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Background: The STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure) demonstrated that coronary artery bypass grafting (CABG) reduced all-cause mortality rates out to 10 years compared with medical therapy alone (MED) in patients with ischemic cardiomyopathy and reduced left ventricular function (ejection fraction ≤35%). We examined the economic implications of these results.Methods: We used a decision-analytic patient-level simulation model to estimate the lifetime costs and benefits of CABG and MED using patient-level resource use and clinical data collected in the STICH trial. Patient-level costs were calculated by applying externally derived US cost weights to resource use counts during trial follow-up. A 3% discount rate was applied to both future costs and benefits. The primary outcome was the incremental cost-effectiveness ratio assessed from the US health care sector perspective.Results: For the CABG arm, we estimated 6.53 quality-adjusted life-years (95% CI, 5.70-7.53) and a lifetime cost of $140 059 (95% CI, $106 401 to $180 992). For the MED arm, the corresponding estimates were 5.52 (95% CI, 5.06-6.09) quality-adjusted life-years and $74 894 lifetime cost (95% CI, $58 372 to $93 541). The incremental cost-effectiveness ratio for CABG compared with MED was $63 989 per quality-adjusted life-year gained. At a societal willingness-to-pay threshold of $100 000 per quality-adjusted life-year gained, CABG was found to be economically favorable compared with MED in 87% of microsimulations.Conclusions: In the STICH trial, in patients with ischemic cardiomyopathy and reduced left ventricular function, CABG was economically attractive relative to MED at current benchmarks for value in the United States.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT00023595. [ABSTRACT FROM AUTHOR]

Aim: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use.Methods: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline. [ABSTRACT FROM AUTHOR]

Background: Coronary artery bypass grafting (CABG) surgery is the gold standard treatment for complex coronary artery disease. Social determinants of health, including primary payer status, are disproportionately associated with adverse outcomes following surgical operations. We sought to examine associations between insurance status, in particular having Medicaid public insurance, and postoperative outcomes following isolated CABG surgeries.Methods: A retrospective review was performed using Florida, California, New York, Maryland, and Kentucky State Inpatient Databases (2007-2014) for isolated CABG patients ≥ 18 years. Multivariate regression for postsurgical inpatient mortality, postsurgical complications, 30- and 90-day readmission rates, total charges, and length of stay yielded adjusted odds ratios (ORs) reported for outcomes by insurance status.Results: Among 312,018 individuals, patients with Medicaid insurance and those designated as Uninsured incurred increased adjusted ORs of postsurgical inpatient mortality (56 and 64%, respectively) compared to Private Insurance. Additionally, Medicaid had the highest adjusted OR for 30-day readmission (OR 1.52, 95% CI 1.45-1.59), 90-day readmission (OR 1.53, 95% CI 1.47-1.59), postsurgical complications (OR 1.10, 95% CI 1.07-1.14) including pulmonary and infectious complications, postoperative length of stay, and total hospital charges (2016 dollars).Conclusions: Medicaid insurance, compared to Private Insurance, is significantly associated with worse outcomes after isolated CABG. Our results demonstrate that Medicaid as a patient’s primary insurance payer is an independent predictor of perioperative risks. Further research may help explain the reasons for the differences in payer groups. [ABSTRACT FROM AUTHOR]

Background: Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy.Methods: A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias.Results: After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups.Conclusion: In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time. [ABSTRACT FROM AUTHOR]

