BELLO: Drug-Coated Balloons Take on De Novo Lesions vs. DES


Drug-eluting balloons (DEB) may prove to be useful in patients with small-vessel coronary artery disease who are not good candidates for stenting. A randomized study published online November 14, 2012, ahead of print in the Journal of the American College of Cardiology. DEB reduce late loss compared with drug-eluting stents (DES) while offering similar rates of restenosis and revascularization.

For the BELLO (Balloon Elution and Late Loss Optimization) trial, Antonio Colombo, MD, of San Raffaele Hospital (Milan, Italy), and colleagues enrolled 182 patients with lesions located in small vessels that had reference diameters less than 2.8 mm (89% were < 2.5 mm). The researchers randomly assigned patients to receive IN.PACT Falcon paclitaxel DEB (Medtronic, Santa Rosa, CA) plus provisional BMS (n = 90) or Taxus Libertè paclitaxel-eluting stents (n = 92; PES; Boston Scientific, Boston, MA).

Superior Protection Against Late Loss

At 6 months, angiographic follow-up was complete in 86.2% of the DEB and 83.7% of the PES groups, and clinical follow-up was nearly 100%. DEB demonstrated noninferiority to PES in terms of in-stent/in-balloon late loss with a delta of 0.25 mm (primary endpoint) and also showed superiority. Restenosis did not differ between the 2 groups at 6 months nor did the clinical outcomes of TLR or MACE (composite of death, MI, and TVR). There were no cases of stent thrombosis (table 1).

Table 1. Six-Month Outcomes

 

DEB

PES

P Value

Late Loss, mm

0.08 ± 0.38

0.29 ± 0.44

0.001a

Restenosis

8.9%

14.1%

0.25

TLR

4.4%

7.6%

0.37

MACE

7.8%

13.2%

0.77

a P < 0.001 for noninferiority.

Not a Replacement for DES

In an e-mail communication, Dr. Colombo told TCTMD that the BELLO study shows that the IN.PACT Falcon DEB is effective in treating not only in-stent restenosis but also de novo and long lesions located in small vessels. “This therapeutic alternative needs to be taken into account when the operator is not keen to implant stents for various clinical reasons,” he noted.

In the paper, the investigators elaborate that the BELLO results should not promote “DEB as a generic substitute to DES but rather as an adjunctive tool.

“These data give support to the use of DEB in circumstances in which the operator may not be fully confident to deploy a DES (eg, small vessel size, long lesions, excessive number of DES required) because the results of DES are not as optimal and in an attempt to limit the amount of metal implanted,” they continue, adding that more data are required on whether the strategy may be suitable for “patients who have trouble adhering to prolonged dual antiplatelet therapy.”

Charting a Future for DEB

In an e-mail communication with TCTMD, Bruno Scheller, MD, of the University of Saarland (Homburg, Germany), said that BELLO was able to show angiographic superiority for DEB over DES but had too small a patient population to identify differences in clinical outcomes. The ongoing BASKET SMALL 2 trial is comparing the SeQuent Please DEB (B.Braun Melsungen AG; Berlin, Germany) with the Taxus Element DES (Boston Scientific), both of which release paclitaxel, in small coronary vessels. With an estimated enrollment of 649 patients, the trial may provide some answers, he reported.

While this strategy is still rare, “[i]n Europe and other countries outside the United States, the proportion of [DEB used for treating] de novo coronary disease is further increasing,” Dr. Scheller said, noting that 27.3% of patients in the SeQuent Please World Wide Registry were treated for this indication.

The invention of stent technology simultaneously “created 2 new diseases: in-stent restenosis and stent thrombosis. Furthermore, a caged vessel excludes late lumen enlargement and advantageous vascular remodeling,” Dr. Scheller explained. DES may reduce restenosis, he said, but they are “limited by delayed healing, late acquired malapposition, and neo-atherosclerosis. There is therefore a need for new technologies to reduce the need for permanent implants in percutaneous vascular treatment.”

According to Dr. Scheller, DEB have even greater potential beyond an additional reduction in restenosis: to lessen the need for antiplatelet therapy and to encourage vascular restoration by leaving no foreign object behind. Eventually, DEB may become the preferred therapy, he predicted, with bioabsorbable stents being reserved for cases that temporarily require a scaffold.

Study Details

Baseline characteristics were similar between the 2 groups apart from smaller vessel size in DEB-treated patients (2.15 ± 0.27 mm vs. 2.26 ± 0.24 mm; P = 0.004). In all, 20.2% of the DEB group required bailout BMS. Predilatation occurred in all but 3.2% of DEB cases, while 17.3% of PES cases involved direct stenting (P = 0.002).

 


Source:
Latib A, Colombo A, Castriota F, et al. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: The BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012;Epub ahead of print.

 

 

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Disclosures
  • The BELLO trial was supported by an unrestricted grant from Invatec SpA.
  • Dr. Colombo reports no relevant conflicts of interest.
  • Dr. Scheller reports being a shareholder of InnoRa GmbH (Berlin, Germany), a company responsible for the preclinical and first clinical studies of this specific DEB.

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