Management of patients undergoing percutaneous vascular interventions: balancing ischaemic benefit and bleeding risk

Since the seminal development of catheter-based balloon angioplasty of vascular disease by Andreas Grüntzig at the University Hosptial in Zurich in the 1970s,1 the procedure has had a huge impact in the management of patients with both peripheral and coronary artery disease. Improvements of the catheter material, the development of stents,2 and antiplatelet drugs have expanded the indications further and further and optimized the clinical results in an unforeseen manner. This Focus Issue begins with the two final articles of the ‘TheYear in Cardiology’ series. First, in the ‘The Year in Cardiology 2016: coronary interventions’ Carlo di Mario, Carlotta Sorini Dini, and William Wijns3 note that in 2016 multiple randomized studies supported the 3- to 5-year efficacy of metallic drug-eluting stents in left main disease, but cast—after an initial enthusiasm for this concept—doubts on the long-term outcome after implantation of fully biodegradable stents.4,5 Furthermore, mixed messages have been published about the importance of physiological guidance of coronary revascularization:6,7 it appears that the tests are helpful for non-culprit lesions in ST-segment elevation myocardial infarction, but of questionable value in multivessel disease of allcomers. Of note, further studies refuted the paradigm that a fully arterial surgical revascularization delivers better clinical outcome. Peripheral arterial disease is the Cinderella of cardiovascular medicine, although the outcome of such patients remains grim.8 In the ‘The Year in Cardiology 2016:peripheralcirculation’, Marco de Carlo and Victor Aboyans review the progress made in this field on behalf of the ESC Working Group on Aorta and Peripheral Vascular Diseases.9 The 2016 epidemiological update of cardiovascular disease in Europe has attributed 45% of the deaths to this category, including 12% due to stroke and 14% to other cardiovascular diseases, highlighting the major burden of non-coronary artery diseases involving the aorta, carotid, and lower extremity arteries and venous thrombo-embolism in Europe. Cumulative hazard function curves determined by Cox regression analyses in the overall population and in patients with or without acute coronary syndrome (ACS) showing the 1-year risk of (A) myocardial infarction (MI) or definite/probable stent thrombosis (ST) (from Palmerini T, Della Riva D, Benedetto U, Bacchi Reggiani L, Feres F, Abizaid A, Gilard M, Morice M-C, Valgimigli M, Hong M-K, Kim B-K, Jang Y, Kim H-S, Woo Park K, Colombo A, Chieffo A, Sangiorgi D, Biondi-Zoccai G, Généreux P, Angelini GD, Pufulete M, White J, Bhatt DL, Stone GW. Three, six, or twelve months of dual antiplatelet therapy after DES implantation in patients with or without acute coronary syndromes: an individual patient data pairwise and network meta-analysis of six randomized trials and 11 473 patients. See Pages 1034–1043). Net predicted risk for cardiovascular death, stroke, or MI and CALIBER major bleeding with prolonged dual antiplatelet therapy. MI, Myocardial infarction; CV, cardiovascular; DAPT, dual antiplatelet therapy. The straight lines correspond to different scenarios of how patients or clinicians may value (or weight) benefits and harms. All patients to the right of a line applicable to their values would be estimated to have a positive net benefit with prolonged DAPT. Panel A: Net benefit for 5613 patients under different benefit vs. harm weighting scenarios. Panel B: Timing of clinical characteristic assessment may impact treatment decisions shows the net benefits calculated using patient characteristics at discharge from acute MI and at 1 year post-acute MI for 5 ‘typical’ patients in the validation cohort (see Supplementary material online, Table S4) (from Pasea L, Chung S-C, Pujades-Rodriguez M, Moayyeri A, Denaxas S, Fox KAA, Wallentin L, Pocock SJ, Timmis A, Banerjee A, Patel R, Hemingway H. Personalising the decision for prolonged dual antiplatelet therapy: development, validation and potential impact of prognostic models for cardiovascular events and bleeding in myocardial infarction survivors. See Pages 1056–1059). Besides dual antiplatelet therapy, the patient’s gender may also influence outcome after infarction. Indeed, gender differences in the presentation and outcome of cardiac conditions have attracted a lot of attention recently.19 Besides biological gender differences, a gender gap in the management of acute coronary syndromes has