follow-up. FFR is an independent powerful predictor of the risk of future cardiac events with a post-stent FFR value of ≥ 0.90 associated with low adverse event rates at follow-up whereas an FFR value of < 0.85 is associated with increased event rates. Angiographic secondary endpoint was late luminal loss (LLL) measured by quantitative coronary analysis (QCA). Clinical secondary endpoints were major adverse cardiac events, major bleeding, and occurrence of stent thrombosis.
This study was designed to assess the noninferiority of the primary endpoint at 9 months follow-up which was evaluated by using a 2-sample Student’s t-test with a one-sided p-value < 0.025. The margin of noninferiority was ≤ 0.05. A two-sided p-value of < 0.05 was considered to be significant for all other studied variables. All analyses were performed according to the intention-to-treat principle. A control coronary angiogram was performed in 84 patients at 9 months follow-up. The results showed normal distribution of FFR and established noninferiority of DCB compared with DES. The mean FFR at 9 months follow-up of patients assigned to the DCB group (n = 35) was 0.92 +/- 0.05 and in patients assigned to the DES group (n = 38) 0.91 +/- 0.06. The mean difference was 0.008 with a 0.012 standard error difference (95% CI: -0.018 to 0.032, 1-sided p = 0.27). However, LLL was not normally distributed unlike the reference vessel diameter and minimum lumen diameters. It was 0.05 mm (interquartile range: -0.40 – 0.20 mm) in the DCB group at 9-months follow-up and 0.00 mm in the DES group (interquartile range: -0.16 – 0.10) (p = 0.51). The mean LVEF at 9 months was 57.1 +/- 6.2 in the DCB group and 58.4 +/- 7.1 in the DES group (p = 0.38) and the medication compliance was high in both groups.
Few of the limitations of this study include the fact that the trial being single-centered involved relatively a small sample size. Other limitations are the use of only Pantera Lux DCB in trial patients, hence, it can not be extrapolated to patients receiving another DCB type and the selection of eligible lesions on the basis of operator’s visual interpretation of coronary angiogram.