- Email: [email protected]
“The Bedouin predicament”
Correspondence
be achieved by adequate lesion preparation (ie, use of appropriately sized non-compliant balloons or plaque modification), routine high-pressure scaffold post-dilatation, and more frequent use of intravascular imaging. In a large four-centre study3 of BVS implantation in an unrestricted patient population, scaffold underexpansion was shown to be an important independent predictor of BVS thrombosis, and the application of a BVS-specific protocol using optimal technique to ensure maximal scaffold dimensions reduced the incidence of BVS thrombosis to acceptable levels. The incidence of metallic drug-eluting stent thrombosis is increased in small vessels, and the effect of vessel size could be even greater for the thick-strut Absorb scaffold. In this regard, although BVS is intended for lesions with reference vessel diameter of 2·5 mm or higher, in the ABSORB III trial4 the reference vessel diameter as measured by quantitative coronary angiography was surprisingly less than 2·25 mm in 19·6% of lesions. Patients in whom such very small vessels were treated had a higher incidence of device thrombosis with Absorb BVS (4·6%) than did those whose small vessels were treated with Xience EES (1·5%), whereas device thrombosis incidence was similar between BVS and EES in patients with appropriately sized vessels (0·8% and 0·5%, respectively). Others have confirmed high scaffold thrombosis rates in very small vessels, in part due to the large polymeric footprint of a mismatched oversized device.3 Analyses of the impact of the use of intravascular imaging and post-dilatation are difficult to interpret in non-randomised studies because of confounding (typically used selectively in more complex lesions, or in those not responding well to standard techniques). However, we did note in ABSORB III that the incidence of BVS thrombosis was lower in very small vessels when routinely post-dilated with a non-compliant balloon at high 128
pressure (≥14 atm). In summary, we expect that appropriate patient selection, optimal technique, and device iteration will result in steady improvements in 1-year outcomes with Absorb BVS, allowing longer-term patient benefits to emerge from restoration of normal coronary physiology and vascular function. GWS has served as a consultant to Osprey, Reva, Boston Scientific, AstraZeneca, Eli Lilly–Daiichi Sankyo partnership, InspireMD, TherOx, Atrium, Volcano, InfraReDx, Miracor, Velomedix, CSI, and Matrizyme, and has stock or stock options with Biostar family of funds, MedFocus family of funds, Caliber, Guided Delivery Systems, Micardia, VNT, Cagent, and Qool Therapeutics. RG has a research grant from Abbott Vascular. TK is an advisory board member for Abbott Vascular. CS is a full-time employee of Abbott Vascular. PWS declares no competing interests.
*Gregg W Stone, Runlin Gao, Takeshi Kimura, Charles Simonton, Patrick W Serruys [email protected] New York Presbyterian Hospital, Columbia University Medical Center, New York, NY 10022, USA (GWS); Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China (RG); Kyoto University Hospital, Kyoto, Japan (TK); Abbott Vascular, Santa Clara, CA, USA (CS); and International Centre for Cardiovascular Health, Imperial College, London, UK (PWS) 1
2
3
4
Stone GW, Gao R, Kimura T, et al. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet 2016; 387: 1277–89. Palmerini T, Benedetto U, Biondi-Zoccai G, et al. Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2015; 65: 2496–507. Puricel S, Cuculi F, Weissner M, et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol 2016; 67: 921–31. Stone GW, Ellis SE, Simonton C, et al. Outcomes of the Absorb bioresorbable vascular scaffold in very small and not very small coronary arteries: the Absorb III randomized trial. J Am Coll Cardiol 2016; 67: 35.
“The Bedouin predicament” I was moved when reading Richard Horton’s Offline: The Bedouin predicament (April 9, p 1498) about the semi-Nomadic Bedouins and the poverty and illiteracy that
challenge provision of health services in the Negev desert.1 The UK also has semi-Nomadic communities: Gypsy and Traveller families. Of all the many ethnic groups recognised in the Census, “white Gypsy or Irish Traveller” communities have the worst health—for example, in terms of limiting long-term illness.2 These populations experience multiple inequalities 3 likely to undermine health in every generation. Despite efforts from dedicated community volunteers, health visitors, teachers, medical anthropologists, and advocates, social exclusion for these communities does not seem to have improved since the Equality Act 2010. Exclusion has probably grown worse, because changes in both Health and Local Authority services have overlooked semi-Nomadic families. Both the physical and mental health of these communities suffer from avoidable gaps in the commissioning and provision of health care, affecting an estimated 300 000 people. 4 Dedicated individuals can only do so much. At a national policy level, who has the foresight to tackle health inequalities across these widespread communities? I have received personal fees from the Department of Health, outside the submitted work, and was a collaborator in the Anglia Gypsy Traveller Health Information Project (funded by the NHS EHU) in the 1990s.
Woody Caan [email protected] Royal Society for Public Health, Duxford CB22 4PA, UK 1 2
3
4
Horton R. Offline: The Bedouin predicament. Lancet 2016; 387: 1498. Becares L. Which ethnic groups have the poorest health? Ethnic health inequalities 1991 to 2011. In: ESRC Centre of Dynamics and Ethnicity (CoDE), ed. Dynamics of diversity: evidence from the 2011 census. University of Manchester, Joseph Rowntree Foundation, 2013. Cemlyn S, Greenfields M, Burnett S, Matthews Z, Whitwell C. Inequalities experienced by Gypsy and Traveller communities: a review. Manchester: Equality and Human Rights Commission, 2009. Lau Y-H, Ridge M. Addressing the impact of social exclusion on mental health in Gypsy, Roma and Traveller communities. Ment Health Soc Incl 2011; 15: 129–37.
