Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease

Rutao Wang, Patrick W Serruys, Chao Gao, Hironori Hara, Kuniaki Takahashi, Masafumi Ono, Hideyuki Kawashima, Neil O'leary, David R Holmes, Adam Witkowski, Nick Curzen, Francesco Burzotta, Stefan James, Robert-Jan van Geuns, Arie Pieter Kappetein, Marie-Angele Morel, Stuart J Head, Daniel J F M Thuijs, Piroze M Davierwala, Timothy O'Brien, Valentin Fuster, Scot Garg, Yoshinobu Onuma, Rutao Wang, Patrick W Serruys, Chao Gao, Hironori Hara, Kuniaki Takahashi, Masafumi Ono, Hideyuki Kawashima, Neil O'leary, David R Holmes, Adam Witkowski, Nick Curzen, Francesco Burzotta, Stefan James, Robert-Jan van Geuns, Arie Pieter Kappetein, Marie-Angele Morel, Stuart J Head, Daniel J F M Thuijs, Piroze M Davierwala, Timothy O'Brien, Valentin Fuster, Scot Garg, Yoshinobu Onuma

Abstract

Aims: The aim of this article was to compare rates of all-cause death at 10 years following coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with or without diabetes.

Methods and results: The SYNTAXES study evaluated up to 10-year survival of 1800 patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) randomized to receive either PCI or CABG in the SYNTAX trial. Ten-year all-cause death according to diabetic status and revascularization strategy was examined. In diabetics (n = 452), the risk of mortality was numerically higher with PCI compared with CABG at 5 years [19.6% vs. 13.3%, hazard ratio (HR): 1.53, 95% confidence interval (CI): 0.96, 2.43, P = 0.075], with the opposite seen between 5 and 10 years (PCI vs. CABG: 20.8% vs. 24.4%, HR: 0.82, 95% CI: 0.52, 1.27, P = 0.366). Irrespective of diabetic status, there was no significant difference in all-cause death at 10 years between patients receiving PCI or CABG, the absolute treatment difference was 1.9% in diabetics (PCI vs. CABG: 36.4% vs. 34.5%, difference: 1.9%, 95% CI: -7.6%, 11.1%, P = 0.551). Among insulin-treated patients (n = 182), all-cause death at 10 years was numerically higher with PCI (47.9% vs. 39.6%, difference: 8.2%, 95% CI: -6.5%, 22.5%, P = 0.227).

Conclusions: The treatment effects of PCI vs. CABG on all-cause death at 10 years in patients with 3VD and/or LMCAD were similar irrespective of the presence of diabetes. There may, however, be a survival benefit with CABG in patients with insulin-treated diabetes. The association between revascularization strategy and very long-term ischaemic and safety outcomes for patients with diabetes needs further investigation in dedicated trials.

Trial registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972 and SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

Keywords: All-cause death; Coronary artery bypass grafting; Diabetes; Percutaneous coronary intervention; SYNTAX.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8720143/bin/ehab441f5.jpg
The treatment effects of PCI versus CABG on all-cause death at 10 years in 3VD/LMCAD patients with pharmacologically treated diabetes and insulin-treated diabetes.
Figure 1
Figure 1
Kaplan–Meier curves for all-cause death at 10 years according to diabetes. (A) All-cause death at 10 years according to diabetes in the overall cohort. (B) All-cause death at 10 years according to diabetes in the percutaneous coronary intervention arm. (C) All-cause death at 10 years according to diabetes in the coronary artery bypass grafting arm. Event rates represent Kaplan–Meier estimates. Note: As Kaplan–Meier estimates, the rate is not the same as the ratio of the numerator and denominator.
Figure 2
Figure 2
Kaplan–Meier curves for all-cause death at 10 years according to treatment strategies in patients with (A) and without (B) diabetes. (A) All-cause death at 10 years according to treatment strategies in patients with diabetes. (B) All-cause death at 10 years according to treatment strategies in patients without diabetes. Event rates represent Kaplan–Meier estimates. Note: As Kaplan–Meier estimates, the rate is not the same as the ratio of the numerator and denominator.
Figure 3
Figure 3
All-cause death at 10 years in the percutaneous coronary intervention and coronary artery bypass grafting arms among diabetic or non-diabetic patients stratified by subgroups.
Figure 4
Figure 4
Kaplan–Meier plots showing the observed vs. predicted treatment benefit of coronary artery bypass grafting over percutaneous coronary intervention according to the SYNTAX score II 2020 in predicted benefit quarters in non-diabetic population (A) and diabetic population (B), and calibration plot (C) showing the observed vs. predicted treatment benefit (absolute difference in mortality between coronary artery bypass grafting and percutaneous coronary intervention) in patients with diabetes (red line) and without diabetes (blue line). The percentages in red or blue figuring in the illustration are the absolute risk differences between coronary artery bypass grafting and percutaneous coronary intervention in each quarter for the diabetic and non-diabetic population. Vertical dashed lines represent quartiles, and the solid red or blue lines represent the mean value and 95% CI of the observed absolute risk differences between coronary artery bypass grafting and percutaneous coronary intervention in each quartile. (D) The individual difference between the predicted mortality (solid lines) by SYNTAX Score II 2020 after either percutaneous coronary intervention or coronary artery bypass grafting as well as the individual observed mortality (dashed lines) in diabetic patients. Blue solid line represents the predicted mortality after percutaneous coronary intervention; Red solid line represents the predicted mortality after coronary artery bypass grafting; Blue dashed line represents the observed mortality after percutaneous coronary intervention; Red dashed line represents the observed mortality after coronary artery bypass grafting.

