Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis.

OBJECTIVES: This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation. METHODS: BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study is a 24-month subgroup analysis of patients with diabetes mellitus having infrainguinal lesions treated with the Passeo-18 Lux DCB. The primary endpoints were freedom from major adverse events (MAEs) within 6 months of intervention and freedom from clinically driven target lesion revascularisation (CD-TLR) within 12 months of intervention. RESULTS: Of the 882 patients in the registry, 418 had diabetes (516 lesions). Most diabetics had concomitant hypertension (88.8%) and hyperlipidaemia (70.3%). Insulin dependence was observed in 48.8% of diabetics. Moreover, smoking (62.2%) and chronic renal insufficiency (41.9%) were also found to be common in this cohort. Chronic limb threatening ischemia (Rutherford class ≥4) was present in 53.1% of all patients. 22.9% of lesions were infrapopliteal, while 22.5% of lesions were treated for in-stent restenosis. The mean target lesion length was 85.6 ± 73.2 mm, and 79.4% of lesions were calcified (of which 17.9% were heavily calcified). Overall, device success was 99.7%. Freedom from MAEs was 90.5% (95% confidence interval (95% CI): 87.2-93.0) at 6 months, 85.4% (95% CI: 81.5-88.6) at 12 months and 80% (95% CI: 75.5-83.8) at 24 months. Freedom from CD-TLR was 95.9% (95% CI: 93.8-97.4), 91.6% (95% CI: 88.7-93.8), and 87.1% (95% CI: 83.5-89.9) at 6, 12, and 24 months, respectively. All-cause mortality at 24 months in diabetics was 16.0% (95% CI: 12.6-20.2), and major target limb amputation was 6.1% (95% CI: 4.1-8.9), which was significantly higher than in non-diabetics (8.4% (95% CI: 6.0-11.6), P = 0.0005 and 1.2% (95% CI: 0.5-2.9), P <0.0001, respectively). At 24 months, 82.0% of patients had improved by ≥1 Rutherford class. CONCLUSION: Treatment of a real-world diabetic patient population with the Passeo-18 Lux DCB resulted in high efficacy and low complication rates, despite the fact that diabetic patients usually suffer from a multitude of concomitant comorbidities. CLINICAL TRIAL REGISTRATION: NCT02276313.

A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach.

AIMS: To select a core list of standard outcomes for diabetes to be routinely applied internationally, including patient-reported outcomes. METHODS: We conducted a structured systematic review of outcome measures, focusing on adults with either type 1 or type 2 diabetes. This process was followed by a consensus-driven modified Delphi panel, including a multidisciplinary group of academics, health professionals and people with diabetes. External feedback to validate the set of outcome measures was sought from people with diabetes and health professionals. RESULTS: The panel identified an essential set of clinical outcomes related to diabetes control, acute events, chronic complications, health service utilisation, and survival that can be measured using routine administrative data and/or clinical records. Three instruments were recommended for annual measurement of patient-reported outcome measures: the WHO Well-Being Index for psychological well-being; the depression module of the Patient Health Questionnaire for depression; and the Problem Areas in Diabetes scale for diabetes distress. A range of factors related to demographic, diagnostic profile, lifestyle, social support and treatment of diabetes were also identified for case-mix adjustment. CONCLUSIONS: We recommend the standard set identified in this study for use in routine practice to monitor, benchmark and improve diabetes care. The inclusion of patient-reported outcomes enables people living with diabetes to report directly on their condition in a structured way.

Low molecular weight heparin for prevention of microvascular occlusion in digital replantation.

