Diabetes, heart failure, and myocardial revascularization: Is there a new message from the ISCHEMIA trial?

Diabetes, Herzinsuffizienz und Myokardrevaskularisation: Gibt es Neuigkeiten von der ISCHEMIA-Studie?

Journal

Herz
ISSN: 1615-6692
Titre abrégé: Herz
Pays: Germany
ID NLM: 7801231

Informations de publication

Date de publication:
Oct 2022
Historique:
accepted: 15 07 2022
pubmed: 13 8 2022
medline: 5 10 2022
entrez: 12 8 2022
Statut: ppublish

Résumé

There is no evidence that the indications for myocardial revascularization differ between patients with and without diabetes. Accepted indications include stable angina that cannot be adequately managed by medication, acute coronary syndromes, severely reduced left ventricular (LV) function due to coronary artery disease, left main stenosis, and advanced coronary artery disease causing substantial inducible ischemia. The recent ISCHEMIA trial challenged the criterion of ischemia. With respect to its primary endpoint, ISCHEMIA showed no benefit of an invasive strategy with systematic myocardial revascularization in patients with stable angina and moderate-to-severe ischemia compared with a conservative strategy. However, myocardial revascularization resulted in a statistically significant and clinically meaningful reduction in angina and an improvement in quality of life. There was a significant reduction in prognostically relevant spontaneous myocardial infarction (MI) in the long term, which came at the cost of an increased rate of peri-interventional MI that was of minor prognostic relevance. The risk profile and number of patients included in the ISCHEMIA trial, as well as the duration of follow-up, are not sufficient to show that the lower incidence of spontaneous infarcts improved survival. In ISCHEMIA, there was no heterogeneity in treatment effect depending on diabetes. Es gibt keine Hinweise, dass sich die Indikationen für eine Myokardrevaskularisation bei Patienten mit und ohne Diabetes unterscheiden. Zu den anerkannten Indikationen gehören eine stabile Angina, die medikamentös nicht angemessen behandelt werden kann, akute Koronarsyndrome, eine stark eingeschränkte linksventrikuläre Funktion aufgrund einer koronaren Herzkrankheit, eine Stenose des linken Hauptstamms und eine fortgeschrittene koronare Herzkrankheit, die eine erhebliche induzierbare Ischämie verursacht. In der 2020 publizierten ISCHEMIA-Studie wurde das Kriterium der Ischämie infrage gestellt. In Bezug auf ihren primären Endpunkt zeigte ISCHEMIA keinen Vorteil einer invasiven Strategie mit systematischer Myokardrevaskularisation bei Patienten mit stabiler Angina pectoris und mäßiger bis schwerer Ischämie im Vergleich zu einer konservativen Strategie. Die Myokardrevaskularisation führte jedoch zu einer statistisch signifikanten und klinisch bedeutsamen Verringerung der Angina pectoris und zu einer Verbesserung der Lebensqualität. Langfristig kam es zu einer signifikanten Verringerung prognostisch relevanter spontaner Myokardinfarkte (MI), allerdings auf Kosten einer erhöhten Rate periinterventioneller MI, die jedoch von geringerer prognostischer Relevanz waren. Das Risikoprofil und die Anzahl der in ISCHEMIA eingeschlossenen Patienten sowie die Dauer der Nachbeobachtung reichen nicht aus, um zu zeigen, dass die geringere Inzidenz spontaner Infarkte das Überleben verbesserte. In ISCHEMIA gab es keine Heterogenität des Behandlungseffekts in Abhängigkeit vom Diabetes.

Autres résumés

Type: Publisher (ger)
Es gibt keine Hinweise, dass sich die Indikationen für eine Myokardrevaskularisation bei Patienten mit und ohne Diabetes unterscheiden. Zu den anerkannten Indikationen gehören eine stabile Angina, die medikamentös nicht angemessen behandelt werden kann, akute Koronarsyndrome, eine stark eingeschränkte linksventrikuläre Funktion aufgrund einer koronaren Herzkrankheit, eine Stenose des linken Hauptstamms und eine fortgeschrittene koronare Herzkrankheit, die eine erhebliche induzierbare Ischämie verursacht. In der 2020 publizierten ISCHEMIA-Studie wurde das Kriterium der Ischämie infrage gestellt. In Bezug auf ihren primären Endpunkt zeigte ISCHEMIA keinen Vorteil einer invasiven Strategie mit systematischer Myokardrevaskularisation bei Patienten mit stabiler Angina pectoris und mäßiger bis schwerer Ischämie im Vergleich zu einer konservativen Strategie. Die Myokardrevaskularisation führte jedoch zu einer statistisch signifikanten und klinisch bedeutsamen Verringerung der Angina pectoris und zu einer Verbesserung der Lebensqualität. Langfristig kam es zu einer signifikanten Verringerung prognostisch relevanter spontaner Myokardinfarkte (MI), allerdings auf Kosten einer erhöhten Rate periinterventioneller MI, die jedoch von geringerer prognostischer Relevanz waren. Das Risikoprofil und die Anzahl der in ISCHEMIA eingeschlossenen Patienten sowie die Dauer der Nachbeobachtung reichen nicht aus, um zu zeigen, dass die geringere Inzidenz spontaner Infarkte das Überleben verbesserte. In ISCHEMIA gab es keine Heterogenität des Behandlungseffekts in Abhängigkeit vom Diabetes.

