Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Comparison of long-term outcomes after directional versus rotational atherectomy in peripheral artery disease.

INTRODUCTION: The rate of atherectomy utilization in peripheral artery diseases (PAD) is growing. The two atherectomy devices available on the market and used most frequently are the directional and rotational ones. Nonetheless, there is a lack of direct comparison between these two types of atherectomy in PAD. AIM: To compare the long-term outcomes after PAD endovascular revascularization with two types of atherectomies: rotational (AR) (Phoenix Philips) and directional (AD) (SilverHawk Medtronic). MATERIAL AND METHODS: This was a single-center, retrospective study of obstructive and symptomatic PAD patients who underwent revascularization with atherectomy. The endpoints were considered as target lesion revascularization (TLR), death, amputations and bailout stenting (BS). RESULTS: The AR group consisted of 97 patients, while the AD group consisted of 85 individuals. There were no significant differences between the groups in terms of baseline characteristics except for an increased critical limb ischemia (CLI) prevalence in the AR group. The mean follow-up for AD and AR was 282.6 ±147.4 and 255.7 ±186.1 days, respectively (p = 0.44). There were no significant differences in the death rate (AD: 1 (1.7%) vs. AR: 5 (5.7%); p = 0.54), amputations (AD: 2 (2.3%) vs. AR: 5 (5.7%); p = 0.45) or bailout stenting (AD: 2 (2.3%) vs. AR: 3 (3.2%); p = 0.74), whereas TLR was more frequent in the AD group (AD: 25 (29%) vs. AR: 15 (15.9%; p = 0.03). The Kaplan-Meier analysis showed no significant differences between the groups in time to TLR, amputation or death. CONCLUSIONS: In this hypothesis-generating study the AR had a lower rate of TLR when compared to the AD. Nevertheless, this should be confirmed in further controlled randomized trials.

Long term outcomes in diabetic patients treated with atherectomy for peripheral artery disease.

BACKGROUND: The prevalence of diabetes has increased significantly in well-developed countries during the last decade and it continues to grow. Diabetes increases the risk of restenosis in patients treated percutaneously for peripheral artery disease. The present study sought to compare outcomes of atherectomy treatment in diabetic (DM) vs. non-diabetic (nDM) patients suffering from peripheral artery disease. METHOD: Between 2008 and 2012, 204 revascularization atherectomy procedures were performed on arteries of the lower extremities. The endpoints included target lesion revascularization (TLR), amputation and death. The type of atherectomy (excisional-soft plaque, orbital-calcified plaque, with active aspiration - with a thrombus) was left to operator discretion. RESULTS: This study contains 132 DM (66% male, age 68 ± 11.2 years) and 72 nDM (63% male, age 75 ± 11.3 years) subjects. DM were younger but had a higher prevalence of coronary artery disease (DM: 91% vs. nDM: 62%, p < 0.0001) and end-stage renal disease (DM: 22% vs. nDM: 2.5%, p < 0.0001). There were no differences in critical limb ischemia between the groups (DM: 21% vs. nDM: 12%, p = = 0.13). Mean time of follow-up was 384 and 411 days in DM and nDM, respectively (p = 0.43). There were no significant differences in TLR (DM: 15.2% vs. nDM: 22.2%, p = 0.249), amputations (DM: 3.0% vs. nDM: 1.5%, p = NS) or death rates (DM: 2.2% vs. nDM: 2.7%, p = NS). Kaplan-Mayer analysis showed no significant differences between the groups in the time to TLR, amputation or death. CONCLUSIONS: Plaque modification with adjusted atherectomy appears to have similar outcomes in diabetic as well as in non-diabetic patients. Nonetheless, a randomized study would be warranted to confirm the findings of the current study.

MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge.

BACKGROUND: This was the first prospective study to assess the safety and efficiency of MynxGrip vascular closure device (VCD) in peripheral interventions with antegrade access. METHODS AND RESULTS: We enrolled 66 consecutive patients from 1 center. All patients were discharged home on the day of procedure and were observed for adverse events at 1 and 30 days of follow-up. No major complications were observed. The rate of minor complications (conversion to manual or mechanical compression) was 7.6%. Postdischarge, 3% of patients experienced minor complications-small abscess, ipsilateral deep vein thrombosis. In 1 patient, a second VCD was deployed after device failure. The derived device failure rate was 5.9%. No patients required hospitalization. No late bleeding and no hematomas >6 cm were noted. The mean time to discharge was 4 hours and 5 minutes. CONCLUSION: The MynxGrip was safe and effective in sealing access sites after antegrade femoral artery puncture with same-day discharge.