BACKGROUND: The success of digital replantation is highly dependent on the patency of the repaired vessels after microvascular anastomosis. Antithrombotic agents are frequently used for preventing vascular occlusion. Low molecular weight heparin (LMWH) has been reported to be as effective as unfractionated heparin (UFH) in peripheral vascular surgery, but with fewer adverse effects. Its benefit in microvascular surgery such as digital replantation is unclear. This is an update of the review first published in 2013. OBJECTIVES: To assess if treatment with subcutaneous LMWH improves the salvage rate of the digits in patients with digital replantation after traumatic amputation. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers, to 17 March 2020. The authors searched PubMed, China National Knowledge Infrastructure (CNKI) and Chinese Electronic Periodical Services (CEPS) on 17 March 2020 and sought additional trials from reference lists of relevant publications. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials comparing treatment with LMWH versus any other treatment in participants who received digital replantation following traumatic digital amputation. DATA COLLECTION AND ANALYSIS: Two review authors (PL, CC) independently extracted data and assessed the risk of bias of the included trials using Cochrane's 'Risk of bias' tool. Disagreements were resolved by discussion. We assessed the certainty of evidence using the GRADE approach. MAIN RESULTS: We included two new randomised trials in this update, bringing the total number of included trials to four. They included a total of 258 participants, with at least 273 digits, from hospitals in China. Three studies compared LMWH versus UFH, and one compared LMWH versus no LMWH. The mean age of participants ranged from 24.5 to 37.6 years. In the studies reporting the sex of participants, there were a total of 145 men and 59 women. The certainty of the evidence was downgraded to low or very low because all studies were at high risk of performance or reporting bias (or both) and there was imprecision in the results due to the small numbers of participants. The three studies comparing LMWH versus UFH reported the success rate of replantation using different units of analysis (participant or digit), so we were unable to combine data from all three studies (one study reported results for both participants and digits). No evidence of a benefit in success of replantation was seen in the LMWH group when compared with UFH, regardless of whether the outcomes were reported by number of participants (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.87 to 1.10; 130 participants, 2 studies; very low-certainty evidence); or by number of digits (RR 0.97, 95% CI 0.90 to 1.04; 200 digits, 2 studies; low-certainty evidence). No studies reported the incidence of compromised microcirculation requiring surgical or non-surgical therapy, or any systemic/other causes of microvascular insufficiency. There was no evidence of a clear difference between the LMWH and UFH groups in occurrence of arterial occlusion (RR 1.08, 95% CI 0.16 to 7.10; 54 participants, 1 study; very low-certainty evidence) or venous occlusion (RR 0.81, 95% CI 0.20 to 3.27; 54 participants, 1 study; very low-certainty evidence). Two studies reported adverse effects. The LMWH and UFH groups showed no evidence of a difference in wound bleeding (RR 0.53, 95% CI 0.23 to 1.23; 130 participants, 2 studies; low-certainty evidence), haematuria (RR 0.43, 95% CI 0.09 to 2.11; 130 participants, 2 studies; very low-certainty evidence), ecchymoses (RR 0.82, 95% CI 0.21 to 3.19; 130 participants, 2 studies; very low-certainty evidence), epistaxis (RR 0.27, 95% CI 0.03 to 2.32; 130 participants, 2 studies; very low-certainty evidence), gingival bleeding (RR 0.18, 95% CI 0.02 to 1.43; 130 participants, 2 studies; very low-certainty evidence), and faecal occult blood (RR 0.27, 95% CI 0.03 to 2.31; 130 participants, 2 studies; very low-certainty evidence). We could not pool data on coagulation abnormalities as varying definitions and tests were used in the three studies. One study compared LMWH versus no LMWH. The success rate of replantation, when analysed by digits, was reported as 91.2% success in the LMWH group and 82.1% in the control group (RR 1.11, 95% CI 0.93 to 1.33; 73 digits, 1 study; very low-certainty evidence). Compromised microcirculation requiring surgical re-exploration, analysed by digits, was 11.8% in the LMWH group and 17.9% in the control group (RR 0.86, 95% CI 0.21 to 3.58; 73 digits, 1 study; very low-certainty evidence). Compromised microcirculation requiring incision occurred in five out of 34 digits (14.7%) in the LMWH group and eight out of 39 digits (20.5%) in the control group (RR 0.72, 95% CI 0.26 to 1.98; 73 digits; very low-certainty evidence). Microvascular insufficiency due to arterial occlusion, analysed by digits, was 11.8% in the LMWH group and 17.9% in the control group (RR 0.66, 95% CI 0.21 to 2.05; 73 digits, 1 study; very low-certainty evidence), and venous occlusion was 14.7% in the LMWH group and 20.5% in the control (RR 0.72, 95% CI 0.26 to 1.98; 73 digits, 1 study; very low-certainty evidence). The study did not report complications or adverse effects. AUTHORS' CONCLUSIONS: There is currently low to very low-certainty evidence, based on four RCTs, suggesting no evidence of a benefit from LMWH when compared to UFH on the success rates of replantation or affect microvascular insufficiency due to vessel occlusion (analysed by digit or participant). LMWH had similar success rates of replantation; and the incidence rate of venous and arterial microvascular insufficiency showed no evidence of a difference between groups when LMWH was compared to no LMWH (analysed by digit). Similar rates of complications and adverse effects were seen between UFH and LMWH. There was insufficient evidence to draw conclusions on any effect on coagulation when comparing LMWH to UFH or no LMWH. The certainty of the evidence was downgraded due to performance and reporting bias, as well as imprecision in the results. Further adequately powered studies are warranted to provide high-certainty evidence.