Background: Spontaneous coronary artery dissection (SCAD) is the most common cause of pregnancy-associated myocardial infarction and remains poorly characterized.Objectives: This study sought to assess presentation, clinical factors, and outcomes of pregnancy-associated spontaneous coronary artery dissection (P-SCAD) compared with spontaneous coronary artery dissection not associated with pregnancy (NP-SCAD).Methods: A Mayo Clinic registry was established in 2010 to include comprehensive retrospective and prospective SCAD data. Records were reviewed to identify women who were pregnant or ≤12 weeks postpartum at time of SCAD. Complete records were available for 323 women; 54 women met criteria for P-SCAD (4 during pregnancy) and they were compared with 269 women with NP-SCAD.Results: Most events occurred within the first month postpartum (35 of 50). Compared with NP-SCAD, P-SCAD patients more frequently presented with ST-segment elevation myocardial infarction (57% vs. 36%; p = 0.009), left main or multivessel SCAD (24% vs. 5%; p < 0.0001; and 33% vs. 14%; p = 0.0027, respectively), and left ventricular function ≤35% (26% vs. 10%; p = 0.0071). Among women with imaging of other vascular territories, P-SCAD was less likely with a diagnosis of fibromuscular dysplasia and extracoronary vascular abnormalities (42% vs. 64%; p = 0.047; and 46% vs. 77%; p = 0.0032, respectively). Compared with U.S. birth data, women with P-SCAD were more often multiparous (p = 0.0167), had a history of infertility therapies (p = 0.0004), and had pre-eclampsia (p = 0.001). On long-term follow-up (median 2.3 years) recurrent SCAD occurred in 51 patients, with no difference in the Kaplan Meier 5-year recurrence rates (10% vs. 23%; p = 0.18).Conclusions: P-SCAD patients had more acute presentations and high-risk features than women with NP-SCAD did. The highest frequency of P-SCAD occurred during the first postpartum month and P-SCAD patients less often had extracoronary vascular abnormalities. Hormonal, hemodynamic variations, and yet-undefined mechanisms might be significant contributors to P-SCAD. (The "Virtual" Multicenter Spontaneous Coronary Artery Dissection [SCAD] Registry [SCAD]; NCT01429727; Genetic Investigations in Spontaneous Coronary Artery Dissection [SCAD]; NCT01427179). [ABSTRACT FROM AUTHOR]

Objectives: We evaluated the angiographic and clinical outcomes of orbital atherectomy to treat severely calcified coronary lesions in diabetic and non-diabetic patients.Background: Diabetics have increased risk for death, myocardial infarction, and target vessel revascularization after percutaneous coronary intervention. Severely calcified coronary lesions are associated with increased cardiac events. Orbital atherectomy facilitates stent delivery and optimizes stent expansion by modifying severely calcified plaque. Outcomes in diabetic patients who undergo orbital atherectomy have not been reported.Methods: Our retrospective multicenter registry included 458 consecutive real-world patients with severely calcified coronary arteries who underwent orbital atherectomy. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events at 30 days.Results: Diabetics represented 42.1% (193/458) of the entire cohort. The primary endpoint was similar in diabetics and non-diabetics (1.0% vs. 3.0%%, P = 0.20), as were 30-day rates of death (0.5% vs. 1.9%, P = 0.41), myocardial infarction (0.5% vs. 1.5%, P = 0.40), target vessel revascularization (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P > 0.9). Angiographic complications and stent thrombosis rate were low and did not differ between the 2 groups.Conclusion: Diabetics represented a sizeable portion of patients who underwent orbital atherectomy. Diabetics who had severely calcified coronary arteries and underwent orbital atherectomy had low event rates that were similar to non-diabetics. Orbital atherectomy appears to be a viable treatment strategy for diabetic patients. Randomized trials with longer-term follow-up are needed to determine the ideal treatment strategy for diabetics. [ABSTRACT FROM AUTHOR]

Objectives: This 2-year follow-up of the XIENCE V® USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients. Background: The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V® USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported. Methods: XIENCE V® USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee. Results: Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively. Conclusion: Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence. These results demonstrate continued safety and effectiveness of the XIENCE V® everolimus-eluting stent in a highly complex, real-world patient population through 2 years. (J Interven Cardiol 2012;25:565-575) [ABSTRACT FROM AUTHOR]

