Drug-eluting stents (DES) have a significantly higher primary patency versus drug-coated balloons (DCB) over 3 years for patients with femoropopliteal artery (FPA) disease, according to a new Japanese study. However, this did not translate into a clinical benefit since clinically driven target lesion revascularization (CD-TLR) was similar between the two groups. The findings from 1,406 FPA patients in a multicenter registry who underwent endovascular therapy with either DES (n = 342) or DCB (n = 1,064) were published Tuesday online in JACC: Cardiovascular Interventions. Long-term data comparing DES to DCB in FPA have remained limited, the authors — led by Tatsuya Nakama, MD, from Tokyo Bay Medical Center — noted, despite both devices now being widely used in the setting. Since the “unique biomechanical challenges” of FPA — including complex vessel motion and external compression — limit the long-term durability of DES, DCB-based “leave nothing behind strategies have gained popularity,” they said. Nevertheless, balloon-based devices are less effective in cases of significant recoil or severe dissection, the researchers stressed, adding that, “In such scenarios, termed lesion preparation failure, DES implantation or bailout stenting is required”. And while a 1-year readout from the BEASTARS (Band of EAST Japan Angioplasty Retrospective Study) registry — looking at DES and DCB without balloon stenting, following successful lesion preparation — showed comparable 1-year outcomes, long-term outcomes have remained unclear, they wrote. The current study therefore looked at the 30-year follow-up results from BEASTARS for patients under the same conditions. At baseline, sex, age and mobility issues were similarly weighted, as were most other lifestyle factors, though cilostazol use was significantly higher in the DES group (35.4% vs 27.4%; P = 0.006). There were also significant baseline differences for; the presence of popliteal lesion (31.3% vs 39.9%, respectively; P = 0.005), history of revascularization (12.3% vs 21.6%, respectively; P = 0.001), in-stent restenosis (9.1% vs 14.2%; P = 0.017), reference vessel diameter (a mean 5.6 mm ± 0.7 in DES vs 5.2 mm ± 0.7 in DCB; P = 0.001), lesion length (a mea of 175 mm ± 97 vs 146 mm ± 91, respectively; P = 0.001), chronic total occlusion rates (42.5% vs 23.6%, respectively; P = 0.001), presence of severe calcification (32.2% vs 24.6%, respectively; P = 0.007), non-compliant balloon use (23.4% vs 29.7%, respectively; P = 0.028) and dissection Grade C after pre-dilation (22.5% vs 10.2%, respectively; P = 0.001). Propensity score matching was performed to minimize the baseline differences, resulting in 314 matched pairs; with 314 patients treated with DES (including 73.9% with the Eluvia device, and 26.1% with the Zilver PTX), and 981 patients given DCB (64.3% with the IN.PACT device, and 35.7% with the Lutonix). Successful lesion preparation was defined as <50% residual stenosis and absence of Grade D or higher dissection. During the median 22.5 months follow-up period (8.8 to 37.1 months), 484 cases of patency loss were observed. After matching, the 3-year primary patency was significantly higher in the DES than in the DCB group, the researchers noted (65.3% vs 59.5%, respectively; P = 0.042). However, freedom from CD-TLR was similar (73.2% vs 72.2%, respectively; P = 0.27). Lesion length >150 mm and dissection Grade C showed significant interaction effects (P = 0.007 and 0.013, respectively), indicating greater benefit from DES in reducing the restenosis risk. “Despite successful lesion preparation, DES demonstrated significantly higher primary patency over 3 years. However, this did not translate into a clinical benefit, as freedom from CD-TLR rates remained comparable between groups,” the authors concluded. Cost considerations However, in an accompanying editorial, Peter Henke, MD, from the University of Michigan, pointed out that cost of the DCB vs DES needs to be considered. “This is widely variable and dependent in part on the setting of the intervention and the local networks,” he wrote. He added that the financial cost of lesion preparation is also a key consideration. “For example, intravascular lithotripsy and/or atherectomy can be a relatively higher cost procedure, and not without risk of complications,” he stressed. “Moreover, there is no comparative evidence to suggest they are beneficial over conventional, less expensive, lesion preparation strategies such as balloon angioplasty before DCB or DES.” Source: Nakama T, Takahara M, Iwata Y, et al. 3-Year Outcomes of Drug-Eluting Stent vs Drug-Coated Balloon for Femoropopliteal Artery Lesions: Propensity Score–Matched Real-World Study. JACC Cardiovasc Interv; 18: 2155-2166. Henke P. Drug-Eluting Stenting vs Drug-Coated Ballon Angioplasty Getting Better Defined. JACC Cardiovasc Interv; 18: 2167-2168. Image Credit: Mark Adams – stock.adobe.com