Observational studies have investigated the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) used in nonvalvular atrial fibrillation. We performed a systematic review and meta-analysis assessing the risk of ischaemic stroke, thromboembolism (TE) and intracranial haemorrhage (ICH) associated with the use of DOACs and VKAs.Medline and Embase were systematically searched until April 2021. Observational studies were gathered and hazard ratios (HRs) with 95% confidence intervals (CI) were extracted. Subgroup analyses based on DOAC doses, history of chronic kidney disease, stroke, exposure to VKA, age and sex were performed. A random-effects model was used.We included 92 studies and performed 107 comparisons. Apixaban was associated with lower risk of stroke (HR: 0.82, 95% CI: 0.68-0.99) compared to dabigatran. Rivaroxaban was associated with lower risk of stroke (HR: 0.90, 95% CI: 0.83-0.98) compared to VKA. Dabigatran (HR: 0.85, 95% CI: 0.80-0.91), rivaroxaban (HR: 0.83, 95% CI: 0.77-0.89) and apixaban (HR: 0.75, 95% CI: 0.65-0.86) were associated with lower risk for TE/stroke compared to VKA. Apixaban (HR: 1.32, 95% CI: 1.03-1.68) and rivaroxaban (HR: 1.58, 95% CI: 1.31-1.89) were associated with higher risk of ICH compared to dabigatran. Dabigatran (HR: 0.48, 95% CI: 0.44-0.52), apixaban (HR: 0.60, 95% CI: 0.49-0.73) and rivaroxaban (HR: 0.73, 95% CI: 0.65-0.81) were associated with lower risk of ICH compared to VKA.Our study demonstrated significant differences in the risk of ischaemic stroke, TE/stroke and ICH associated with individual DOACs compared to both other DOACs and VKA.
Iliac artery anatomy can have a dramatic impact on the success of endovascular complex aortic aneurysm (CAA) procedures as endograft delivery systems need to be advanced and manipulated through these access vessels. The aim of this study was to evaluate the outcomes of iliac artery conduits with emphasizes on open vs endovascular conduits performed to facilitate CAA endovascular repair.All patients who had open or endovascular iliac conduits prior to endovascular CAA repair to treat thoracoabdominal, juxtarenal, or suprarenal aneurysms at the University of Colorado Hospital from January 2009 through January 2019 were included. Patients who presented with symptomatic or ruptured aortic aneurysms were excluded. Outcomes of interest included postoperative complications and mortality in patients undergoing iliac conduits.Twenty-seven patients with a total of 42 conduits were included in the study. The majority of patients (N = 15, 56%) were female and the average age was 72 ± 9 years. The calculated VQI cardiac index was .6% (range, .3%-.8%). Eighteen (43%) endovascular and 24 (57%) open iliac conduits were performed during the study period. Thirty (71%) conduits were performed in a staged fashion, while 12 (29%) were performed at the same time as endovascular CAA repair. The mean time between conduit and definitive aneurysm repair surgery was 130 ± 68 days in the endovascular and 107 ± 79 days in the open groups (P = .87). No aneurysm rupture occurred during the staging period in either group. The median follow-up for the entire cohort was 18 ± 22 months. The median length of hospital stay for patients undergoing endovascular and open ICs was 6 (ranging, 1-28 days) and 7 days (ranging, 3-18 days), respectively. Patients undergoing open conduits had significantly more complications than those undergoing endovascular conduit (endoconduit) creation. A total of 4 (15%) patients died within 30 days after aneurysm repair. Out of 23 survivors, 18 (78%) patients were discharged home, 4 (18%) patients were discharged to a skilled nursing facility, and 1 (4%) patient was discharged to an acute rehabilitation facility. No mortality difference based on type of conduit was found.Overall complication rate associated with creation of open iliac artery conduits is not negligible. Endoconduits, which carry less morbidity than open conduits, are preferred as a first-line adjunctive access procedure to facilitate complex endovascular aortic aneurysm repair.
Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.