Objectives: Indications for the use of stents are evolving and their optimal place in therapy remains to be defined. The objective was to compare the 1-year clinical and economic outcomes of percutaneous transluminal coronary agioplasty (PTCA) with and without the use of stents. Methods: This retrospective database analysis was conducted using data from 60 US academic medical centers in 1996 and 1997. Outcomes of interest included in-hospital mortality (both on sentinel and readmission visits), readmission rates, revascularization procedures, length of stay, and the cost of sentinel and readmission hospitalization. Results: A total of 27,020 patients either did (n = 13,254) or did not (n = 13,766) receive coronary stents in conjunction with PTCA. The median cost of hospitalization for the stent group was about $1,409 higher (mean, $1,200) than the no-stent group and the length of stay was similar (4.3 days vs. 4.5 days, respectively, P = .2628). Mortality rates on readmission (0.9% stent vs. 0.8% no-stent, P = NS) did not differ. However, patients in the stent group had better mortality rates compared to the no-stent group during the sentinel visit (1.7% vs. 2.7%, P < .001). Stent use was not associated with a significantly lower risk of a revascularization procedure on readmission to the same institution (OR 0.95, 95% CI 0.87–1.04, P = .28). Conclusions: Stents were associated with a 1% decrease of inpatient mortality during the sentinel visit without impacting length of stay or readmission rates. This advantage was associated with a $1,409 higher median cost of hospitalization in the stent group. [ABSTRACT FROM AUTHOR]

Previous studies have demonstrated that regionalization of resources for cardiac catheterization, percutaneous coronary artery angioplasty (PTCA), and coronary artery bypass graft surgery (CABG) reduces the rate of procedure use. It was hypothesized that the impact of regionalization would be greater for the elderly and for African-Americans than for other populations. Discharge medical records of 30,901 patients admitted to a Veterans Affairs (VA) medical center between October 1, 1993, and September 30, 1994, with a diagnosis of coronary artery disease were analyzed. The presence of a cardiac catheterization laboratory in the patients' local VA facility significantly increased the likelihood of undergoing catheterization, PTCA, and CABG, as determined by odds ratios and associated confidence limits estimated by logistic regression techniques. The presence of a cardiac surgical facility also significantly increased the likelihood of having the procedures. The odds ratios estimating the effects of resource availability were significantly greater for the subgroup of patients aged > or =70 years than for the younger subgroup for catheterization, PTCA, and CABG and for African-Americans than for white patients for PTCA and CABG. Thus, within the VA health care system, regionalization of cardiac procedures has a significant impact on utilization rates of tertiary cardiac procedures. These differences are significantly greater for the elderly and for African-Americans than for the general population. [ABSTRACT FROM AUTHOR]

Abstract: For patients enrolled in the Coronary Artery Surgery Study (CASS), surgery was recommended for 46.5 per ¢ of Blacks and 59.4 per ¢ of Whites, despite similar clinical and angiographic characteristics. Of those recommended, 80.5 per ¢ of Blacks and 90.4 per ¢ of Whites had bypass surgery. These differences were most apparent for Black laborers. Overall, only 38.0 per ¢ of Blacks had coronary artery bypass surgery, whereas 58.4 per ¢ of Whites received surgery. [ABSTRACT FROM AUTHOR]

The author discusses developments in the health care system in the U.S. as of October 2013. She claims that in the country's current system, it is easier to provide a patient with 10 state-of-the-art stents than to access a generic life-prolonging pill. She cites as example the case of a middle-aged Jamaican-American female who has a coronary artery disease.

Reports that the U.S. Food and Drug Administration has approved the first drug-eluting stent for angioplasty procedures to open clogged coronary arteries. Method of leaving a stent permanently in the artery to keep the vessel open after angioplasty; Slow release of a drug by the stent; Possible impact on the occurrence of re-blockages for patients with heart disease; Approval of the Cypher Sirolimus-Eluting Coronary Stent, a tiny metal mesh tube that is covered with the drug sirolimus; Approval of the stent based on a review of laboratory and animal tests and two clinical studies of safety and effectiveness conducted by the manufacturer.

The article focuses on the study conducted by the U.S. National Heart, Lung and Blood Institute (NHBLI) Dynamic Registry on the efficacy of drug-eluting stents (DES) for off-label use as compared to off-label bare-metal stents (BMS). Patients who are using off-label stents have been associated with lower risks of repeat revascularization without the risk of myocardial infarction. However, medical experts have cautioned that further studies are needed to support the off-label use of DES.

The article focuses on the findings of a phase 2 clinical study about the use of an oral thrombin receptor antagonist, SCH 530348, on patients undergoing percutaneous coronary intervention (PCI) in the U.S. The findings were presented during the 56th Annual Scientific Session of the American College of Cardiology in Louisiana. The researchers reported that the addition of SCH 530348 to standard antiplatelet therapy results to no increase in major and minor bleeding on PCI patients.