- Email: [email protected]
Coronary intervention: radial artery access comes of age
Comment
MRC/UVRI Uganda Research Unit on AIDS, PO Box 49, Entebbe, Uganda (AE, SC, PK); London School of Hygiene & Tropical Medicine, London, UK (AE, SC, DM, PK); Uganda Virus Research Institute, Entebbe, Uganda (BN, BB, PK, EKM); Department of Medical Microbiology (BB, MJ) and Infectious Diseases Institute (AK), Makerere University College of Health Sciences, Kampala, Uganda; Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (GP); Department of Parasitology, Leiden University Medical Centre, Leiden, The Netherlands (MY); Department of Pathology, University of Cambridge, Cambridge, UK (DD, AM); Makerere University Directorate of Research and Graduate Studies, Kampala, Uganda (EKR); and Kyambogo University, Kampala, Uganda (EKR) [email protected] We have received funding from the Wellcome Trust and European Union. We declare no competing interests. 1
2 3
Wellcome Trust. Developing Excellence in Leadership, Training and Science Initiative. http://www.wellcome.ac.uk/Funding/Biomedical-science/ Funding-schemes/Strategic-awards-and-initiatives/WTP057105.htm (accessed May 29, 2015). European Commission. Horizon 2020. https://ec.europa.eu/programmes/ horizon2020/ (accessed May 29, 2015). European and Developing Countries Clinical Trials Partnership. http://www. edctp.org/ (accessed May 29, 2015).
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Nachega JB, Uthman OA, Ho YS, et al. Current status and future prospects of epidemiology and public health training and research in the WHO African region. Int J Epidemiol 2012; 41: 1829–46. Ndebele P, Wassenaar D, Benatar S, et al. Research ethics capacity building in sub-Saharan Africa: a review of NIH Fogarty-funded programs 2000–2012. J Empir Res Hum Res Ethics 2014; 9: 24–40. Boutayeb A. The double burden of communicable and non-communicable diseases in developing countries. Trans R Soc Trop Med Hyg 2006; 100: 191–99. Ramsay M. Africa: continent of genome contrasts with implications for biomedical research and health. FEBS Lett 2012; 586: 2813–19. Nakanjako D, Ssewanyana I, Nabatanzi R, et al. Impaired T-cell proliferation among HAART-treated adults with suboptimal CD4 recovery in an African cohort. BMC immunology 2013; 14: 26. Nakimuli A, Chazara O, Byamugisha J, et al. Pregnancy, parturition and preeclampsia in women of African ancestry. Am J Obstet Gynecol 2014; 210: 510–20.e1. Nakimuli A, Chazara O, Farrell L, et al. A KIR B centromeric region present in Africans but not Europeans protects pregnant women from pre-eclampsia. Proc Natl Acad Sci USA 2015; 112: 845–50. Mpairwe H, Webb EL, Muhangi L, et al. Anthelminthic treatment during pregnancy is associated with increased risk of infantile eczema: randomised-controlled trial results. Pediatr Allergy Immunol 2011; 22: 305–12. Mpairwe H, Ndibazza J, Webb EL, et al. Maternal hookworm modifies the risk factors for eczema in childhood: birth cohort in Uganda. Pediatr Allergy Immunol 2014; 25: 481–88.
It has taken a quarter of a century for the level of evidence supporting radial artery access, rather than femoral access, for cardiac intervention to reach that of common pharmaceutical interventions, such as antiplatelet therapy in acute coronary syndrome.1,2 Historically, small trials and meta-analyses seemed to suggest that radial compared with femoral access reduced bleeding complications related to access site.3 However, early uptake of the radial technique (ie, during 1993–2003) among interventional cardiologists was slow for several reasons. First, the radial technique is slightly more challenging than a femoral approach and needs experience to perfect. Second, the early trials supporting its use were relatively small, and not sufficiently compelling to affect guidelines and prompt a change in practice. Finally, and perhaps most importantly, there has been under-recognition of the importance of bleeding as an undesirable outcome after coronary intervention. However, over the past 15 years, a substantial body of evidence has accumulated showing not only that bleeding is a major concern, but that it is also associated with increased mortality, a relation that might be causal.4 Pharmacological treatments that reduce bleeding have been associated with reductions www.thelancet.com Vol 385 June 20, 2015
in mortality.5,6 If this relation is real, it should not matter how bleeding is reduced: a procedural technique that reduces bleeding should also reduce mortality. The first large multicentre trial of radial access, RIVAL (n=7021),7 involved high-volume percutaneous coronary intervention operators, many of whose practice was in transition from primarily femoral to radial access. In RIVAL, there was no difference in the primary outcome of death, myocardial infarction, stroke, or major bleeding between patient groups receiving radial and femoral access. There was, however, a more than 60% reduction in major vascular complications with radial access. Additionally, there did seem to be a reduction in the primary outcome in high-volume radial centres and in those patients with ST-elevation myocardial infarction.8,9 Subsequently, practice guidelines for the first time provided a class IIa recommendation for radial access.10,11 In The Lancet, Marco Valgimigli and the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial investigators12 should be congratulated for doing the largest trial to date (n=8404) comparing radial with femoral access for coronary intervention in patients with acute coronary syndrome. They did
McMaster University, Hamilton, Canada
Coronary intervention: radial artery access comes of age
Published Online March 16, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)60507-4 See Articles page 2465
2437
Comment
not simply seek to replicate RIVAL, but instead built upon its findings and specifically tested the benefit of transradial versus transfemoral access in high-volume radial centres. Operators were required to have done most of their procedures transradially (>50%), and to have done at least 75 transradial percutaneous coronary interventions, in the previous year. The trial used coprimary outcomes, with a two-sided p value of 0·025 needed to declare superiority for each of the two outcomes.12 Based on this criterion, the first coprimary outcome of death, myocardial infarction, or stroke did not meet statistical significance, although numerically there were fewer events in the radial group (369 [8·8%] patients with radial access vs 429 [10·3%] patients with femoral access; rate ratio [RR] 0·85, 95% CI 0·74–0·99; p=0·0307). For the second coprimary outcome, net adverse clinical events, there was clear evidence of superiority of the radial technique, with a 17% reduction in death, myocardial infarction, stroke, or major bleeding (410 [9·8%] patients vs 486 [11·7%] patients; 0·83, 0·73–0·96; p=0·0092). There was also an apparent 28% reduction in mortality (66 [1·6%] patients vs 91 [2·2%] patients; 0·72, 0·53–0·99; p=0·045) with radial access. Finally, there was a significant interaction by radial centre volume, with the greatest benefit of radial access seen in the highest volume centres (ie, those doing at least 80% of their procedures via radial access). How do we integrate the results of RIVAL and MATRIX? The difference in bleeding definitions used in the two trials probably accounts for the differences in bleeding reported. Furthermore, despite being similar sized trials, MATRIX had a three times higher event rate than RIVAL (ie, death, myocardial infarction, and stroke: 10·3% in MATRIX vs 3·2% in RIVAL in the control groups).7 This difference was probably because patients in cardiogenic shock and even post-cardiac arrest were enrolled in MATRIX but not in RIVAL. As a result, MATRIX had power to detect more modest reductions (ie, a 15% relative risk reduction) in the primary outcome. Finally, MATRIX was done by radial experts, and thus validated the subgroup hypothesis from RIVAL that showed the greatest benefit in the highest volume centres. One implication of these findings is that centres should strive to maximise their volumes of radial procedures, rather than reserving the procedure for patients in whom femoral access is not possible. By contrast with RIVAL, 2438
the consistency of findings for radial access between non-ST elevation coronary syndrome and ST-elevation myocardial infarction in MATRIX emphasises the importance of testing subgroup findings from previous trials, and suggests a benefit of radial access for the entire spectrum of patients with acute coronary syndrome. The results of MATRIX, in the context of RIVAL and other smaller trials, suggest that, at the very least, access site bleeding will be substantially reduced and, at best, that there will be a corresponding reduction in mortality. Although the apparent reduction in mortality in MATRIX should be interpreted cautiously given that it was a secondary outcome, a meta-analysis including MATRIX shows consistency for the reduction in mortality.12 In a health-care era in which patient-centred outcomes are being recognised to be increasingly important, even if mortality was not explicitly shown to have been reduced, based on the reduction in bleeding and patients’ preferences, radial access should probably become the default approach in most centres. Radial access has grown rapidly over the past 10 years, and now accounts for more than 50% of procedures in many countries. The rate of radial access in the USA has lagged behind that in other countries, but has increased from 1·2% in 2007 to 16·1% in 2012.13 Unlike a pharmaceutical intervention, which simply requires physicians to know the appropriate dose and write a prescription, a procedural innovation needs training and for physicians to go through the discomfort of a learning curve. However, adoption of new techniques is essential in medicine. We cannot imagine a general surgeon continuing to practise open cholecystectomy without gaining the expertise needed for laparoscopic cholecystectomy. Similarly, interventional cardiologists will be expected to be proficient in transradial intervention. Many large randomised trials now show the benefits of radial access. The next step is for guideline committees in both the USA and Europe to consider these data carefully and upgrade recommendations to make radial access the default approach for coronary angiography and intervention. *Sanjit S Jolly, Shamir R Mehta McMaster University and the Population Health Research Institute, Hamilton General Hospital, Hamilton, ON L8L 2X2, Canada [email protected]
www.thelancet.com Vol 385 June 20, 2015
Comment
We declare no competing interests. 1 2
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Wallentin L, Becker RC, Budaj A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361: 1045–57. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001; 345: 494–502. Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J 2009; 157: 132–40. Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006; 114: 774–82. Yusuf S, Mehta SR, Chrolavicius S, et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006; 354: 1464–76. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med 2008; 358: 2218–30. Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011; 377: 1409–20. Mehta SR, Jolly SS, Cairns J, et al. Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation. J Am Coll Cardiol 2012; 60: 2490–99.
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Jolly SS, Cairns J, Yusuf S, et al. Procedural volume and outcomes with radial or femoral access for coronary angiography and intervention. J Am Coll Cardiol 2014; 63: 954–63. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv 2012; 79: 453–95. Steg PG, James SK, Atar D, et al. ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2012; 33: 2569–619. Valgimigli M, Gagnor A, Calabró P, et al, for the MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet 2015; published online March 16. http://dx.doi.org/10.1016/S01406736(15)60292-6. Feldman DN, Swaminathan RV, Kaltenbach LA, et al. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national cardiovascular data registry (2007–2012). Circulation 2013; 127: 2295–306.
PARTNERs in the future of surgical aortic valve replacement
www.thelancet.com Vol 385 June 20, 2015
