Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions.

PURPOSE: To compare the performance of drug-coated balloons (DCB) and drug-eluting stents (DES) in long femoropopliteal lesions. METHODS: A retrospective dual center study included 228 patients (139 men; median age 69 years) with femoropopliteal lesions ≥10 cm suffering from peripheral artery disease (Rutherford categories 1-5) treated either with DCB or DES. Propensity score stratification was used to minimize bias. The 131 DCB patients (77 men; mean age 68.9±10.5 years) had a mean lesion length of 194.4±86.3 mm (range 100-450), while the 97 DES patients (62 men; mean age 68.2±8.0 years) had lesions averaging 195.0±64.5 mm (range 100-350) in length. Restenotic lesions were treated in 68 (51.9%) DCB patients and 43 (44.3%) DES patients; over half the lesions in both groups were total occlusions [DCB: 69 (52.7%), DES: 61 (62.9%)]. Outcome measures were patency (peak systolic velocity ratio <2.4), clinically driven target lesion revascularization (TLR), event-free survival, and freedom from worsening of Rutherford classification by ≥2 categories. RESULTS: In the DCB cohort, provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flow-limiting dissection (13, 9.9%), and other reasons (6, 4.6%). There was no procedure-related mortality in either cohort. The binary restenosis rates were 23.9% (26/109) and 30.4% (24/79, p=0.319) in the DCB and DES cohorts, respectively, and clinically driven TLR rates were 15.6% (17/109) vs. 19.0% (15/79, p=0.543), respectively. Estimates for freedom from clinically driven TLR and event-free survival were not different between the study cohorts nor were outcomes regarding the ankle-brachial index and Rutherford category. CONCLUSION: DCB and DES perform equally well in the endovascular treatment of femoropopliteal lesions ≥10 cm and better than traditional endovascular treatment. In a real world setting of TASC C and D lesions, the provisional stent rate in the DCB cohort is low.

Structural Damage of Jailed Guidewire During the Treatment of Coronary Bifurcation Lesions: A Microscopic Randomized Trial.

OBJECTIVES: The study sought to compare the safety (resistance to damage) and efficacy (ability to cross the side branch) of polymer-coated and non-polymer-coated guidewires in the jailed wire technique used during the percutaneous treatment of bifurcation lesions. BACKGROUND: The jailed wire technique is a useful strategy in the treatment of bifurcation lesions by provisional stenting. However, these wires can be damaged or even be broken during their removal. METHODS: We performed a randomized study in patients with bifurcation lesions treated by provisional stenting. The jailed wire technique was mandatory, and the types of guidewires, polymer-coated (n = 115) and non-polymer-coated (n = 120), were randomized. After the procedures, the wires were evaluated by stereoscopic microscopy. The induced damage in the wires was classified as follows: no damage, mild, moderate, or severe. RESULTS: The clinical characteristics were similar between patients treated with polymer-coated or non-polymer-coated wires. Polymer-coated wires were significantly (p < 0.001) more resistant to retrieval damage (only 2 wires showed mild damage) than were non-polymer-coated wires. However, 63 (55%) of the non-polymer-coated wires were damaged; 37 (32%), 24 (21%), and 2 (2%) had mild, moderate, and severe damage, respectively. Additionally, the jailed length of the wire was a factor contributing to the degree of wire damage. The time of side branch wiring was shorter in the polymer-coated wire group (19 ± 40 s vs. 42 ± 72 s; p < 0.05). CONCLUSIONS: Jailed wires during interventional procedures of bifurcation lesions commonly showed microscopic damage. Polymer-coated wires were more resistant to retrieval damage and were more efficient in crossing the side branch ostium than non-polymer-coated wires. (Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Stereoscopic Microscopy Study; NCT02516891).

Procedural and Long-Term Outcomes of Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions: The BONITO Registry (Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions).

BACKGROUND: There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions. METHODS AND RESULTS: We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43±1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS- and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS. CONCLUSIONS: Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings.