Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary results.

BACKGROUND: There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality. METHODS: We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline). RESULTS: A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively. CONCLUSIONS: Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.

An Integrative Approach for Improved Assessment of Cardiovascular Safety Data.

Cardiovascular adverse effects in drug development are a major source of compound attrition. Characterization of blood pressure (BP), heart rate (HR), stroke volume (SV), and QT-interval prolongation are therefore necessary in early discovery. It is, however, common practice to analyze these effects independently of each other. High-resolution time courses are collected via telemetric techniques, but only low-resolution data are analyzed and reported. This ignores codependencies among responses (HR, BP, SV, and QT-interval) and separation of system (turnover properties) and drug-specific properties (potencies, efficacies). An analysis of drug exposure-time and high-resolution response-time data of HR and mean arterial blood pressure was performed after acute oral dosing of ivabradine, sildenafil, dofetilide, and pimobendan in Han-Wistar rats. All data were modeled jointly, including different compounds and exposure and response time courses, using a nonlinear mixed-effects approach. Estimated fractional turnover rates [h-1, relative standard error (%RSE) within parentheses] were 9.45 (15), 30.7 (7.8), 3.8 (13), and 0.115 (1.7) for QT, HR, total peripheral resistance, and SV, respectively. Potencies (nM, %RSE within parentheses) were IC 50 = 475 (11), IC 50 = 4.01 (5.4), EC 50 = 50.6 (93), and IC 50 = 47.8 (16), and efficacies (%RSE within parentheses) were I max = 0.944 (1.7), Imax = 1.00 (1.3), E max = 0.195 (9.9), and Imax = 0.745 (4.6) for ivabradine, sildenafil, dofetilide, and pimobendan. Hill parameters were estimated with good precision and below unity, indicating a shallow concentration-response relationship. An equilibrium concentration-biomarker response relationship was predicted and displayed graphically. This analysis demonstrates the utility of a model-based approach integrating data from different studies and compounds for refined preclinical safety margin assessment. SIGNIFICANCE STATEMENT: A model-based approach was proposed utilizing biomarker data on heart rate, blood pressure, and QT-interval. A pharmacodynamic model was developed to improve assessment of high-resolution telemetric cardiovascular safety data driven by different drugs (ivabradine, sildenafil, dofetilide, and pimobondan), wherein system- (turnover rates) and drug-specific parameters (e.g., potencies and efficacies) were sought. The model-predicted equilibrium concentration-biomarker response relationships and was used for safety assessment (predictions of 20% effective concentration, for example) of heart rate, blood pressure, and QT-interval.

Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis.

PURPOSE: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). RESULTS: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. CONCLUSIONS: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.

New and emerging cardiovascular and antihypertensive drugs.

INTRODUCTION: Hypertension and cardiovascular diseases (CVD) are very common conditions and account for significant medical disability and death worldwide. Therefore, their successful management is very critical for the prevention of the significant cardiovascular and socioeconomic consequences arising from their poor management. Areas Covered: Although we have several effective cardiovascular (CV) drugs for their treatment, they are not all completely successful for the effective management of CVD and hypertension. Thus, the need for the discovery and development of new drugs is necessary. For this review, a Medline search of the English language was conducted between 2010 and June 2020 and 62 pertinent papers were retrieved. These papers contain information on newly released and emerging new cardiovascular drugs. EXPERT OPINION: These new chemical entities have different mechanisms of action and in preliminary studies have been successful in the treatment of hypertension, CVD, heart failure, stroke, and type 2 diabetes mellitus. These drugs can be used either alone or in combination with other antihypertensive and cardiovascular drugs. Hopefully, these new classes of cardiovascular drugs would be effective for the treatment of hypertension and CVD and decrease their socioeconomic consequences.

Gender Differences in the Outcomes of Drug-Coated Balloon Treatment in Symptomatic Femoropopliteal Arterial Disease.

OBJECTIVES: To assess 24-month outcome differences based on sex in symptomatic femoro-popliteal arterial disease of patients treated with drug-coated balloon (DCB). BACKGROUND: Peripheral artery disease affects over 12 million people in the United States. Drug-coated balloons have shown to be effective in treating patients with symptomatic femoropopliteal arterial occlusive disease. Debate remains regarding its safety and efficacy in female gender. We investigated the differential treatment effect between genders. METHODS: Patients (93 females and 102 males) with symptomatic femoropopliteal arterial disease treated with DCB from November 2014 to November 2015 were included in this retrospective study. We compared the resting ankle-brachial indices (ABIs) and peak systolic velocities (PSVs) by arterial duplex between the male and female patients at 6, 12, and 24 months postintervention. RESULTS: Females had significantly smaller vessels (4.70 ± 0.9, P = .02) and higher body mass index (BMI; 30.0 ± 3.7, P = .002) than males. Females had significantly decreased ABI and PSV at the 6-month (ABI: 0.90 ± 0.15, P = .05 and PSV: 188.30 ± 103.1, P = .02), 12-month (ABI: 0.86 ± 0.15, P < .0001 and PSV: 219.10 ± 100.10, P = .001), and at 24-month (ABI: 0.84 ± 0.2, P = .0001 and PSV: 251.0 ± 135.9, P < .0001) intervals when compared to males. Females had increased clinically driven target lesion revascularization (TLR) at 6 months (females = 8 vs males = 4, P = .22), 12 months (females = 12 vs males = 4, P = .02), and 24 months (females = 14 vs males = 6, P = .03). In simple logistic regression analysis, BMI, age, reference vessel diameter (RVD), and gender were strongly associated with target lesion restenosis. The final model included the above and it produced the following odds ratios (ORs): BMI (OR = 1.07, 95% confidence interval [CI]: 0.98-1.2), age (OR: 1.0, CI: 0.96-1.03), RVD (OR: 1.6, CI: 1.02-2.4), and gender (OR: 3.5, CI: 1.6-7.8). CONCLUSION: Females treated with DCBs have significantly decreased ABI, PSVs, and an increased rate of TLR than their male counterparts.

Assessment of Vascular Patency and Inflammation with Intravascular Optical Coherence Tomography in Patients with Superficial Femoral Artery Disease Treated with Zilver PTX Stents.

PURPOSE: Zilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents. METHODS: Serial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage. RESULTS: Percentage of malapposed struts decreased from 10.3 ±â€¯7.9% post-intervention to 1.1 ±â€¯2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ±â€¯4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ±â€¯19%. The average neointimal area was 7.8 ±â€¯3.8 mm2. Maximal luminal narrowing was 61.1 ±â€¯25.0%, and average luminal narrowing was 35.4 ±â€¯18.2%. Average peri-strut low-intensity area (PLIA) per strut was 0.017 ±â€¯0.018 mm2. Average number of neovessels per mm of stent was 0.138 ±â€¯0.181. Average macrophage angle per frame at follow-up was 7 ±â€¯11°. Average thrombus area at follow-up was 0.0093 ±â€¯0.0184 mm2. CONCLUSION: At 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages. SUMMARY: Thirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.

The impact of a pharmacist-driven, collaborative practice on diabetes management in an Urban underserved population: a mixed method assessment.

The objective of this manuscript is to describe the results of a pharmacist-driven, Type 2 diabetes targeted, collaborative practice within an urban, underserved federally qualified health center. Pharmacists within a primary care team managed patients with chronic illnesses utilizing a collaborative practice agreement. Pharmacists, pharmacy residents, and supervised students provided care for patients with Type 2 diabetes. The first visit incorporated past medical history, medication reconciliation, determination of adherence and patient knowledge of diabetes pathophysiology, care plan, including diet and exercise, medications, and possible complications. Pharmacists had the authority to optimize medications and order laboratory tests and referrals. Diabetes, hypertension, and medication use outcomes data were collected and analyzed to assess the impact of clinical pharmacy services. Patient and provider satisfaction were assessed via surveys and focus group interviews. Ninety-nine patients were included in the evaluation. The mean A1c level was 9.8% at baseline and 8.4% at follow-up (p< .05). There were significant improvements in patient attainment of A1c <9%, ACE Inhibitor/angiotensin receptor blocker and statin use, and tobacco cessation at follow-up (p< .05). Eleven providers who responded to the satisfaction survey answered 73% of the questions with strongly agree. The seven patients who participated in the satisfaction survey, and focus group were satisfied with the care they received from the pharmacists. The focus group highlighted similar personal goals, barriers, and interests in nutrition education. Working as part of a collaborative care team, pharmacists were able to have a significant impact on improving the health outcomes of patients with Type 2 diabetes and patient and provider perceptions of the vital role of pharmacists.

Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of In-Stent Restenosis.

OBJECTIVES: This study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR). BACKGROUND: DCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies. METHODS: This is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24 months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization. RESULTS: A total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6 months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4 ±â€¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, these parameters were 52.6 ±â€¯10% and 55.2% (IQR 49.3-58.5), respectively. In-segment LLL was 0.25 ±â€¯0.43 mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6 months, 13.3% at 12 months, and 13.3% at 24 months. CONCLUSIONS: In this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR. SUMMARY: We sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4 ±â€¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, corresponding values were 52.6 ±â€¯10% and 55.2% (IQR 49.3-58.5), respectively. The observed in-segment LLL was 0.25 ±â€¯0.43 mm and binary restenosis rate was 7.7%. TLF was 10% at 6 months and 13.3% at 12 and 24 months.

Health care utilisation and medication one year after myocardial infarction in Germany - a claims data analysis.

BACKGROUND: After myocardial infarction, guidelines recommend pharmaceutical treatment with a combination of five different types of drugs for prevention in patients. However, studies from different countries have shown that this goal is not achieved in many patients. The aim of this study was to assess both healthcare and prescribed pharmaceutical treatment in the fourth quarter after index myocardial infarction. METHODS: We conducted a claims data analysis with the data of patients who had had a myocardial infarction in the years 2013 or 2014, using information from the largest German health insurance fund ('AOK'). We analysed contact with physicians, hospital care and actual prescriptions for medication recommended in international guidelines, referring to beta-blockers, ACE inhibitors or angiotensin II receptor blockers, P2Y12-antiplatelet agents, acetylsalicylic acid and statins, one year after myocardial infarction. Analysis was stratified by age and sex, compared between patient groups and over time. RESULTS: We identified 2352 patients who had survived myocardial infarction. Some 96.9% of these participants had at least one contact with their general practitioner (GP) one year after myocardial infarction, 22.8% contacted a cardiologist and 19.7% were hospitalised. Prescription rates range from 37.8% for acetylsalicylic acid to 70.4% for ACE inhibitors. However, only 24.1% received statins, beta-blockers, ACE inhibitors and an antiplatelet drug simultaneously. Prescription of recommended drugs after myocardial infarction decreased steadily over time. DISCUSSION: Long-term medical prevention after myocardial infarction is improvable. GPs should take care of the pharmaceutical prevention after myocardial infarction as they are the physicians seen most intensively in this period.

Ivabradine drug utilization study in five European countries: A multinational, retrospective, observational study to assess effectiveness of risk-minimization measures.

PURPOSE: This drug utilization study of ivabradine evaluated prescriber compliance with the new risk minimization measures (RMMs), communicated starting 2014 following preliminary results from the SIGNIFY study. METHODS: This was a multinational (five European countries) chart review study with two study periods: pre-RMM and post-RMM. Patients initiating ivabradine for chronic stable angina pectoris in routine clinical practice were identified across general practitioners and specialists. The primary outcome analysis evaluated the compliance with the new RMMs, ie, use in patients with a heart rate greater than or equal to 70 bpm at initiation, no doses higher than those recommended in the summary of product characteristics (SmPC) at initiation and during 6 months of follow-up, and no concomitant use of verapamil or diltiazem. RESULTS: Overall, 711 and 506 eligible patients were included in the pre-RMM and post-RMM periods, respectively. The percentage of patients prescribed ivabradine according to the new RMMs increased significantly in the post-RMM period (70.6% and 78.4% in the pre- and post-RMM periods respectively; P value = .0035). The compliance to RMMs increased for all the criteria assessed independently: the proportions of patients with (a) heart rate ≥ 70 bpm at initiation (79.4% and 85.2%, respectively; P value = .0141), (b) no dose higher than the SmPC doses at initiation and during follow-up (92.8% and 94.1%, respectively; P value = .3957), and (c) no concomitance with verapamil or diltiazem (96.1% and 99.2%, respectively; P value = .0007). CONCLUSIONS: The RMMs for ivabradine were well implemented across the five participating European countries confirming a favorable benefit-risk balance of ivabradine in chronic stable angina pectoris.

Impact of Race and Ethnicity on the Clinical and Angiographic Characteristics, Social Determinants of Health, and 1-Year Outcomes After Everolimus-Eluting Coronary Stent Procedures in Women.

Background The impact of race/ethnicity on coronary stent outcomes in women is unknown. We compared baseline characteristics, social determinants of health, and 1-year outcomes in female African Americans (AA) and Hispanic/Latinas (HL) versus white women after coronary everolimus-eluting stent implantation in all-comer patients. Methods and Results We pooled 1863 women from the PLATINUM Diversity (n=1057 women) and PROMUS ELEMENT PLUS (n=806 women) postapproval studies, with some overlap in study sites. Social determinants of health data were only available for PLATINUM Diversity. The primary end point was 1-year major adverse cardiac events (death, myocardial infarction, or target vessel revascularization). Outcomes were risk adjusted using multivariate Cox regression. The study sample comprised 1417 white (76.1%, reference group), 296 AA (15.9%), and 107 HL (5.7%) women. AA were older, and both AA and HL had more diabetes mellitus and hypertension than white women. AA had larger reference vessel diameters but less lesion calcification, whereas HL had less lesion tortuosity but more calcification. Compared with white women, there was a trend toward higher unadjusted 1-year major adverse cardiac events in AA (12.0% versus 8.0%; P=0.06) but similar rates in HL (11.0% versus 8.0%; P=0.32), and after risk adjustment, there were no differences (AA women: hazard ratio, 1.47; 95% CI, 1.00-2.17; HL women: hazard ratio, 1.33; 95% CI, 0.71-2.44). AA had a 3-fold higher adjusted risk of 1-year myocardial infarction (hazard ratio, 3.45; 95% CI, 1.72-7.14; P=0.01) and increased risk of target vessel revascularization (hazard ratio, 1.82; 95% CI, 1.10-2.94; P=0.02). Independent predictors of major adverse cardiac events included renal disease, prior myocardial infarction, silent ischemia, history of stroke, and multivessel disease. Conclusions Race and ethnicity confer heterogeneity in women undergoing everolimus-eluting stent implantation. Despite more comorbidities and less favorable social determinants of health, AA and HL women have similar 1-year major adverse cardiac events to white women, although AA women seem to have a higher risk of 1-year myocardial infarction. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02240810.

Cardiac massage for trauma patients in the battlefield: An assessment for survivors.

INTRODUCTION: Survival from traumatic cardiopulmonary arrest (TCA) has been reported at a rate as low as 0-2.6% in the civilian pre-hospital setting, and many consider resuscitation of this group to be futile. The aim of this investigation was to describe patients who received cardiac massage during TCA in a battlefield setting; we also aimed to identify predictors of survival. METHODS: We conducted a review of the Department of Defense Trauma Registry to identify patients who received cardiac massage in the battlefield between 2007 and 2014. Patients were also grouped according to location of cardiac arrest: pre-hospital (PH) and in-hospital (IH). The groups were compared and evaluated by injury, transport time, type of resuscitation, and pre-hospital procedures. Outcome variables included survival to discharge and 30-day survival. Categorical variables were analysed using chi-square or Fisher's exact tests. Wilcoxon tests were performed for continuous variables. Regression modelling was used to assess for predictors of survival. RESULTS: 75 of all 582 patients (13%, 95% CI 10-16) survived to 30 days, and all survivors were transported out of the battlefield; 23 PH (7.8%, 95% CI 5.2-12) and 52 IH (17%, 95% CI 13-22) patients survived to 30 days (p < 0.001). Closed-chest cardiac massage with the administration of intravenous medications was associated with 30-day survival among IH patients. CONCLUSIONS: We report a 13% survival to 30 days among all patients receiving cardiac massage in a battlefield setting. Closed-chest cardiac massage predicted survival among IH TCA victims who also received intravenous medications in this review of combat-related TCA.

Assessment of strut coverage of everolimus-eluting platinum chromium stent 2 weeks after implantation by optical coherence tomography.