References

    1. Einarson TR, Acs A, Ludwig C, Panton UH. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007-2017. Cardiovasc Diabetol 2018;17:83.
    1. Roffi M, Angiolillo DJ, Kappetein AP. Current concepts on coronary revascularization in diabetic patients. Eur Heart J 2011;32:2748–2757.
    1. Kapur A, Hall RJ, Malik IS, Qureshi AC, Butts J, de Belder M, Baumbach A, Angelini G, de Belder A, Oldroyd KG, Flather M, Roughton M, Nihoyannopoulos P, Bagger JP, Morgan K, Beatt KJ. Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial. J Am Coll Cardiol 2010;55:432–440.
    1. Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S 3rd, Bertrand M, Fuster V; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012;367:2375–2384.
    1. Kappetein AP, Head SJ, Morice MC, Banning AP, Serruys PW, Mohr FW, Dawkins KD, Mack MJ; on behalf of the SYNTAX Investigators. Treatment of complex coronary artery disease in patients with diabetes: 5-year results comparing outcomes of bypass surgery and percutaneous coronary intervention in the SYNTAX trial. Eur J Cardiothorac Surg 2013;43:1006–1013.
    1. Head SJ, Milojevic M, Daemen J, Ahn J-M, Boersma E, Christiansen EH, Domanski MJ, Farkouh ME, Flather M, Fuster V, Hlatky MA, Holm NR, Hueb WA, Kamalesh M, Kim Y-H, Mäkikallio T, Mohr FW, Papageorgiou G, Park S-J, Rodriguez AE, Sabik JF, Stables RH, Stone GW, Serruys PW, Kappetein AP. Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. Lancet 2018;391:939–948.
    1. Windecker S, Neumann FJ, Juni P, Sousa-Uva M, Falk V. Considerations for the choice between coronary artery bypass grafting and percutaneous coronary intervention as revascularization strategies in major categories of patients with stable multivessel coronary artery disease: an accompanying article of the task force of the 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 2019;40:204–212.
    1. BARI Investigators. The final 10-year follow-up results from the BARI randomized trial. J Am Coll Cardiol 2007;49:1600–1606.
    1. Thuijs DJFM, Kappetein AP, Serruys PW, Mohr F-W, Morice M-C, Mack MJ, Holmes DR, Curzen N, Davierwala P, Noack T, Milojevic M, Dawkins KD, da Costa BR, Jüni P, Head SJ; SYNTAX Extended Survival Investigators. Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial. Lancet 2019;394:1325–1334.
    1. Ong AT, Serruys PW, Mohr FW, Morice MC, Kappetein AP, Holmes DR Jr, Mack MJ, van den Brand M, Morel MA, van Es GA, Kleijne J, Koglin J, Russell ME. The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design, rationale, and run-in phase. Am Heart J 2006;151:1194–1204.
    1. Serruys PW, Morice M-C, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009;360:961–972.
    1. Mohr FW, Morice M-C, Kappetein AP, Feldman TE, Ståhle E, Colombo A, Mack MJ, Holmes DR, Morel M-A, Dyck NV, Houle VM, Dawkins KD, Serruys PW. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013;381:629–638.
    1. Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park S-J, Park D-W, Ahn J-M, Kappetein AP, Head SJ, Thuijs DJFM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D. Redevelopment and validation of the SYNTAX score II to individualise decision making between percutaneous and surgical revascularisation in patients with complex coronary artery disease: secondary analysis of the multicentre randomised controlled SYNTAXES trial with external cohort validation. Lancet 2020;396:1399–1412.
    1. Pocock SJ, McMurray JJV, Collier TJ. Statistical controversies in reporting of clinical trials: art 2 of a 4-part series on statistics for clinical trials. J Am Coll Cardiol 2015;66:2648–2662.