been implicated in the worse outcome of women after such an event, although not all studies could confirm that.20–22 In a third research manuscript, entitled ‘Acute coronary syndrome in women: rising hospitalizations in middle-aged French women, 2004–2014’, Amélie Gabet and colleagues from the Institut de Veille Sanitaire in Saint-Maurice, France analysed trends in annual incidence of hospitalized acute coronary syndromes in France from 2004 to 2014.23 In 2014, a total of 113 407 patients, 32.2% women and 67.8% men, were hospitalized for acute coronary syndromes. Among women, a quarter were younger than 65 years of age and one-third presented with an ST-segment elevation myocardial infarction, one-fifth with a non-ST-segment elevation myocardial infarction, and nearly half of the patients with unstable angina. From 2004 to 2014, the rates of age-standardized admissions for acute coronary syndrome in women of <65 years of age increased by 6.3%. This rise in acute coronary syndrome was driven by a significant 21.7% increase in ST-segment elevation myocardial infarction and 53.7% increase in non-ST-segment elevation myocardial infarction. The largest increase in ST-segment elevation myocardial infarction was observed among women aged between 45 and 54 years of age, with an increase of 3.6% per year. In those 65 years of age or older, significant decreases in all acute coronary syndrome types were observed. Gabet et al. conclude that this nationwide study showed disturbing trends in the annual incidence of ST-segment elevation myocardial infarction, especially among younger women. This increase is being largely attributed to an increase in smoking and obesity in this patient population. Efforts to strengthen primary prevention of cardiovascular disease in younger women is urgently required as these main risk factors are modifiable, and as there is a growing evidence of higher short-term mortality of coronary heart disease in women. This manuscript is accompanied by an insightful Editorial by Catherine Gebhard from the University of Zurich in Switzerland.24 Bleeding is affecting outcome not only after infarction during long-term dual antiplatelet therapy, but also acutely during primary percutaneous intervention. Most commonly, access site bleedings are complicating the procedure. Some, but not all studies suggested that the radial access is associated with less bleeding,25,26 although not all confirmed a clinically relevant difference.27 This issue has been further investigated in a research article entitled ‘Radialvs.femoral access in patients with acute coronary syndromes with or without ST-segment elevation: apre-specified analysis from the randomized minimizing adverse haemorrhagic events by transradial access site and systemic implementation of angioX (MATRIX Access)’ by Pascal Vranckx and colleagues from the Virga Jesseziekenhuis in Hasselt, Belgium.28 In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) programme, patients were randomized to radial or femoral access, stratified by ST-segment elevation and non-ST-segment elevation myocardial infarction. The 30-day co-primary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke. Net adverse clinical events were defined as major adverse cardiovascular events or major bleeding. In the overall study population, radial access reduced the net adverse clinical events, but not the major adverse cardiovascular events endpoint at the pre-specified 0.025 alpha. Major adverse cardiovascular events occurred in 6.1% of ST-segment elevation myocardial infarctions with radial access and in 6.3% with femoral access. In non-ST-segment elevation patients, 11.3% with radial access and 13.9% with femoral access had such events. Net adverse clinical events occurred in 7.2% of ST-segment elevation myocardial infarctions with radial access and in 8.3% with femoral access. In non-ST-segment elevation infarctions, the rates were 12.2% with radial access and 14.7% with femoral access. All-cause mortality and access site-actionable bleeding favoured radial access irrespective of acute coronary syndrome type. The authors conclude that radial as compared with femoral access provided consistent, albeit moderate, benefit across the whole spectrum of patients with acute coronary syndrome. These clinically important findings are further discussed in an Editorial by Sanjit Singh Jolly from the McMaster University Population Health Research Institute in Hamilton, Ontario (Canada).29 The editors hope that this issue of the European Heart Journal will be of interest to its readers.