The risk of periodontitis for peripheral vascular disease: a systematic review.

Periodontitis is one of the risk factors associated with peripheral artery disease. This meta-analysis evaluates how periodontitis contributes to the pathogenesis and progression of peripheral artery disease. We systematically searched electronic databases Ovid Medline, Embase, Cochrane Library and Pubmed. Grey literature was also searched via Google Scholar. All studies evaluating the relationship between the incidence of periodontitis and peripheral artery disease were included. Subgroup analyses of carotid artery disease and lower extremity arterial disease were also conducted. Odds ratios (OR) and 95% confidence intervals (CI) were pooled and analyzed. The I² statistic was used to evaluate heterogeneity. Within a total of 25 studies, including 22,090 participants based on eligibility criteria, the incidence of peripheral artery disease was significantly higher among those with periodontitis (OR: 1.60, 95% CI 1.41-1.82, P < 0.001, I² = 80.5%). In subgroup analysis, periodontitis was still a risk for lower extremity arterial disease (OR: 3.00, 95% CI 2.23-4.04, P < 0.001, I² = 0%) and carotid artery disease (OR: 1.39, 95% CI 1.24-1.56, P < 0.001, I² = 79.4%). Periodontitis is significantly associated with the incidence of lower extremity arterial disease and carotid artery disease.

The Association of Periodontitis and Peripheral Arterial Occlusive Disease-A Systematic Review.

Background: Observational studies support an association between periodontitis (PD) and atherosclerotic vascular disease, but little is known specifically about peripheral arterial occlusive disease (PAOD). OBJECTIVES: To systematically review the evidence for an association between PD and PAOD. DATA SOURCES: Medline via PubMed. REVIEW METHODS: We searched the Pubmed database for original studies, case reports, case series, meta-analyses and systematic reviews that assessed whether there is an association between PD (all degrees of severity) and PAOD (all degrees of severity). The reporting of this systematic review was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement following the Population, Intervention, Control, and Outcome (PICO) format. RESULTS: 17 out of 755 detected studies were included in the qualitative synthesis. Nine studies demonstrated associations between PD and PAOD, and two studies reported associations between tooth loss and PAOD. Six studies addressed the pathomechanism regarding PD as a possible trigger for PAOD. No study that dismissed an association could be detected. Odds ratios or hazard ratios ranged from 1.3 to 3.9 in four large cohort studies after adjusting for established cardiovascular risk factors. CONCLUSIONS: The presented evidence supports a link between PD and PAOD. Further studies which address the temporality of PD and PAOD and randomized controlled intervention trials examining the causal impact of PD on PAOD are needed. Although our results cannot confirm a causal role of PD in the development of PAOD, it is likely that PD is associated with PAOD and plays a contributing role.

Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon).

BACKGROUND: Numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB. METHODS: This was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months. RESULTS: Patients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014). CONCLUSIONS: Superiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry.

With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

Association between periodontitis and peripheral artery disease: a systematic review and meta-analysis.

BACKGROUND: Inflammation is a common feature of both peripheral arterial disease (PAD) and periodontitis. Some studies have evaluated the association between PAD and periodontitis. However, there is still no specialized meta-analysis that has quantitatively assessed the strength of the association. Thus, we conducted this meta-analysis to critically assess the strength of the association between PAD and periodontitis. METHODS: PubMed, Embase, and the Cochrane Library were searched for observational studies of the association between periodontitis and PAD in February 2018. Risk ratios (RRs) and their 95% confidence intervals (CIs) from included studies were pooled to evaluate the strength of the association between periodontitis and PAD. Weighted mean differences (WMDs) and their 95% CIs were pooled to compare the difference in periodontal-related parameters between PAD and non-PAD patients. RESULTS: Seven studies including a total of 4307 participants were included in the meta-analysis. The pooled analysis showed that there was a significant difference in the risk of periodontitis between PAD patients and non-PAD participants (RR = 1.70, 95% CI = 1.25-2.29, P = 0.01). There was also a significant difference in number of missing teeth between PAD patients and non-PAD participants (WMD = 3.75, 95% CI = 1.31-6.19, P = 0.003). No significant difference was found in clinical attachment loss between PAD patients and non-PAD participants (WMD = - 0.05, 95% CI = - 0.03-0.19, P = 0.686). CONCLUSION: In conclusion, the results of this meta-analysis revealed a significant relationship between periodontitis and PAD. Moreover, our study indicated that PAD patients had more missing teeth than control subjects did. Further high-quality and well-designed studies with specific inclusion and exclusion criteria are required to strengthen the conclusions of this study.