www.thelancet.com Vol 388 July 9, 2016
be achieved by adequate lesion preparation (ie, use of appropriately sized non-compliant balloons or plaque modification), routine high-pressure scaffold post-dilatation, and more frequent use of intravascular imaging. In a large four-centre study3 of BVS implantation in an unrestricted patient population, scaffold underexpansion was shown to be an important independent predictor of BVS thrombosis, and the application of a BVS-specific protocol using optimal technique to ensure maximal scaffold dimensions reduced the incidence of BVS thrombosis to acceptable levels. The incidence of metallic drug-eluting stent thrombosis is increased in small vessels, and the effect of vessel size could be even greater for the thick-strut Absorb scaffold. In this regard, although BVS is intended for lesions with reference vessel diameter of 2·5 mm or higher, in the ABSORB III trial4 the reference vessel diameter as measured by quantitative coronary angiography was surprisingly less than 2·25 mm in 19·6% of lesions. Patients in whom such very small vessels were treated had a higher incidence of device thrombosis with Absorb BVS (4·6%) than did those whose small vessels were treated with Xience EES (1·5%), whereas device thrombosis incidence was similar between BVS and EES in patients with appropriately sized vessels (0·8% and 0·5%, respectively). Others have confirmed high scaffold thrombosis rates in very small vessels, in part due to the large polymeric footprint of a mismatched oversized device.3 Analyses of the impact of the use of intravascular imaging and post-dilatation are difficult to interpret in non-randomised studies because of confounding (typically used selectively in more complex lesions, or in those not responding well to standard techniques). However, we did note in ABSORB III that the incidence of BVS thrombosis was lower in very small vessels when routinely post-dilated with a non-compliant balloon at high 128
pressure (≥14 atm). In summary, we expect that appropriate patient selection, optimal technique, and device iteration will result in steady improvements in 1-year outcomes with Absorb BVS, allowing longer-term patient benefits to emerge from restoration of normal coronary physiology and vascular function. GWS has served as a consultant to Osprey, Reva, Boston Scientific, AstraZeneca, Eli Lilly–Daiichi Sankyo partnership, InspireMD, TherOx, Atrium, Volcano, InfraReDx, Miracor, Velomedix, CSI, and Matrizyme, and has stock or stock options with Biostar family of funds, MedFocus family of funds, Caliber, Guided Delivery Systems, Micardia, VNT, Cagent, and Qool Therapeutics. RG has a research grant from Abbott Vascular. TK is an advisory board member for Abbott Vascular. CS is a full-time employee of Abbott Vascular. PWS declares no competing interests.
*Gregg W Stone, Runlin Gao, Takeshi Kimura, Charles Simonton, Patrick W Serruys [email protected] New York Presbyterian Hospital, Columbia University Medical Center, New York, NY 10022, USA (GWS); Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China (RG); Kyoto University Hospital, Kyoto, Japan (TK); Abbott Vascular, Santa Clara, CA, USA (CS); and International Centre for Cardiovascular Health, Imperial College, London, UK (PWS) 1
2
3
4
Stone GW, Gao R, Kimura T, et al. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet 2016; 387: 1277–89. Palmerini T, Benedetto U, Biondi-Zoccai G, et al. Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2015; 65: 2496–507. Puricel S, Cuculi F, Weissner M, et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol 2016; 67: 921–31. Stone GW, Ellis SE, Simonton C, et al. Outcomes of the Absorb bioresorbable vascular scaffold in very small and not very small coronary arteries: the Absorb III randomized trial. J Am Coll Cardiol 2016; 67: 35.
“The Bedouin predicament” I was moved when reading Richard Horton’s Offline: The Bedouin predicament (April 9, p 1498) about the semi-Nomadic Bedouins and the poverty and illiteracy that
challenge provision of health services in the Negev desert.1 The UK also has semi-Nomadic communities: Gypsy and Traveller families. Of all the many ethnic groups recognised in the Census, “white Gypsy or Irish Traveller” communities have the worst health—for example, in terms of limiting long-term illness.2 These populations experience multiple inequalities 3 likely to undermine health in every generation. Despite efforts from dedicated community volunteers, health visitors, teachers, medical anthropologists, and advocates, social exclusion for these communities does not seem to have improved since the Equality Act 2010. Exclusion has probably grown worse, because changes in both Health and Local Authority services have overlooked semi-Nomadic families. Both the physical and mental health of these communities suffer from avoidable gaps in the commissioning and provision of health care, affecting an estimated 300 000 people. 4 Dedicated individuals can only do so much. At a national policy level, who has the foresight to tackle health inequalities across these widespread communities? I have received personal fees from the Department of Health, outside the submitted work, and was a collaborator in the Anglia Gypsy Traveller Health Information Project (funded by the NHS EHU) in the 1990s.
Woody Caan [email protected] Royal Society for Public Health, Duxford CB22 4PA, UK 1 2
3
4
Horton R. Offline: The Bedouin predicament. Lancet 2016; 387: 1498. Becares L. Which ethnic groups have the poorest health? Ethnic health inequalities 1991 to 2011. In: ESRC Centre of Dynamics and Ethnicity (CoDE), ed. Dynamics of diversity: evidence from the 2011 census. University of Manchester, Joseph Rowntree Foundation, 2013. Cemlyn S, Greenfields M, Burnett S, Matthews Z, Whitwell C. Inequalities experienced by Gypsy and Traveller communities: a review. Manchester: Equality and Human Rights Commission, 2009. Lau Y-H, Ridge M. Addressing the impact of social exclusion on mental health in Gypsy, Roma and Traveller communities. Ment Health Soc Incl 2011; 15: 129–37.
www.thelancet.com Vol 388 July 9, 2016