Long-Term (10-Year) Outcomes of Stenting or Bypass Surgery for Left Main Coronary Artery Disease in Patients With and Without Diabetes Mellitus

Kyusup Lee, Jung-Min Ahn, Yong-Hoon Yoon, Do-Yoon Kang, Seo-Young Park, Euihong Ko, Hanbit Park, Sang-Cheol Cho, Sangwoo Park, Tae Oh Kim, Pil Hyung Lee, Seung-Whan Lee, Seong-Wook Park, Duk-Woo Park, Seung-Jung Park, Kyusup Lee, Jung-Min Ahn, Yong-Hoon Yoon, Do-Yoon Kang, Seo-Young Park, Euihong Ko, Hanbit Park, Sang-Cheol Cho, Sangwoo Park, Tae Oh Kim, Pil Hyung Lee, Seung-Whan Lee, Seong-Wook Park, Duk-Woo Park, Seung-Jung Park

Abstract

Background Data are still limited regarding whether there are differential long-term outcomes after percutaneous coronary intervention versus coronary artery bypass grafting (CABG) for left main coronary artery disease with or without diabetes mellitus (DM). Methods and Results Using the 10-year data from the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry, we sought to examine the effect of DM on comparative outcomes after percutaneous coronary intervention or CABG in patients with unprotected left main coronary artery disease. The outcomes of interest were all-cause mortality; a composite of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization. The primary adjusted analyses were performed with the use of propensity scores and inverse-probability weighting. Of 2240 patients with left main coronary artery revascularization, 722 (32%) had DM. In the overall population, the adjusted 10-year risks of death and composite outcome were similar between percutaneous coronary intervention and CABG, irrespective of DM status (Pinteraction: 0.41, mortality; 0.40, composite outcome). However, in the cohort of bare-metal stents and concurrent CABG, we observed differential outcomes after stenting and CABG by DM status (Pinteraction: 0.09, mortality; 0.04, composite outcome), favoring CABG in patients with DM. In the cohort of drug-eluting stents and concurrent CABG, the better effect of CABG over stenting was narrowed in patients with DM without a significant interaction (Pinteraction: 0.63, mortality; 0.47, composite outcome). Conclusions In this cohort of patients with longest follow-up who underwent left main coronary artery revascularization, the clinical impact of DM favoring CABG over percutaneous coronary intervention has diminished over time from the bare-metal stent to the drug-eluting stent era. Registration URL: http://www.clini​caltr​ials.gov. Unique identifier: NCT02791412.

Keywords: coronary artery bypass grafting; diabetes mellitus; left main disease; stents.