The SYNERGY coronary stent is new-generation drug-eluting stents, which has a thin-strut platinum-chromium platform with everolimus in a biodegradable polymer applied to the abluminal surface. It would be speculated that favorable arterial healing with early strut coverage could be achieved. The present study investigated the degree of strut coverage using optical coherence tomography (OCT) 2 weeks after SYNERGY implantation and clinical factors contributing to strut coverage. A total of 29 patients who underwent staged percutaneous coronary intervention (PCI) to residual lesions 2 weeks after the index PCI with SYNERGY stent implantation were enrolled. At the time of staged PCI, OCT examinations of the SYNERGY stent were performed for conventional OCT analysis on both cross-sectional and strut level. SYNERGY stent showed a high level of strut coverage and apposition, and the percentage was 82.4 ± 12.4% and 96.2 ± 5.0%, respectively. The lesion complexity was significantly related to greater strut coverage on univariate analysis; however, it was found to be insignificant in multivariate analysis. Our findings suggest early arterial healing after SYNERGY stent implantation.

[Generic medicinal products: if you know them, you do not avoid them]. / I medicinali equivalenti: se li conosci non li eviti...

Although equivalent (generic) medicinal products have been introduced in the Italian market since decades, Italy is still among the latest for prescription of equivalent medicinal products. Several reasons may explain this behavior such as a scant familiarity with equivalent medicinal products, a general skepticism toward "not branded-named" medications and an "indolent laziness" both by specialists and general practitioners. Yet, the wider use of the generic drug could: (i) save economical resources for the National and Regional Health Services and allow to allocate them in clinical research and development of new therapies; (ii) reduce the economic burden for the patients by saving the brand drug-related co-payments, especially if they are on polytherapy. Moreover, given that current resources for our health system are limited, preferring drug with expired patent should be an "ethical" issue and a mandatory duty. The purpose of this brief review is to propose a concise but exhaustive analysis on equivalent medicinal products, in order to clarify still existing doubts and to remove remaining cultural obstacles to their use, if any, in the field of clinical cardiology.

Assessment of adherence to medication for cardiovascular diseases: measurement tools.

The effectiveness of treatment and prevention of chronic illnesses can be optimised with adherence to medication treatment. This is very often assessed by means of a self-report. However, the challenge here is to choose the most suitable questionnaire or the one that is best overall in a given situation. The aim of this systematic review was to assess existing self-reported medication adherence scales, which measure adherence to treatment for cardiovascular disease. The review demonstrated that relatively few disease-specific adherence scales exist. Generic questionnaires and those specific to adherence to hypertension treatment are the most numerous. Questionnaires specifically measuring adherence to anti-haemorrhage treatment for atrial fibrillation are particularly necessary and noticeably absent. The two most important aspects that need to be taken into account when selecting the most appropriate scale in a given context are the subject of the measurement (what) and the method of validation (how).

Comparison of Different Strategies to Measure Medication Adherence via Claims Data in Patients With Chronic Heart Failure.

Medication adherence correlates with morbidity and mortality in patients with chronic heart failure (CHF), but is difficult to assess. We conducted a retrospective methodological cohort study in 3,808 CHF patients, calculating adherence as proportion of days covered (PDC) utilizing claims data from 2010 to 2015. We aimed to compare different parameters' influence on the PDC of elderly CHF patients exemplifying a complex chronic disease. Investigated parameters were the assumed prescribed daily dose (PDD), stockpiling, and periods of hospital stay. Thereby, we investigated a new approach using the PDD assigned to different percentiles. The different dose assumptions had the biggest influence on the PDC, with variations from 41.9% to 83.7%. Stockpiling and hospital stays increased the values slightly. These results queries that a reliable PDC can be calculated with an assumed PDD. Hence, results based on an assumed PDD have to be interpreted carefully and should be presented with sensitivity analyses to show the PDC's possible range.

Burden of medical co-morbidities and benefit from surgical revascularization in patients with ischaemic cardiomyopathy.