Secondhand smoke exposure and risk of incident peripheral arterial disease and mortality: a Scotland-wide retrospective cohort study of 4045 non-smokers with cotinine measurement.

BACKGROUND: Active smoking is an important risk factor for all-cause mortality and peripheral arterial disease (PAD). In contrast, published studies on the associations with secondhand smoke (SHS) are limited. The aim of this study was to examine the associations between SHS exposure and incident PAD, as well as mortality, among middle-aged non-smokers. METHODS: We undertook a retrospective, cohort study using record linkage of the Scottish Health Surveys between 1998 and 2010 to hospital admissions and death certificates. Inclusion was restricted to participants aged > 45 years. Cox proportional hazard models were used to examine the association between SHS exposure and incident PAD (hospital admission or death) and all-cause mortality, with adjustment for potential confounders. RESULTS: Of the 4045 confirmed non-smokers (self-reported non-smokers with salivary cotinine concentrations < 15 ng/mL), 1163 (28.8%) had either moderate or high exposure to SHS at baseline. In men, high exposure to SHS (cotinine ≥2.7 ng/mL) was associated with increased risk of all-cause mortality (fully adjusted hazard ratio [HR] 1.54, 95% CI 1.07-2.22, p = 0.020) with evidence of a dose-relationship (p for trend = 0.004). In men, high exposure to SHS was associated with increased risk of incident PAD over the first five years of follow-up (fully adjusted HR 4.29, 95% CI 1.14-16.10, p = 0.031) but the association became non-significant over longer term follow-up. CONCLUSIONS: SHS exposure was independently associated with all-cause mortality and may be associated with PAD, but larger studies, or meta-analyses, are required to confirm the latter.

Relationship between tooth loss and peripheral arterial disease among women.

AIM: We assessed the longitudinal association between tooth loss and peripheral arterial disease (PAD) within the Nurses' Health Study. MATERIALS AND METHODS: After excluding participants with prior cardiovascular diseases, 277 of 79,663 women were confirmed as PAD cases during 16 years of follow-up. Number of teeth and recent tooth loss were reported initially in 1992. Subsequent tooth loss was recorded in 1996 and in 2000. We evaluated the associations of baseline number of teeth and recent tooth loss with risk of PAD, adjusting for age, smoking, diabetes, hypertension, high cholesterol, aspirin use, family history of myocardial infarction, BMI, alcohol consumption, physical activity, postmenopausal hormone use, and use of vitamin E, vitamin D, multivitamin and calcium. RESULTS: Incident tooth loss during follow-up was significantly associated with higher hazard of PAD (HR = 1.31 95% CI: 1.00-1.71). However, the association appeared inverse among never smokers. There was no dose-response relationship between baseline number of teeth and PAD. CONCLUSIONS: Tooth loss showed a modest association with PAD, but no dose-response relationship was observed.

Periodontitis deteriorates peripheral arterial disease in Japanese population via enhanced systemic inflammation.

Peripheral arterial disease (PAD) is a common manifestation of arterial stenosis of the extremity that reduces arterial flow. While patients with periodontitis are at a high risk of PAD, little causal information has been provided to date. To clarify the relationship, we conducted this cross-sectional study. The oral condition of patients with or without PAD, who attended Tokyo Medical and Dental University Hospital, was evaluated. Blood examinations and dental clinical measurements, including number of teeth, probing pocket depth (PPD), bleeding on probing (BOP) and clinical attachment level (CAL) were performed. Chi-square test was performed to compare gender, smoker rate, prevalence of DM, hypertension and dyslipidemia and edentulous rate. Wilcoxon test was used to compare bacterial counts and anti-bacterial antibodies and Student's t test was used to compare the other numerical values. The subjects were patients with (n = 34) or without (n = 956) PAD. We revealed that the PAD patients had more missing teeth (17.5 ± 11.0), a higher rate of edentulism (18%), and higher serum inflammatory factor levels than non-PAD patients (10.9 ± 8.7, 5%, respectively). On the other hand, there was no significant difference between hypertension, dyslipidemia, smoking status, HbA1c, bacterial antibody titers, and bacterial counts between the groups. In conclusion, we clarified that PAD patients had decreased tooth number and worsened oral and periodontal condition with enhanced systemic inflammation.

