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.


Continue Reading

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.

Related Articles

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.

Reference

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