Identifiants

pubmed: 35962199
doi: 10.1007/s00059-022-05132-8
pii: 10.1007/s00059-022-05132-8
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

442-448

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.

Références

Sarwar N, Gao P, Seshasai SR et al (2010) Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet 375(9733):2215–2222
pubmed: 20609967 doi: 10.1016/S0140-6736(10)60484-9
Hammoud T, Tanguay JF, Bourassa MG (2000) Management of coronary artery disease: therapeutic options in patients with diabetes. J Am Coll Cardiol 36(2):355–365
pubmed: 10933343 doi: 10.1016/S0735-1097(00)00732-4
Resnick HE, Shorr RI, Kuller L et al (2001) Prevalence and clinical implications of American Diabetes Association-defined diabetes and other categories of glucose dysregulation in older adults: the health, aging and body composition study. J Clin Epidemiol 54(9):869–876
pubmed: 11520645 doi: 10.1016/S0895-4356(01)00359-6
Beckman JA, Creager MA, Libby P (2002) Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA 287(19):2570–2581
pubmed: 12020339 doi: 10.1001/jama.287.19.2570
Ledru F, Ducimetière P, Battaglia S et al (2001) New diagnostic criteria for diabetes and coronary artery disease: insights from an angiographic study. J Am Coll Cardiol 37(6):1543–1550
pubmed: 11345363 doi: 10.1016/S0735-1097(01)01183-4
Norhammar A, Malmberg K, Diderholm E et al (2004) Diabetes mellitus: the major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revascularization. J Am Coll Cardiol 43(4):585–591
pubmed: 14975468 doi: 10.1016/j.jacc.2003.08.050
Mente A, Yusuf S, Islam S et al (2010) Metabolic syndrome and risk of acute myocardial infarction a case-control study of 26,903 subjects from 52 countries. J Am Coll Cardiol 55(21):2390–2398
pubmed: 20488312 doi: 10.1016/j.jacc.2009.12.053
Marso SP, Mercado N, Maehara A et al (2012) Plaque composition and clinical outcomes in acute coronary syndrome patients with metabolic syndrome or diabetes. JACC Cardiovasc Imaging 5(3 Suppl):S42–S52
pubmed: 22421230 doi: 10.1016/j.jcmg.2012.01.008
Silva JA, Escobar A, Collins TJ et al (1995) Unstable angina. A comparison of angioscopic findings between diabetic and nondiabetic patients. Circulation 92(7):1731–1736
pubmed: 7671354 doi: 10.1161/01.CIR.92.7.1731
Ishii H, Umeda F, Nawata H (1992) Platelet function in diabetes mellitus. Diabetes Metab Rev 8:53–66
pubmed: 1633739 doi: 10.1002/dmr.5610080106
Ceriello A (1993) Coagulation activation in diabetes mellitus: a role of hyperglycemia and therapeutic prospects. Diabetologia 36:1119–1125
pubmed: 8270125 doi: 10.1007/BF00401055
Haffner SM, Lehto S, Rönnemaa T et al (1998) Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med 339(4):229–234
pubmed: 9673301 doi: 10.1056/NEJM199807233390404
Barzilay JI, Kronmal RA, Bittner V et al (1994) Coronary artery disease and coronary artery bypass grafting in diabetic patients aged 〉 or = 65 years (report from the Coronary Artery Surgery Study [CASS]Registry). Am J Cardiol 74:334–339
pubmed: 8059694 doi: 10.1016/0002-9149(94)90399-9
Scheen AJ, Warzee F, Legrand VM (2004) Drug-eluting stents: meta-analysis in diabetic patients. Eur Heart J 25(23):2167–2168 (author reply 2168–9)
pubmed: 15571834 doi: 10.1016/j.ehj.2004.07.041
Bangalore S, Kumar S, Fusaro M et al (2012) Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22,844 patient years of follow-up from randomised trials. BMJ 345:e5170
pubmed: 22885395 pmcid: 3415955 doi: 10.1136/bmj.e5170
Van Belle E, Ketelers R, Bauters C et al (2001) Patency of percutaneous transluminal coronary angioplasty sites at 6‑month angiographic follow-up: a key determinant of survival in diabetics after coronary balloon angioplasty. Circulation 103(9):1218–1224
pubmed: 11238264 doi: 10.1161/01.CIR.103.9.1218
Neumann FJ, Sousa-Uva M, Ahlsson A et al (2019) 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 40(2):87–165
pubmed: 30165437 doi: 10.1093/eurheartj/ehy394
Collet JP, Thiele H, Barbato E et al (2021) 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 42(14):1289–1367
pubmed: 32860058 doi: 10.1093/eurheartj/ehaa575
Knuuti J, Wijns W, Saraste A et al (2020) 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J 41(3):407–477
pubmed: 31504439 doi: 10.1093/eurheartj/ehz425
Keeley EC, Boura JA, Grines CL (2003) Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet 361:13–20
pubmed: 12517460 doi: 10.1016/S0140-6736(03)12113-7
Velazquez EJ, Lee KL, Jones RH et al (2016) Coronary-artery bypass surgery in patients with Ischemic cardiomyopathy. N Engl J Med 374(16):1511–1520
pubmed: 27040723 pmcid: 4938005 doi: 10.1056/NEJMoa1602001
Bangalore S, Guo Y, Samadashvili Z et al (2016) Revascularization in patients with multivessel coronary artery disease and severe left ventricular systolic dysfunction: everolimus-eluting stents versus coronary artery bypass graft surgery. Circulation 133(22):2132–2140
pubmed: 27151532 pmcid: 6330114 doi: 10.1161/CIRCULATIONAHA.115.021168
Hachamovitch R, Rozanski A, Shaw LJ et al (2011) Impact of ischaemia and scar on the therapeutic benefit derived from myocardial revascularization vs. medical therapy among patients undergoing stress-rest myocardial perfusion scintigraphy. Eur Heart J 32(8):1012–1024
pubmed: 21258084 doi: 10.1093/eurheartj/ehq500
Shaw LJ, Berman DS, Maron DJ et al (2008) Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation 117(10):1283–1291
pubmed: 18268144 doi: 10.1161/CIRCULATIONAHA.107.743963
Yusuf S, Zucker D, Peduzzi P et al (1994) Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet 344(8922):563–570
pubmed: 7914958 doi: 10.1016/S0140-6736(94)91963-1
Lüscher TF, Creager MA, Beckman JA, Cosentino F (2003) Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part II. Circulation 108(13):1655–1661
pubmed: 14517152 doi: 10.1161/01.CIR.0000089189.70578.E2
Bangalore S, Pencina MJ, Kleiman NS, Cohen DJ (2013) Prognostic implications of procedural vs spontaneous myocardial infarction: results from the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry. Am Heart J 166(6):1027–1034
pubmed: 24268217 doi: 10.1016/j.ahj.2013.09.008
Damman P, Wallentin L, Fox KA et al (2012) Long-term cardiovascular mortality after procedure-related or spontaneous myocardial infarction in patients with non-ST-segment elevation acute coronary syndrome: a collaborative analysis of individual patient data from the FRISC II, ICTUS, and RITA‑3 trials (FIR). Circulation 125(4):568–576
pubmed: 22199015 doi: 10.1161/CIRCULATIONAHA.111.061663
Fox KA, Clayton TC, Damman P et al (2010) Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol 55(22):2435–2445
pubmed: 20359842 doi: 10.1016/j.jacc.2010.03.007
O’Donoghue ML, Vaidya A, Afsal R et al (2012) An invasive or conservative strategy in patients with diabetes mellitus and non-ST-segment elevation acute coronary syndromes: a collaborative meta-analysis of randomized trials. J Am Coll Cardiol 60(2):106–111
pubmed: 22766336 doi: 10.1016/j.jacc.2012.02.059
Zimmermann FM, Omerovic E, Fournier S et al (2019) Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data. Eur Heart J 40(2):180–186
pubmed: 30596995 doi: 10.1093/eurheartj/ehy812
Johnson NP, Tóth GG, Lai D et al (2014) Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol 64(16):1641–1654
pubmed: 25323250 doi: 10.1016/j.jacc.2014.07.973
Fearon WF, Nishi T, De Bruyne B et al (2018) Clinical outcomes and cost-effectiveness of fractional flow reserve-guided percutaneous coronary intervention in patients with stable coronary artery disease: three-year follow-up of the FAME 2 trial (fractional flow reserve versus Angiography for Multivessel evaluation). Circulation 137(5):480–487
pubmed: 29097450 doi: 10.1161/CIRCULATIONAHA.117.031907
Baron SJ, Chinnakondepalli K, Magnuson EA et al (2017) Quality-of-life after everolimus-eluting stents or bypass surgery for left-main disease: results from the EXCEL trial. J Am Coll Cardiol 70(25):3113–3122
pubmed: 29097293 doi: 10.1016/j.jacc.2017.10.036
