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The Arterial Revascularization Trial: It Is What It Is

2019; Wiley; Volume: 8; Issue: 23 Linguagem: Inglês

10.1161/jaha.119.015046

2047-9980

Harold L. Lazar,

Aortic Disease and Treatment Approaches

HomeJournal of the American Heart AssociationVol. 8, No. 23The Arterial Revascularization Trial: It Is What It Is Open AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessEditorialPDF/EPUBThe Arterial Revascularization Trial: It Is What It Is Harold L. Lazar, MD Harold L. LazarHarold L. Lazar *Correspondence to: Harold L. Lazar, MD, 80 East Concord Street, Boston, MA 02118. E‐mail: E-mail Address: [email protected] Division of Cardiac Surgery, , The Boston University School of Medicine, , Boston, , MA Originally published22 Nov 2019https://doi.org/10.1161/JAHA.119.015046Journal of the American Heart Association. 2019;8:e015046This article is a commentary on the followingDisagreement Between Randomized and Observational Evidence on the Use of Bilateral Internal Thoracic Artery Grafting: A Meta‐Analytic ApproachDespite an increased emphasis for the use of bilateral internal mammary artery (BITA) grafting in coronary artery bypass graft (CABG) patients, a recent study from the Society of Thoracic Surgeons (STS) database revealed that only 4.9% of CABG patients received BITA grafts.1 The most common reasons for not embracing BITA grafting stem from the increased risk of sternal wound complications and the quality of data from published studies comparing BITA and single internal mammary artery (SITA) grafting. The majority of data are derived from retrospective, nonrandomized studies and meta‐analyses with great variability in propensity‐matching leading to selection bias. Patients undergoing BITA grafting tend to be younger with fewer comorbidities. Data are lacking regarding graft patency, the quality of the vessels grafted and their Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) scores, causes of death—cardiac versus noncardiac; and compliance with Goal Directed Medical Therapy (GDMT).Because of these deficiencies, the ART (Arterial Revascularization Trial) was initiated in 2004 to address these concerns and define the role of BITA grafting in the CABG patient.2 This was a multicenter, prospective trial involving 3102 CABG patients in which patients were randomized to receive either BITA or SITA grafts along with GDMT. In addition, both groups received saphenous vein grafts and 21.8% of the SITA group and 19.4% of the BITA patients also received a radial artery (RA) graft. The patients were well matched with respect to age (mean=63 years), diabetes mellitus (23% of whom 5.5% were insulin dependent), sex, hypertension, smoking habits, and other comorbidities. After 10 years, there was no significant difference in mortality from any cause (20.3% BITA versus 21.2% SITA), the composite end point of death, myocardial infarction, or stroke (24.9% BITA versus 27.3% SITA) or the need for a repeat revascularization procedure (10.3% BITA versus 10.0% SITA).3 There was, however, a significant increase in the incidence of sternal wound complications in BITA patients (3.5% BITA versus 1.9% SITA; P=0.005) and the need for sternal wound reconstruction (2.0% BITA versus 0.6% SITA; P<0.02).Several explanations have been proposed to explain the lack of benefits of BITA grafting in the ART trial: There was a high crossover rate in this trial—14% of patients assigned to the BITA group actually had a SITA.21.8% of SITA patients also received a RA graft; in essence these patients actually had multiple arterial grafting (MAG). The RA has been shown to have superior patency compared with saphenous vein grafts, which has resulted in improved long‐term outcomes.4There were no routine follow‐up angiograms, so the true incidence of BITA and SITA patency was not known. In a recent study from the New York State (NYS) cardiac database, CABG patients receiving MAG versus