Abstract Anemia is common amongst patients undergoing percutaneous coronary intervention (PCI) and current guidelines fail to offer recommendations for its management. This review aims to examine the ...relationship between baseline anemia and mortality, Major Adverse Cardiovascular Events (MACE) and major bleeding in patients undergoing PCI. We searched MEDLINE and EMBASE for studies that evaluated mortality and adverse outcomes in anemic and non-anemic patients who underwent PCI. Data were collected on study design, participant characteristics, definition of anemia, follow up and adverse outcomes. Random effects meta-analysis of risk ratios was performed using inverse variance method. A total of 44 studies were included in the review with 230,795 participants. The prevalence of baseline anemia was 26,514/170,914 (16%). There was an elevated risk of mortality and MACE with anemia compared to no anemia pooled RR 2.39 (2.02-2.83), p<0.001 and RR 1.51 (1.34-1.71), p<0.001, respectively. The risk of myocardial infarction and bleeding with anemia compared to no anemia was elevated, pooled RR 1.33 (1.07-1.65), p=0.01 and RR 1.97 (1.03-3.77), p<0.001, respectively. The risk of mortality per unit incremental decrease in hemoglobin(g/dl) was RR 1.19 (1.09-1.30), p<0.001 and the risk of mortality, MACE and re-infarction per 1 unit incremental decrease in hematocrit(%) was RR 1.07 (1.05-1.10), p=0.04, RR 1.09 (1.08-1.10) and RR 1.06 (1.03-1.10), respectively. The prevalence of anemia in contemporary cohorts of patients undergoing PCI is significant and is associated with significant increases in post procedural mortality, MACE, re-infarction and bleeding. The optimal strategy for the management of anemia in such patients remains uncertain.
OBJECTIVESThis study sought to determine the effect of adding computed tomography-derived fractional flow reserve (FFRCT) data to computed tomography angiographic (CTA) data alone for assessment of ...lesion severity and patient management in 200 patients with chest pain.BACKGROUNDInvasive and noninvasive tests used in the assessment of patients with angina all have disadvantages. The ideal screening test for patients presenting for the first time with chest pain would describe both coronary anatomy and the presence of ischemia and would be readily accessible, low cost, and noninvasive.METHODSTwo hundred patients with stable chest pain underwent CTA for clinical reasons, and FFRCT was calculated. Three experienced interventional cardiologists assessed the CTA result for each patient and by consensus developed a management plan (optimal medical therapy, percutaneous coronary intervention, coronary artery bypass graft surgery, or more information required). FFRCT data for each vessel were then revealed, and the interventional cardiologists made a second plan by consensus, using the same 4 options. The primary endpoint for the study was the difference between the 2 strategies.RESULTSOverall, after disclosure of FFRCT data there was a change in the allocated management category on the basis of CTA alone in 72 cases (36%). This difference is explained by a discordance between the CTA- and FFRCT-derived assessments of lesion severity. For example, FFRCT was >0.80 in 13 of 44 vessels (29.5%) graded as having a stenosis >90%. In contrast, FFRCT was ≤0.80 in 17 of 366 vessels (4.6%) graded as having stenosis ≤50%.CONCLUSIONSThis study demonstrates proof of concept that the availability of FFRCT results has a substantial effect on the labeling of significant coronary artery disease and therefore on the management of patients compared to CTA alone. Further studies are needed to determine whether FFRCT has potential as a noninvasive diagnostic and management screening tool for patients with stable chest pain.
Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary ...angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone.
We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events.
In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415;
=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90;
=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (
=0.64).
A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life.
URL: https://www.
gov; Unique identifier: NCT01070771.
Objectives
We assessed the impact of diabetes mellitus (DM) on mortality after percutaneous coronary intervention (PCI) for left main stem (LMS) disease. Second, we compared mortality outcomes ...between non‐insulin treated (NITDM) and insulin treated diabetes (ITDM) in different clinical settings.
Background
There is a paucity of “real world” outcomes data in diabetic patients undergoing LMS PCI.
Methods
We undertook a retrospective analysis of consecutive patients undergoing unprotected LMS PCI at 2 high volume tertiary centers. Diabetic status and clinical setting for PCI were recorded. The primary outcome measure was all‐cause 30‐day and long‐term mortality (up to 36 months) post index PCI.
Results
Between 2003 and 2017, 2,675 patients undergoing index LMS PCI were analyzed. Of those, 77.1% were non‐DM, 15.8% NITDM, and 7.1% ITDM. Overall, DM status was not associated with higher 30‐day mortality (OR 1.39, 95% CI 0.89–2.16, p = .15). During a median follow‐up of 36 months, there was a borderline statistical association of DM with long‐term mortality in all PCI settings (HR 1.31, 95% CI 1.00–1.71, p = .05). Compared to non‐DM, ITDM but not NITDM was associated with short‐ and long‐term mortality in all clinical presentations.
Conclusions
Overall, DM did not impact on 30‐day mortality and had only a borderline statistical association with long‐term mortality. It did not have an influence on mortality in non‐emergency LMS PCI. The impact of DM on mortality outcomes following LMS PCI was only significant in the insulin treated patients.
