5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique.

BACKGROUND: Bioresorbable vascular scaffolds (BVS) were designed to improve late event-free survival compared with metallic drug-eluting stents. However, initial trials demonstrated worse early outcomes with BVS, in part due to suboptimal technique. In the large-scale, blinded ABSORB IV trial, polymeric everolimus-eluting BVS implanted with improved technique demonstrated noninferior 1-year outcomes compared with cobalt chromium everolimus-eluting stents (CoCr-EES). OBJECTIVES: This study sought to evaluate the long-term outcomes from the ABSORB IV trial. METHODS: We randomized 2,604 patients at 147 sites with stable or acute coronary syndromes to BVS with improved technique vs CoCr-EES. Patients, clinical assessors, and event adjudicators were blinded to randomization. Five-year follow-up was completed. RESULTS: Target lesion failure at 5 years occurred in 216 (17.5%) patients assigned to BVS and 180 (14.5%) patients assigned to CoCr-EES (P = 0.03). Device thrombosis within 5 years occurred in 21 (1.7%) BVS and 13 (1.1%) CoCr-EES patients (P = 0.15). Event rates were slightly greater with BVS than CoCr-EES through 3-year follow-up and were similar between 3 and 5 years. Angina, also centrally adjudicated, recurred within 5 years in 659 patients (cumulative rate 53.0%) assigned to BVS and 674 (53.3%) patients assigned to CoCr-EES (P = 0.63). CONCLUSIONS: In this large-scale, blinded randomized trial, despite the improved implantation technique, the absolute 5-year rate of target lesion failure was 3% greater after BVS compared with CoCr-EES. The risk period for increased events was limited to 3 years, the time point of complete scaffold bioresorption; event rates were similar thereafter. Angina recurrence after intervention was frequent during 5-year follow-up but was comparable with both devices.(Absorb IV Randomized Controlled Trial; NCT02173379).

Trends in Acute Myocardial Infarction by Race and Ethnicity.

Background Trends in acute myocardial infarction (AMI) incidence rates for diverse races/ethnicities are largely unknown, presenting barriers to understanding the role of race/ethnicity in AMI occurrence. Methods and Results We identified AMI hospitalizations for Kaiser Permanente Southern California members, aged ≥35 years, during 2000 to 2014 using discharge diagnostic codes. We excluded hospitalizations with missing race/ethnicity information. We calculated annual incidence rates (age and sex standardized to the 2010 US census population) for AMI, ST-segment-elevation myocardial infarction, and non-ST-segment-elevation myocardial infarction by race/ethnicity (Hispanic and non-Hispanic racial groups: Asian or Pacific Islander, black, and white). Using Poisson regression, we estimated annual percentage change in AMI, non-ST-segment-elevation myocardial infarction, and ST-segment-elevation myocardial infarction incidence by race/ethnicity and AMI incidence rate ratios between race/ethnicity pairs, adjusting for age and sex. We included 18 630 776 person-years of observation and identified 44 142 AMI hospitalizations. During 2000 to 2014, declines in AMI, non-ST-segment-elevation myocardial infarction, and ST-segment-elevation myocardial infarction were 48.7%, 34.2%, and 69.8%, respectively. Age- and sex-standardized AMI hospitalization rates/100 000 person-years declined for Hispanics (from 307 to 162), Asians or Pacific Islanders (from 271 to 158), blacks (from 347 to 199), and whites (from 376 to 189). Annual percentage changes ranged from -2.99% to -4.75%, except for blacks, whose annual percentage change was -5.32% during 2000 to 2009 and -1.03% during 2010 to 2014. Conclusions During 2000 to 2014, AMI, non-ST-segment-elevation myocardial infarction, and ST-segment-elevation myocardial infarction hospitalization incidence rates declined substantially for each race/ethnic group. Despite narrowing rates among races/ethnicities, differences persist. Understanding these differences can help identify unmet needs in AMI prevention and management to guide targeted interventions.

Sex-Specific Trends in Acute Myocardial Infarction Within an Integrated Healthcare Network, 2000 Through 2014.