single arterial grafts had significantly lower 7‐year mortality (12.7% versus 14.3%; P<0.001).5 This improvement in survival was not observed in patients who had undergone off‐pump CABG. The incidence of off‐pump CABG was 18% in the NYS series but was 40.6% in the ART trial. It is conceivable that the increased use of off‐pump CABG may have resulted in decreased graft patency and contributed to the 7‐year mortality in ART.The sample size of ART may have been too small to show a statistically significant decrease in mortality and the composite end point of death, myocardial infarction, and stroke at 10 years. In the NYS series at 7 years, MAG patients had a significant decrease in death and major adverse cardiovascular events.5 However, the sample size in the NYS series was 3 times greater than in ART.Adherence to GDMT was extremely high in ART. GDMT is underutilized in CABG patients and was achieved in only 50% of patients 5 years following surgery.6, 7, 8 Compliance with GDMT after CABG has been reported to be as low as 23% for angiotensin‐converting enzyme inhibitors, 28% for statins, and only 70% for aspirin.9, 10 In ART, after 10 years, compliance with angiotensin‐converting enzyme inhibitors was 71%, 90% for statins, 81% for aspirin, and 74% for β‐blockers.3 Noncompliance with GDMT after CABG has been found to decrease long‐term survival, freedom from myocardial infarctions, and the need for repeat coronary revascularization procedures.8, 11In this issue of the Journal of the American Heart Association (JAHA), Gaudino and coauthors provide another explanation for the failure of ART to show superiority for BITA grafting.12 They performed propensity matching from selected observational and meta‐analysis studies involving SITA and BITA patients and found that the 10‐year survival of the SITA arm of ART was significantly higher than that of the matched observational studies and that the 10‐year survival of the BITA arm was significantly lower. They concluded that the improved outcomes of SITA patients and the decreased outcomes of BITA patients in ART may have contributed to the lack of superiority of BITA grafting in this trial. There are, however, several important limitations in this analysis. A table comparing the risk profiles of the patients in ART with those of the matched studies would have been helpful to determine whether the comorbidities of the patients in these 2 cohorts were similar. Important data such as the completeness of revascularization, STS Predicted Risk Of Mortality (PROM) scores, the incidence of diabetes mellitus and insulin‐dependent patients, smoking habits, NYHA Class, and the urgency of surgery were not provided. No mention is made of the percentage of patients who were adherent to GDMT or the percentage of patients who received RA grafting. Important long‐term data such as the cause of death (cardiac versus noncardiac), the incidence of myocardial infarctions, strokes, and the need for repeat revascularization are not provided.Another explanation for the lack of superiority for BITA grafting in the ART trial may be that not all CABG patients will benefit from BITA grafting. When determining which CABG patients will benefit the most from BITA grafting, the following factors should be taken into consideration: Age—Lytle et al first showed that improved BITA grafting was seen only after 10 years.13 In the NYS series, the survival advantage for MAG was seen after 7 years and in ART, the survival curves began to diverge to show a nonsignificant advantage from BITA grafting after 7 years. Therefore, CABG patients undergoing BITA should have a life expectancy of at least 7 to 10 years. The NYS series and other series showed increased survival with BITA or MAG only in patients younger than 70 years5, 14, 15 and in some series, younger than 65 years.16, 17Comorbidities—Patients with comorbidities that result in limited life expectancy, such as end stage renal disease, active