Final Kissing Balloon Unnecessary in Single-Stent Approach to Bifurcation Lesions

In patients with bifurcation lesions, drug-eluting stent (DES) implantation in the main vessel works well regardless of whether the procedure is finalized by kissing balloon dilatation, according to a paper published online December 20, 2010, ahead of print in Circulation.

Results from the Nordic-Baltic Bifurcation Study III were previously presented September 25, 2009, at the annual Transcatheter Cardiovascular Therapeutics symposium in San Francisco, CA.

Simple Approach to Single Stenting?

For the multicenter trial, Matti Niemelä, MD, of the University of Oulu (Oulu, Finland), and colleagues looked at 477 patients with bifurcation lesions who were receiving sirolimus-eluting Cypher Select+ stents (Cordis/Johnson & Johnson, Miami Lakes, FL) in the main vessel. Subjects were randomized to undergo PCI with (n = 238) or without (n = 239) final kissing balloon dilatation. Baseline characteristics were similar between the 2 treatment groups. Three-quarters of patients were being treated for stable angina and the remainder for unstable angina.

The researchers found that procedure and fluoroscopy times were longer and contrast media use was higher when the kissing balloon technique was used. But at 6 months, the primary endpoint of MACE (defined as CV death, non-procedure-related index lesion MI, TLR, or stent thrombosis) and its components were equivalent for both strategies, as was symptom relief (table 1).

Table 1. Procedural Characteristics and 6-Month Clinical Outcomes

Abbreviation: CCS, Canadian Cardiovascular Society.

Among patients who completed 8-month angiographic follow-up, rates of binary restenosis (defined as diameter stenosis ≥ 50%) were similar irrespective of balloon use in both the entire lesion and the main vessel. In the side branch, however, binary restenosis was more common when final kissing balloon dilatation was not performed (table 2).

Table 2. Binary Restenosis at 8 Months

The difference in side branch restenosis rates was even more apparent in the 239 patients (50.1%) deemed to have “true” bifurcation lesions according to the Medina classification: 7.6% with vs. 20.0% without kissing balloon (P = 0.024).

Restenosis Not a Worry

In an e-mail communication with TCTMD, David Hildick-Smith, MD, of Royal Sussex County Hospital (Brighton, United Kingdom), seemed to find the results reassuring. “The take-home message is that if the operator does not wish to do kissing balloon inflations, this seems to be acceptable, but if the operator does wish to do kissing balloon inflations, there is no apparent penalty for doing so,” he commented. “And there are theoretical advantages which still make it attractive.”

Differences in clinical outcomes related to restenosis should be apparent by 6 months, Dr. Hildick-Smith said. And the higher rate of side branch restenosis that occurred in the absence of kissing balloon is not a concern, because it “only matters if the side branch is large caliber or particularly long length,” he added.

Study investigator Dr. Niemelä told TCTMD that binary restenosis actually was quite rare in both treatment groups. The finding indicates that inflation to open the stent struts “is not necessary in bifurcation lesions. This especially applies to non-true bifurcation lesions,” he said.

However, Dr. Hildick-Smith pointed out that just half of patients had true bifurcations. Only among these patients would you expect final kissing balloon inflations to matter, he said.

Complex Approach Can Be Appropriate

While kissing balloon is considered mandatory after 2-stent techniques such as culotte and crush, Dr. Niemelä said, it is not yet known whether the approach improves outcomes after single stenting of the main vessel.

Despite the scanty evidence, operators have tended to use balloon inflation to open the stent struts toward the side branch during single-stent procedures, “probably on the basis of results that have been observed when dealing with 2-stent strategy,” he reported, noting that the current results suggest that keeping things simple is easiest. More randomized data are needed to better understand the treatment of true bifurcations with a large side branch, Dr. Niemelä added.

So is the simplest single-stent strategy always preferred for bifurcation lesions? No, said Dr. Hildick-Smith, explaining that there is still a role for more complex techniques in patients with side branches measuring at least 2.75 mm in diameter or with ostial disease longer than 5 mm.

“For these patients, failure to treat the side branch disease adequately is likely to leave them with symptoms and therefore stenting the side branch in addition to the main vessel is a very reasonable option,” he said, noting that this issue is being explored by the new EBC-TWO trial. “Equally, kissing balloon inflation offers much more than just prevention of stenosis—it ensures future access to the vessel, allows the ostium of the side branch to be covered by the main vessel stent, and allows the stent in the proximal vessel to be expanded fully. . . . Many operators therefore still use kissing balloon inflations for true bifurcation lesions where the side branch is diseased and is greater than 2.5 mm in diameter.”

 

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Source:
Niemelä M, Kervinen K, Erglis A, et al. Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: The Nordic-Baltic Bifurcation Study III. Circulation. 2011;123:79-86.

 

 

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