BACKGROUND: In recent decades, the rates of incident acute myocardial infarction (AMI) have declined in the United States, yet disparities by sex remain. In an integrated healthcare delivery system, we examined temporal trends in incident AMI among women and men. METHODS: We identified hospitalized AMI among members ≥35 years of age in Kaiser Permanente Southern California. The first hospitalization for AMI overall, and for ST-segment-elevation MI and non-ST-segment-elevation MI was identified by International Classification of Diseases, Ninth Revision, Clinical Modification primary discharge diagnosis codes in each calendar year from 2000 through 2014. Age- and sex-standardized incidence rates per 100 000 person-years were calculated by using direct adjustment to the 2010 US Census population. Average annual percent changes (AAPCs) and period percent changes were calculated, and trend tests were conducted using Poisson regression. RESULTS: We identified 45 331 AMI hospitalizations between 2000 and 2014. Age- and sex-standardized incidence rates of AMI declined from 322.4 (95% CI, 311.0-333.9) in 2000 to 174.6 (95% CI, 168.2-181.0) in 2014, representing an AAPC of -4.4% (95% CI, -4.2 to -4.6) and a period percent change of -46.6%. The AAPC for AMI in women was -4.6% (95% CI, -4.1 to -5.2) between 2000 and 2009 and declined to -2.3% (95% CI, -1.2 to -3.4) between 2010 and 2014. The AAPC for AMI in men was stable over the study period (-4.7% [95% CI, -4.4 to -4.9]). The AAPC for ST-segment-elevation MI hospitalization overall was -8.3% (95% CI, -8.0% to -8.6%).The AAPC in ST-segment-elevation MI changed among women in 2009 (2000-2009: -10.2% [95% CI, -9.3 to -11.1] and in 2010-2014: -5.2% [95% CI, -3.1 to -7.3]) while remaining stable among men (-8.0% [95% CI, -7.6 to -8.4]). The AAPC for non-ST-segment-elevation MI hospitalization was smaller than for ST-segment-elevation MI among both women and men (-1.9% [95% CI, -1.5 to -2.3] and -2.8% [95% CI, -2.5 to -3.2], respectively). CONCLUSIONS: These results suggest that the incidence of hospitalized AMI declined between 2000 and 2014; however, declines in AMI have slowed among women in comparison with men in recent years. Determining unmet care needs among women may reduce these sex-based AMI disparities.

Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial.

BACKGROUND: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. METHODS: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. FINDINGS: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided pnon-inferiority=0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided pnon-inferiority=0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference -0·3%, 95% CI -3·4% to 2·9%; one-sided pnon-inferiority=0·0008; two-sided psuperiority=0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586). INTERPRETATION: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. FUNDING: Abbott Vascular.

Rare case of myocardial infarction in a 19-year-old caused by a paradoxical coronary artery embolism.

This case focuses on a 19-year-old man who developed an inferior ST-segment elevation myocardial infarction as a result of a previously undetected large atrial septal defect. This cardiac anomaly facilitated the transport of a paradoxical embolism that occluded the right coronary artery.

Anaphylactoid reactions to radiocontrast agents: prevention and treatment in the cardiac catheterization laboratory.

The use of iodinated contrast agents for angiography dates back to the 1920s. The initial prototype has undergone modifications to reduce the toxicity and discomfort associated with the early contrast molecules. More importantly, these changes have dramatically decreased the rate and risk for severe adverse reactions such as hypersensitivity and anaphylaxis. With over 15 million contrast-requiring procedures performed annually in the United States, it is important to understand the risk factors, pathogenesis, diagnosis, prevention and treatment of contrast-induced anaphylactoid reactions. Reviews of adverse reactions are sparse in the cardiology literature, except for a landmark review in 1995 by Goss et al, which has served as the only practice guideline to date for cardiologists. In this report, we review the most recent literature to provide a guide for the general and interventional cardiologist in regards to the pretreatment and management of contrast-related reactions specifically in the cardiac catheterization laboratory.

Recent advances in hemodynamics: noncoronary applications of a pressure sensor angioplasty guidewire.