smoking, peripheral vascular disease, uncontrolled or insulin‐dependent diabetes mellitus, and those with underlying malignancies are also unlikely to benefit from BITA grafting.Incomplete Revascularization—The inability to achieve complete revascularization in CABG patients may be because of irreversibly damaged myocardium, and small and diffusely diseased distal target vessels. Schwann et al have shown that incomplete revascularization is associated with decreased long‐term survival following CABG despite the use of BITA and MAG.18Sternal Issues—In both the ART and NYS series, the incidence of sternal wound complications was significantly higher in patients with BITA grafting.2, 3, 5 Patients at risk for sternal complications such as obese patients, diabetic females on insulin, frail patients with osteoporosis, patients with chest wall deformities, those on steroids, and heavy smokers with chronic obstructive pulmonary disease are all at risk for sternal wound complications, and in whom BITA grafting should be avoided.Distal Target Vessel Stenosis—The degree of distal target vessel stenosis is also an important factor in determining the suitability for BITA and MAG. All ITA grafts have decreased patency in vessels with <70% stenosis, while RA grafting is best for patients with at least an 80% stenosis.Finally, although ART failed to show the superiority of BITA versus SITA grafting after 10 years, it should not be considered a "failed" study. In fact, it is a "landmark" trial. The real conclusion from ART is that when RA grafts and GDMT are performed in conjunction with SITA grafting, the overall results are equivalent to what can be obtained with BITA grafting, without the increased risk of sternal wound complications that contribute to increased morbidity and mortality. Furthermore, ART highlights the importance of GDMT to optimize the short‐ and long‐term outcomes following CABG. Rather than attempting to explain the reasons for the shortcomings of ART, the authors should be encouraged to continue to analyze the ART data to determine which subgroups of patients will derive the greatest benefits from BITA grafting.DisclosuresNone.Footnotes*Correspondence to: Harold L. Lazar, MD, 80 East Concord Street, Boston, MA 02118. E‐mail: harold.l.[email protected]comThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.References1 Schwann TA, Habib RH, Wallace A, Shahian DM, O'Brien S, Jacobs JP. Operative outcomes of multiple arterial versus single arterial coronary bypass grafting. Ann Thorac Surg. 2018; 105:1109–1120.CrossrefMedlineGoogle Scholar2 Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U, Flather M; for the ART Investigators . Randomized trial of bilateral versus single internal thoracic artery grafts. N Engl J Med. 2016; 375:2540–2549.CrossrefMedlineGoogle Scholar3 Taggart DP, Benedetto U, Gerry S, Altman DG, Gray AM, Lees B, Gaudino M, Zamuar V, Bochenek A, Buxton B, Choong C, Clark S, Deja M, Desai J, Hasan R, Jasinski M, O'Keefe P, Mores F, Pepper J, Seevanayagam S, Sudarshan C, Trivedi U, Wos S, Puskas J, Flather M; Arterial Revascularization Trial Investigators . Bilateral versus single internal‐thoracic‐artery grafts at 10 years. N Engl J Med. 2019; 380:437–446.CrossrefMedlineGoogle Scholar4 Gaudino M, Benedetto U, Fremes S. Radial artery or saphenous vein graft in coronary artery bypass surgery. N Engl J Med. 2018; 378:2069–2077.CrossrefMedlineGoogle Scholar5 Samadashuili Z, Sundt TM, Wechsler A, Chikwe J, Adams DH, Smith CR, Jordan D, Girardi L, Lahey SJ, Gold JP, Ashraf MH, Hannon EL. Multiple versus single arterial coronary bypass graft surgery for multivessel disease. J Am Coll Cardiol. 2019; 74:1275–1285.CrossrefMedlineGoogle Scholar6 Hiratzka LF, Eagle KA, Liang L, Foranow GC, LaBresh KA, Peterson ED. Get With the Guidelines Steering Committee: atherosclerosis secondary prevention performance measures after coronary artery bypass surgery compared with percutaneous coronary interventions and non‐intervention patients. Circulation. 