Figures

Figure 1. Kaplan–Meier curves for 10‐year outcomes…
Figure 1. Kaplan–Meier curves for 10‐year outcomes after PCI or CABG in patients with or without DM.
The left panel (A through C) shows cumulative event curves for patients with DM and the right panel (D through F) showed event curves for patients without DM. The upper panel (A and D) indicates all‐cause death, the middle panel (B and E) indicates a composite of death, Q‐wave MI, or stroke; and the lower panel (C and F) indicates target‐vessel revascularization. CABG indicates coronary artery bypass grafting; DM, diabetes mellitus; MI, myocardial infarction; non‐DM, non–diabetes mellitus; and PCI, percutaneous coronary intervention.
Figure 2. Adjusted event curves for 10‐year…
Figure 2. Adjusted event curves for 10‐year outcomes after PCI or CABG in patients with or without DM using inverse probability weighting.*
The left panel (A through C) shows cumulative event curves for patients with DM, and the right panel (D through F) shows event curves for patients without DM. The upper panel (A and D) indicates all‐cause death, the middle panel (B and E) indicates a composite of death, Q‐wave MI, or stroke; and the lower panel (C and F) indicates target‐vessel revascularization. *Inverse probability of treatment weighting gives different weights to patients based on their characteristics, to create a “virtual” data set that mimics the data that would have been observed if the treatment was randomly assigned. This figure was drawn with individuals after weighting to study population. The adjusted survival curves were estimated with the use of the inverse‐probability‐weighting approach of Cole and Hernan.33 aHR indicates adjusted hazard ratio; CABG, coronary artery bypass grafting; DM, diabetes mellitus; MI, myocardial infarction; non‐DM, non–diabetes mellitus; and PCI, percutaneous coronary intervention.
Figure 3. Adjusted event curves for 10‐year…
Figure 3. Adjusted event curves for 10‐year outcomes after BMS or concurrent CABG in Patients with or without DM using inverse probability weighting.
The left panel (A through C) shows cumulative event curves for patients with DM, and the right panel (D through F) shows event curves for patients without DM. The upper panel (A and D) indicates all‐cause death; the middle panel (B and E) indicates a composite of death, Q‐wave MI, or stroke; and the lower panel (C and F) indicates target‐vessel revascularization. aHR indicates adjusted hazard ratio; CABG, coronary artery bypass grafting; DM, diabetes mellitus; MI, myocardial infarction; non‐DM, non–diabetes mellitus; and PCI, percutaneous coronary intervention.
Figure 4. Adjusted event curves for 10‐year…
Figure 4. Adjusted event curves for 10‐year outcomes after DES or concurrent CABG in patients with or without DM using inverse probability weighting.
The left panel (A through C) shows cumulative event curves for patients with DM, and the right panel (D through F) shows event curves for patients without DM. The upper panel (A and D) indicates all‐cause death; the middle panel (B and E) indicates a composite of death, Q‐wave MI, or stroke; and the lower panel (C and F) indicates target‐vessel revascularization. aHR indicates adjusted hazard ratio; BMS, bare‐metal stent; CABG, coronary artery bypass grafting; DES, drug‐eluting stent; DM, diabetes mellitus; MI, myocardial infarction; and non‐DM, non–diabetes mellitus; and PCI, percutaneous coronary intervention.

