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In patients with femoropopliteal artery disease, angioplasty with a paclitaxel-coated balloon is clinically more effective than an uncoated balloon, reducing the need for reintervention with no apparent safety concerns, according to results of a meta-analysis published online July 31, 2012, ahead of print in Circulation: Cardiovascular Interventions.

Investigators led by Massimiliano Fusaro, MD, of the Deutsches Herzzentrum (Munich Germany), analyzed results of 4 trials (2004-2011) that randomized 381 patients with symptomatic femoropopliteal disease to angioplasty with paclitaxel-coated balloons (n = 186) or uncoated balloons (n = 195). All patients also received medical therapy.

The trials included were:

• THUNDER (n = 154; Paccocath, Bavaria Medizin Technologie/Bayer, Leverkusen, Germany)
• FemPac (n = 87; Paccocath, Bavaria Medizin Technologie/Bayer, Leverkusen, Germany)
• LEVANT I (n = 101; Moxy DCB, Lutonix, New Hope, MN)
• PACIFIER (n = 91; In.Pact Pacific, Medtronic-Invatec, Minneapolis, MN)

Clinical Advantage Shores up Angiographic Superiority

After a median follow-up of 10 months, the rate of TLR (the primary endpoint) was 25%, but the incidence was markedly lower with paclitaxel-coated balloons compared with uncoated balloons. There was no difference between the 2 groups for all-cause mortality (table 1).

Table 1. Clinical Outcomes

 
Angiographic follow-up at 6 months also showed an advantage for paclitaxel-coated balloons in binary restenosis and late lumen loss (table 2).

Table 2. Angiographic Outcomes

 
No heterogeneity was seen among the trials for clinical or angiographic endpoints.

The authors say the finding of a 25.5% absolute risk reduction in TLR with a paclitaxel-coated balloon is important because although earlier studies showed angiographic advantages, results regarding reductions in the need for reintervention were inconsistent. Importantly, in the current analysis, most of the repeat procedures were driven by symptoms rather than the “oculostenotic reflex,” they add.

Dr. Fusaro and colleagues note that adjunctive stenting after balloon angioplasty is relatively common (up to 21% for paclitaxel-coated balloons and 34% for uncoated balloons in the trials analyzed). Although the practice is due mainly to dissection or suboptimal results, an additional rationale is to provide longer vessel patency. With the demonstrated reduction in TLR, however, the motivation for such crossover stenting is reduced. “Any potential ‘stent-sparing’ effect is of particular relevance in these patients due to the typically diffuse nature of [femoropopliteal artery] disease burden and the adverse effects of long-segment stenting,” the investigators observe.

An important limitation of the meta-analysis, the authors acknowledge, is that the clinical impact of paclitaxel-coated balloon angioplasty cannot be fully explored by evaluating TLR and mortality estimates. Clinical endpoints such as pain-free walking distance, change in Rutherford class, grade of wound healing, risk of limb-specific reinterventions, and amputation-free survival are also important. In addition, exclusion of patients with severely impaired arterial outflow precluded meaningful evaluation of the effect of paclitaxel balloons on outcomes such as amputation. 

Impact Expected on European Practice

In an e-mail communication with TCTMD, Bruno Scheller, MD, of the University of Saarland (Homburg, Germany), wrote that “for the first time, the meta-analysis shows a consistent clinical benefit of drug-coated balloon therapy. Therefore, it will have a major impact on decision making in interventional therapy for peripheral arterial disease.”

However, he observed, a class effect of drug-coated balloons cannot be assumed, so clinical evidence of safety and efficacy is required for each of the technologies involved.

He added that in THUNDER, the largest of the trials in the meta-analysis, the benefit of the paclitaxel-coated balloon was independent of the severity of dissections, and thus “it seems that the ‘drug-coated balloon-only’ concept avoiding [adjunctive] stent implantation provides the best long-term results.”

In a telephone interview with TCTMD, Gary M. Ansel, MD, of Riverside Methodist Hospital (Columbus, OH), agreed that the finding of reduced need for reintervention will likely have an impact on European practice, but he noted that the technology is not yet available in the United States.

European health care authorities “have tended to look at procedural costs more than outcomes costs,” Dr. Ansel continued. “But as the economies are all struggling, and as we get more sophisticated in our cost analyses and look not just at in-hospital costs but at patient costs over a year as well as the clinical benefit, I think these are pretty powerful data that support broadened usage of this technique.”

A New Gold Standard

Dr. Scheller noted that in the early first-in-man trials “the cleanest approach was to compare drug-coated balloons with conventional angioplasty” but that the field has evolved and future trials will incorporate more effective comparators.

Dr. Ansel concurred. “I think we’re going to see [plain] angioplasty start to go away as a comparator,” he said, noting that a VIVA Physicians review (Rocha-Singh KJ, et al. Catheter Cardiovasc Interv. 2007:69:910-919) found a 1-year restenosis rate of 72% in longer lesions with conventional angioplasty. “Nowadays, that is getting to be unacceptable,” he commented.

“Once it’s available, the gold standard is going to have to be the paclitaxel-coated stent,” Dr. Ansel continued. “Then the next step is to compare drug-coated stents and drug-coated balloons. I think they are both going to have their niches, and data will tell us when to best use which technology.”

Dr. Ansel added that heparin-coated stent grafts are also “coming on strong” as an alternative for treating femoropopliteal lesions, demonstrating 74% 1-year primary patency in the VIPER trial.

Addressing the need for new options, he added, “I just hope the United States can move along [toward approval] so that we can catch up with the rest of the world.”

Study Details

Provisional bare-nitinol stenting was allowed in the trials. In 1 study, all patients underwent per-protocol predilation with an undersized uncoated balloon prior to randomization.

 

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Source:
Cassese S, Byrne RA, Ott I, et al. Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: A meta-analysis of randomized trials. Circ Cardiovasc Interv. 2012:Epub ahead of print

 

 

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