A randomized controlled trial led by Dr. Nicola Vos published in JACC: Cardiovascular Interventions showed that a treatment strategy involving the use of a drug-coated balloon (DCB) was non-inferior to drug-eluting stents (DES) for patients with ST-elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI). The data here suggest that using DCB could be both safe and feasible.
PCI is the preferred reperfusion strategy in patients with STEMI. Stenting has been proven to reduce the need for repeat revascularization as compared to plain old balloon angioplasty. However, whether routine stenting alone leads to a reduced incidence of cardiac death or recurrent myocardial infarction is not known. Additionally, the presence of vascular implants is associated with an increased risk of late stent thrombosis and impaired vasomotor function. In theory, using a drug-coated balloon could be an alternative to using a stent as it avoids the complications of stent implantation. Additionally, the absence of an implant could avoid the need for long term dual antiplatelet therapy (DAPT). Through the REVELATION trial, the investigators aimed to address this gap in knowledge.
“To our knowledge this is the first prospective, randomized controlled trial comparing a DCB strategy with stenting in STEMI using a physiologic endpoint. The REVELATION trial showed noninferiority of DCB compared with DES regarding the primary endpoint of FFR at 9-months follow-up. In addition, there was no significant difference in LLL, and although adverse event rates were low, both treatment groups had comparable clinical outcomes at 9-months follow-up.” – Dr. Nicola Vos, M.D.
The REVELATION trial randomized 120 patients with STEMI who were intended to be treated with primary PCI to either DCB or DES. Patients who had severe calcification or residual stenosis of more than 50% after thrombus aspiration and mandatory pre-dilatation were excluded. Additionally, patients with a history of MI, stent implantation less than a month ago, contraindications for dual antiplatelet therapy, had cardiogenic shock or were intubated were excluded. For patients in the DCB group, bailout stenting with a bare-metal stent was advised only if there was residual stenosis of more than 50% after balloon dilatation or life-threatening coronary dissection occurred. All patients received DAPT for 1 year after the procedure. The primary endpoint was the functional assessment of the infarct-related lesion by fractional-flow reserve (FFR) at 9 months. Clinical secondary endpoints included major adverse cardiac events, the occurrence of stent thrombosis, and major bleeding.
Of the 120 patients included in the study, 60 were randomized to DCB and 60 to DES. One patient randomized to DCB was switched to DES due to the unavailability of an appropriately sized DCB. FFR was measured in 73 patients. The mean FFR was 0.92 ± 0.05 and 0.91 ± 0.06 in the DCB and DES groups respectively. The mean difference was 0.008 (95% CI -0.018 to 0.032, 1 sided p = 0.27). The trial showed that DCB was non-inferior to DES. At 9 months, there were no deaths or recurrent myocardial infarctions. There were no major bleeding events reported in either group. One patient in the DES group underwent revascularization due to in-stent restenosis.
This is one of the first randomized controlled trials comparing stenting and DCB in patients with STEMI. The trial showed that DCB was non-inferior to DES with respect to FFR by 9 months. Additionally, the clinical outcomes by 9 months were comparable between the two groups. However, it is important to note that the results here were achieved from a highly selective and inclusion depended on successful culprit lesion preparation. When comparing the results of this study to others performed, Dr. Vos wrote, “Several studies have shown positive coronary remodeling after DCB, confirming the advantage of DCB in terms of maintenance of coronary vasomotor response and vessel geometry. Our study did not confirm these results. LLL calculated at 9-months follow-up was 0.05 mm (interquartile range: 0.40 to 0.20) in the DCB group versus 0.00 mm (interquartile range: 0.16 to 0.10) in the DES group (p = 0.51). Although these results do not show signs of positive remodeling in the DCB group, the LLL [late luminal loss] in both groups is extremely low compared with other compatible studies.” Based on the results of this study, the investigators believe that DCB could be a safe and feasible strategy in a subset of patients with STEMI in whom the culprit lesion is adequately prepared.
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