Dataset Information

Is There Still a Place for Revascularisation in the Management of Stable Coronary Artery Disease Following the ISCHEMIA Trial?

ABSTRACT: The ISCHEMIA trial (International study of comparative health effectiveness with medical and invasive approaches; ClinicalTrials.gov Identifier: NCT01471522) has informed practice in patients with stable angina and confirms what other less definitive data have taught us, that in the absence of severe symptoms, significant left main disease or significant left ventricular dysfunction, there is no prognostic benefit of an early invasive/revascularisation strategy with optimal medical therapy (OMT) over OMT alone. Like all quality randomised trials, it has nuances: the invasive treatment group had much better relief of angina than the OMT alone group, and the rate of spontaneous myocardial infarction (MI) in follow-up was lower in the invasive group, although only after a prevalence of periprocedural MI. The clinical outcome consequence of the MI data, if indeed there is one, will only become clear at later follow-up. OMT is a powerful treatment, and reflex revascularisation in patients with little or no angina is not.

SUBMITTER: Gala ABE

PROVIDER: S-EPMC9524617 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Is There Still a Place for Revascularisation in the Management of Stable Coronary Artery Disease Following the ISCHEMIA Trial?

Gala Andre Briosa E ABE Curzen Nick N

Heart international 20200808 1

The ISCHEMIA trial (International study of comparative health effectiveness with medical and invasive approaches; ClinicalTrials.gov Identifier: NCT01471522) has informed practice in patients with stable angina and confirms what other less definitive data have taught us, that in the absence of severe symptoms, significant left main disease or significant left ventricular dysfunction, there is no prognostic benefit of an early invasive/revascularisation strategy with optimal medical therapy (OMT) ...[more]

PMID: 36277662

Similar Datasets

Project description:ObjectiveTo investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease.DesignBayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials while maintaining randomisation.Eligibility criteria for selecting studiesA strategy of initial medical treatment compared with revascularisation by coronary artery bypass grafting or Food and Drug Administration approved techniques for percutaneous revascularization: balloon angioplasty, bare metal stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease.Data sourcesMedline and Embase from 1980 to 2013 for randomised trials comparing medical treatment with revascularisation.Main outcome measureAll cause mortality.Results100 trials in 93,553 patients with 262,090 patient years of follow-up were included. Coronary artery bypass grafting was associated with a survival benefit (rate ratio 0.80, 95% credibility interval 0.70 to 0.91) compared with medical treatment. New generation drug eluting stents (everolimus: 0.75, 0.59 to 0.96; zotarolimus (Resolute): 0.65, 0.42 to 1.00) but not balloon angioplasty (0.85, 0.68 to 1.04), bare metal stents (0.92, 0.79 to 1.05), or early generation drug eluting stents (paclitaxel: 0.92, 0.75 to 1.12; sirolimus: 0.91, 0.75 to 1.10; zotarolimus (Endeavor): 0.88, 0.69 to 1.10) were associated with improved survival compared with medical treatment. Coronary artery bypass grafting reduced the risk of myocardial infarction compared with medical treatment (0.79, 0.63 to 0.99), and everolimus eluting stents showed a trend towards a reduced risk of myocardial infarction (0.75, 0.55 to 1.01). The risk of subsequent revascularisation was noticeably reduced by coronary artery bypass grafting (0.16, 0.13 to 0.20) followed by new generation drug eluting stents (zotarolimus (Resolute): 0.26, 0.17 to 0.40; everolimus: 0.27, 0.21 to 0.35), early generation drug eluting stents (zotarolimus (Endeavor): 0.37, 0.28 to 0.50; sirolimus: 0.29, 0.24 to 0.36; paclitaxel: 0.44, 0.35 to 0.54), and bare metal stents (0.69, 0.59 to 0.81) compared with medical treatment.ConclusionAmong patients with stable coronary artery disease, coronary artery bypass grafting reduces the risk of death, myocardial infarction, and subsequent revascularisation compared with medical treatment. All stent based coronary revascularisation technologies reduce the need for revascularisation to a variable degree. Our results provide evidence for improved survival with new generation drug eluting stents but no other percutaneous revascularisation technology compared with medical treatment.

