On behalf of the ESC Working Group on Aorta and Peripheral Vascular Diseases
More than 83 million people live with cardiovascular (CV) disease in the ESC member countries, with peripheral vascular diseases as the most predominant condition (more than 35 million) followed by ischaemic heart disease (>29 million), underlining the public health burden of the former in our continent. (
The ESC collaborated with European Society of Vascular Surgery (ESVS) to publish the most comprehensive guidelines document on the management of peripheral arterial diseases (PADs), encompassing all the peripheral territories. (
The VIVA trial demonstrated the interest of multiple vascular screening to improve population longevity (
COMPASS-PAD ( |
Double-blind: interest of low-dose rivaroxaban (alone or with aspirin) in patients with PADs | Rivaroxaban 2.5 mg x 2 + Aspirin 100 mg (R + A: 2492) or Riva 5 mg x 2 (R: 2474) | Aspirin 100 mg (A: 2504) | LEAD (past revascularization, claudication with proven LEAD, or CAD with ABI < 0.90) or carotid disease (past revascularization or carotid stenosis > 50%) | CV death, MI or Stroke: R+A vs. A = -28% (P = 0.0047); R vs. A = −14% (P = 0.19). -46% reduction of MALE for R + A vs. A. +61% bleeding risk, but not fatal bleeding. |
VIVA ( |
Open: interest of vascular screening in general population | Screening for hypertension, LEAD and AAA (25 078) | No screening (25 078) | Men aged 65–74 years in Central Denmark | Mortality (HR 0.93; 95% CI 0.88–0.98) |
Moresoli ( |
Meta-analysis: CAS versus CEA in patients with asymptomatic carotid stenosis | CAS (1881) | CEA (1138) | Asymptomatic carotid stenosis | Any peri-procedural stroke and long-term stroke (RR 1.24; 95% CI 0.76–2.03) or death (RR 1.72; 95% CI 0.95–3.11) |
EMPA-REG (LEAD subgroup) ( |
Double-blind: efficacy and safety of empagliflozin on top of standard care in type 2 diabetic patients with LEAD | Empagliflozin (982) | Placebo (479) | LEAD (past revascularization or amputation, stenosis > 50%, or ABI < 0.90) | CV death: HR, 0.57; 95%CI, 0.37–0.88. -38% all-cause mortality reduction |
No increased risk of amputation. | |||||
FOURIER (LEAD subgroup) ( |
Double-blind: interest of evolocumab on top of statins to reduce cardiovascular events | Evolocumab (1856) | Placebo (1780) | Claudication and ABI < 0.85 or prior revascularization | Composite: CV death, MI, stroke, hospitalization for unstable angina, or coronary revascularization: −21% (P < 0.01). MALE also reduced by − 42% (P < 0.01) |
ICE ( |
Open: SES vs. BES for iliac occlusive disease | SES (340) | BES (320) | Moderate to severe claudication caused by iliac artery stenosis or occlusion | Binary restenosis at 12 months 6.1% (SES) vs. 14.9% (BES) P = 0.006 |
ISAR-STATH ( |
Open: endovascular techniques for superficial femoral artery revascularization | DCB + stent (48) or atherectomy (52) | BMS (55) | stenosis or occlusion of superficial femoral artery | (1) Diameter stenosis in percentages measured by angiography 34%. 56% vs. 55%; P = 0.009 and 0.007; |
(2) Binary restenosis rate 7.23% vs. 22.52% vs. 24.54%; P = 0.0017 PEB + stent vs. BA + stent | |||||
ILLUMENATE pivotal ( |
Single-blind: DCB vs. PTA in femoropopliteal disease | DCB (200) | PTA (100) | Rutherford Class 2–4 LEAD caused by femoropopliteal stenosis or occlusion | (1) Composite: 12 months of freedom from device and procedure-related 30 days of death, and from target limb major amputation and CD-TLR: 92.1% vs. 83.2% P = 0.001; |
(2) 12 monthsa primary patency 76.3% vs. 57.6% P = 0.003 | |||||
ILLUMENATE EU ( |
Single-blind: DCB vs. PTA in femoro-popliteal disease | DCB (222) | PTA (72) | Moderate to severe claudication or ischemic rest pain caused by femoro-popliteal stenosis or occlusion | (1) Composite: 30 days of freedom from device- and procedure-related death, and 12 monthsb from target limb major amputation and CD-TLR: 94.1% vs. 83.3%. |
(2) Primary patency 12 monthsb and freedom from CD-TLR 83.9% vs. 60.6% P = 0.001 | |||||
EINSTEIN-choice ( |
Double-blind: Efficacy & safety of two doses of rivaroxaban vs. aspirin in long-term after VTE | Rivaroxaban 10 mg OD (R10: 1127) | Aspirin 100 mg OD (A: 1131) | After 6–12 months of anticoagulation for acute DVT or PE | Symptomatic recurrent fatal or nonfatal VTE |
Rivaroxaban 20 mg OD (R20: 1107) | R20 vs. A: −66% (P < 0.001) | ||||
R10 vs. A: −74%(P < 0.001) | |||||
No significant increase major bleeding risk | |||||
ATTRACT ( |
Openc: efficacy and safety of pharmaco-mechanical thrombolysis to prevent PTS after proximal DVT | Pharmaco-mechanical thrombolysis + anticoagulation (337) | Anticoagulation (355) | Post-thrombotic syndrome between 6 and 24 months | No significant difference in PTS rates (47% in the pharmacomechanical-thrombolysis group vs. 48% in the control group; P = 0.56) |
PEITHO (long-term results) ( |
