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Drug-coated balloons shown noninferior to DES in thin coronaries

Key clinical point: Drug-coated balloon treatment worked as well as drug-eluting stents in thin coronaries.

Major finding: Twelve-month MACE occurred in 7.33% of balloon-treated patients and in 7.45% of stent-treated patients.

Study details: BASKET-SMALL 2, an international, multicenter randomized trial with 758 patients.

Disclosures: The investigator-initiated study received partial funding from B. Braun, the company that markets the drug-coated balloon (SeQuent Please) tested in the study. Dr. Jeger has received research funding from B. Braun. Dr. Mehran has been a consultant to Abbott, Bayer, BSC, and CSL Behring and has received research funding from Abbott, Astra Zeneca, Bayer, BCC, DSI, and Janssen.

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Promising results need longer follow-up and more patients

Treating thin coronary arteries is a problem because they have a higher risk for in-stent restenosis, although usually we will put a stent in arteries that are at least 2.5 mm wide and sometimes in coronaries as narrow as 2.25 mm. That’s using the narrowest stent we have available. Sometimes in vessels this size, if the result from initial balloon angioplasty looks good on angiography, we accept that outcome and do not place a stent.

Dr. Steen Dalby Kristensen, Aarhus University, Skejby, Denmark

Dr. Steen Dalby Kristensen

The idea of using a drug-coated balloon for de novo stenoses in narrow coronaries is appealing. BASKET-SMALL 2 is an interesting and clinically relevant study. I would like to see longer follow-up and results from more patients. We know that the risk for in-stent restenosis continues beyond 1 year. The comparator group was not ideal because a quarter of these patients received a first-generation drug-eluting stent. For the immediate future, I think the majority of patients with these narrow coronary arteries will continue to receive a drug-eluting stent.

Steen Dalby Kristensen, MD , is a professor of cardiology at Aarhus University in Skejby, Denmark. He had no relevant disclosures. He made these comments in a video interview.


 

REPORTING FROM THE ESC CONGRESS 2018

When treating de novo coronary stenoses in arteries thinner than 3 mm, drug-coated balloons (DCBs) performed virtually identically to conventional drug-eluting stents (DESs) for preventing the clinical consequences of restenosis during 12 months following coronary intervention, according to results from a prospective, randomized, multicenter trial.

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Drug-coated balloons are already used to treat in-stent coronary restenosis. The findings of the current study establish the tested DCB as noninferior to a DES for treating coronary stenoses in narrow arteries less than 3 mm in diameter, Raban V. Jeger, MD, said at the annual congress of the European Society of Cardiology. The DCB approach avoids placing a metal stent in a narrow coronary and thus has no long-term risk for in-stent thrombosis, said Dr. Jeger, a professor of cardiology at Basel (Switzerland) University Hospital. Dr. Jeger acknowledged that the tested DCB is more expensive than the second-generation DES used as the comparator in most of the control patients, “but I think the benefit to patients is worth” the added cost, he said when discussing his report.

The BASKET-SMALL 2 (NCT01574534) study enrolled 758 patients at 14 centers in Switzerland, Germany, and Austria. The trial limited enrollment to patients who were scheduled to undergo percutaneous coronary intervention for stenosis in a coronary artery that was at least 2.0 mm and less than 3.0 mm in diameter and had first undergone successful predilatation without any flow-limiting dissections or residual stenosis, a step in the DCB procedure that adds to the procedure’s cost.

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The study randomized patients to treatment with either a balloon coated with paclitaxel/iopromide (SeQuent Please) or a DES. The first quarter of patients randomized into the DES arm received a first-generation, paclitaxel-eluting DES (Taxus Element); the remaining patients in the comparator arm received a second-generation everolimus-eluting DES (Xience). The DCB tested is not approved for U.S. marketing.

The primary endpoint was the combined rate of cardiac death, nonfatal MI, or target vessel revascularization during 12 months of follow-up. In the intention-to-treat analysis, this occurred in 7.33% of the DCB patients and in 7.45% of the DES patients, a difference that was not statistically significant and that met the prespecified criterion for noninferiority of the DCB. Concurrently with Dr. Jeger’s report at the congress, the results also appeared in an article published in The Lancet (Lancet. 2018 Sep 8;392[10190]:849-56).

One limitation of the study was that the first 25% of patients enrolled into the DES arm received a first-generation DES, while the remaining 75% received a second-generation device. Analysis of the primary endpoint by DES type showed that events occurred more than twice as often in the patients who received a first-generation DES, and their inclusion may have affected the comparator group’s results.

Coronary arteries that need percutaneous intervention and are less than 3 mm in diameter constitute about a third of all target vessels, and they are especially common among women and in patients with diabetes, Dr. Jeger said. Despite this, women made up about a quarter of the study enrollment, and about a third had diabetes. He also noted that a key aspect of adopting the DCB approach into routine practice is that operators would need to have the “courage” to accept some amount of recoil and “minor” dissections after DCB treatment and not feel compelled to correct these with a stent.

Dr. Roxana Mehran, Mount Sinai Medical School, New York Mitchel L. Zoler/MDedge News

Dr. Roxana Mehran

Other features of the BASKET-SMALL 2 trial also have raised concerns about the immediate clinical implications of the results, said Roxana Mehran, MD, a professor of medicine at Icahn School of Medicine at Mount Sinai, New York, and the congress’s designated discussant for the report.

The study began in 2012, which means it took more than 5 years to enroll and suggests that the study may have a selection bias. Dr. Mehran also questioned whether it was really a small vessel study, with an enrollment criterion of less than 3 mm in diameter. A future study should be done in “truly” small vessels, those thinner than 2.5 mm, she said.

Dr. Mehran agreed it’s attractive to speculate that, by using a DCB and avoiding stent placement, fewer patients will eventually have very-late adverse events, but this must be proven with longer follow-up and in larger numbers of patients, she said.

mzoler@mdedge.com

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