The use of the pressure sensor coronary guidewire is expanding into the peripheral circulation as well as into the realm of valvular heart disease. Small mechanistic studies and case reports have described the use of pressure wire technology in the renal and femoral arteries as well as in mechanical aortic valves. The use of this technology to measure hemodynamically significant stenoses in noncoronary locations will be discussed and a review of basic and more advanced hemodynamics in relation to problems encountered in clinical practice will be provided.

Percutaneous closure of a patent foramen ovale via left axillary vein approach with the Amplatzer Cribriform septal occluder.

Percutaneous closure of a patent foramen ovale (PFO) was successfully performed via the left axillary vein in a 52-year-old female with a history of left posterior cerebral artery embolic cerebrovascular accident (CVA) and inferior vena cava (IVC) interruption with a Simon Nitinol Filter precluding standard access via the common femoral vein. Utilizing a 6 French Amplatzer 180 degrees patent ductus arteriosus delivery sheath and a 25-mm Amplatzer Cribriform occluder, the PFO was successfully closed utilizing general anesthesia and transesophageal echocardiography guidance. This case demonstrates the advantages of the axillary vein approach over the internal jugular or hepatic vein approach in patients with anatomy precluding standard percutaneous closure.

A pilot study: reports of benefits from a 6-month, multidisciplinary, shared medical appointment approach for heart failure patients.

ABSTRACT Heart failure continues to be the leading cause of hospitalization among older adults. Noncompliance with medications, dietary indiscretion, failure to recognize symptoms, and failed social support systems contribute to increased morbidity. Multidisciplinary medical approaches have proven successful for heart failure. In 2004, the Naval Medical Center San Diego started a multidisciplinary shared medical appointment for patients with complicated cases of heart failure. Patients enrolled in the heart failure clinic were monitored prospectively for 6 months. Validated questionnaires concerning satisfaction with care, self-care management, depression, and quality-of-life measures were administered at baseline and 6 months after enrollment. Thirty-nine individuals were enrolled in the clinic, with 33 completing 6 months of follow-up monitoring to date. Hospital admissions for any cause decreased from 11 to eight, whereas congestive heart failure-related admissions decreased from four to two. There was a total of six deaths. During the 6 months of enrollment, use of angiotensin-converting enzyme inhibitors and beta-receptor blockers had absolute increases of 20% and 19%, respectively. Statistically significant improvements were seen in the Beck Depression Inventory and Self-Care Management Index results. A multidisciplinary approach to heart failure patients using the shared medical appointment model can improve patient satisfaction, enhance quality of life, and help reduce hospitalizations while improving provider efficiency.

Risk reduction with clopidogrel in the management of peripheral arterial disease.

Peripheral arterial disease (PAD) is a condition typified by decreased arterial blood flow in the non-coronary branches of the aorta as a result of chronic atherosclerosis. Despite the higher prevalence of PAD compared with other cardiovascular entities such as myocardial infarction and stroke, far less import is given to its diagnosis and treatment. In this review, we highlight principal diagnostic and therapeutic considerations in the management of PAD and its complications. We particularly emphasize the role of clopidogrel in the reduction of risks associated with PAD.

Current treatment of peripheral arterial disease: role of percutaneous interventional therapies.

Despite advances in medical therapies to help prevent the development of atherosclerosis and improve the management of patients with established peripheral arterial disease (PAD), the prevalence of PAD and associated morbidity remains high. Over the past decade, percutaneous revascularization therapies for the treatment of patients with PAD have evolved tremendously, and a great number of patients can now be offered treatment options that are less invasive than traditional surgical options. With the surgical approach, there is significant symptomatic improvement, but the associated morbidity and mortality preclude its routine use. Although newer percutaneous treatment options are associated with lower procedural complications, the technical advances have outpaced the evaluation of these treatments in adequately designed clinical studies, and therapeutic options are available that may not have been rigorously investigated. Therefore, for physicians treating patients with PAD, an understanding of the various therapies available, along with the inherent benefits and limitations of each treatment option is imperative as a greater number of patients with PAD are being encountered.