leaving only one patient alive at 5 years without. Even more important for elderly patients (mean age was 83 years) is quality of life, and 86% of the 49 survivors who received TAVR in PARTNER 1 had New York Heart Association (NYHA) functional class 1 or 2. A benefit of this size is remarkable for inoperable old patients treated with a first generation medical device. However, a concern is that 48% of the patients undergoing TAVR were readmitted to hospital in Kapadia and colleagues’ study,2 and the idea of competing risk in
Published Online March 15, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)60568-2 See Articles pages 2477 and 2485
Chassenet/Science Photo Library
Aortic stenosis is the most common valve disease, the occurrence of which increases with age.1 Incidence of aortic stenosis is expected to rise because of population ageing. For decades, surgical aortic valve replacement (SAVR) was the gold standard of care for individuals with symptomatic severe aortic stenosis—in properly selected patients, substantially improving symptoms and life expectancy.1 Although physicians have learned how to care for critically ill old patients and enable many to survive major surgical procedures, operating on patients at very high risk is often not suitable. Technical limitations—eg, porcelain aorta, chest wall deformity, and chest irradiation—further limit the ability to operate on certain patients with aortic stenosis. In The Lancet, Samir Kapadia and colleagues2 present the 5-year results of the PARTNER 1 randomised trial in patients with aortic stenosis who were unsuitable for surgery, which compared transcatheter aortic valve replacement (TAVR) with standard treatment. 358 patients were enrolled, and TAVR provided a survival benefit of almost 22% (all-cause mortality 71·8% with TAVR vs 93·6% with standard treatment; HR 0·50, 95% CI 0·39–0·65) and a 28% lower cardiovascular mortality (57·5% vs 85·9%). Only six patients in the standard treatment group were alive at 5 years, of whom five had had aortic valve replacement
2439
MRC/UVRI Uganda Research Unit on AIDS, PO Box 49, Entebbe, Uganda (AE, SC, PK); London School of Hygiene & Tropical Medicine, London, UK (AE, SC, DM, PK); Uganda Virus Research Institute, Entebbe, Uganda (BN, BB, PK, EKM); Department of Medical Microbiology (BB, MJ) and Infectious Diseases Institute (AK), Makerere University College of Health Sciences, Kampala, Uganda; Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (GP); Department of Parasitology, Leiden University Medical Centre, Leiden, The Netherlands (MY); Department of Pathology, University of Cambridge, Cambridge, UK (DD, AM); Makerere University Directorate of Research and Graduate Studies, Kampala, Uganda (EKR); and Kyambogo University, Kampala, Uganda (EKR) [email protected] We have received funding from the Wellcome Trust and European Union. We declare no competing interests. 1
2 3
Wellcome Trust. Developing Excellence in Leadership, Training and Science Initiative. http://www.wellcome.ac.uk/Funding/Biomedical-science/ Funding-schemes/Strategic-awards-and-initiatives/WTP057105.htm (accessed May 29, 2015). European Commission. Horizon 2020. https://ec.europa.eu/programmes/ horizon2020/ (accessed May 29, 2015). European and Developing Countries Clinical Trials Partnership. http://www. edctp.org/ (accessed May 29, 2015).
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Nachega JB, Uthman OA, Ho YS, et al. Current status and future prospects of epidemiology and public health training and research in the WHO African region. Int J Epidemiol 2012; 41: 1829–46. Ndebele P, Wassenaar D, Benatar S, et al. Research ethics capacity building in sub-Saharan Africa: a review of NIH Fogarty-funded programs 2000–2012. J Empir Res Hum Res Ethics 2014; 9: 24–40. Boutayeb A. The double burden of communicable and non-communicable diseases in developing countries. Trans R Soc Trop Med Hyg 2006; 100: 191–99. Ramsay M. Africa: continent of genome contrasts with implications for biomedical research and health. FEBS Lett 2012; 586: 2813–19. Nakanjako D, Ssewanyana I, Nabatanzi R, et al. Impaired T-cell proliferation among HAART-treated adults with suboptimal CD4 recovery in an African cohort. BMC immunology 2013; 14: 26. Nakimuli A, Chazara O, Byamugisha J, et al. Pregnancy, parturition and preeclampsia in women of African ancestry. Am J Obstet Gynecol 2014; 210: 510–20.e1. Nakimuli A, Chazara O, Farrell L, et al. A KIR B centromeric region present in Africans but not Europeans protects pregnant women from pre-eclampsia. Proc Natl Acad Sci USA 2015; 112: 845–50. Mpairwe H, Webb EL, Muhangi L, et al. Anthelminthic treatment during pregnancy is associated with increased risk of infantile eczema: randomised-controlled trial results. Pediatr Allergy Immunol 2011; 22: 305–12. Mpairwe H, Ndibazza J, Webb EL, et al. Maternal hookworm modifies the risk factors for eczema in childhood: birth cohort in Uganda. Pediatr Allergy Immunol 2014; 25: 481–88.