AIMS: The landmark STICH trial found that surgical revascularization compared to medical therapy alone improved survival in patients with heart failure (HF) of ischaemic aetiology and an ejection fraction (EF) ≤ 35%. However, the interaction between the burden of medical co-morbidities and the benefit from surgical revascularization has not been previously described in patients with ischaemic cardiomyopathy. METHODS AND RESULTS: The STICH trial (ClinicalTrials.gov Identifier: NCT00023595) enrolled patients ≥ 18 years of age with coronary artery disease amenable to coronary artery bypass grafting (CABG) and an EF ≤ 35%. Eligible participants were randomly assigned 1:1 to receive medical therapy (MED) (n = 602) or MED/CABG (n = 610). A modified Charlson co-morbidity index (CCI) based on the availability of data and study definitions was calculated by summing the weighted points for all co-morbid conditions. Patients were divided into mild/moderate (CCI 1-4) and severe (CCI ≥ 5) co-morbidity. Cox proportional hazards models were used to evaluate the association between CCI and outcomes and the interaction between severity of co-morbidity and treatment effect. The study population included 349 patients (29%) with a mild/moderate CCI score and 863 patients (71%) with a severe CCI score. Patients with a severe CCI score had greater functional limitations based on 6-min walk test and impairments in health-related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire. A total of 161 patients (Kaplan-Meier rate = 50%) with a mild/moderate CCI score and 579 patients (Kaplan-Meier rate = 69%) with a severe CCI score died over a median follow-up of 9.8 years. After adjusting for baseline confounders, patients with a severe CCI score were at higher risk for all-cause mortality (hazard ratio 1.44, 95% confidence interval 1.19-1.74; P < 0.001). There was no interaction between CCI score and treatment effect on survival (P = 0.756). CONCLUSIONS: More than 70% of patients had a severe burden of medical co-morbidities at baseline, which was independently associated with increased risk of death. There was not a differential benefit of surgical revascularization with respect to survival based on severity of co-morbidity.

Health Economic Evaluation of an Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Compared to a Thin, Durable-Polymer Everolimus-Eluting Stent.

OBJECTIVES: The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating. BACKGROUND: The recent BIOFLOW V trial, an international FDA approval trial (ClinicalTrials.gov: NCT02389946), has shown that an ultrathin, bioresorbable polymer sirolimus-eluting stent had a significantly lower rate of target lesion failure and target vessel-related myocardial infarction than a thin, durable polymer everolimus-eluting stent at 12 months, driven by a lower rate of peri-procedural myocardial infarction (ppMI). METHODS: We used a Markov model to project mortality and cost outcomes of that lower ppMI rate from a U.S. health system perspective over a 12-month horizon. Model parameters were derived from BIOFLOW V trial data, a systematic literature review and expert interviews. RESULTS: Use of the bioresorbable polymer sirolimus-eluting stent compared to durable polymer everolimus-eluting stent is associated with net reductions in medical cost of $124 (Interquartile Range (IQR) $97-154) per patient in 2018 US$, of which $115 (IQR $76-124) accrues to the initial admission and $10 (IQR $7-72) to cost of follow-up. The lower rate of ppMI translates into a gain of 0.000017 (IQR 0.000011-0.000022) quality-adjusted life-years (QALY) per patient. CONCLUSIONS: Lower ppMI rates of bioresorbable polymer sirolimus-eluting stent translate into reductions in direct medical cost, while improving patient outcomes. Most of the cost reduction is attributed to the initial admission with moderate savings up to 12 months post-discharge.

Small-vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus-eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post-Approval studies.

OBJECTIVE: We evaluated 1-year outcomes after platinum chromium everolimus-eluting stents (PtCr-EES) in small versus non-small coronary arteries within a large, diverse sample of men, women, and minorities. BACKGROUND: There exists limited outcomes data on the use of second-generation drug-eluting stent to treat small diameter coronary arteries. METHODS: We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small-vessel percutaneous coronary intervention (SV-PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk-adjust outcomes. RESULTS: We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small-vessel PCI. SV-PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81-1.30) or TVF (adjHR 1.07; 95%CI 0.82-1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV-PCI (adjHR 0.41; 95%CI 0.23-0.74 and adjHR 0.39; 95%CI 0.20-0.75, respectively) and for non-SV-PCI (adjHR 0.61; 95%CI 0.38-0.99 and adjHR 0.45; 95%CI 0.27-0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. CONCLUSION: In a large diverse contemporary PCI outcomes database, SV-PCI with PtCr-EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.