Clinical predictors of future ischemic events in patients with acute coronary syndrome (ACS) are also risk factors for bleeding, with patients often at high-risk of both outcomes. We aimed to define ...the clinical outcomes and provision of guideline-recommended care in ACS management for different combinations of ischemic and bleeding risk defined using a combined GRACE and CRUSADE score.
A retrospective observational analysis of a national ACS database was performed for patients with ACS admitted to three tertiary centres from January 2010 to March 2016. Patients were stratified into 9 groups based on possible CRUSADE-GRACE risk combinations. Multiple logistic regression was used to estimate adjusted odds ratios (ORs 95% CI) for outcomes (in-hospital net adverse cardiac events (NACE), in-hospital all-cause mortality, 30-day mortality and treatment strategy).
A total of 17,701 patients were included in the analysis. We observed a graded risk of mortality and adverse events in the high-risk GRACE strata (Groups 3, 6 and 9). Almost a third of patients with ACS were at a ‘dual high-risk’ (Group 9, 32%) and were independently associated with higher in-hospital NACE (composite of cardiac mortality, all-cause bleeding and re-infarction): aOR 6.33 3.55, 11.29, all-cause mortality: aOR 14.17 5.27, 38.1, all-cause bleeding: aOR 4.82 1.96, 11.86, and 30-day mortality: aOR 10.79 5.33, 21.81. This group was also the least likely to be offered coronary angiography (aOR 0.24 0.20, 0.29) and dual anti-platelet therapy (aOR 0.26 0.20, 0.34).
One in five patients presenting with an ACS are high ischemic and high bleeding risk, and these patients are more likely to experience poor clinical outcomes and reduced odds of receiving guideline-recommended therapy.
•Combined bleeding-ischemic risk assessment demonstrates that one in three ACS patients are at a 'dual high-risk' of both events.•‘Dual high-risk’ bleeding-ischemic groups are at greater risk of adverse outcomes and yet less likely to receive guideline-based therapy.•Further work is required to identify alternative management strategies that would improve the outcomes of ‘dual high-risk’ patients.
To assess safety of early discharge following primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI).
Retrospective analysis of prospectively collected data ...of 2448 STEMI patients treated with PPCI surviving to hospital discharge. Post-discharge all-cause mortality was reported at 1, 7, and 30 days and long-term follow up. A total of 1542 patients (63.0%) were discharged within 2 days of admission (early discharge group) and 906 patients (37.0%) after 2 days (late discharge group). In both groups, no deaths were recorded 1 day post discharge. The early and late discharge group mortality figures for 7 days were 0 and 4 patients (0.04%) and between 7 and 30 days were 11 (0.7%) and 11 patients (1.2%), respectively. During a mean follow up of 584 days, 178 patients (7.3%) died: 67 in the early discharge group (4.3%) and 111 in the late discharge group (12.3%).
This exploratory, observational study demonstrates that discharging low-risk STEMI patients within 2 days following PPCI is safe. For providers of health care, early discharge can help to allay the cost of providing a 24-hour PPCI service and adds to the recognized benefits arising from PPCI.
Primary percutaneous coronary intervention (pPCI) has improved clinical outcomes in patients with ST-segment-elevation myocardial infarction. However, as many as 50% of patients still have suboptimal ...myocardial reperfusion and experience extensive myocardial necrosis. The PiCSO-AMI-I trial (Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I) evaluated whether PiCSO therapy can further reduce myocardial infarct size (IS) in patients undergoing pPCI.
Patients with anterior ST-segment-elevation myocardial infarction and Thrombolysis in Myocardial Infarction flow 0-1 were randomized at 16 European centers to PiCSO-assisted pPCI or conventional pPCI. The PiCSO Impulse Catheter (8Fr balloon-tipped catheter) was inserted via femoral venous access after antegrade flow restoration of the culprit vessel and before proceeding with stenting. The primary end point was the difference in IS (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance. Secondary end points were the extent of microvascular obstruction and intramyocardial hemorrhage at 5 days and IS at 6 months.
Among 145 randomized patients, 72 received PiCSO-assisted pPCI and 73 conventional pPCI. No differences were observed in IS at 5 days (27.2%±12.4% versus 28.3%±11.45%;
=0.59) and 6 months (19.2%±10.1% versus 18.8%±7.7%;
=0.83), nor were differences between PiCSO-treated and control patients noted in terms of the occurrence of microvascular obstruction (67.2% versus 64.6%;
=0.85) or intramyocardial hemorrhage (55.7% versus 60%;
=0.72). The study was prematurely discontinued by the sponsor with no further clinical follow-up beyond 6 months. However, up to 6 months of PiCSO use appeared safe with no device-related adverse events.
In this prematurely discontinued randomized trial, PiCSO therapy as an adjunct to pPCI did not reduce IS when compared with conventional pPCI in patients with anterior ST-segment-elevation myocardial infarction. PiCSO use was associated with increased procedural time and contrast but no increase in adverse events up to 6 months.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03625869.
PDF