It has taken a quarter of a century for the level of evidence supporting radial artery access, rather than femoral access, for cardiac intervention to reach that of common pharmaceutical interventions, such as antiplatelet therapy in acute coronary syndrome.1,2 Historically, small trials and meta-analyses seemed to suggest that radial compared with femoral access reduced bleeding complications related to access site.3 However, early uptake of the radial technique (ie, during 1993–2003) among interventional cardiologists was slow for several reasons. First, the radial technique is slightly more challenging than a femoral approach and needs experience to perfect. Second, the early trials supporting its use were relatively small, and not sufficiently compelling to affect guidelines and prompt a change in practice. Finally, and perhaps most importantly, there has been under-recognition of the importance of bleeding as an undesirable outcome after coronary intervention. However, over the past 15 years, a substantial body of evidence has accumulated showing not only that bleeding is a major concern, but that it is also associated with increased mortality, a relation that might be causal.4 Pharmacological treatments that reduce bleeding have been associated with reductions www.thelancet.com Vol 385 June 20, 2015
in mortality.5,6 If this relation is real, it should not matter how bleeding is reduced: a procedural technique that reduces bleeding should also reduce mortality. The first large multicentre trial of radial access, RIVAL (n=7021),7 involved high-volume percutaneous coronary intervention operators, many of whose practice was in transition from primarily femoral to radial access. In RIVAL, there was no difference in the primary outcome of death, myocardial infarction, stroke, or major bleeding between patient groups receiving radial and femoral access. There was, however, a more than 60% reduction in major vascular complications with radial access. Additionally, there did seem to be a reduction in the primary outcome in high-volume radial centres and in those patients with ST-elevation myocardial infarction.8,9 Subsequently, practice guidelines for the first time provided a class IIa recommendation for radial access.10,11 In The Lancet, Marco Valgimigli and the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial investigators12 should be congratulated for doing the largest trial to date (n=8404) comparing radial with femoral access for coronary intervention in patients with acute coronary syndrome. They did
McMaster University, Hamilton, Canada
Coronary intervention: radial artery access comes of age
Published Online March 16, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)60507-4 See Articles page 2465
2437
Comment
not simply seek to replicate RIVAL, but instead built upon its findings and specifically tested the benefit of transradial versus transfemoral access in high-volume radial centres. Operators were required to have done most of their procedures transradially (>50%), and to have done at least 75 transradial percutaneous coronary interventions, in the previous year. The trial used coprimary outcomes, with a two-sided p value of 0·025 needed to declare superiority for each of the two outcomes.12 Based on this criterion, the first coprimary outcome of death, myocardial infarction, or stroke did not meet statistical significance, although numerically there were fewer events in the radial group (369 [8·8%] patients with radial access vs 429 [10·3%] patients with femoral access; rate ratio [RR] 0·85, 95% CI 0·74–0·99; p=0·0307). For the second coprimary outcome, net adverse clinical events, there was clear evidence of superiority of the radial technique, with a 17% reduction in death, myocardial infarction, stroke, or major bleeding (410 [9·8%] patients vs 486 [11·7%] patients; 0·83, 0·73–0·96; p=0·0092). There was also an apparent 28% reduction in mortality (66 [1·6%] patients vs 91 [2·2%] patients; 0·72, 0·53–0·99; p=0·045) with radial access. Finally, there was a significant interaction by radial centre volume, with the greatest benefit of radial access seen in the highest volume centres (ie, those doing at least 80% of their procedures via radial access). How do we integrate the results of RIVAL and MATRIX? The difference in bleeding definitions used in the two trials probably accounts for the differences in bleeding reported. Furthermore, despite being similar sized trials, MATRIX had a three times higher event rate than RIVAL (ie, death, myocardial infarction, and stroke: 10·3% in MATRIX vs 3·2% in RIVAL in the control groups).7 This difference was probably because patients in cardiogenic shock and even post-cardiac arrest were enrolled in MATRIX but not in RIVAL. As a result, MATRIX had power to detect more modest reductions (ie, a 15% relative risk reduction) in the primary outcome. Finally, MATRIX was done by radial experts, and thus validated the subgroup hypothesis from RIVAL that showed the greatest benefit in the highest volume centres. One implication of these findings is that centres should strive to maximise their volumes of radial procedures, rather than reserving the procedure for patients in whom femoral access is not possible. By contrast with RIVAL, 2438