References

    1. Frye RL, August P, Brooks MM, Hardison RM, Kelsey SF, MacGregor JM, Orchard TJ, Chaitman BR, Genuth SM, Goldberg SH, et al. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009;360:2503–2515.
    1. Castelvecchio S, Menicanti L, Garatti A, Tramarin R, Volpe M, Parolari A. Myocardial revascularization for patients with diabetes: coronary artery bypass grafting or percutaneous coronary intervention? Ann Thorac Surg. 2016;102:1012–1022.
    1. Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, et al. Percutaneous coronary intervention versus coronary‐artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360:961–972.
    1. Hlatky MA, Boothroyd DB, Bravata DM, Boersma E, Booth J, Brooks MM, Carrie D, Clayton TC, Danchin N, Flather M, et al. Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease: a collaborative analysis of individual patient data from ten randomised trials. Lancet. 2009;373:1190–1197.
    1. Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, et al. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012;367:2375–2384.
    1. Head SJ, Milojevic M, Daemen J, Ahn JM, Boersma E, Christiansen EH, Domanski MJ, Farkouh ME, Flather M, Fuster V, et al. 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. Fihn SD, Blankenship JC, Alexander KP, Bittl JA, Byrne JG, Fletcher BJ, Fonarow GC, Lange RA, Levine GN, Maddox TM, et al. 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2014;130:1749–1767.
    1. Neumann FJ, Sousa‐Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J. 2019;40:87–165.
    1. Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM III, et al. Everolimus‐eluting stents or bypass surgery for left main coronary artery disease. N Engl J Med. 2016;375:2223–2235.
    1. Park DW, Park SJ. Percutaneous coronary intervention of left main disease: pre‐ and post‐EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic‐Baltic‐British Left Main Revascularization Study) era. Circ Cardiovasc Interv. 2017;10:e004792.
    1. Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open‐label, non‐inferiority trial. Lancet. 2016;388:2743–2752.
    1. Park DW, Ahn JM, Yun SC, Yoon YH, Kang DY, Lee PH, Lee SW, Park SW, Seung KB, Gwon HC, et al. 10‐year outcomes of stents versus coronary artery bypass grafting for left main coronary artery disease. J Am Coll Cardiol. 2018;72:2813–2822.
    1. Seung KB, Park D‐W, Kim Y‐H, Lee S‐W, Lee CW, Hong M‐K, Park S‐W, Yun S‐C, Gwon H‐C, Jeong M‐H. Stents versus coronary‐artery bypass grafting for left main coronary artery disease. N Engl J Med. 2008;358:1781–1792.
    1. Park D‐W, Seung KB, Kim Y‐H, Lee J‐Y, Kim W‐J, Kang S‐J, Lee S‐W, Lee CW, Park S‐W, Yun S‐C. Long‐term safety and efficacy of stenting versus coronary artery bypass grafting for unprotected left main coronary artery disease: 5‐year results from the MAIN‐COMPARE (revascularization for unprotected left main coronary artery stenosis: comparison of percutaneous coronary angioplasty versus surgical revascularization) registry. J Am Coll Cardiol. 2010;56:117–124.
    1. Robins JM, Hernan MA, Brumback B. Marginal structural models and causal inference in epidemiology. Epidemiology. 2000;11:550–560.
    1. Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015;34:3661–3679.
    1. Rosenbaum PR. Model‐based direct adjustment. J Am Stat Assoc. 1987;82:387–394.
    1. Therneau TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. New York, NY: Springer; 2000.
    1. Silvain J, Vignalou JB, Barthelemy O, Kerneis M, Collet JP, Montalescot G. Coronary revascularization in the diabetic patient. Circulation. 2014;130:918–922.
    1. Bhatt DL. CABG the clear choice for patients with diabetes and multivessel disease. Lancet. 2018;391:913–914.
    1. Kappetein AP, Head SJ. CABG or PCI for revascularisation in patients with diabetes? Lancet Diabetes Endocrinol. 2013;1:266–268.
    1. Park S‐J, Park D‐W. Diabetes in myocardial revascularization for left main coronary artery disease: predictor or decision maker?. J Am Coll Cardiol. 2019;73:1629–1632.
    1. Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, Kappetein AP, Colombo A, Holmes DR Jr, Mack M, et al. Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet. 2013;381:639–650.
    1. Milojevic M, Serruys PW, Sabik JF, Kandzari DE, Schampaert E, van Boven AJ, Horkay F, Ungi I, Mansour S, Banning AP, et al. Bypass surgery or stenting for left main coronary artery disease in patients with diabetes. J Am Coll Cardiol. 2019;73:1616–1628.
    1. Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM III, Lembo NJ, et al. Five‐year outcomes after PCI or CABG for left main coronary disease. N Engl J Med. 2019;381:1820–1830.
    1. Farkouh ME, Domanski M, Dangas GD, Godoy LC, Mack MJ, Siami FS, Hamza TH, Shah B, Stefanini GG, Sidhu MS, et al. Long‐term survival following multivessel revascularization in patients with diabetes: the FREEDOM follow‐on study. J Am Coll Cardiol. 2019;73:629–638.
    1. Thuijs DJFM, Kappetein AP, Serruys PW, Mohr F‐W, Morice M‐C, Mack MJ, Holmes DR Jr, Curzen N, Davierwala P, Noack T, et al. 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. Doenst T, Haverich A, Serruys P, Bonow RO, Kappetein P, Falk V, Velazquez E, Diegeler A, Sigusch H. PCI and CABG for treating stable coronary artery disease: JACC review topic of the week. J Am Coll Cardiol. 2019;73:964–976.
    1. Gersh BJ, Frye RL. Methods of coronary revascularization—things may not be as they seem. N Engl J Med. 2005;352:2235–2237.
    1. Head SJ, Mack MJ, Holmes DR Jr, Mohr FW, Morice M‐C, Serruys PW, Kappetein AP. Incidence, predictors and outcomes of incomplete revascularization after percutaneous coronary intervention and coronary artery bypass grafting: a subgroup analysis of 3‐year SYNTAX data. Eur J Cardiothorac Surg. 2012;41:535–541.
    1. Lee PH, Ahn JM, Chang M, Baek S, Yoon SH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, et al. Left main coronary artery disease: secular trends in patient characteristics, treatments, and outcomes. J Am Coll Cardiol. 2016;68:1233–1246.
    1. Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Furtado RHM. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta‐analysis of cardiovascular outcome trials. Lancet. 2019;393:31–39.
    1. Cole SR, Hernan MA. Adjusted survival curves with inverse probability weights. Comput Methods Programs Biomed. 2004;75:45–49.

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