Double-blind: long-term efficacy and safety of thrombolysis for intermediate-risk PE | Tenecteplase (506) | Placebo (499) | Intermediate-risk PE < 5 days and RV dysfunction and/or troponin release | Median FU 37 months: |
No significant difference in terms of mortality, residual dyspnoea, and chronic thrombo-embolic pulmonary hypertension | |||||
A, aspirin; AAA, abdominal aorta aneurysm; BES, balloon-expandable stent; CAD, coronary artery disease; CAS, carotid artery stenting; CD, clinically driven; CEA, carotid endarterectomy; CV, cardiovascular; DCB, drug-coated balloon; DES, drug-eluting stent; DVT, deep-vein thrombosis; HR, hazard-ratio; LEAD, lower-extremities artery disease; MALE, major adverse limb events; MI, myocardial infarction; PADs, peripheral arterial diseases; PTA, plain balloon angioplasty; PTS, post-thrombotic syndrome; R, rivaroxaban, R + A, rivaroxaban plus aspirin; RR, relative risk; SES, self-expandable stent; SFA, superficial femoral artery; TLR, target lesion revascularization. |
The COMPASS trial randomized 27 395 patients either with coronary artery disease (CAD) or PADs [lower-extremity artery disease (LEAD) or carotid stenosis or prior carotid revascularization] to three different antithrombotic strategies. In the pre-defined sub-analysis of patients with PADs, the results were consistent with those obtained in the entire population (
The 2017 ESC guidelines (
Many patients with LEAD are diabetic. Recently strikingly positive results on the CV benefits of sodium glucose cotransporter 2-inhibitors have been presented, although concerns were raised regarding the increased risk of amputation (mostly minor) with canaglifozin. (
In another review of 60 998 hospitalizations of patients undergoing revascularization or amputation in the USA for CLTI, the 30-days readmission rate was 20%, mainly due to infections, persistent CLTI symptoms, cardiac conditions, and procedural complications. (
Regarding revascularization, the Iliac, Common and External Artery Stent Trial (ICE) is the first RCT to compare balloon-expandable (BES) vs. self-expandable stents (SES). (
Cardiac risk should be assessed in patients undergoing vascular surgery. (
Patients with asymptomatic carotid artery stenosis should benefit from best medical therapy. (
Neurologic ischaemic events and stenosis progression in patients with asymptomatic carotid stenosis according to the quality of risk factors management. Adapted from Shah et al. (
A meta-analysis of five RCTs including 3019 asymptomatic patients compared carotid artery stenting (CAS) to surgery (CEA). (
Women are at increased risk of peri-operative stroke, but gender-specific data are sparse. In the National Surgical Quality Improvement Program database (5620 CEA and 141 CAS), the early post-operative outcomes in women with symptomatic carotid artery stenosis were compared. During the first 30 days, MACE occurred in 12.2% and 5.2%, respectively after CAS and CEA (P < 0.001). (
Early revascularization after an ischaemic stroke/TIA is recommended in case of carotid stenosis, but the influence of the timing on revascularization techniques has been poorly studied. In a pooled analysis of individual data of 4138 patients from four RCTs, the risk of stroke or death after CAS was higher than after CEA in those treated within 7 days (8.3% vs. 1.3%, RR 6.7; 95% CI 2.1–21.9, adjusted for age, sex, and type of qualifying event). (
In a German registry (2009–14), a total of 13 086 CAS procedures were analysed. (
Current practice of carotid revascularization was evaluated in 12 countries. (
Echocardiography remains the most frequent imaging method to assess the proximal aorta. The diameter varies according to the cardiac cycle, site, and mode of measurement as well as age and body size. In the multicentre collaborative NORRE study including more than 700 healthy individuals, the normal reference ranges for the proximal aorta dimensions have been set. (
Two studies from the Multi-Ethnic Study of Atherosclerosis reported on aortic calcification on computed tomography (CT): the first assessed the ascending aorta calcium and showed that this condition is rare in general population (3.4%). (
Regarding aortic events, so far only the aortic diameter is considered as a risk marker from imaging for aortic dissection. Two independent case-control studies, comparing patients with type-B aortic dissection (TB-AD) with controls, suggest that beyond the diameter, the age-related elongation of the aortic arch is also associated with increased risk of TB-AD. (
After screening, small AAAs require follow-up of the diameter, typically assessed by 2D ultrasound (US). Using 3D-US for assessment of AAA volume in 179 patients with small AAAs, it was found that 3D-US was accurate in assessing both diameter and volume as compared to CT. (
Data from one of the most comprehensive and nationwide registries in Europe come from Finland, showing the improvement in the prognosis of patients with unruptured and ruptured AAA during the last 2 decades (