Utilisation of bivalirudin and vascular closure devices for same-day discharge after percutaneous coronary and peripheral interventions.

BACKGROUND: Currently the majority of coronary and peripheral interventions are performed with an overnight stay. This increases the cost and does not reduce logistic constraints on hospital resources. We hypothesised that by combining bivalirudin with vascular closure devices we can safely discharge patients on the same day after percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) without increasing their risk of bleeding. AIM: To evaluate the safety and the feasibility of same-day discharge after PCI and PTA using bivalirudin and vascular closure devices. METHODS: This is a retrospective analysis of 833 consecutive patients who underwent percutaneous procedures in our centre between January 2007 and February 2010. The population was divided into interventional and diagnostic arms. All interventions were done with use of bivalirudin for anticoagulation and vascular closure devices for achieving haemostasis. Haemostasis in the diagnostic cohort was achieved with standard manual compression. The mean time of observation was 30 days. The mean age of patients was 64.3 years. The primary endpoint was any bleeding event meeting GUSTO criteria. The secondary endpoints included local vascular complications, major adverse cardiac and cerebrovascular events, time to ambulation and discharge, as well as need for overnight hospitalisation. RESULTS: In 30-day observation the primary endpoint occurred in 4.0% of patients in the interventional group and in 2.6% of patients in the diagnostic group (p = 0.31). The frequency of local vascular complications was higher in the interventional group although it was not statistically significant (3.1% vs. 2.9%; p = 0.33). Patients from the interventional group were ambulated sooner compared to the diagnostic group (117.5 vs. 131 min; p = 0.003). Time to discharge was 316.4 ± 38.7 min and 214.2 ± 23.4 min for interventional and diagnostic procedures, respectively (p < 0.001). CONCLUSIONS: PCI and PTA in the selected group of patients, with use of bivalirudin and vascular closure devices, do not appear to have increased risk of post-procedural events when compared to diagnostic procedures, and can be done safely without the need for an overnight stay.

Safety and biocompatibility of a novel self-expanding nitinol carotid stent with hybrid cell design in a porcine model of neointimal hyperplasia.

BACKGROUND: Stent design may influence the outcomes, suggesting that adverse event rates vary according to free cell area and cell design. Open cell design technology of self-expandable stents, dedicated for carotid revascularisation has better deliverability, although closed cell technology is expected to cause fewer thromboembolic events. AIM: To evaluate the feasibility and vascular response of novel, hybrid cell, self-expandable nitinol stents (MER®, Balton, Poland) implanted into porcine carotid arteries. Hybrid cell design combines open and closed cell technology. METHODS: All tested stents were implanted with 10% overstretch into 10 carotid segments of Polish domestic pigs. Control angiography was obtained immediately before and after vascular interventions as well as 28 days after the procedure. Thereafter, animals were sacrificed, and the treated segments were harvested and evaluated in the independent histopathology laboratory. RESULTS: All stents were easily introduced and implanted, showing good angiographic acute outcome. At 28 days, in the angiography, all vessels were patent with no signs of thrombi or excessive neointimal formation, with the late lumen loss of -0.11 ± 0.3 mm and percentage diameter stenosis 10.18 ± 8.1%. There was a 10% increase in the vessel reference diameter when compared to baseline (4.57 ± 0.5 vs. 4.96 ± 0.3 mm, p < 0.01). In the histopathology, mean area stenosis was 17.4% and mean intimal thickness was 0.20 mm. At histopathology, the mean injury, inflammation, and fibrin scores were low. Endothelialisation was complete in all stents, and neointimal tissue appeared moderately mature as shown by the moderate mean neointimal smooth muscle score. Nonetheless, histopathology shows one stent affected by peri-strut granulomas and one stent affected by marked mineralisation. CONCLUSIONS: The novel Polish self-expandable nitinol carotid stent with hybrid cell technology shows optimal biocompatibility and a vascular healing profile, and therefore may be introduced for first-in-man application.