Drug-Coated Balloon in Line With DES in Small De Novo Lesions

Patrice Wendling

August 31, 2018

MUNICH — In patients with small de novo coronary lesions, drug-coated balloon (DCB) angioplasty was comparable with the preferred treatment strategy of second-generation drug-eluting stents (DES), in the noninferiority BASKET-SMALL 2 trial.

In a per protocol analysis, 12-month major adverse cardiovascular events (MACE) were similar among those treated with a paclitaxel-coated balloon (SeQuent Please, B. Braun Melsungen) and DES (7.57% vs 7.52%; P = .0217 for noninferiority).

Results were also similar in a full-population analysis (7.33% vs 7.45%; P = .0152), according to findings reported here at the European Society of Cardiology (ESC) Congress 2018 and published simultaneously online in the Lancet.

"We have a potential benefit of leaving behind an intact vessel without armor, without a stent," study author Raban Jeger, MD, University Hospital Basel, Switzerland, said at a press conference. "Therefore, we don't expect any thrombotic events, and no prolonged dual antiplatelet therapy is necessary. In drug-coated balloons, you just need 4 weeks of dual antiplatelet therapy."

Following the formal presentation of the results, discussant Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York City, said DCB "is safe and comparable to DES in terms of MACE and offers an important alternative in patients with small-vessel disease."

"This important potential benefit of not having a permanent implant in our patients with diffuse long lesions is tremendous."

Several factors have to be considered, however, when interpreting the results, noted Mehran. Specifically, 14% of enrolled patients had to go into a separate registry because of flow-limiting dissections or residual stenosis; 25% of patients were treated with the Taxus Element (Boston Scientific) paclitaxel-eluting stent, which could negatively affect the DES arm; and the long enrollment period of almost 5 years could introduce selection bias.

In addition, the inclusion criteria of vessels with diameters of 2 mm to less than 3 mm was an operator assessment without a systematic angiographic core lab, she said. The mean effective size of DCB or DEC was 2.75 mm and 2.57 mm, respectively, with the smaller stent size another potential disadvantage.

"You wonder if these are truly small vessels, if you are including going to a 3-mm vessel," said Mehran.

Mehran concluded that longer-term data are necessary and that the trial "sets the stage for a larger study in truly small-vessel disease of less than 2.5 millimeters in diameter."

Increased Mortality

For BASKET-SMALL 2, investigators at 14 centers in Germany, Austria, and Switzerland screened 883 patients with de novo coronary lesions and an indication for percutaneous coronary intervention.

After successful predilatation (no flow-limiting dissections or residual stenosis above 30%), 382 patients were randomly assigned to receive DCB and 376 to receive DES, initially with the SeQuent Please and then with the Xience everolimus-eluting stent (Abbott Vascular), after the former stent was no longer available in Germany because of litigation, Jeger said.

The two groups were well balanced, with the exception of a higher proportion of men in the DCB group. Three-quarters of patients presented with stable angina; the median ejection fraction was 60% in both groups.

Of the three MACE components, DCB was associated with numerically more cardiac deaths than DES (3.1% vs 1.3%) but also numerically less nonfatal myocardial infarction (1.6% vs 3.5%) and target vessel revascularization (3.4% vs 4.5%). 

The DCB and DES groups had similar rates of major bleeding (1.1% vs 2.4%) and stent thrombosis (0.8% vs 1.1%), which was possible as bailout stenting was allowed in DCB cases with flow-limiting dissections or significant residual stenosis.

Commenting to theheart.org | Medscape Cardiology, ESC spokesperson Steen Dalby Kristensen, MD, Aarhus University, Skejby, Denmark, said small-vessel disease is not uncommon and that he sees these patients in his practice every week.

"Sometimes we are in doubt about whether we should put a stent in or leave the balloon result and now we might have something sort of in between that we can do," he said. "We can put in a balloon with a drug that might limit the number of patients that develop restenosis, and this is interesting."

"To say whether we should use the drug-coated balloon in all patients with small vessels, I think at this moment is too much," said Kristensen. "We need to see longer-term data and maybe also more data comparing stents that are newer and better because the stent technology has improved since this study."

ESC spokesperson Professor Joep Perk, MD, Linnaeus University, Kalmar, Sweden, told theheart.org | Medscape Cardiology: "These results may open new territory, especially in diabetic patients and women, where these artery values are more common."

"It's promising, it's really promising, but as in all these studies, you need far longer results… At 4 or 5 years, does it really last?"

The investigators noted that the benefits of DCBs might not be seen until after 2 to 5 years and that rigorous lesion preparation is mandatory to avoid complications.

Jeger also cautioned that there is a "steep learning curve" for DCB angioplasty because interventionalists need the "courage not to treat just the image but the vessel, and sometimes you have some recoil or some minor dissection and you just need the courage to leave that and not to expect stent-like results."

In a related editorial, Hee Hwa Ho and Paul Jau Lueng Ong, from Tan Tock Seng Hospital, Singapore, write that the "investigators should be commended for doing this study because, in daily practice, at least 30% of PCI involve small coronary vessels."

Although DCB have a class 1 indication in the 2014 ESC guidelines for the treatment of bare-metal and DES in-stent restenosis, they note that robust, randomized data are scarce for their use in small de novo coronary lesions.

The finding of noninferiority regarding MACE rates at 12 months "supports the use of DCB beyond in-stent restenosis (ie, in small native coronary artery disease)," the editorialists conclude.

The study was supported by the Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B. Braun Medical AG. Jeger reports research contracts with B. Braun Medical AG. Perk and the editorialists report no relevant conflicts of interest.

Lancet. Published online August 28, 2018. Abstract, Editorial

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