    1. Koskinas KC, Windecker S. Revascularization in complex multivessel coronary artery disease after FREEDOM. Is there an indication for PCI and drug-eluting stents? Herz 2016;41:224–232.
    1. Farkouh ME, Domanski M, Dangas GD, Godoy LC, Mack MJ, Siami FS, Hamza TH, Shah B, Stefanini GG, Sidhu MS, Tanguay JF, Ramanathan K, Sharma SK, French J, Hueb W, Cohen DJ, Fuster V; FREEDOM Follow-On Study Investigators. Long-term survival following multivessel revascularization in patients with diabetes: the FREEDOM follow-on study. J Am Coll Cardiol 2019;73:629–638.
    1. Tam DY, Dharma C, Rocha R, Farkouh ME, Abdel-Qadir H, Sun LY, Wijeysundera HC, Austin PC, Udell JA, Gaudino M, Fremes SE, Lee DS. Long-term survival after surgical or percutaneous revascularization in patients with diabetes and multivessel coronary disease. J Am Coll Cardiol 2020;76:1153–1164.
    1. Bourassa MY, Holubkov R, Sopko G, Detre KM. Long-term outcome of patients with incomplete vs complete revascularization after multivessel PTCA. A report from the NHLBI PTCA Registry. Eur Heart J 1998;19:103–111.
    1. Hannan EL, Racz M, Holmes DR, King SB 3rd, Walford G, Ambrose JA, Sharma S, Katz S, Clark LT, Jones RH. Impact of completeness of percutaneous coronary intervention revascularization on long-term outcomes in the stent era. Circulation 2006;113:2406–2412.
    1. Takahashi K, Serruys PW, Gao C, Ono M, Wang R, Thuijs D, Mack MJ, Curzen N, Mohr FW, Davierwala P, Milojevic M, Wykrzykowska JJ, de Winter RJ, Sharif F, Onuma Y, Head SJ, Kappetein AP, Morice MC, Holmes DR Jr. Ten-year all-cause death according to completeness of revascularization in patients with three-vessel disease or left main coronary artery disease: insights from the SYNTAX extended survival study. Circulation 2021;doi:10.1161/CIRCULATIONAHA.120.046289.
    1. Dangas GD, Farkouh ME, Sleeper LA, Yang M, Schoos MM, Macaya C, Abizaid A, Buller CE, Devlin G, Rodriguez AE, Lansky AJ, Siami FS, Domanski M, Fuster V; FREEDOM Investigators. Long-term outcome of PCI versus CABG in insulin and non-insulin-treated diabetic patients: results from the FREEDOM trial. J Am Coll Cardiol 2014;64:1189–1197.
    1. Benedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg 2015;47:59–65; discussion 65.
    1. Sharma PK, Agarwal S, Ellis SG, Goel SS, Cho L, Tuzcu EM, Lincoff AM, Kapadia SR. Association of glycemic control with mortality in patients with diabetes mellitus undergoing percutaneous coronary intervention. Circ Cardiovasc Interv 2014;7:503–509.
    1. Zheng J, Cheng J, Zhang Q, Qi C, Wang T, Xiao X. Association between glycosylated hemoglobin level and cardiovascular outcomes in diabetic patients after percutaneous coronary intervention. Medicine (Baltimore) 2016;95:e3696.
    1. Tennyson C, Lee R, Attia R. Is there a role for HbA1c in predicting mortality and morbidity outcomes after coronary artery bypass graft surgery? Interact Cardiovasc Thorac Surg 2013;17:1000–1008.
    1. Wang J, Luo X, Jin X, Lv M, Li X, Dou J, Zeng J, An P, Chen Y, Chen K, Mu Y. Effects of preoperative HbA1c levels on the postoperative outcomes of coronary artery disease surgical treatment in patients with diabetes mellitus and nondiabetic patients: a systematic review and meta-analysis. J Diabetes Res 2020;2020:3547491.
    1. Qaseem A, Wilt TJ, Kansagara D, Horwitch C, Barry MJ, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Hemoglobin A1c targets for glycemic control with pharmacologic therapy for nonpregnant adults with type 2 diabetes mellitus: a guidance statement update from the American College of Physicians. Ann Intern Med 2018;168:569–576.