Project description:BackgroundThe ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) postulated that patients with stable coronary artery disease (CAD) and moderate or severe ischemia would benefit from revascularization. We investigated the relationship between severity of CAD and ischemia and trial outcomes, overall and by management strategy.MethodsIn total, 5179 patients with moderate or severe ischemia were randomized to an initial invasive or conservative management strategy. Blinded, core laboratory-interpreted coronary computed tomographic angiography was used to assess anatomic eligibility for randomization. Extent and severity of CAD were classified with the modified Duke Prognostic Index (n=2475, 48%). Ischemia severity was interpreted by independent core laboratories (nuclear, echocardiography, magnetic resonance imaging, exercise tolerance testing, n=5105, 99%). We compared 4-year event rates across subgroups defined by severity of ischemia and CAD. The primary end point for this analysis was all-cause mortality. Secondary end points were myocardial infarction (MI), cardiovascular death or MI, and the trial primary end point (cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest).ResultsRelative to mild/no ischemia, neither moderate ischemia nor severe ischemia was associated with increased mortality (moderate ischemia hazard ratio [HR], 0.89 [95% CI, 0.61-1.30]; severe ischemia HR, 0.83 [95% CI, 0.57-1.21]; P=0.33). Nonfatal MI rates increased with worsening ischemia severity (HR for moderate ischemia, 1.20 [95% CI, 0.86-1.69] versus mild/no ischemia; HR for severe ischemia, 1.37 [95% CI, 0.98-1.91]; P=0.04 for trend, P=NS after adjustment for CAD). Increasing CAD severity was associated with death (HR, 2.72 [95% CI, 1.06-6.98]) and MI (HR, 3.78 [95% CI, 1.63-8.78]) for the most versus least severe CAD subgroup. Ischemia severity did not identify a subgroup with treatment benefit on mortality, MI, the trial primary end point, or cardiovascular death or MI. In the most severe CAD subgroup (n=659), the 4-year rate of cardiovascular death or MI was lower in the invasive strategy group (difference, 6.3% [95% CI, 0.2%-12.4%]), but 4-year all-cause mortality was similar.ConclusionsIschemia severity was not associated with increased risk after adjustment for CAD severity. More severe CAD was associated with increased risk. Invasive management did not lower all-cause mortality at 4 years in any ischemia or CAD subgroup. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01471522.

Project description:BackgroundPatients who are not candidates for traditional coronary artery bypass grafting (CABG) and amenable only for percutaneous coronary intervention (PCI) with stents can receive the "gold standard" left internal thoracic artery (LITA) to left anterior descending artery (LAD) anastomosis through robotic-assisted CABG and PCI to non-LAD coronary targets.AimsWe aimed to analyse clinical outcomes of robotic-assisted CABG.MethodsA total of 2,280 consecutive patients who had undergone robotic-assisted CABG between May 2005 and June 2021 were included in our study. Robotic-assisted LITA harvest was followed by LITA-LAD manual anastomosis through a 4 cm left thoracotomy. Hybrid coronary intervention (HCR) consists of stent implantation in a non-LAD coronary artery performed within 7 days after robotic-assisted LITA-LAD. We performed a propensity-adjusted analysis comparison after dividing all robotic-assisted CABG patients into three time periods: 2005-2010, 615 patients; 2011-2016, 904 patients; and 2017-2021, 761 patients.ResultsThe mean age increased from 64.5 years in the first time period to 65.8 years in the second time period to 68.1 years in the third (p<0.0001). Operative time was progressively reduced in the three periods (6.4; 6.2; 5.5 hours; p<0.001). The incidence of conversion to sternotomy remained similar for each period (1.8%; 1.7%; 1.5%; p=0.53). Thirty-day mortality in the three periods included 9 (1.4%), 9 (1.0%), and 7 (0.9%) patients, respectively (p=0.91), while 8 (0.3%) patients had PCI with stents in the entire group. The mean follow-up for the entire population was 4.2 years. At follow-up, the rates of all-cause death, major adverse cardiac and cerebrovascular events, non-fatal stroke, and repeat revascularisation with stents were significantly decreased from the first to the last period (pË0.0001).ConclusionsRobotic-assisted CABG and HCR provide good long-term outcomes in patients who are not candidates for conventional CABG.

Dataset Information

Is There Still a Place for Revascularisation in the Management of Stable Coronary Artery Disease Following the ISCHEMIA Trial?

Publications

Is There Still a Place for Revascularisation in the Management of Stable Coronary Artery Disease Following the ISCHEMIA Trial?

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets