Drug-Eluting Balloons Reduce Restenosis, TLR in Diabetic Patients with CLI

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Employing drug-eluting balloons (DEBs) to treat in-stent restenosis in the femoropopliteal artery reduces the risk of recurrent restenosis and repeat intervention at 1 year compared with standard angioplasty. Results of the small study using historical controls appear in the February 2014 issue of the Journal of Endovascular Therapy.

For the DEBATE-ISR (Drug-Eluting Balloon in Peripheral Intervention for In-Stent Restenosis) study, Francesco Liistro, MD, of San Donato Hospital (Arezzo, Italy), and colleagues enrolled 44 consecutive diabetic patients with claudication or critical limb ischemia (72.7% male; mean age 74 years) who were treated with the IN.PACT Admiral paclitaxel-eluting balloon (Medtronic, Santa Rosa, CA) from January 2010 to December 2011. One-year outcomes were compared with a group of 42 historical controls (54.8% male; mean age 76) treated with standard balloon angioplasty from 2008 to 2009.

Available DEB lengths at study inception were 40, 60, 80, and 120 mm. In cases with lesions longer than 100 mm, 2 or more DEBs were used with a minimum 5-mm balloon overlap at the edges to avoid geographic miss. In case of additional stenting, the segment was pretreated with a DEB for a total length equal to the stent (Maris Plus nitinol stent; Medtronic) with an additional 10 mm at both edges.

Procedural success was obtained in all treated lesions, and no adverse clinical events occurred during hospitalization in either group. Concomitant below-the-knee intervention was performed in almost half of patients. Two patients, 1 in each group, had impending distal embolization after predilation of occlusive in-stent restenosis and were successfully treated with a thrombus aspiration catheter. Eighteen additional stents were implanted (11 in 8 controls, 7 in 5 study patients), with a no difference in mean length between the groups (P = 0.2).

At 1 year, there were no differences in hard outcomes, but DEB-treated patients fared better in terms of TLR and binary restenosis (table 1). Assessment of vessel patency was possible in 93% of each cohort (P = 0.9), with an angiographic evaluation in 61.4% of study patients vs 61.9% of controls (P = 0.9).

Table 1. Outcomes at 12 Months

^a log-rank P value.

Multivariate analysis showed that baseline Tosaka class III, or totally occluded, in-stent lesions, were positively linked (OR 4.9; 95% CI 1.6-15.2; P = 0.006) and DEB treatment was negatively tied (OR 0.09; 95% CI 0.03-0.27; P < 0.001) to any recurring restenosis. Moreover, baseline Tosaka class III ISR (OR 4.8; 95% CI 1.5-15.2; P = 0.007) and DEB treatment (OR 0.2; 95% CI 0.07-0.6; P = 0.03) were the only factors independently associated with occlusive restenosis.

‘An Attractive Option’

The results “offer important reassurance to clinicians regarding the safety of this strategy, as no aneurysm formation, recently reported with DEB use in the coronary district, was observed,” Dr. Liistro and colleagues write. “Thus, DEBs appear as an attractive option for femoropopliteal [in-stent restenosis].”

The authors were surprised that when restenosis did occur in DEB-treated patients, it was occlusive most of the time. “A possible explanation of this phenomenon is related to the fixed amount of drug available in the balloon, perhaps not enough to control the malignant [tendency] of intimal hyperplasia in predisposed patients,” they suggest. “Debulking might potentially be of special interest in these complicated cases.”

In an accompanying editorial, Ehrin J. Armstrong, MD, MSc, of the University of Colorado, Denver (Denver, CO), and John R. Laird, MD, of the University of California, Davis (Sacramento, CA), say the results “are particularly impressive in light of the high-risk patient population being treated.”

However, they add, “we cannot draw definitive conclusions regarding the benefit of DEBs [because] use of historical controls can result in recall bias or misclassification.”

Additionally, other treatment facets can improve with time, Drs. Armstrong and Laird suggest. “For example, there were longer balloon inflation times for the DEB cohort, and increased inflation time may translate into better results with balloon angioplasty regardless of whether the balloon is coated with a drug,” they write.

Potential Drawbacks

Bruno Scheller, MD, of the University of Saarland (Homburg, Germany), told TCTMD in an e-mail that because drug-coated balloons “work [so well] in the treatment of coronary [in-stent restenosis],” he was not surprised at the positive results of the study. “The most important advantage of [drug-coated balloons] is the avoidance of another layer of metal in a situation where previously implanted stents did not work,” he explained. “Therefore, I do not see relevant drawbacks for [drug-coated balloons] in this clinical scenario.”

However, the editorial lists multiple drawbacks of DEB use including “the potential need for multiple balloons to treat long lesions, the need for bailout stenting in some cases, and the added cost of this technology.” Drs. Armstrong and Laird observe that “drug-eluting nitinol stents may also prove to be an effective modality for [femoropopliteal in-stent restenosis],;” although they admit that “the prospect of another layer of stents in the [superficial femoral artery] is less attractive.”

The editorial and Dr. Scheller agree that randomized studies are necessary to prove superiority of DEBs over other modalities. Dr. Scheller said that the results of 2 pivotal trials studying the final role of drug-coated balloons in the treatment of superficial femoral artery disease, LEVANT II and SFA I/II, will be presented in the coming months.

Study Details

CLI was the indication for intervention in the majority of patients. In-stent restenosis had an occlusive (Tosaka class III) pattern in more than half of the patients, and restenosis length was more than 100 mm in the majority of patients. Stent fracture was present in 28 lesions.

Baseline differences were well balanced between the study groups. However, balloon inflation time was longer in DEB-treated patients vs controls (131 ± 10 vs 60 ± 20 seconds; P < 0.01).

 

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Sources:
1. Liistro F, Angioli P, Porto I, et al. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014;21:1-8.

2. Armstrong EJ, Laird JR. Treatment of femoropopliteal in-stent restenosis for patients with diabetes: do we have an answer to the DEBATE? [editorial]. J Endovasc Ther. 2014;21:9-11.

 

 

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