REVELATION: Drug-Coated Balloons Entices in Select STEMI

Patrice Wendling

May 24, 2019

PARIS — After a bumpy road with bioabsorbable scaffolds, the strategy of leaving no implant behind found an ally in a prospective trial of drug-coated balloon (DCB) angioplasty for select patients with acute ST-segment elevation myocardial infarction (STEMI).

The primary end point of fractional flow reserve (FFR) at 9 months was noninferior between treatment with a paclitaxel-releasing DCB and drug-eluting stents (DES) in the REVELATION trial (mean, 0.92 vs 0.91; = .27).

The angiographic secondary end point of late luminal loss also was similar between groups (0.05 vs 0.00 mm; P = .51), according to results presented here at the Congress of the European Association of Percutaneous Cardiovascular Intervention 2019 and published simultaneously in JACC Cardiovascular Interventions.

Although cardiologists may be hesitant to abandon their mainstay therapy of DES, "especially in STEMI, these are typically the patients and lesions that may benefit from this strategy," lead author Nicola Vos, MD, OLVG Hospital, Amsterdam, told theheart.org | Medscape Cardiology.

She noted than an important part of STEMI is erosion as the underlying mechanism of the acute infarction in around one of five patients. And for these patients, or those with rupture of a nonsignificant plaque without severe calcification, a balloon strategy is enough.

"In younger patients, I think the absence of a permanent vascular scaffold is also especially of interest because it gives you the opportunity for the future in case of restenosis to place a stent or use a CABG," she said. "And maybe when you don't have to leave a permanent scaffold behind, you might abate the need for prolonged dual antiplatelet therapy in these STEMI patients as well."

Between October 2014 and November 2017, 120 patients were evenly assigned to treatment with DCB (Pantera Lux, Biotronik) or DES (Orsiro, Biotronik or Xience, Abbott) if they had a de novo, nonseverely calcified culprit lesion in a native coronary artery with residual stenosis of 50% or less by visual assessment after thrombus aspiration and mandatory predilation. Most were men (87%), their average age was only 57.4 years, and 72% had single-vessel disease.

Procedural success was achieved in all patients, with no periprocedural serious adverse events. At 9-month follow-up, there were no deaths; the mean left ventricular ejection fraction was 57.1% in the DCB group and 58.4% in the DES group (P =.38)

Speaking to theheart.org | Medscape Cardiology, Patrick Serruys, MD, Imperial College London, said: "I think the drug-coating balloon is making some serious progress," with no less than five DCBs already approved in Europe.

"But what we don't want is to inflate the balloon like in the good old days and be called at 6 PM by the chief nurse that the patient again has pain; that was a nightmare for us," he said. "If that scenario comes back, it will immediately create resistance to drug-coating balloons. But a drug-coating balloon that is done after good preparation with some imaging to see there is no damage or hematoma in the wall, that could work quite nicely."

The researchers demonstrated feasibility of the strategy in the 2011 pilot PAPPA trial and, in keeping with the times, required thrombus aspiration and mandatory predilatation, but also advised performing the DCB angioplasty with an oversized balloon-to-artery ratio above 1, explained Vos. This resulted in an increased number of dissections, prompting crossover stenting in 41% of patients.

The investigators changed the REVELATION protocol and advised physicians to use the DCB with a 1:1 artery ratio, which decreased the bailout rate to 18% (eight cases for ≥type C dissection, two for residual stenosis >50%, and one crossover to DES).

"Still, if you look at the atm [atmosphere] used to inflate the balloons for predilatation, as well as the DCBs, they were both overinflated, above nominal pressure," Vos said in an interview. "So I really do think that if you can use these balloons properly, with a 1:1 ratio, we can really decrease the amount of dissections and bailout stenting."

With the aggressive protocol needed to adequately utilize the DCB, "these results are hardly surprising," Omeed Neghabat, MD, and Niels Ramsing Holm, MD, both at Aarhus University Hospital, Denmark, write in an accompanying editorial.

Although the strict protocol did not translate into lower FFR at follow-up, the achieved final lumen diameters were significantly smaller with DCB (2.64 vs 2.88 mm; P <.01), they note.

"Consequently, the evaluated approach, yielding noninferior FFR and apparently good clinical results, is a strategy with routine DCB in combination with DES in about one in five cases," say Neghabat and Holm.

After the formal presentation, panelist Göran Olivecrona, MD, PhD, Lund University, Sweden, observed that only 120 patients were accrued over the 3-year study period and questioned whether this reflected a "lack of operator enthusiasm" to randomize STEMI patients.

"For the interventional cardiologists, it's kind of nerve-racking to prevent stenting in these kind of patients," acknowledged Vos, who added that the slow enrollment was more likely because it was a highly selected population.

Olivecrona also questioned the high rate of thrombus aspiration at 78%.

Vos responded that "we know that routine thrombus aspiration does not reduce mortality" but that optimal lesion preparation is essential in a DCB strategy and that removing as much thrombus as possible may mean predilation can be less aggressive and may facilitate DCB drug delivery.

Commenting further on this point to theheart.org | Medscape Cardiology, Vos said that, "in the case of using a DCB specifically, if thrombus aspiration adds something, I don't think those data are available, I'm not aware of it. So that's really something we have to discuss, but in general I don't think we're going to use it."

Finally, session cochair Peter Ludman, MD, University Hospitals Birmingham, United Kingdom, asked whether the study results have prompted their operators to use DCBs in clinical practice.

"Sometimes we do, especially in really young patients with lesions in large vessel segments and after thrombus aspiration and predilation there is not significant plaque," Vos said. "Yes they do."

The study was funded by BV Cardioresearch OLVG. Vos and Neghabat report no relevant conflicts of interest. Holm reports institutional research grants and speaker fees from Abbott and Boston Scientific.

JACC Cardiovasc Interv. Published online May 21, 2019. Abstract, Editorial

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org  | Medscape Cardiology, join us on Twitter and Facebook.

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