Long-Term Primary Patency Rate After Nitinol Self-Expandable Stents Implantation in Long, Totally Occluded Femoropopliteal (TASC II C & D) Lesions.

BACKGROUND: Endovascular therapy for long femoropopliteal lesions using percutaneous transluminal balloon angioplasty or first-generation of peripheral stents has been associated with unacceptable one-year restenosis rates. However, with recent advances in equipment and techniques, a better primary patency rate is expected. This study was conducted to detect the long-term primary patency rate of nitinol self-expandable stents implanted in long, totally occluded femoropopliteal lesions TransAtlantic Inter-Society Census (TASC II type C & D), and determine the predictors of reocclusion or restenosis in the stented segments. METHODS: The demographics, clinical, anatomical, and procedural data of 213 patients with 240 de novo totally occluded femoropopliteal (TASC II type C & D) lesions treated with nitinol self-expandable stents were retrospectively analysed. Of these limbs, 159 (66.2%) presented with intermittent claudication, while 81 (33.8%) presented with critical limb ischaemia. The mean-time of follow-up was 36±22.6 months, (range: 6.3-106.2 months). Outcomes evaluated were, primary patency rate and predictors of reocclusion or restenosis in the stented segments. RESULTS: The mean age of the patients was 70.9±9.3 years, with male gender 66.2%. Mean pre-procedural ABI was 0.45±0.53. One-hundred-and-seventy-five (73%) lesions were TASC II type C, while 65 (27%) were type D lesions. The mean length of the lesions was 17.9±11.3mm. Procedure related complications occurred in 10 (4.1%) limbs. There was no periprocedural mortality. Reocclusion and restenosis were detected during follow-up in 45 and 30 limbs respectively, and all were re-treated by endovascular approach. None of the patients required major amputation. Primary patency rates were 81.4±1.1%, 77.7±1.9% and 74.4±2.8% at 12, 24, and 36 months respectively. Male gender, severe calcification, and TASC II D lesion were independent predictors for reocclusion, while predictors of restenosis were DM, smoking and TASC II D lesions. CONCLUSIONS: Treatment of long, totally occluded femoropopliteal (TASC II C & D) lesions with nitinol self-expandable stents is safe and is associated with highly acceptable long-term primary patency rates.

Incidence, predictors, and prognosis of in-stent occlusion after endovascular treatment with nitinol stents for femoropopliteal lesions.

OBJECTIVE: Widespread use of self-expanding nitinol stent-based endovascular treatment (EVT) for femoropopliteal (FP) lesions has been fueled by its less-invasive nature and modest durability; however, prevalence, predictors and prognosis of in-stent occlusion are undefined and were investigated here. METHODS: This study entailed a multicenter, retrospective analysis of a prospectively maintained database. Between January 2004 and December 2011, 2447 de novo FP lesions (mean length, 143 ± 87 mm; 52% chronic total occlusions) from 2008 patients (mean age, 73.0 ± 9.2 years; 71% male; 61% diabetics; 32% critical limb ischemia; and 24% on hemodialysis) were treated with nitinol stent-based EVT. Study outcome was in-stent occlusion: rates (1, 3, and 5 years), predictors and association with limb prognosis. RESULTS: In-stent occlusion rate was 5.2%, 11.2%, and 16.4% at 1, 3, and 5 years, respectively (mean follow-up, 2.3 ± 1.7 years). Female sex, critical limb ischemia, and Transatlantic Inter-Society Consensus II class C/D (multivariate Cox proportional hazard ratio [HR], 1.75, 1.49, and 3.34, respectively) were independent predictors of in-stent occlusion after FP stenting, which was associated with poor limb prognosis (major amputation, HR 6.35; major adverse limb event, major adverse limb event, HR, 21.1). CONCLUSIONS: Moderate in-stent occlusion rates were observed after nitinol stent-based EVT. Closer attention is warranted with high-risk cases because of poorer limb prognosis.

