DCB, DES perform equally well in long femoropopliteal lesions

Drug-coated balloons and drug-eluting stents were associated with similar mortality and binary restenosis rates in a cohort of older patients with longer femoropopliteal lesions, outperforming traditional endovascular treatment, according to study researchers.

The objective of the retrospective dual center study was to compare DCB with DES in a cohort of 228 patients with lesions ≥10 cm. Patients in the cohort had a median age of 69 years and Rutherford categories 1 to 5 peripheral artery disease.

The researchers used propensity score stratification to minimize bias.

There were 131 patients in the DCB group, 77 of whom were men. The mean lesion length in this arm was 194.4 ± 86.3 mm (range, 100-450). In the DES group, there were 97 patients (62 men) with a lesion length of 195 ± 64.5 mm (range, 100-350).

Sixty-eight patients (51.9%) in the DCB group and 43 patients (44.2%) in the DES group underwent treatment for restenotic lesions.

Total occlusions occurred in 52.7% of the DCB arm and 62.9% of the DES arm.

Primary outcome measures included patency — defined as peak systolic velocity ratio <2.4 — clinically driven target lesion revascularization, event-free survival and freedom from worsening of Rutherford classification by ≥2 categories.

Among patients in the DCB group, provisional stent placement was performed in 18.3% of lesions. The reasons for these interventions were refractory stenosis (3.8%), flow-limiting dissection (9.9%) or other reasons (4.6%).

Neither group experienced procedure-related death.

Binary restenosis occurred in 23.9% of the DCB group and 30.4% of the DES group (P=.319). DCB yielded a 15.6% rate of clinically driven TLR, while DES was associated with a 19% rate of clinically driven TLR (P=.543).

No differences were reported in estimates for freedom from clinically driven TLR and event-free survival. Similarly, outcomes regarding ankle-brachial index and Rutherford category were not different between the two groups.

The researchers concluded that the two interventions perform with equal efficacy and better than traditional endovascular treatment in this patient population.

Ehrin J. Armstrong, MD, MSc, of the division of cardiology at the University of Colorado School of Medicine and VA Eastern Colorado Healthcare System, suggested in an editorial accompanying the paper that one of the strengths of the study was that it included real-world lesions.

“While some studies have published results of DES in the treatment of long [femoropopliteal] lesions, there is little published data regarding DCB for lesions exceeding 100 mm,” he wrote. “This study therefore provides important comparative data on the treatment of long [femoropopliteal] lesions with DCB and DES.”

Another strength of the study is that it included a large proportion of patients with restenosis or chronic total occlusions, according to Armstrong. He noted that the broad inclusion criteria make the findings more applicable to general populations. “Third, most of the patients had dedicated duplex ultrasound follow-up at regular intervals, thereby allowing an estimate of restenosis over time,” he wrote.

Experts are encouraged to exercise caution in interpreting the results because the study is a post-hoc analysis, he said, adding that there are other limitations. “For example, a significantly lower percentage of patients in the DCB group underwent subintimal angioplasty, suggesting possible selection bias in the DCB vs. DES group that may not have been accounted for in the propensity stratification model,” Armstrong wrote. “Second, 18% of patients in the DCB group required provisional stent placement. It is unknown what the combined effects are of DCB in conjunction with a bare nitinol stent.”

Armstrong highlighted the trend toward improved patency among patients who received a provisional stent in addition to DCB. He also noted that clopidogrel was given for 1 month in the DCB group and 3 months in the DES group. “A longer duration of clopidogrel in the DES group could limit the risk of restenosis or target lesion failure,” he wrote. “Despite these limitations, however, the novel data from this article provide important insights into the relative outcomes of DCB vs. DES in real-world patients.

“These new treatments will occupy a significant niche in the treatment of [femoropopliteal] disease and may become first-line therapy,” he added.

For more information:

Armstrong EJ. J Endovasc Ther. 2014;21:369-372.

Zeller T. J Endovasc Ther. 2014;21:359-368.

Disclosure: The researchers report financial disclosures with Cook Inc. and Medtronic. Armstrong reports no relevant financial disclosures.