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In contrast, by capturing data on all interventions, large observational registries may more accurately reflect routine clinical practice. In the absence of randomization, however, their fundamental limitation is that they cannot account for all confounding factors, which may influence both the choice and the outcome of different interventions. Propensity matching for both cardiac and non-cardiac comorbidity can only partially mitigate this problem. Accepting this limitation, independent registries have consistently reported that an initial strategy of CABG rather than PCI in propensity-matched patients with MVD or LM CAD improved survival over a 3- to 5-year period by ∼5%, accompanied by a four- to seven-fold reduction in the need for reintervention [ 32–37 ]. The differing populations in RCTs and registries may partly explain the apparent differences in the respective efficacies of the two procedures, at least in patients with the most severe CAD.

The adverse impact of demonstrable ischaemia on clinical outcome [death, myocardial infarction (MI), ACS, occurrence of angina] has been well recognized for over two decades [ 13 , 38 ]. While symptomatic patients with no or little evidence of ischaemia have no prognostic benefit from revascularization, asymptomatic patients with a significant mass of ischaemic myocardium do [ 13 , 38 ]. Most recently, in a small nuclear substudy of the COURAGE trial (which reported no overall survival benefit of PCI over OMT), involving just over 300 patients, 100 patients with > 10% ischaemic myocardium had a lower risk of death or MI with revascularization [ 14 ].

The efficacy of PCI (with or without stenting) vs. OMT has been addressed in several meta-analyses [ 29 , 30 , 39–42 ] and a large RCT [ 43 ]. Most meta-analyses reported no mortality benefit, increased non-fatal periprocedural MI, and reduced need for repeat revascularization with PCI. One meta-analysis [ 41 ] reported a survival benefit for PCI over OMT (respective mortalities of 7.4% vs. 8.7% at an average follow-up of 51 months), but this study included patients with recent MI and CABG patients in the revascularized group. Another meta-analysis reported reduced mortality for PCI vs. OMT, even after exclusion of MI patients [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.68–0.99] [ 30 ].

The COURAGE RCT [ 43 ] randomized 2287 patients with known significant CAD and objective evidence of myocardial ischaemia to OMT alone or to OMT+PCI. At a median follow-up of 4.6 years, there was no significant difference in the composite of death, MI, stroke, or hospitalization for unstable angina. Freedom from angina was greater by 12% in the PCI group at 1 year but was eroded by 5 years, by which time 21% of the PCI group and 33% of the OMT group had received additional revascularization ( P ≪ 0.001). The authors concluded that an initial strategy of PCI in stable CAD did not reduce the risk of death, MI, or MACE when added to OMT. The severity of CAD in COURAGE was, at most, moderate, with the relative proportions of one-, two- and three-vessel CAD being 31%, 39%, and 30%, while only 31% of patients had proximal LAD disease. Furthermore, patients with LM disease were excluded and most patients had normal LV function.

Table 3.

Adjusted Odds Ratios for the Association Between Defined Exposures and Severe Sepsis or Septic Shock Within 90 Days After Hospital Discharge in a Cohort of US Hospitals

Abbreviations: CI, confidence interval; OR, odds ratio.

Multivariable logistic model adjusted for sex, age, primary payer, previous hospitalizations within 90 days, length of stay, comorbidity score, surgical or medical diagnosis-related group, emergency room visit, critical care stays during index visit, month and year of index visit, hospital size (No. of beds), hospital urban/rural location, hospital teaching status, hospital census division, and various chronic conditions based on ( ) discharge codes including: metastatic disease, congestive heart failure, dementia, renal failure, weight loss, hemiplegia, alcohol abuse, any tumor, arrhythmia, pulmonary disease, coagulopathy, complicated diabetes, anemia, fluid and electrolyte disorders, liver disease, peripheral vascular disorder, psychosis, pulmonary circulatory disorders, human immunodeficiency virus/AIDS, hypertension, obesity, hyperlipidemia, uncomplicated diabetes, ischemic heart disease, atrial fibrillation, and ventricular fibrillation.