Low molecular weight heparin for prevention of microvascular occlusion in digital replantation.

BACKGROUND: The success of digital replantation is highly dependent on the patency of the repaired vessels after microvascular anastomosis. Antithrombotic agents are frequently used for preventing vascular occlusion. Low molecular weight heparin (LMWH) has been reported to be as effective as unfractionated heparin (UFH) in peripheral vascular surgery, but with fewer adverse effects. Its benefit in microvascular surgery such as digital replantation is unclear. OBJECTIVES: To assess whether subcutaneous LMWH treatment improves the salvage rate of the digits in patients with digital replantation after traumatic amputation. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (October 2012), CENTRAL (2012, Issue 10) and trials databases. In addition, the authors searched PubMed, CNKI (China National Knowledge Infrastructure) and CEPS (Chinese Electronic Periodical Services), and sought additional trials from reference lists of relevant publications. SELECTION CRITERIA: We selected randomised or quasi-randomised controlled trials of LMWH in patients who received digital replantation. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias of the included trials. Disagreements were resolved by discussion. MAIN RESULTS: Two randomised trials involving 114 patients with at least 122 replanted digits met the inclusion criteria and were included. Both trials compared the efficacy and safety of LMWH with UFH. We found no trials comparing LMWH with placebo or other anticoagulants. The data from the two included studies were insufficient for meta-analysis. The overall success rate of replantation did not differ between the LMWH and UFH groups, 92.3% versus 89.2% in one trial (risk ratio (RR) 1.03; 95% confidence interval (CI) 0.87 to 1.22) and 94.3% versus 94.15% in the other trial (RR 1.00; 95% CI 0.89 to 1.13). The incidence of both postoperative arterial and venous insufficiency were reported in one trial and did not significantly differ between the LMWH and UFH groups (RR 1.08; 95% CI 0.16 to 7.10 and RR 0.81; 95% CI 0.20 to 3.27, respectively). Direct and indirect causes of microvascular insufficiency were not reported in the trials. Different methods were used to monitor the adverse effects related to anticoagulation in the two trials. Bleeding tendency was monitored for the LMWH and UFH groups in one trial and was reported by the incidence of wound haemorrhage (11.5% versus 17.9%; RR 0.65; 95% CI 0.17 to 2.44), ecchymoses (3.8% versus 10.7%; RR 0.36; 95% CI 0.04 to 3.24), haematuria (3.8% versus 7.1%; RR 0.54; 95% CI 0.05 to 5.59), nasal bleeding (0% versus 7.1%; RR 0.21; 95% CI 0.01 to 4.28), gingival bleeding (0% versus 10.7%; RR 0.15, 95% CI 0.01 to 2.83) and faecal occult blood (0% versus 3.6%; RR 0.36; 95% CI 0.02 to 8.42). The bleeding tendency was increased in the UFH group but this was not statistically significant. This trial also monitored coagulability changes using parameters such as antithrombin activity, factor Xa activity, bleeding time, clotting time and activated partial thromboplastin time (aPTT). No comparison was made between the LMWH and UFH groups but all data consistently showed that coagulability was reduced more in the UFH group than in the LMWH group. The other trial reported a postoperative decrease in platelet count in the UFH group (preoperative 278.4 ± 18.7 x 10(9)/L, postoperative 194.3 ± 26.5 x 10(9)/L; P < 0.05) but not in the LMWH group (preoperative 260.8 ± 32.5 x 10(9)/L, postoperative 252.4 ± 29.1 x 10(9)/L; P > 0.05). AUTHORS' CONCLUSIONS: Current limited evidence based on two small-scaled low-to-medium quality randomised trials found no differences in the success rate of replantation between LMWH and UFH, but a lower risk of postoperative bleeding and hypocoagulability after the use of LMWH. Further well-designed and adequately powered clinical trials are warranted.

Periodontal disease measures and risk of incident peripheral artery disease: The Atherosclerosis Risk in Communities (ARIC) Study.