Elevated plasma fibrinogen level predicts suboptimal response to therapy with both single- and double-bolus eptifibatide during percutaneous coronary intervention.

OBJECTIVES: This study sought to determine the factors associated with suboptimal platelet inhibition (PI) with single- and double-bolus eptifibatide during percutaneous coronary intervention (PCI). BACKGROUND: Although PI > or = 95% measured 10 min after glycoprotein IIb/IIIa inhibitor therapy is associated with improved outcomes following PCI, this level of PI often is not achieved. METHODS: We prospectively studied 150 patients undergoing PCI with single-bolus eptifibatide (180 microg/kg) (n = 100) and double-bolus eptifibatide (180 microg/kg administered 10 min apart) (n = 50) followed by standard infusion (2 microg/kg/min). Measuring platelet aggregation at baseline and at 10 min and 30 to 45 min after eptifibatide bolus, patients were classified as optimal responders (OPT) (> or =95% PI) or suboptimal responders (sub-OPT) (<95% PI) based on 10-min PI after final bolus. RESULTS: Suboptimal PI was achieved in 61% of patients with single-bolus eptifibatide and in 36% with double-bolus eptifibatide. In the single-bolus group, sub-OPT had higher fibrinogen levels (324 +/- 85 mg/dl vs. 259 +/- 49 mg/dl, p = 0.0002), platelet counts (221 +/- 70 vs. 186 +/- 47, p = 0.008), and white blood cell counts (7.7 +/- 2.3 vs. 6.6 +/- 1.9, p = 0.02). In the double-bolus group, sub-OPT also had higher fibrinogen levels (324 +/- 68 mg/dl vs. 278 +/- 53 mg/dl, p = 0.01) and were more likely to be smokers (38.9% vs. 9.4%, p = 0.01). Multivariable analysis showed that fibrinogen level was the only independent predictor of suboptimal PI, with fibrinogen cutoffs at 375 and 325 mg/dl predicting suboptimal PI (single-bolus: 100% and 90.0%, respectively; double-bolus: 100% and 60%, respectively) with both doses. CONCLUSIONS: During PCI, both single- and double-bolus eptifibatide provide suboptimal PI in a substantial proportion of patients. A fibrinogen level >375 mg/dl is a strong predictor of suboptimal PI.

Role of antiplatelet therapy in cardiovascular disease I: Acute coronary syndromes.

The acute coronary syndromes (ACS), consisting of ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina, remain a leading cause of death in the United States. Through the process of atherothrombosis, underlying atherosclerosis can progress to an acute ischemic coronary event. This disease mechanism is also common to ischemic stroke and peripheral arterial disease. As ACS is a heterogeneous disease, accurate patient diagnosis and risk categorization is essential. Treatment approaches for both STEMI and NSTEMI ACS consist of a combination of surgical intervention and pharmacotherapy, with antiplatelet agents such as clopidogrel, aspirin and glycoprotein IIb/IIIa receptor antagonists playing an essential role.

Role of antiplatelet therapy in cardiovascular disease II: Ischemic stroke.

The etiology of cerebrovascular disease is heterogeneous, with the majority of strokes being of ischemic origin. Transient ischemic attack is now considered to be an important precursor and long-term risk factor for ischemic stroke. Given the lack of acute therapies for ischemic stroke, current treatments focus on secondary prevention through risk-factor management, pharmacotherapy and interventional approaches. As illustrated in this paper, antiplatelet agents (e.g. clopidogrel, aspirin, dipyridamole) are the cornerstone of therapy for prevention of recurrent ischemic stroke.

Role of antiplatelet therapy in cardiovascular disease III: Peripheral arterial disease.

Peripheral arterial disease (PAD) is a common manifestation of the atherosclerotic disease process, typically affecting vascular beds in the lower extremities. In its most severe form PAD may lead to limb amputation. Patients with PAD are also at increased cross-risk of thrombosis at coronary and cerebrovascular sites. However, despite its prevalence and severity, PAD is underdiagnosed and undertreated. In this collection of case studies, the role of the antiplatelet agent clopidogrel in current treatment strategies for the management of PAD is highlighted.