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Appropriate Revascularization in Stable Angina: Lessons From the BARI 2D Trial

Krone, Ronald J; Althouse, Andrew D; Tamis-Holland, Jacqueline; Venkitachalam, Lakshmi; Campos, Arturo; Forker, Alan; Jacobs, Alice K; Ocampo, Salvador; Steiner, George; Fuentes, Francisco; Pena Sing, Ivan R; Brooks, Maria Mori
BACKGROUND: The 2012 Guidelines for Diagnosis and Management of Patients with Stable Ischemic Heart Disease recommend intensive antianginal and risk factor treatment (optimal medical management [OMT]) before considering revascularization to relieve symptoms. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial randomized patients with ischemic heart disease and anatomy suitable to revascularization to (1) initial OMT with revascularization if needed or (2) initial revascularization plus OMT and found no difference in major cardiovascular events. Ultimately, however, 37.9% of the OMT group was revascularized during the 5-year follow-up period. METHODS: Data from the 1192 patients randomized to OMT were analyzed to identify subgroups in which the incidence of revascularization was so high that direct revascularization without a trial period could be justified. Multivariate logistic analysis, Cox regression models of baseline data, and a landmark analysis of participants who did not undergo revascularization at 6 months were constructed. RESULTS: The models that used only data available at the time of study entry had limited predictive value for revascularization by 6 months or by 5 years; however, the model incorporating severity of angina during the first 6 months could better predict revascularization (C statistic = 0.789). CONCLUSIONS: With the possible exception of patients with severe angina and proximal left anterior descending artery disease, this analysis supports the recommendation of the 2012 guidelines for a trial of OMT before revascularization. Patients could not be identified at the time of catheterization, but a short period of close follow-up during OMT identified the nearly 40% of patients who underwent revascularization.
PMCID:4265566
PMID: 25475464
ISSN: 0828-282x
CID: 1410582

Characteristics of plaque disruption by intravascular ultrasound in women presenting with myocardial infarction without obstructive coronary artery disease

Iqbal, Sohah N; Feit, Frederick; Mancini, G B John; Wood, David; Patel, Rima; Pena-Sing, Ivan; Attubato, Michael; Yatskar, Leonid; Slater, James N; Hochman, Judith S; Reynolds, Harmony R
BACKGROUND: In a prospective study, we previously identified plaque disruption (PD: plaque rupture or ulceration) in 38% of women with myocardial infarction (MI) without angiographically obstructive coronary artery disease (CAD), using intravascular ultrasound (IVUS). Underlying plaque morphology has not been described in these patients and may provide insight into the mechanisms of MI without obstructive CAD. METHODS: Forty-two women with MI and <50% angiographic stenosis underwent IVUS (n = 114 vessels). Analyses were performed by a blinded core laboratory. Sixteen patients had PD (14 ruptures and 5 ulcerations in 18 vessels). Plaque area, % plaque burden, lumen area stenosis, eccentricity, and remodeling index were calculated for disrupted plaques and largest plaque by area in each vessel. RESULTS: Disrupted plaques had lower % plaque burden than the largest plaque in the same vessel (31.9% vs 49.8%, P = .005) and were rarely located at the site of largest plaque (1/19). Disrupted plaques were typically fibrous and were not more eccentric or remodeled than the largest plaque in the same vessel. CONCLUSIONS: Plaque disruption was often identifiable on IVUS in women with MI without obstructive CAD. Plaque disruption in this patient population occurred in fibrous or fibrofatty plaques and, contrary to expectations based on prior studies of plaque vulnerability, did not typically occur in eccentric, outwardly remodeled, or soft plaque in these patients. Plaque disruption rarely occurred at the site of the largest plaque in the vessel. These findings suggest that the pathophysiology of PD in women with MI without angiographically obstructive CAD may be different from MI with obstructive disease and requires further investigation.
PMID: 24766982
ISSN: 0002-8703
CID: 941662

Favorable effects of insulin sensitizers pertinent to peripheral arterial disease in type 2 diabetes: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial

Althouse, Andrew D; Abbott, J Dawn; Sutton-Tyrrell, Kim; Forker, Alan D; Lombardero, Manuel S; Buitron, L Virginia; Pena-Sing, Ivan; Tardif, Jean-Claude; Brooks, Maria Mori
OBJECTIVE: The aim of this manuscript was to report the risk of incident peripheral arterial disease (PAD) in a large randomized clinical trial that enrolled participants with stable coronary artery disease and type 2 diabetes and compare the risk between assigned treatment arms. RESEARCH DESIGN AND METHODS: The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial randomly assigned participants to insulin sensitization (IS) therapy versus insulin-providing (IP) therapy for glycemic control. Results showed similar 5-year mortality in the two glycemic treatment arms. In secondary analyses reported here, we examine the effects of treatment assignment on the incidence of PAD. A total of 1,479 BARI 2D participants with normal ankle-brachial index (ABI) (0.91-1.30) were eligible for analysis. The following PAD-related outcomes are evaluated in this article: new low ABI
PMCID:3781574
PMID: 23735723
ISSN: 0149-5992
CID: 941652

