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MUNICH -- A drug-coated balloon (DCB) was on par with second-generation stents for use in native vessels measuring 2-3 mm in diameter, a randomized non-inferiority trial showed.

In a 758-person, all-comers population with an indication for percutaneous coronary intervention (PCI), the paclitaxel-eluting SeQuent Please DCB was associated with as many major adverse cardiac events at 12 months as drug-eluting stents (DES), according to a late-breaking trial session at the European Society of Cardiology (ESC) meeting here.

The endpoint of cardiac death, non-fatal MI, and target vessel revascularization occurred in 7.5% of patients who received DCB compared with 7.3% of patients who received DES (HR 0.97, 95% CI 0.58-1.64), Raban Jeger, MD, of Switzerland's University Hospital in Basel, and colleagues showed in the published report of the BASKET-SMALL 2 study in .

"A stent-free treatment of coronary artery disease with DCB is safe if an acceptable angiographic result can be obtained after predilatation of the lesion," the authors maintained.

Cumulative event rates were numerically lowest among the Xience stent group, and were slightly higher in the DCB group followed by the Taxus group, with the highest rate of events in the small group of patients assigned to the DCB group who required bailout stenting.

The DCB and DES arms of the trial shared similar rates of:

• Cardiac death: 3.1% versus 1.3% (HR 2.33, 95% CI 0.82-6.61)
• Stent thrombosis: 0.8% versus 1.1% (HR 0.73, 95% CI 0.16-3.26)
• Major bleeding: 1.1% versus 2.4% (HR 0.45, 95% CI 0.14-1.46)

The benefits of DCBs might not be seen until after 2-5 years, the investigators suggested. "Because there are no stents, there's no stent thrombosis and no in-stent restenosis," Jeger said at a press conference.

He noted that there is a "steep learning curve" associated with DCB placement in small vessels, however, as operators have to be comfortable leaving patients with recoil and minor dissections after the procedure. Additionally, Jeger stressed that all patients had to have successful predilatation -- with no evidence of flow-limiting dissections or residual stenosis >30% -- in order to be included in the study, which was conducted from 2012 to 2017.

Most patients presented with stable angina (70%). Mean age was 67.2 years in the DCB group and 68.4 years in the DES group, and over 70% of the study population were men. The groups were well-balanced at baseline with the exception of more men being in the DCB arm.

The Taxus Element was chosen as the comparator device at first because it eluted the same drug -- paclitaxel -- as SeQuent Please; when it was no longer available in Germany due to an infringement lawsuit, the everolimus-eluting Xience came in as the replacement.

"We know Taxus is really not the best stent," commented Steen Dalby Kristensen, MD, DMSc, of Aarhus University in Denmark, adding that BASKET-SMALL 2 was overall too small a trial to change his practice.

Even so, the trial sets the stage for larger studies in truly small vessels (<2.5 mm) for which there are no dedicated devices and disproportionately affect women and patients with diabetes, according to ESC session discussant Roxana Mehran, MD, of New York City's Icahn School of Medicine at Mount Sinai.

Mehran pointed out that those groups were surprisingly still underrepresented in the trial. In addition, vessel size should have been evaluated angiographically, she said, not with operator assessment.

An informal poll during the session saw the audience roughly split between DES and DCB for small vessels before the BASKET-SMALL 2 presentation. In the end, DCB emerged as the dominant strategy among voters.

Jeger acknowledged that overall costs are "probably higher" with DCBs, which are by themselves more expensive than DES but also require more demanding lesion preparation with more balloons.

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