the consistency of findings for radial access between non-ST elevation coronary syndrome and ST-elevation myocardial infarction in MATRIX emphasises the importance of testing subgroup findings from previous trials, and suggests a benefit of radial access for the entire spectrum of patients with acute coronary syndrome. The results of MATRIX, in the context of RIVAL and other smaller trials, suggest that, at the very least, access site bleeding will be substantially reduced and, at best, that there will be a corresponding reduction in mortality. Although the apparent reduction in mortality in MATRIX should be interpreted cautiously given that it was a secondary outcome, a meta-analysis including MATRIX shows consistency for the reduction in mortality.12 In a health-care era in which patient-centred outcomes are being recognised to be increasingly important, even if mortality was not explicitly shown to have been reduced, based on the reduction in bleeding and patients’ preferences, radial access should probably become the default approach in most centres. Radial access has grown rapidly over the past 10 years, and now accounts for more than 50% of procedures in many countries. The rate of radial access in the USA has lagged behind that in other countries, but has increased from 1·2% in 2007 to 16·1% in 2012.13 Unlike a pharmaceutical intervention, which simply requires physicians to know the appropriate dose and write a prescription, a procedural innovation needs training and for physicians to go through the discomfort of a learning curve. However, adoption of new techniques is essential in medicine. We cannot imagine a general surgeon continuing to practise open cholecystectomy without gaining the expertise needed for laparoscopic cholecystectomy. Similarly, interventional cardiologists will be expected to be proficient in transradial intervention. Many large randomised trials now show the benefits of radial access. The next step is for guideline committees in both the USA and Europe to consider these data carefully and upgrade recommendations to make radial access the default approach for coronary angiography and intervention. *Sanjit S Jolly, Shamir R Mehta McMaster University and the Population Health Research Institute, Hamilton General Hospital, Hamilton, ON L8L 2X2, Canada [email protected]
www.thelancet.com Vol 385 June 20, 2015
Comment
We declare no competing interests. 1 2
3
4
5 6 7
8
Wallentin L, Becker RC, Budaj A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361: 1045–57. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001; 345: 494–502. Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J 2009; 157: 132–40. Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006; 114: 774–82. Yusuf S, Mehta SR, Chrolavicius S, et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006; 354: 1464–76. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med 2008; 358: 2218–30. Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011; 377: 1409–20. Mehta SR, Jolly SS, Cairns J, et al. Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation. J Am Coll Cardiol 2012; 60: 2490–99.
9
10
11
12
13
Jolly SS, Cairns J, Yusuf S, et al. Procedural volume and outcomes with radial or femoral access for coronary angiography and intervention. J Am Coll Cardiol 2014; 63: 954–63. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv 2012; 79: 453–95. Steg PG, James SK, Atar D, et al. ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2012; 33: 2569–619. Valgimigli M, Gagnor A, Calabró P, et al, for the MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet 2015; published online March 16. http://dx.doi.org/10.1016/S01406736(15)60292-6. Feldman DN, Swaminathan RV, Kaltenbach LA, et al. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national cardiovascular data registry (2007–2012). Circulation 2013; 127: 2295–306.
PARTNERs in the future of surgical aortic valve replacement
www.thelancet.com Vol 385 June 20, 2015
leaving only one patient alive at 5 years without. Even more important for elderly patients (mean age was 83 years) is quality of life, and 86% of the 49 survivors who received TAVR in PARTNER 1 had New York Heart Association (NYHA) functional class 1 or 2. A benefit of this size is remarkable for inoperable old patients treated with a first generation medical device. However, a concern is that 48% of the patients undergoing TAVR were readmitted to hospital in Kapadia and colleagues’ study,2 and the idea of competing risk in
Published Online March 15, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)60568-2 See Articles pages 2477 and 2485
Chassenet/Science Photo Library
Aortic stenosis is the most common valve disease, the occurrence of which increases with age.1 Incidence of aortic stenosis is expected to rise because of population ageing. For decades, surgical aortic valve replacement (SAVR) was the gold standard of care for individuals with symptomatic severe aortic stenosis—in properly selected patients, substantially improving symptoms and life expectancy.1 Although physicians have learned how to care for critically ill old patients and enable many to survive major surgical procedures, operating on patients at very high risk is often not suitable. Technical limitations—eg, porcelain aorta, chest wall deformity, and chest irradiation—further limit the ability to operate on certain patients with aortic stenosis. In The Lancet, Samir Kapadia and colleagues2 present the 5-year results of the PARTNER 1 randomised trial in patients with aortic stenosis who were unsuitable for surgery, which compared transcatheter aortic valve replacement (TAVR) with standard treatment. 358 patients were enrolled, and TAVR provided a survival benefit of almost 22% (all-cause mortality 71·8% with TAVR vs 93·6% with standard treatment; HR 0·50, 95% CI 0·39–0·65) and a 28% lower cardiovascular mortality (57·5% vs 85·9%). Only six patients in the standard treatment group were alive at 5 years, of whom five had had aortic valve replacement
2439