Antithrombotic Therapy for Symptomatic Peripheral Arterial Disease: A Systematic Review and Network Meta-Analysis.

BACKGROUND: High-quality evidence from trials directly comparing single antiplatelet therapies in symptomatic peripheral arterial disease (PAD) to dual antiplatelet therapies or acetylsalicylic acid (ASA) plus low-dose rivaroxaban is lacking. Therefore, we conducted a network meta-analysis on the effectiveness of all antithrombotic regimens studied in PAD. METHODS: A systematic search was conducted to identify randomized controlled trials. The primary endpoints were major adverse cardiovascular events (MACE) and major bleedings. Secondary endpoints were major adverse limb events (MALE) and acute limb ischaemia (ALI). For each outcome, a frequentist network meta-analysis was used to compare relative risks (RRs) between medication and ASA. ASA was the universal comparator since a majority of studies used ASA as in the reference group. RESULTS: Twenty-four randomized controlled trials were identified including 48,759 patients. With regard to reducing MACE, clopidogrel [RR 0.78, 95% confidence interval (CI) 0.66-0.93], ticagrelor (RR 0.79, 95% CI 0.65-0.97), ASA plus ticagrelor (RR 0.79, 95% CI 0.64-0.97), and ASA plus low-dose rivaroxaban (RR 0.84, 95% CI 0.76-0.93) were more effective than ASA, and equally effective to one another. As compared to ASA, major bleedings occurred more frequently with vitamin K antagonists, rivaroxaban, ASA plus vitamin K antagonists, and ASA plus low-dose rivaroxaban. All regimens were similar to ASA concerning MALE, while ASA plus low-dose rivaroxaban was more effective in preventing ALI (RR 0.67, 95% CI 0.55-0.80). Subgroup analysis in patients undergoing peripheral revascularization revealed that ≥ 3 months after intervention, evidence of benefit regarding clopidogrel, ticagrelor, and ASA plus ticagrelor was lacking, while ASA plus low-dose rivaroxaban was more effective in preventing MACE (RR 0.87, 95% CI 0.78-0.97) and MALE (RR 0.89, 95% CI 0.81-0.97) compared to ASA. ASA plus clopidogrel was not superior to ASA in preventing MACE ≥ 3 months after revascularization. Evidence regarding antithrombotic treatment strategies within 3 months after a peripheral intervention was lacking. CONCLUSION: Clopidogrel, ticagrelor, ASA plus ticagrelor, and ASA plus low-dose rivaroxaban are superior to ASA monotherapy and equally effective to one another in preventing MACE in PAD. Of these four therapies, only ASA plus low-dose rivaroxaban provides a higher risk of major bleedings. More than 3 months after peripheral vascular intervention, ASA plus low-dose rivaroxaban is superior in preventing MACE and MALE compared to ASA but again at the cost of a higher risk of bleeding, while other treatment regimens show non-superiority. Based on the current evidence, clopidogrel may be considered the antithrombotic therapy of choice for most PAD patients, while in patients who underwent a peripheral vascular intervention, ASA plus low-dose rivaroxaban could be considered for the long-term (> 3 months) prevention of MACE and MALE.

Two-year results of a multicenter randomized controlled trial comparing Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial).

OBJECTIVE: Endothermal techniques have proved to be effective for treatment of incompetent truncal veins. The tumescentless mechanochemical ablation (MOCA) technique has become an alternative treatment modality, but its outcome with regard to endothermal techniques is still unclear. METHODS: A multicenter prospective randomized controlled trial was designed comparing MOCA with radiofrequency ablation (RFA) to treat great saphenous vein incompetence with the hypothesis that MOCA is associated with less postprocedural pain and a comparable anatomic and clinical success rate at 1-year follow-up. Disease-specific quality of life and general health-related quality of life (HRQoL) were measured using questionnaires. Inclusion was terminated prematurely because reimbursement was suspended. RESULTS: A total of 213 patients (46.3% of intended number of patients) were randomized, of whom 209 were treated (105 in the MOCA group and 104 in the RFA group). Overall median pain scores during the first 14 days were lower after MOCA (0.2 vs 0.5 after RFA; P = .010), although the absolute difference was small. At 30 days, similar complication numbers (MOCA, n = 62; RFA, n = 63) and HRQoL scores (Aberdeen Varicose Vein Questionnaire: MOCA, 8.9; RFA, 7.6; P = .233) were observed. Hyperpigmentation was reported in seven patients in the MOCA group and two patients in the RFA group (P = .038). In the MOCA group, there were four complete failures (3.8%) compared with none in the RFA group (P = .045), although in one patient at 1 year, the vein showed occlusion. Median 30-day Venous Clinical Severity Score (VCSS) was significantly lower at 30 days after MOCA (1.0 vs 2.0 in the RFA group; P = .001), whereas VCSS was comparable at baseline (MOCA, 4.0; RFA, 5.0; P = .155). The 1- and 2-year anatomic success rate was lower after MOCA (83.5% and 80.0%) compared with RFA (94.2% and 88.3%; P = .025 and .066), mainly driven by partial recanalizations. After 2 years of follow-up, no differences were observed in the number of complete failures. Similar clinical success rates at 1 year (MOCA, 88.7%; RFA, 93.2%; P = .315) and 2 years (MOCA, 93.0%; RFA, 90.4%; P = .699) and no differences in HRQoL scores on the Aberdeen Varicose Vein Questionnaire at 1 year (MOCA, 7.5; RFA, 7.0; P = .753) and 2 years (MOCA, 5.0%; RFA, 4.8%; P = .573) were observed. There were two cardiac serious adverse events, a ventricular fibrillation in the MOCA group (1 year) and an unstable angina in the RFA group (2 years). One deep venous thrombosis occurred in the RFA group on 1-year duplex ultrasound, without clinical sequelae. CONCLUSIONS: Unilateral treatment with MOCA in the short term resulted in less postoperative pain but more hyperpigmentation compared with RFA and a faster improvement in VCSS. More anatomic failures were reported after MOCA, mostly driven by partial recanalizations, but both techniques were associated with similar clinical outcomes at 1 year and 2 years.

Mid- and Long-Term Outcome of Currently Available Endografts for the Treatment of Infrarenal Abdominal Aortic Aneurysm.

Currently, there is a wide range of commercially available endografts for infrarenal abdominal aortic aneurysm (AAA) repair. Results of long-term follow up after endovascular aneurysm repair (EVAR) are limited. Thereby, the durability of these endografts and the difference between manufacturers is not fully clear. In this review, studies with mid- and long-term results, with a minimum median follow up of 36 months per endograft, were included describing results with Cook Zenith? Flex? endograft (Cook Medical Inc., Bloomington, Indiana) (n=6), Cordis Corporate INCRAFT? (Cordis Corporation, Freemont, California) (n=1), Gore? EXCLUDER? (W.L. Gore & Associates Inc., Flagstaff, Arizona) (n=3), Medtronic Endurant? (Medtronic plc, Santa Rosa, California) (n= 6), and Vascutek Anaconda? (Vascutek Ltd., Inchinnan, Scotland) (n=2). The assisted technical success varied between 83% and 100%, and the perioperative mortality, early reintervention, and early conversion rates were comparable for the studied endografts. At three-year follow up, the freedom from AAA-rupture and AAA-related death varied between 98% and 100%. The results demonstrated an increasing complication and reintervention rate over time. When adhering to the instruction for use, minor differences were seen during follow up between the endografts. Latest generation endografts continue to have good postoperative results, the reintervention-rate of 10-20% over time mandates an ongoing close patient follow up. The choice of a specific design depends on native patient anatomy and the experience of the implanting surgeon.

Mechanochemical Endovenous Occlusion of Varicose Veins Using the ClariVein® Device.

INTRODUCTION: In the last decade, minimally invasive endothermal ablation techniques have replaced surgery for the treatment of superficial venous insufficiency to reduce postoperative complications and recovery time and to improve quality of life. To avoid the risks of nerve damage and need for tumescent anesthesia to improve patient comfort, an alternative heatless technique has been introduced recently. METHODS: Endovenous mechanochemical occlusion using the ClariVein® catheter (Vascular Insights LLC, Quincy, MA) is a new technique combining mechanical injury to the venous endothelium coupled with simultaneous catheter-guided infusion of a liquid sclerosant. This produces irreversible damage to the endothelium resulting in fibrosis of the vein. RESULTS: The technique is related to a low complication rate and a success rate of 96% at two years and sustained quality of life improvement. This closure rate is comparable to endothermal techniques, but significantly less postoperative pain and earlier return to normal activities and work has been reported with endovenous mechanochemical occlusion. CONCLUSION: Mechanochemical occlusion using ClariVein® has proven to be safe and effective and has several advantages compared to endothermal techniques. The possibility of retrograde ablation of distal SSV insufficiency in C6 ulceration is considered a significant advantage. Randomized comparative studies with long-term follow up will continue to define the definite place of mechanochemical occlusion.