    1. Hakeem A, Garg N, Bhatti S, Rajpurohit N, Ahmed Z, Uretsky BF. Effectiveness of percutaneous coronary intervention with drug-eluting stents compared with bypass surgery in diabetics with multivessel coronary disease: comprehensive systematic review and meta-analysis of randomized clinical data. J Am Heart Assoc 2013;2:e000354.
    1. Esper RB, Farkouh ME, Ribeiro EE, Hueb W, Domanski M, Hamza TH, Siami FS, Godoy LC, Mathew V, French J, Fuster V. SYNTAX score in patients with diabetes undergoing coronary revascularization in the FREEDOM trial. J Am Coll Cardiol 2018;72:2826–2837.
    1. Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2019;40:87–165.
    1. Genereux P, Palmerini T, Caixeta A, Rosner G, Green P, Dressler O, Xu K, Parise H, Mehran R, Serruys PW, Stone GW. Quantification and impact of untreated coronary artery disease after percutaneous coronary intervention: the residual SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) score. J Am Coll Cardiol 2012;59:2165–2174.
    1. Farooq V, Serruys PW, Bourantas CV, Zhang Y, Muramatsu T, Feldman T, Holmes DR, Mack M, Morice MC, Stahle E, Colombo A, de Vries T, Morel MA, Dawkins KD, Kappetein AP, Mohr FW. Quantification of incomplete revascularization and its association with five-year mortality in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial validation of the residual SYNTAX score. Circulation 2013;128:141–151.
    1. Burgess SN, Juergens CP, Nguyen T, Leung M, Robledo KP, Thomas L, Mussap C, Lo STH, French JK. Diabetes and incomplete revascularisation in ST elevation myocardial infarction. Heart Lung Circ 2021;30:471–480.
    1. Kent DM, Steyerberg E, van Klaveren D. Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects. BMJ 2018;363:k4245.
    1. Gaudino M, Hameed I, Farkouh ME, Rahouma M, Naik A, Robinson NB, Ruan Y, Demetres M, Biondi-Zoccai G, Angiolillo DJ, Bagiella E, Charlson ME, Benedetto U, Ruel M, Taggart DP, Girardi LN, Bhatt DL, Fremes SE. Overall and cause-specific mortality in randomized clinical trials comparing percutaneous interventions with coronary bypass surgery: a meta-analysis. JAMA Intern Med. 2020;180:1638.
    1. Stolker JM, Spertus JA, Cohen DJ, Jones PG, Jain KK, Bamberger E, Lonergan BB, Chan PS. Rethinking composite end points in clinical trials: insights from patients and trialists. Circulation 2014;130:1254–1261.
    1. Li G, Taljaard M, Van den Heuvel ER, Levine MA, Cook DJ, Wells GA, Devereaux PJ, Thabane L. An introduction to multiplicity issues in clinical trials: the what, why, when and how. Int J Epidemiol 2017;46:746–755.
    1. Lauer MS, Blackstone EH, Young JB, Topol EJ. Cause of death in clinical research: time for a reassessment? J Am Coll Cardiol 1999;34:618–620.
    1. Akl EA, Briel M, You JJ, Sun X, Johnston BC, Busse JW, Mulla S, Lamontagne F, Bassler D, Vera C, Alshurafa M, Katsios CM, Zhou Q, Cukierman-Yaffe T, Gangji A, Mills EJ, Walter SD, Cook DJ, Schunemann HJ, Altman DG, Guyatt GH. Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review. BMJ 2012;344:e2809.
    1. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2010;33(Suppl. 1):S62—S6 9.
    1. Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016;375:311–322.
    1. Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE–TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347–357.
    1. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373:2117–2128.
    1. Handelsman Y, Lepor NE. PCSK9 inhibitors in lipid management of patients with diabetes mellitus and high cardiovascular risk: a review. J Am Heart Assoc 2018;7:e008953.

Source: PubMed

3
Předplatit