Ankle-brachial index and cardiovascular outcomes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial

Abbott, J Dawn; Lombardero, Manuel S; Barsness, Gregory W; Pena-Sing, Ivan; Buitron, L Virginia; Singh, Premranjan; Woodhead, Gail; Tardif, Jean-Claude; Kelsey, Sheryl F
BACKGROUND: Peripheral arterial disease increases cardiovascular risk in many patient populations. The risks associated with an abnormal ankle-brachial index (ABI) in patients with type 2 diabetes and stable coronary artery disease have not been well described with respect to thresholds and types of cardiovascular events. METHODS: We examined 2,368 patients in the BARI 2D trial who underwent ABI assessment at baseline. Death and major cardiovascular events (death, myocardial infarction and stroke) during follow-up (average 4.3 years) were assessed across the ABI spectrum and by categorized ABI: low (1.3), or noncompressible. RESULTS: A total of 12,568 person-years were available for mortality analysis. During follow-up, 316 patients died, and 549 had major cardiovascular events. After adjustment for potential confounders, with normal ABI as the referent group, a low ABI conferred an increased risk of death (relative risk [RR] 1.6, CI 1.2-2.2, P = .0005) and major cardiovascular events (RR 1.4, CI 1.1-1.7, P = .004). Patients with a high ABI had similar outcomes as patients with a normal ABI, but risk again increased in patients with a noncompressible ABI with a risk of death (RR 1.9, CI 1.3-2.8, P = .001) and major cardiovascular event (RR 1.5, CI 1.1-2.1, P = .01). CONCLUSIONS: In patients with coronary artery disease and type 2 diabetes, ABI screening and identification of ABI abnormalities including a low ABI (<1.0) or noncompressible artery provide incremental prognostic information.
PMCID:3474978
PMID: 23067918
ISSN: 0002-8703
CID: 183122

Response to Letters Regarding Article, "Mechanisms of Myocardial Infarction in Women Without Angiographically Obstructive Coronary Artery Disease" [Letter]

Reynolds, Harmony R.; Lqbal, Sohah N.; Slater, James N.; Feit, Frederick; Pena-Sing, Ivan; Attubato, Michael J.; Yatskar, Leonid; Kalhorn, Rebecca T.; Hochman, Judith S.; Srichai, Monvadi B.; Axel, Leon; Mancini, G. B. John; Wood, David A.; Lobach, Iryna V.
ISI:000307472600005
ISSN: 0009-7322
CID: 2961882

Mechanisms of Myocardial Infarction in Women Without Angiographically Obstructive Coronary Artery Disease

Reynolds HR; Srichai MB; Iqbal SN; Slater JN; Mancini GB; Feit F; Pena-Sing I; Axel L; Attubato MJ; Yatskar L; Kalhorn RT; Wood DA; Lobach IV; Hochman JS
BACKGROUND: . Unique identifier: NCT00798122
PMCID:3619391
PMID: 21900087
ISSN: 1524-4539
CID: 137093

Sex and race are associated with the absence of epicardial coronary artery obstructive disease at angiography in patients with acute coronary syndromes

Chokshi, Neel P; Iqbal, Sohah N; Berger, Rachel L; Hochman, Judith S; Feit, Frederick; Slater, James N; Pena-Sing, Ivan; Yatskar, Leonid; Keller, Norma M; Babaev, Anvar; Attubato, Michael J; Reynolds, Harmony R
BACKGROUND: A substantial minority of patients with acute coronary syndromes (ACS) do not have a diameter stenosis of any major epicardial coronary artery on angiography ('no obstruction at angiography') of >/= 50%. We examined the frequency of this finding and its relationship to race and sex. HYPOTHESIS: Among patients with myocardial infarction, younger age, female sex and non-white race are associated with the absence of obstructive coronary artery disease at angiography. METHODS: We reviewed the results of all angiograms performed from May 19, 2006 to September 29, 2006 at 1 private (n = 793) and 1 public (n = 578) urban academic medical center. Charts were reviewed for indication and results of angiography, and for demographics. RESULTS: The cohort included 518 patients with ACS. There was no obstruction at angiography in 106 patients (21%), including 48 (18%) of 258 patients with myocardial infarction. Women were more likely to have no obstruction at angiography than men, both in the overall cohort (55/170 women [32%] vs 51/348 men [15%], P < 0.001) and in the subset with MI (29/90 women [32%] vs 19/168 men [11%], P < 0.001). Black patients were more likely to have no obstruction at angiography relative to any other subgroup (24/66 [36%] vs 41/229 [18%] Whites, 31/150 [21%] Hispanics, and 5/58 [9%] Asians, P = 0.001). Among women, Black patients more frequently had no obstruction at angiography compared with other ethnic groups (16/27 [59%] vs 17/59 [29%] Whites, 17/60 [28%] Hispanics, and 3/19 [6%] Asians, P = 0.001). CONCLUSIONS: A high proportion of a multiethnic sample of patients with ACS were found to have no stenosis >/= 50% in diameter at coronary angiography. This was particularly common among women and Black patients.
PMID: 20734447
ISSN: 1932-8737
CID: 111980

Factors related to the selection of surgical versus percutaneous revascularization in diabetic patients with multivessel coronary artery disease in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) trial

Kim, Lauren J; King, Spencer B 3rd; Kent, Kenneth; Brooks, Maria Mori; Kip, Kevin E; Abbott, J Dawn; Jacobs, Alice K; Rihal, Charanjit; Hueb, Whady A; Alderman, Edwin; Sing, Ivan R Pena; Attubato, Michael J; Feit, Frederick
OBJECTIVES: We evaluated demographic, clinical, and angiographic factors influencing the selection of coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in diabetic patients with multivessel coronary artery disease (CAD) in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) trial. BACKGROUND: Factors guiding selection of mode of revascularization for patients with diabetes mellitus and multivessel CAD are not clearly defined. METHODS: In the BARI 2D trial, the selected revascularization strategy, CABG or PCI, was based on physician discretion, declared independent of randomization to either immediate or deferred revascularization if clinically warranted. We analyzed factors favoring selection of CABG versus PCI in 1,593 diabetic patients with multivessel CAD enrolled between 2001 and 2005. RESULTS: Selection of CABG over PCI was declared in 44% of patients and was driven by angiographic factors including triple vessel disease (odds ratio [OR]: 4.43), left anterior descending stenosis >or=70% (OR: 2.86), proximal left anterior descending stenosis >or=50% (OR: 1.78), total occlusion (OR: 2.35), and multiple class C lesions (OR: 2.06) (all p < 0.005). Nonangiographic predictors of CABG included age >or=65 years (OR: 1.43, p = 0.011) and non-U.S. region (OR: 2.89, p = 0.017). Absence of prior PCI (OR: 0.45, p < 0.001) and the availability of drug-eluting stents conferred a lower probability of choosing CABG (OR: 0.60, p = 0.003). CONCLUSIONS: The majority of diabetic patients with multivessel disease were selected for PCI rather than CABG. Preference for CABG over PCI was largely based on angiographic features related to the extent, location, and nature of CAD, as well as geographic, demographic, and clinical factors. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305)
PMCID:3625397
PMID: 19463459
ISSN: 1876-7605
CID: 133681

Sex and race are associated with the finding of non-obstructive coronary artery disease in patients with acute coronary syndromes [Meeting Abstract]

Chokshi, NP; Berger, RL; Hochman, JS; Keller, NM; Feit, F; Attubato, MJ; Slater, JN; Pena-Sing, I; Babaev, A; Reynolds, HR
ISI:000253997101383
ISSN: 0735-1097
CID: 78384

Prospective Evaluation of the Use and Outcome of Admission Stool Guaiac Testing: The Digital Rectal Examination on Admission to the Medical Service (DREAMS) Study

Bini, Edmund J; Reinhold, Jean-Pierre; Weinshel, Elizabeth H; Generoso, Ramon; Salman, Loay; Dahr, Georges; Pena-Sing, Ivan
BACKGROUND: Although physicians often perform fecal occult blood testing at the time of hospital admission, the practice of admission stool guaiac (ASG) testing has not been evaluated prospectively. The aim of this study was to determine the frequency and outcomes of digital rectal examination (DRE) and ASG testing in patients admitted to the hospital. METHODS: We prospectively evaluated 2143 patients admitted to the medical service at our hospital over a 1-year period. A detailed clinical history was obtained, and the proportion of patients who had DRE and ASG testing, the frequency of positive tests, and the results of follow-up testing were determined. RESULTS: A DRE was performed in 1539 of the 2143 subjects (71.8%), and 1.8% had abnormal findings, 21.8% had a normal examination, and the result of ASG testing was the only documented finding in the remaining 76.4% of patients. ASG testing was performed in 1342 of the 2143 subjects (62.6%), and the ASG test was positive in 237 persons (17.7%). However, only 161 (67.9%) of those with a positive ASG test had further diagnostic testing and a colonic source of occult gastrointestinal blood loss was detected in 68 (42.2%) of these 161 persons. CONCLUSIONS: Although DRE and ASG testing are commonly performed on admission to the hospital, documentation of the findings and follow-up of positive tests are poor. These findings highlight the need to improve physician training on the appropriate use and documentation of the DRE and fecal occult blood testing
PMID: 17016139
ISSN: 0192-0790
CID: 68742