Faculty Bibliography

Importance: Reduced rates of cardiac catheterization, percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) are an unintended consequence of public reporting of cardiogenic shock outcomes in New York. Objectives: To evaluate whether the referral rates for cardiac catheterization, PCI, or CABG have improved in New York since cardiogenic shock was excluded from public reporting in 2008 and compare them with corresponding rates in Michigan, New Jersey, and California. Design, Setting, and Participants: Patients with cardiogenic shock complicating acute myocardial infarction from 2002 to 2011 were identified using the National Inpatient Sample. Propensity score matching was used to assemble a cohort of patients with cardiogenic shock with similar baseline characteristics in New York and Michigan. Main Outcomes and Measures: Percutaneous coronary intervention (primary outcome), invasive management (cardiac catheterization, PCI, or CABG), revascularization (PCI or CABG), and CABG were evaluated with reference to 3 calendar year periods: 2002-2005 (time 1: cardiogenic shock included in publicly reported outcomes), 2006-2007 (time 2: cardiogenic shock excluded on a trial basis), and 2008 and thereafter (time 3: cardiogenic shock excluded permanently) in New York and compared with Michigan. Results: Among 2126 propensity score-matched patients representing 10795 (weighted) patients with myocardial infarction complicated by cardiogenic shock in New York and Michigan, 905 (42.6%) were women and mean (SE) age was 69.5 (0.3) years. A significantly higher proportion of the patients underwent PCI (time 1 vs 2 vs 3: 31.1% vs 39.8% vs 40.7% [OR, 1.50; 95% CI, 1.12-2.01; P = .005 for time 3 vs 1]), invasive management (time 1 vs 2 vs 3: 59.7% vs 70.9% vs 73.8% [OR, 1.84; 95% CI, 1.37-2.47; P < .001 for time 3 vs 1]), or revascularization (43.1% vs 55.9% vs 56.3% [OR, 1.66; 95% CI, 1.26-2.20; P < .001 for time 3 vs 1]) after the exclusion of cardiogenic shock from public reporting in New York. However, during the same periods, a greater proportion of patients underwent PCI (time 1 vs 2 vs 3: 41.2% vs 52.6% vs 57.8% [OR, 1.93; 95% CI, 1.45-2.56; P < .001 for time 3 vs 1]), invasive management (time 1 vs 2 vs 3: 64.4% vs 80.5% vs 78.6% [OR, 2.01; 95% CI, 1.47-2.74; P < .001 for time 3 vs 1]), or revascularization (51.2% vs 65.8% vs 68.0% [OR, 2.00; 95% CI, 1.50-2.66; P < .001 for times 3 vs 1]) in Michigan. Results were largely similar in several sensitivity analyses comparing New York with New Jersey or California. Conclusions and Relevance: Although the rates of PCI, invasive management, and revascularization have increased substantially after the exclusion of cardiogenic shock from public reporting in New York, these rates remain consistently lower than those observed in other states without public reporting.

IMPORTANCE: Prior studies have shown that patients with insulin-treated diabetes mellitus (ITDM) have a higher risk of cardiovascular events. However, this finding is controversial, as other studies have shown that the increased risk of cardiovascular events disappears after risk adjustment. In addition, the choice of a drug-eluting stent (limus- vs taxol-eluting) in ITDM is controversial, with studies showing worse outcomes with an everolimus-eluting stent compared with a paclitaxel-eluting stent. OBJECTIVES: To assess the outcomes of patients with ITDM vs non-ITDM who underwent percutaneous coronary intervention and to assess the efficacy and safety of an everolimus-eluting stent vs a paclitaxel-eluting stent based on insulin use status. DESIGN, SETTING, AND PARTICIPANTS: A prespecified analysis was conducted of the Taxus Element vs Xience Prime in a Diabetic Population (TUXEDO) clinical trial, which enrolled 1830 patients with ITDM and non-ITDM from June 23, 2011, to March 12, 2014. Patients were randomized 1:1 to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. MAIN OUTCOMES AND MEASURES: The primary end point was target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization at 1 year after the intervention. RESULTS: Among the 1830 patients (1377 male) in the TUXEDO trial, 747 patients (40.8%) were receiving insulin (ITDM group). Compared with the 1083 patients with non-ITDM, those with ITDM had a significant increase in target vessel failure (42 [5.6%] vs 36 [3.3%]; P = .02), death or myocardial infarction (43 [5.8%] vs 35 [3.2%]; P = .009), death (26 [3.5%] vs 18 [1.7%]; P = .01), and subacute stent thrombosis (8 [1.1%] vs 3 [0.3%]; P = .03). However, in a propensity score-adjusted analysis to account for baseline differences between the 2 groups, the differences in outcomes were no longer significant. In patients with ITDM, everolimus-eluting stents reduced the rate of target vessel failure (13 of 382 [3.4%] vs 29 of 365 [7.9%]; P = .007), major adverse cardiac events (15 of 382 [3.9%] vs 30 of 365 [8.2%]; P = .01), myocardial infarction (5 of 382 [1.3%] vs 16 of 365 [4.4%]; P = .01), stent thrombosis (2 of 382 [0.5%] vs 11 of 365 [3.0%]; P = .009), target lesion revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001), and target vessel revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001) when compared with paclitaxel-eluting stents. The results largely trended in the same direction in patients with non-ITDM (P > .05 for the interaction). CONCLUSIONS AND RELEVANCE: Patients with ITDM had a significant increase in the risk of cardiovascular events in unadjusted models that was largely attenuated after propensity score adjustment. Everolimus-eluting stents reduced the rate of cardiovascular events, including stent thrombosis, when compared with paclitaxel-eluting stents in patients with ITDM. TRIAL REGISTRATION: ctri.nic.in Identifier: CTRI/2011/06/001830.