Severe sepsis/septic shock was defined as a hospital stay within 90 days of the index stay that included an discharge diagnosis of severe sepsis ( code 995.92) or septic shock (785.52), identified in any position on the hospital discharge bill.

The secondary outcome of sepsis used a published definition for hospital administrative data, the “Angus definition,” which requires codes for both infection and acute organ dysfunction within the same hospitalization or a sepsis-specific diagnosis [23].

High-risk antibacterial exposures included any receipt of third- or fourth-generation cephalosporins, fluoroquinolones, lincosamides, β-lactam/β-lactamase inhibitor combinations, oral vancomycin, or carbapenems.

Low-risk antibacterial exposures included receipt of first- or second-generation cephalosporins, macrolide, tetracycline, metronidazole, or sulfa without receipt of a high-risk antibiotic.

Control antibacterial exposures included any receipt of an aminoglycoside, penicillin, or intravenous vancomycin (antibiotics that minimally disrupt gastrointestinal flora) without receipt of intermediate- or high-risk antibiotics.

We also used a similar model with the same exposures that used any readmission within 90 days as the outcome, rather than either of the sepsis outcomes.

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Table 3.

Adjusted Odds Ratios for the Association Between Defined Exposures and Severe Sepsis or Septic Shock Within 90 Days After Hospital Discharge in a Cohort of US Hospitals

Abbreviations: CI, confidence interval; OR, odds ratio.

Multivariable logistic model adjusted for sex, age, primary payer, previous hospitalizations within 90 days, length of stay, comorbidity score, surgical or medical diagnosis-related group, emergency room visit, critical care stays during index visit, month and year of index visit, hospital size (No. of beds), hospital urban/rural location, hospital teaching status, hospital census division, and various chronic conditions based on ( ) discharge codes including: metastatic disease, congestive heart failure, dementia, renal failure, weight loss, hemiplegia, alcohol abuse, any tumor, arrhythmia, pulmonary disease, coagulopathy, complicated diabetes, anemia, fluid and electrolyte disorders, liver disease, peripheral vascular disorder, psychosis, pulmonary circulatory disorders, human immunodeficiency virus/AIDS, hypertension, obesity, hyperlipidemia, uncomplicated diabetes, ischemic heart disease, atrial fibrillation, and ventricular fibrillation.

Severe sepsis/septic shock was defined as a hospital stay within 90 days of the index stay that included an discharge diagnosis of severe sepsis ( code 995.92) or septic shock (785.52), identified in any position on the hospital discharge bill.

The secondary outcome of sepsis used a published definition for hospital administrative data, the “Angus definition,” which requires codes for both infection and acute organ dysfunction within the same hospitalization or a sepsis-specific diagnosis [23].

High-risk antibacterial exposures included any receipt of third- or fourth-generation cephalosporins, fluoroquinolones, lincosamides, β-lactam/β-lactamase inhibitor combinations, oral vancomycin, or carbapenems.

Low-risk antibacterial exposures included receipt of first- or second-generation cephalosporins, macrolide, tetracycline, metronidazole, or sulfa without receipt of a high-risk antibiotic.

Control antibacterial exposures included any receipt of an aminoglycoside, penicillin, or intravenous vancomycin (antibiotics that minimally disrupt gastrointestinal flora) without receipt of intermediate- or high-risk antibiotics.

We also used a similar model with the same exposures that used any readmission within 90 days as the outcome, rather than either of the sepsis outcomes.

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Because most patients exposed to ≥4 classes of antibiotics were also in the high-risk antibiotic group, we further evaluated the dose response within the high-risk group alone. We also limited the analysis to those with an infection-related primary discharge code during the index stay. Dose responses were observed when our analysis was limited to one of these groups ( Table 3 ).

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