Abdallah MS, Wang K, Magnuson EA et al (2017) Quality of life after surgery or DES in patients with 3‑vessel or left main disease. J Am Coll Cardiol 69(16):2039–2050
pubmed: 28427580 doi: 10.1016/j.jacc.2017.02.031
Abdallah MS, Wang K, Magnuson EA et al (2013) Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial. JAMA 310(15):1581–1590
pubmed: 24129463 pmcid: 4370776 doi: 10.1001/jama.2013.279208
Maron DJ, Hochman JS, Reynolds HR et al (2020) Initial invasive or conservative strategy for stable coronary disease. N Engl J Med 382(15):1395–1407
pubmed: 32227755 pmcid: 7263833 doi: 10.1056/NEJMoa1915922
Bangalore S, Maron DJ, O’Brien SM et al (2020) Management of coronary disease in patients with advanced kidney disease. N Engl J Med 382(17):1608–1618
pubmed: 32227756 pmcid: 7274537 doi: 10.1056/NEJMoa1915925
Chaitman BR, Alexander KP, Cyr DD et al (2021) Myocardial infarction in the ISCHEMIA trial: impact of different definitions on incidence, prognosis, and treatment comparisons. Circulation 143(8):790–804
pubmed: 33267610 doi: 10.1161/CIRCULATIONAHA.120.047987
Spertus JA, Jones PG, Maron DJ et al (2020) Health-status outcomes with invasive or conservative care in coronary disease. N Engl J Med 382(15):1408–1419
pubmed: 32227753 pmcid: 7261489 doi: 10.1056/NEJMoa1916370
Reynolds HR, Shaw LJ, Min JK et al (2021) Outcomes in the ISCHEMIA trial based on coronary artery disease and Ischemia severity. Circulation 144(13):1024–1038
pubmed: 34496632 pmcid: 8478888 doi: 10.1161/CIRCULATIONAHA.120.049755
Lopes RD, Alexander KP, Stevens SR et al (2020) Initial invasive versus conservative management of stable Ischemic heart disease in patients with a history of heart failure or left ventricular dysfunction: insights from the ISCHEMIA trial. Circulation 142(18):1725–1735
pubmed: 32862662 pmcid: 7703498 doi: 10.1161/CIRCULATIONAHA.120.050304
Newman JD, Anthopolos R, Mancini GBJ et al (2021) Outcomes of participants with diabetes in the ISCHEMIA trials. Circulation 144(17):1380–1395
pubmed: 34521217 doi: 10.1161/CIRCULATIONAHA.121.054439
Farkouh ME, Domanski M, Sleeper LA et al (2012) Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 367(25):2375–2384
pubmed: 23121323 doi: 10.1056/NEJMoa1211585
Head SJ, Milojevic M, Daemen J et al (2018) Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. Lancet 391(10124):939–948
pubmed: 29478841 doi: 10.1016/S0140-6736(18)30423-9
BARI I. Influence of diabetes on 5‑year mortality and morbidity in a randomized trial comparing CABG and PTCA in patients with multivessel disease: the Bypass Angioplasty Revascularization Investigation (BARI). Circulation 1997;96:1761–9.
Kappetein AP, Head SJ, Morice MC et al (2013) 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 43(5):1006–1013
pubmed: 23413014 doi: 10.1093/ejcts/ezt017
Kapur A, Hall RJ, Malik IS et al (2010) 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 55(5):432–440
pubmed: 20117456 doi: 10.1016/j.jacc.2009.10.014
Milojevic M, Serruys PW, Sabik JF 3rd et al (2019) Bypass surgery or stenting for left main coronary artery disease in patients with diabetes. J Am Coll Cardiol 73(13):1616–1628
pubmed: 30947913 doi: 10.1016/j.jacc.2019.01.037
Stone GW, Kappetein AP, Sabik JF et al (2019) Five-year outcomes after PCI or CABG for left main coronary disease. N Engl J Med 381(19):1820–1830
pubmed: 31562798 doi: 10.1056/NEJMoa1909406
Lawton JS, Tamis-Holland JE, Bangalore S et al (2022) 2021 ACC/AHA/SCAI guideline for coronary artery revascularization: executive summary: a report of the American college of cardiology/American heart association joint committee on clinical practice guidelines. Circulation 145(3):e4–e17
pubmed: 34882436

Auteurs

Franz-Josef Neumann (FJ)

Klinik für Kardiologie und Angiologie, Universitäts-Herzzentrum, Universitätsklinikum Freiburg, Campus Bad Krozingen, Südring 15, 79189, Bad Krozingen, Germany. franz-josef.neumann@universitaets-herzzentrum.de.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH