The REVELATION trial showed noninferiority of a drug-coated balloon (DCB) compared with drug-eluting stent (DES) in primary percutaneous coronary intervention for ST-elevation myocardial infarction (STEMI), according to a study published in JACC: Cardiovascular Interventions. There was no significant difference in late luminal loss, and both treatment groups had comparable clinical outcomes at 9-months follow-up.
In this prospective, randomized controlled trial, the investigators assessed the safety and efficacy of treatment done in a 1:1 fashion to either treatment with DCB (n=60) or DES (n=60) between October 2014 and November 2017.
There was no significant difference in baseline characteristics or in angiographic features between the two groups. Patients received 1 year of treatment with dual antiplatelet therapy because of STEMI and periprocedural bivalirudin.
Successful PPCI was defined as diameter stenosis less than 30% and thrombolysis in myocardial infarction flow grade 2 or higher for DCB angioplasty, and DS less than 20% and thrombolysis in myocardial infarction flow grade 2 or higher for stent use. Patients were contacted by telephone at 1 month and yearly up to 5 years after they were randomly selected, in addition to clinical follow-up during the index hospitalization and at 9 months.
The mean fractional flow reserve measured at 9-months follow-up of patients assigned to be treated with DCB (n=35) was 0.92±0.05 and 0.91±0.06 in patients treated with DES.
Noninferiority of DCB with DES was established based on a mean difference of 0.008 with a standard error difference of 0.012 (95% CI, -0.018 to 0.032; 1-sided P =.27).
No deaths were reported at 9-months follow-up, and target lesion revascularization was available for 112 out of 120 patients. The mean left ventricular ejection fraction at 9 months was 57.1±6.2% in the DCB group and 58.4±7.1% in the DES group (P =.38).
This study is limited by the relatively small number of patients included and the fairly high dropout rate during follow-up.
The researchers concluded that DCB angioplasty may allow for the restoration of normal coronary physiology and enable positive vessel remodeling while leaving all percutaneous and surgical treatment options open.
Disclosures: The REVELATION clinical trial was funded by BV Cardioresearch OLVG.
Vos NS, Fagel ND, Amoroso G, et al. Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction: the REVELATION randomized trial [published online May 21, 2019]. JACC Cardiovasc Interv. doi:10.1016/j.jcin.2019.04.016