Optimal balloon angioplasty for infrapopliteal lesions is often limited by severe calcification, which has been associated with decreased procedural success and lower long-term patency.This was a prospective, randomized, multicenter pilot trial that included adult subjects with calcified lesions located from the popliteal segment below the knee (BTK) joint to within 5 cm above the ankle with ≥70% diameter stenosis by angiography. Patients were randomized 1:1 to undergo orbital atherectomy (OA) with adjunctive drug-coated balloon (DCB) angioplasty versus plain balloon angioplasty (BA) and DCB angioplasty (control). The periprocedural and 12 month outcomes of both procedures were compared.Overall, 66 subjects (OA + DCB = 32 vs control = 34) were included in an intention to treat analysis. Baseline demographics and lesion characteristics were well-balanced. The mean lesion length was 101.3 mm (SD = 72.8 mm) and 78.8 (SD = 61.0 mm) in the OA + DCB and control groups, respectively, with almost all lesions having severe calcification per the Peripheral Academic Research Consortium (PARC) criteria. Chronic total occlusions (CTOs) were present in 43.8% and 35.3% of the patients in the OA + DCB and control groups, respectively. The technical success of OA + DCB versus DCB was 81.8% and 89.2%, respectively, with 3 slow flow/no reflow, 1 perforation, 1 severe dissection occurred in OA + DCB group, and one distal embolization occurred in the control group. The target lesion primary patency rate was numerically higher in the OA + DCB versus control group at 6 (88.2% vs 50.0%, p=0.065) and 12 month follow-up (88.2% vs 54.5%, p=0.076). The 12 month freedom from major adverse events, clinically-driven target lesion revascularization, major amputation, and all-cause mortality rates were similar between both groups.The results of the Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified BTK (OPTIMIZE BTK) pilot study indicated that utilization of OA + DCB is safe for infrapopliteal disease. Further prospective adequately powered studies should investigate the potential benefit of combined OA + DCB for BTK lesions.
Infrapopliteal arterial disease results from 2 major etiologies: medial calcification and intimal atheromatous plaque. Lesion calcification constitutes one of the most widely encountered risk factors for percutaneous transluminal angioplasty failure. Intravascular lithotripsy (IVL) creates selective fracturing of calcium deposits in the arterial wall, increasing the compliance of the target artery and facilitating angioplasty. Results regarding IVL utilization at femoropopliteal and infrapopliteal lesions have been very promising in terms of safety and efficacy. This review presents currently available data on IVL outcomes for infrapopliteal lesions and provides technical information for optimal use of IVL in these challenging lesions.
Purpose: Balloon angioplasty for the treatment of femoropopliteal lesions is often complicated by postangioplasty dissections. While dissections are known to affect patency and reintervention after balloon angioplasty, the association between dissections and major adverse limb event (MALE) after drug-coated balloon (DCB) angioplasty remains uncertain. Thus, the postangioplasty dissection and bailout stenting patterns were investigated. Materials and Methods: This was a single-center retrospective study enrolling patients with de novo femoropopliteal lesions treated with DCB with/without stenting. Postangioplasty target vessel dissection was graded based to the coronary artery classification grades A-F, with grade C-F considered “severe.” Cox regression analysis was performed to examine the association of dissection severity with outcomes during 2-year follow up, among nonstented cases. Results: In 85.3% of the cases (N=203/238) a postangioplasty dissection was observed. The average dissection length was 55.57 mm (SD 36.71 mm), with 1 dissection present in 91.8% (N=180/196) and 2 or more dissections present in 8.2% (N=16/196). Dissection severity was grade A (19.8%), B (20.6%), C (23.1%), D (10.9%), E (10.1%), and F (0.8%). Bailout stenting was required in 40.4% of the patients, being more prevalent among grade C and grade E cases. Among 142 nonstented cases, dissections were present in 85.2%. A total of 75 (52.8%) of these dissections were grade A and B, while 46 (32.4%) were grade C to F. Among nonstented cases, grade C (hazard ratio [HR] 5.83; 95% CI 1.25 to 27.31; p=0.025) and grade D (HR 6.32; 95% CI 1.39 to 28.86; p=0.017) vs grade A dissections were associated with a higher risk for 2-year MALE. Multivariate analysis adjusting for several lesion characteristics demonstrated a statistically significant higher risk for 2-year MALE among the severe dissection group (HR 2.94; 95% CI 1.27 to 6.79; p = 0.012). Interestingly, the risks of limb loss (HR 1.30; 95% CI 0.22 to 7.79; p=0.774) and repeat revascularization (HR 0.95; 95% CI 0.40 to 2.26; p=0.905) during follow-up were similar between the 2 groups. Conclusion: This study indicated that nonstented moderate and severe postangioplasty dissections after DCB angioplasty were associated with higher risk for MALE. Future studies are needed to validate our results and determine other dissection characteristics (eg, total dissection length, lumen area, total number of dissections) that may affect the efficacy of DCB.
