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Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials.

Abstract

BACKGROUND

The impact of sex on clinical outcomes of percutaneous coronary intervention and coronary artery bypass graft for patients with multivessel coronary disease and unprotected left main disease could be dissimilar between Western and Asian populations.

METHODS AND RESULTS

To assess clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft in women and men with multivessel coronary disease and unprotected left main disease, a pooled analysis (n=3280) was performed using the patient-level data from 3 large randomized trials: SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. The primary end point was all-cause death. Of 3280 patients, 794 patients (24.2%) were women. The median follow-up period was 1806 days (1611-1837 days). In women, a high heterogeneity of the treatment effect among the 3 trials was found for all-cause death (I2>50%), whereas in men, it was consistent across the 3 trials. In the Western trial (SYNTAX), female sex favored coronary artery bypass graft compared with percutaneous coronary intervention (hazard ratio(percutaneous coronary intervention) 2.213; 95% confidence interval, 1.242-3.943; P=0.007), whereas in the Asian women (PRECOMBAT and BEST), the treatment effect was neutral between both strategies. Sex interaction with treatment strategy was evident in the Western trial (Pinteraction=0.019) but not in the Asian trials (PRECOMBAT Pinteraction=0.469 and BEST Pinteraction=0.472; I2=58%).

CONCLUSIONS

The present meta-analysis suggested the presence of the heterogeneous sex-treatment interaction across Asian and Western trials. Considering the ongoing globalization of our medical practice, the heterogeneity of the sex-treatment interaction needs to be well recognized and taken into account during the decision making of the treatment strategy.

CLINICAL TRIAL REGISTRATIONS

URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00114972, NCT00997828, NCT00422968.

Authors+Show Affiliations

From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.). patrick.w.j.c.serruys@gmail.com.

Pub Type(s)

Journal Article
Meta-Analysis

Language

eng

PubMed ID

28495897

Citation

Sotomi, Yohei, et al. "Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: a Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials." Circulation. Cardiovascular Interventions, vol. 10, no. 5, 2017.
Sotomi Y, Onuma Y, Cavalcante R, et al. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circ Cardiovasc Interv. 2017;10(5).
Sotomi, Y., Onuma, Y., Cavalcante, R., Ahn, J. M., Lee, C. W., van Klaveren, D., ... Serruys, P. W. (2017). Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circulation. Cardiovascular Interventions, 10(5), doi:10.1161/CIRCINTERVENTIONS.117.005027.
Sotomi Y, et al. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: a Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circ Cardiovasc Interv. 2017;10(5) PubMed PMID: 28495897.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. AU - Sotomi,Yohei, AU - Onuma,Yoshinobu, AU - Cavalcante,Rafael, AU - Ahn,Jung-Min, AU - Lee,Cheol Whan, AU - van Klaveren,David, AU - de Winter,Robbert J, AU - Wykrzykowska,Joanna J, AU - Farooq,Vasim, AU - Morice,Marie-Claude, AU - Steyerberg,Ewout W, AU - Park,Seung-Jung, AU - Serruys,Patrick W, PY - 2017/01/22/received PY - 2017/03/30/accepted PY - 2017/5/13/entrez PY - 2017/5/13/pubmed PY - 2018/2/28/medline KW - coronary artery bypass KW - meta-analysis KW - percutaneous coronary intervention KW - randomized controlled trial KW - sex JF - Circulation. Cardiovascular interventions JO - Circ Cardiovasc Interv VL - 10 IS - 5 N2 - BACKGROUND: The impact of sex on clinical outcomes of percutaneous coronary intervention and coronary artery bypass graft for patients with multivessel coronary disease and unprotected left main disease could be dissimilar between Western and Asian populations. METHODS AND RESULTS: To assess clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft in women and men with multivessel coronary disease and unprotected left main disease, a pooled analysis (n=3280) was performed using the patient-level data from 3 large randomized trials: SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. The primary end point was all-cause death. Of 3280 patients, 794 patients (24.2%) were women. The median follow-up period was 1806 days (1611-1837 days). In women, a high heterogeneity of the treatment effect among the 3 trials was found for all-cause death (I2>50%), whereas in men, it was consistent across the 3 trials. In the Western trial (SYNTAX), female sex favored coronary artery bypass graft compared with percutaneous coronary intervention (hazard ratio(percutaneous coronary intervention) 2.213; 95% confidence interval, 1.242-3.943; P=0.007), whereas in the Asian women (PRECOMBAT and BEST), the treatment effect was neutral between both strategies. Sex interaction with treatment strategy was evident in the Western trial (Pinteraction=0.019) but not in the Asian trials (PRECOMBAT Pinteraction=0.469 and BEST Pinteraction=0.472; I2=58%). CONCLUSIONS: The present meta-analysis suggested the presence of the heterogeneous sex-treatment interaction across Asian and Western trials. Considering the ongoing globalization of our medical practice, the heterogeneity of the sex-treatment interaction needs to be well recognized and taken into account during the decision making of the treatment strategy. CLINICAL TRIAL REGISTRATIONS: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00114972, NCT00997828, NCT00422968. SN - 1941-7632 UR - https://www.unboundmedicine.com/medline/citation/28495897/Geographical_Difference_of_the_Interaction_of_Sex_With_Treatment_Strategy_in_Patients_With_Multivessel_Disease_and_Left_Main_Disease:_A_Meta_Analysis_From_SYNTAX__Synergy_Between_PCI_With_Taxus_and_Cardiac_Surgery__PRECOMBAT__Bypass_Surgery_Versus_Angioplasty_Using_Sirolimus_Eluting_Stent_in_Patients_With_Left_Main_Coronary_Artery_Disease__and_BEST__Bypass_Surgery_and_Everolimus_Eluting_Stent_Implantation_in_the_Treatment_of_Patients_With_Multivessel_Coronary_Artery_Disease__Randomized_Controlled_Trials_ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCINTERVENTIONS.117.005027?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -