Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
28916664
PubMed Central
PMC5610560
DOI
10.1161/strokeaha.117.017570
PII: STROKEAHA.117.017570
Knihovny.cz E-zdroje
- Klíčová slova
- carotid stenosis, coronary artery bypass, endarterectomy, carotid, randomized controlled trial, stroke,
- MeSH
- bezpečnost pacientů normy MeSH
- karotická endarterektomie škodlivé účinky normy MeSH
- koronární bypass škodlivé účinky normy MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- senioři MeSH
- stenóza arteria carotis diagnóza epidemiologie chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND AND PURPOSE: The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG. METHODS: Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days. RESULTS: From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, -3.2% to 20.8%; PWALD=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes. CONCLUSIONS: Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing. CLINICAL TRIAL REGISTRATION: URL: https://www.controlled-trials.com. Unique identifier: ISRCTN13486906.
Zobrazit více v PubMed
Naylor AR, Mehta Z, Rothwell PM, Bell PR. Carotid artery disease and stroke during coronary artery bypass: a critical review of the literature. Eur J Vasc Endovasc Surg. 2002;23:283–294. doi: 10.1053/ejvs.2002.1609. PubMed
Mao Z, Zhong X, Yin J, Zhao Z, Hu X, Hackett ML. Predictors associated with stroke after coronary artery bypass grafting: a systematic review. J Neurol Sci. 2015;357:1–7. doi: 10.1016/j.jns.2015.07.006. PubMed
Illuminati G, Ricco JB, Caliò F, Pacilè MA, Miraldi F, Frati G, et al. Short-term results of a randomized trial examining timing of carotid endarterectomy in patients with severe asymptomatic unilateral carotid stenosis undergoing coronary artery bypass grafting. J Vasc Surg. 2011;54:993–999; discussion 998. doi: 10.1016/j.jvs.2011.03.284. PubMed
Hertzer NR, Loop FD, Beven EG, O’Hara PJ, Krajewski LP. Surgical staging for simultaneous coronary and carotid disease: a study including prospective randomization. J Vasc Surg. 1989;9:455–463. PubMed
Naylor AR, Bown MJ. Stroke after cardiac surgery and its association with asymptomatic carotid disease: an updated systematic review and meta-analysis. Eur J Vasc Endovasc Surg. 2011;41:607–624. doi: 10.1016/j.ejvs.2011.02.016. PubMed
Mahmoudi M, Hill PC, Xue Z, Torguson R, Ali G, Boyce SW, et al. Patients with severe asymptomatic carotid artery stenosis do not have a higher risk of stroke and mortality after coronary artery bypass surgery. Stroke. 2011;42:2801–2805. doi: 10.1161/STROKEAHA.111.618082. PubMed
Schoof J, Lubahn W, Baeumer M, Kross R, Wallesch CW, Kozian A, et al. Impaired cerebral autoregulation distal to carotid stenosis/occlusion is associated with increased risk of stroke at cardiac surgery with cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2007;134:690–696. doi: 10.1016/j.jtcvs.2007.03.018. PubMed
Naylor AR. Time to rethink management strategies in asymptomatic carotid artery disease. Nat Rev Cardiol. 2011;9:116–124. doi: 10.1038/nrcardio.2011.151. PubMed
Naylor AR, Cuffe RL, Rothwell PM, Bell PR. A systematic review of outcomes following staged and synchronous carotid endarterectomy and coronary artery bypass. Eur J Vasc Endovasc Surg. 2003;25:380–389. doi: 10.1053/ejvs.2002.1895. PubMed
Naylor R, Cuffe RL, Rothwell PM, Loftus IM, Bell PR. A systematic review of outcome following synchronous carotid endarterectomy and coronary artery bypass: influence of surgical and patient variables. Eur J Vasc Endovasc Surg. 2003;26:230–241. PubMed
Knipp SC, Scherag A, Beyersdorf F, Cremer J, Diener HC, Haverich JA, et al. CABACS Study Group. Randomized comparison of synchronous CABG and carotid endarterectomy vs. isolated CABG in patients with asymptomatic carotid stenosis: the CABACS trial. Int J Stroke. 2012;7:354–360. doi: 10.1111/j.1747-4949.2011.00687.x. PubMed
European Carotid Surgery Trialists' Collaborative Group. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the mrc European Carotid Surgery Trial (ECST). Lancet. 1998;351:1379–1387. PubMed
Rothwell PM, Eliasziw M, Gutnikov SA, Fox AJ, Taylor DW, Mayberg MR, et al. Carotid Endarterectomy Trialists’ Collaboration. Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet. 2003;361:107–116. PubMed
Nicolaides AN, Kakkos SK, Griffin M, Sabetai M, Dhanjil S, Tegos T, et al. Asymptomatic Carotid Stenosis and Risk of Stroke (ACSRS) Study Group. Severity of asymptomatic carotid stenosis and risk of ipsilateral hemispheric ischaemic events: results from the ACSRS study. Eur J Vasc Endovasc Surg. 2005;30:275–284. PubMed
Kalbe E, Kessler J, Calabrese P, Smith R, Passmore AP, Brand M, et al. DemTect: a new, sensitive cognitive screening test to support the diagnosis of mild cognitive impairment and early dementia. Int J Geriatr Psychiatry. 2004;19:136–143. doi: 10.1002/gps.1042. PubMed
Kessler J, Calabrese P, Kalbe E. DemTect-B: A parallel test version to the cognitive screening instrument DemTect-A. Fortschr Neurol Psychiatr. 2010;78:532–535. doi: 10.1055/s-0029-1245452. PubMed
Aqua - Bundesauswertung zum Erfassungsjahr 2014. 10-2 Karotis-Revaskularisation. Qualitätsindikatoren. https://www.sqg.de/downloads/Bundesauswertungen/2014/bu_Gesamt_10N2-KAROT_2014.pdf. Accessed June 16, 2011.
Prasad SM, Li S, Rankin JS, O’Brien SM, Gammie JS, Puskas JD, et al. Current outcomes of simultaneous carotid endarterectomy and coronary artery bypass graft surgery in North America. World J Surg. 2010;34:2292–2298. doi: 10.1007/s00268-010-0506-4. PubMed
Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, et al. Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001;344:395–402. doi: 10.1056/NEJM200102083440601. PubMed
Feldman DN, Swaminathan RV, Geleris JD, Okin P, Minutello RM, Krishnan U, et al. Comparison of trends and in-hospital outcomes of concurrent carotid artery revascularization and coronary artery bypass graft surgery: The United States experience 2004 to 2012. JACC Cardiovasc Interv. 2017;10:286–298. doi: 10.1016/j.jcin.2016.11.032. PubMed
Bonati LH, Dobson J, Algra A, Branchereau A, Chatellier G, Fraedrich G, et al. Short-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data. Lancet. 2010;376:1062–1073. PubMed
Brott TG, Hobson RW, II, Howard G, Roubin GS, Clark WM, Brooks W, et al. CREST Investigators. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363:11–23. doi: 10.1056/NEJMoa0912321. PubMed PMC
Rosenfield K, Matsumura JS, Chaturvedi S, Riles T, Ansel GM, Metzger DC, et al. ACT I Investigators. Randomized trial of stent versus surgery for asymptomatic carotid stenosis. N Engl J Med. 2016;374:1011–1020. doi: 10.1056/NEJMoa1515706. PubMed
Naylor AR, Mehta Z, Rothwell PM. A systematic review and meta-analysis of 30-day outcomes following staged carotid artery stenting and coronary bypass. Eur J Vasc Endovasc Surg. 2009;37:379–387. doi: 10.1016/j.ejvs.2008.12.011. PubMed
Shishehbor MH, Venkatachalam S, Sun Z, Rajeswaran J, Kapadia SR, Bajzer C, et al. A direct comparison of early and late outcomes with three approaches to carotid revascularization and open heart surgery. J Am Coll Cardiol. 2013;62:1948–1956. doi: 10.1016/j.jacc.2013.03.094. PubMed
Versaci F, Reimers B, Del Giudice C, Schofer J, Giacomin A, Saccà S, et al. Simultaneous hybrid revascularization by carotid stenting and coronary artery bypass grafting: the SHARP study. JACC Cardiovasc Interv. 2009;2:393–401. doi: 10.1016/j.jcin.2009.02.010. PubMed
Eckstein HH, Reiff T, Ringleb P, Jansen O, Mansmann U, Hacke W SPACE 2 Investigators. SPACE-2: a missed opportunity to compare carotid endarterectomy, carotid stenting, and best medical treatment in patients with asymptomatic carotid stenoses. Eur J Vasc Endovasc Surg. 2016;51:761–765. doi: 10.1016/j.ejvs.2016.02.005. PubMed
