Courtesy of Dr. Carlos Fava.

The incidence of peripheral vascular disease is clearly increasing, progressing towards critical ischemic claudication and amputation. Angioplasty is currently the treatment of choice for these pathologies.

Several times, an implanted stent ends up cracking due to extensive calcification, increasing the rate of restenosis and worsening critical ischemia.

Technological development on drug-eluting baloons (DEB) and directional atherectomy (DA) may improve outcomes.

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This study randomized 102 patients. Among them, 48 underwent directional atherectomy + DEB (DA was performed using the SilverHawk or TurboHawk devices, and DEBs eluted paclitaxel), and 54 received DEB only. There were 19 patients who were not randomized (NR) due to excessive calcification. They underwent DA with TurboHawk and DEB.

The mean age was 69 years old (most patients were men); risk factors and comorbidities were similar in all arms.

Lesion lengths were longer in the DA + DEB group (112.3 ± 40.3 mm vs. 96.6 ± 40.9 mm; p = 0.05). In the not randomized group (118.7 ± 56.2 mm) there were no differences as regards the rate of obstruction.

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Technical success (≤30% residual stenosis) was 89.6% for the DA+DEB group vs. 64.2% for the DEB group (p = 0.004). In the NR group, the rate of success was 84.2%. Use of a filter for distal embolic protection (SpiderFX) was 84.2% in the DA+DEB group and 100% in the NR group.

Among the randomized patients, 16.7% of the DA+DEB patients received predilation, and so did 74.1% in the DEB-only group. In the NR group, this rate was 31.6%. Bail-out bare metal stenting was performed in 3.7% and postdilatation was performed in 6.3% vs. 33.3% (p = 0.001).

After a 1-year follow-up, there were no differences in angiographic stenosis in the treated vessel (DA+DEB 33.6% ± 17.7% vs. 36.4± 17.6%), clinically driven target-lesion revasculatization (7.3% vs. 8%), patency as assessed by Doppler echocardiography (84.6% vs. 81.3%; 68.8% for the NR group), and freedom from major events (89.3% vs. 90%).

Conclusion

DA+DEB treatment was effective and safe, but the study lacked statistical power to show significant differences between both methods of revascularization in a 1-year follow-up.

Editorial Comment

This is the first randomized prospective study comparing both strategies at a 1-year follow-up, showing the effectiveness and safety of its use.

While there were no differences, higher-scale and longer-follow-up studies are warranted.

Technological development is crucial for better results in this area.

Courtesy of Dr. Carlos Fava.

Original title: Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency. Twelve-Month Results of the DEDINITIVE AR Study.

Reference: Thomas Zeller, et al. Circ Cardiovasc Interv 2017;10:e004848.

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