BACKGROUND: The association of periodontal disease with atherosclerotic cardiovascular diseases is well known, but not specifically with incident peripheral artery disease (PAD). Therefore, we studied the associations of periodontal disease with incident PAD in a population-based setting. METHODS: Among 9,793 participants (aged 53-75 years) without prevalent PAD, self-reported history of periodontal disease was ascertained. Of these, 5,872 participants underwent full-mouth examinations from which periodontal status was defined using the US Centers for Disease Control and Prevention-American Academy of Periodontology (CDC-AAP) definition. We quantified the association of periodontal disease with incident PAD (defined by hospital admission diagnosis or procedures) using multivariable Cox regression models. RESULTS: During a median follow-up of 20.1 years, 360 participants (3.6%) developed PAD. In models accounting for potential confounders including diabetes and smoking pack-years, there was higher hazard of PAD in participants with self-reported tooth loss because of periodontal disease (hazard ratio:1.54 [95% CI:1.20-1.98]), history of periodontal disease treatment (1.37 [1.05-1.80]), and periodontal disease diagnosis (1.38 [1.09-1.74]), compared to their respective counterparts. The clinical measure of periodontal disease (n = 5,872) was not significantly associated with incident PAD in the fully adjusted model (e.g., 1.53 [0.94-2.50] in CDC-AAP-defined severe periodontal disease versus no disease). CONCLUSION: We observed a modest association of self-reported periodontal disease, especially when resulting in tooth loss, with incident PAD in the general population. Nonetheless, a larger study with the clinical measure of periodontal disease is warranted.

Risk of Peripheral Arterial Occlusive Disease with Periodontitis and Dental Scaling: A Nationwide Population-Based Cohort Study.

Periodontitis (PD) is a common oral disease associated with various other diseases, particularly those affecting the cardiovascular system. This study explored whether peripheral artery occlusive disease (PAOD) is associated with PD and dental scaling. This study was a retrospective cohort study design from 2000 to 2018. The study population was newly diagnosed with periodontitis. The comparison group was defined as never diagnosed with periodontitis. The outcome variable was defined with the diagnosis of peripheral arterial occlusive disease (PAOD). The propensity score matching was performed by age, sex, comorbidities, and dental scaling between the two groups. Kaplan-Meier analysis was used to calculate the cumulative incidence of PAOD among the two groups. To perform the independent risk of the PAOD group, the multivariate Cox proportional hazard model was used to estimate the hazard ratios. First, 792,681 patients with PD and 458,521 patients with no history of PD were selected from Taiwan's Longitudinal Health Insurance Database, which comprises the data of two million beneficiaries. After propensity score matching between the PD and non-PD groups for age, sex, comorbidities, and dental scaling, 357,106 patients in each group were analyzed for PAOD risk. The incidence density, relative risk, and cumulative incidence of PAOD were higher in the PD group than in the non-PD group. After adjusting for all variables, the risk of PAOD for the PD group was greater than for the non-PD group (adjusted hazard ratio = 1.03; 95% CI, 1.01-1.06). Undergoing at least one dental scaling procedure reduced the risk of PAOD. Age over 65 years was also a risk factor. In conclusion, patients with PD have an increased risk of PAOD. In addition, our results can lead to increased attention to oral hygiene, as dental scaling has a trend towards a lower risk of PAOD.

Risk of peripheral arterial disease in patients with periodontitis: A nationwide, population-based, matched cohort study.

BACKGROUND AND AIMS: The association between coronary heart disease (CHD) caused by atherosclerosis and periodontitis has already been established. Peripheral arterial disease (PAD) is also caused by atherosclerosis, but the characteristics of the target artery and the disease are different from those of CHD. The aim of this study was to determine whether the risk of PAD was high in patients with periodontitis. METHODS: For this study, we used data from the Korean National Health Insurance Service-Health Screening Cohort (NHIS-HEALS) database that were collected between January 2003 and December 2014. We compared the incidence of PAD between patients with periodontitis and a matched control group selected from among 514,832 people enrolled in the NHIS-HEALS database to confirm the increased incidence of PAD in patients with periodontitis. RESULTS: The incidence per 1000 person-years was 2.40 in the patients with periodontitis and 2.08 in the matched controls. The hazard ratio (HR) of PAD in the periodontitis group compared with that in the matched group was 1.15 (95% confidence interval, 1.07-1.23). In the subgroup analysis, sex, age, smoking, and hypertension statistically modified the influence of periodontitis on PAD risk. CONCLUSIONS: Control of periodontitis is important in the prevention of PAD, in addition to correcting conventional risk factors such as diabetes mellitus, hypertension, dyslipidemia, and smoking.