Management of abdominal aorta aneurysm in the nationwide registry in Finland, 2000–14. Adapted from Laine et al. (
In some countries, AAAs are repaired by EVAR at a lower diameter than recommended in guidelines. Based on data from almost 40 000 Medicare patients undergoing EVAR from 2001 to 2008, earlier AAA repair by 5 mm has major consequences, with 22% excess EVAR procedures and 42% and 37% increase in open and endovascular re-interventions. (
After EVAR lifelong surveillance is necessary and CT-angiography has been the preferred modality, while ultrasound duplex scanning (DUS) with and without contrast enhancement (CEUS) is an alternative. A Cochrane review of 42 studies (
After an acute episode of venous thromboembolism (VTE) anticoagulation is indicated for at least 3 months. (
Once the decision to extend anticoagulant treatment is taken, common agreement is to continue with the initial compound. The latest EINSTEIN-CHOICE trial (
In patients with proximal DVT treated with DOACs, persistence of residual vein thrombosis is likely to occur less frequently than in patients treated with conventional anticoagulation. These results may have implications for the prognosis of patients with DVT. (
According to current guidelines, adjuvant catheter-directed thrombolysis may be considered in selected patients with acute ilio-femoral DVT, if performed in experienced centres, to diminish risk of post-thrombotic syndrome (PTS). However, the recently published ATTRACT trial (692 patients) failed to show the additional interest of catheter-directed thrombolysis to decrease the risk of PTS, but did result in a higher risk of major bleeding. (
The clinical usefulness of VTE risk prediction scores in ambulatory cancer patients is debated. A cohort of 876 cancer patients compared several scores (
Very high-risk tumours (pancreatic or gastric cancer)a | 2 | 2 | 2 | 2 |
High-risk tumours (lung, gynaecological, lymphoma, bladder, or testicular cancer) | 1 | 1 | 1 | 1 |
Pre-chemotherapy haemoglobin <10 g/dL or use of erythropoietin stimulating agents | 1 | 1 | 1 | 1 |
Pre-chemotherapy white blood cell count >11 × 109/L | 1 | 1 | 1 | 1 |
Pre-chemotherapy platelet count ≥350 × 109/L | 1 | 1 | 1 | 1 |
Body mass index >35 kg/m2 | 1 | 1 | 1 | |
D-dimer >1.44 µg/mL | 1 | |||
Soluble P-selectin ≥53.1 ng/mL | 1 | |||
World Health Organization (WHO) performance status ≥2 | 1 | |||
Gemcitabine chemotherapy | 1 | |||
Platinum-based chemotherapy | 1 | |||
Cut-off for classification of high-risk patients (points) | ≥3 | ≥5 | ≥3 | ≥3 |
Numbers represent the value attributed to each characteristic in the scores. |
Diagnostic algorithms are frequently used to identify patients in whom pulmonary embolism (PE) can be ruled out without the use of computed tomography pulmonary angiography (CTPA). In a study of 3465 patients with suspected PE, the YEARS decision rule (based on three clinical items combined with two D-dimer cut-offs) yielded a 14% decrease in CTPA examinations compared to conventional strategies (
The YEARS diagnostic strategy in case of suspicion for pulmonary embolism. CTPA, computed tomography pulmonary angiography; DVT, deep vein thrombosis; PE, pulmonary embolism.
The prevalence of PE in patients presenting with syncope has been highly debated this year, following the PESIT trial, reported last year, (
The PEITHO trial investigated long-term prognosis in patients with intermediate-risk PE randomized to receive thrombolysis or placebo. (
The mention of trade names, commercial products organizations, and the inclusion of advertisements in the journal does not imply endorsement by the European Heart Journal, the editors, the editorial board, Oxford University Press or the organization to which the authors are affiliated. The editors and publishers have taken all reasonable precautions to verify drug names and doses, the results of experimental work and clinical findings published in the journal. The ultimate responsibility for the use and dosage of drugs mentioned in the journal and in interpretation of published material lies with the medical practitioner, and the editors and publisher cannot accept liability for damages arising from any error or omissions in the journal. Please inform the editors of any errors.
The opinions expressed in the European Heart Journal are those of the authors and contributors, and do not necessarily reflect those of the European Society of Cardiology, the editors, the editorial board, Oxford University Press or the organization to which the authors are affiliated.
OUP and the ESC are not responsible or in any way liable for the accuracy of the translation, for any errors, omissions or inaccuracies, or for any consequences arising therefore. Sandra Makarović and Kristina Selthofer-Relatić are solely responsible for the translation published in this reprint. Translation edited by: Mario Ivanuša. Language editing: Tomislav Salopek.