2007; 116:2017–2212.LinkGoogle Scholar7 Hlatky MA, Solomon MD, Shilane D, Leong TK, Brindis R, Go AS. Use of medications for secondary prevention after coronary bypass surgery compared with percutaneous coronary intervention. J Am Coll Cardiol. 2013; 61:295–301.CrossrefMedlineGoogle Scholar8 Pinho‐Gomes AC, Azevedo L, Aha J‐M, Park S‐J, Hamza TH, Farkousch ME. Compliance with guideline directed medical therapy in contemporary coronary revascularization trials. J Am Coll Cardiol. 2018; 71:591–602.CrossrefMedlineGoogle Scholar9 Filion KB, Pilote L, Rahme E, Eisenberg MJ. Use of perioperative cardiac medical therapy among patients undergoing coronary artery bypass graft surgery. J Card Surg. 2008; 23:209–215.CrossrefMedlineGoogle Scholar10 Looi KL, Kl Chow, Looi JL, Lee M, Halliday S, White H. Under‐use of secondary prevention medication in acute coronary syndrome patients treated with in‐hospital coronary artery bypass graft surgery. N Z Med J. 2011; 124:18–27.MedlineGoogle Scholar11 Kurlansky P, Herbert M, Prince S, Mack M. Coronary artery bypass graft versus percutaneous coronary intervention: meds matter: impact of adherence to medical therapy on comparative outcomes. Circulation. 2016; 134:1238–1246.LinkGoogle Scholar12 Gaudino M, Rahouma M, Hameed I, Khan FM, Taggart DP, Flather M, Biondi‐Zoccai G, Fremes SE. The disagreement between randomized and observational evidence on the use of bilateral internal thoracic artery grafting: a meta‐analytic approach. J Am Heart Assoc. 2019; 8:e014638. DOI: 10.1161/JAHA.119.014638.LinkGoogle Scholar13 Lytle BW, Blackstone EH, Sabik JF, Houghtaling P, Loop FD, Cosgrove DM. The effect of bilateral internal thoracic artery grafting on survival during 20 postoperative years. Ann Thorac Surg. 2004; 78:2005–2012.CrossrefMedlineGoogle Scholar14 DeSimone JP, Malenka DJ, Weldner PW, Iribane A, Leavitt BJ, McCulllough JN. Coronary revascularization with single vs bilateral mammary arteries: is it time for a change?Ann Thorac Surg. 2018; 106:466–472.CrossrefMedlineGoogle Scholar15 Kieser TM, Lewin AM, Graham MM, Martin BJ, Galbraith DD, Rabi EM. Outcomes associated with bilateral internal thoracic artery grafting: the importance of age. Ann Thorac Surg. 2011; 92:1269–1275.CrossrefMedlineGoogle Scholar16 Mohammadi S, Dagenais F, Voisine P. Lessons learned from the use of 1977 in situ bilateral mammary arteries: a retrospective study. J Cardiothorac Surg. 2014; 9:158–163.CrossrefMedlineGoogle Scholar17 Kurlansky PA, Traad EA, Dorman MJ, Galbut DL, Ebra G. Bilateral versus single internal thoracic artery grafting in the elderly: long term survival benefit. Ann Thorac Surg. 2015; 100:1374–1381.CrossrefMedlineGoogle Scholar18 Schwann TA, Yammine MB, El‐Hage‐Gleiman AKM, Engoren MC, Bonnell MR, Habib RH. The effect of completeness of revascularization during coronary artery bypass grafting with single versus multiple arterial grafts. J Card Surg. 2018; 33:620–628.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Qureshi S, Boulemden A, Darwin O, Shanmuganathan S, Szafranek A and Naik S (2021) Multiarterial coronary grafting using the radial artery as a second arterial graft: how far does the survival benefit extend?, European Journal of Cardio-Thoracic Surgery, 10.1093/ejcts/ezab308, 61:1, (216-224), Online publication date: 27-Dec-2022. Related articlesDisagreement Between Randomized and Observational Evidence on the Use of Bilateral Internal Thoracic Artery Grafting: A Meta‐Analytic ApproachMario Gaudino, et al. Journal of the American Heart Association. 2019;8 December 3, 2019Vol 8, Issue 23Article InformationMetrics Copyright © 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.https://doi.org/10.1161/JAHA.119.015046PMID: 31752636 Originally publishedNovember 22, 2019 KeywordsEditorialscoronary artery bypass graftcoronary artery bypass graft surgeryPDF download SubjectsCardiovascular SurgeryMeta AnalysisRevascularization