The trials and tribulations of percutaneous coronary intervention in hospitals without on-site CABG surgery.
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ABSTRACT:
SUBMITTER: Kinlay S
PROVIDER: S-EPMC4504239 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC11307489 | biostudies-literature
Project description:BackgroundPrior registry data suggest that 4%-20% of patients require noncardiac surgery (NCS) within 2 years of percutaneous coronary intervention (PCI). Contemporary data on NCS after PCI in the United States among women and men are limited. We determined the rate of early hospital readmission for NCS and associated outcomes in a large cohort of patients who underwent PCI in the United States.MethodsAdults undergoing PCI between January 1 and June 30, 2014, were identified from the Nationwide Readmission Database. Patients readmitted for NCS within 6 months of PCI were identified. Outcomes of interest were in-hospital death, myocardial infarction (MI), and bleeding defined by International Classification of Diseases, Ninth Revision, codes.ResultsAmong 221,379 patients who underwent PCI and survived to hospital discharge, 3.5% (n = 7,696) were readmitted for NCS within 6 months post-PCI, and 41% of these hospitalizations were elective. Early NCS was complicated by MI in 4.7% of cases, and 21% of perioperative MIs were fatal. Bleeding was recorded in 32.0% of patients. All-cause mortality occurred in 4.4% of patients (n = 339) readmitted for surgery. The risk of death or MI was greatest when NCS was performed within the first month after PCI.ConclusionsDespite clear guidelines to avoid surgery early after PCI, NCS was performed in 1 of every 29 patients with recent PCI, corresponding to as many as ~30,000 patients each year nationwide. Surgical mortality and perioperative MI were high in this setting. Strategies to minimize perioperative thrombotic and bleeding risks during readmission for NCS after PCI are necessary.
| S-EPMC6861674 | biostudies-literature
Project description:BackgroundCoronary angioplasty has been replacing coronary artery bypass grafting (CABG) because of the relative advantage in terms of recovery time and noninvasiveness of the procedure. Compared to other Organization for Economic Cooperation and Development (OECD) countries, Korea has experienced a rapid increase in coronary angioplasty volumes.MethodsWe analyzed changes in procedure volumes of CABG and of percutaneous coronary intervention (PCI) from three sources: the OECD Health Data, the National Health Insurance Service (NHIS) surgery statistics, and the National Health Insurance claims data.ResultsWe found the ratio of procedure volume of PCI to that of CABG per 100,000 population was 19.12 in 2014, which was more than triple the OECD average of 5.92 for the same year. According to data from NHIS statistics, this ratio was an increase from 11.4 to 19.3 between 2006 and 2013.ConclusionWe found that Korea has a higher ratio of total procedure volumes of PCI with respect to CABG and also a more rapid increase of volumes of PCI than other countries. Prospective studies are required to determine whether this increase in absolute volumes of PCI is a natural response to a real medical need or representative of medical overuse.
| S-EPMC5173333 | biostudies-literature
Project description:Left main stem (LMS) disease is associated with significant morbidity and mortality. Traditionally coronary artery bypass grafting (CABG) has been the gold standard for treatment of these lesions. However over the past decade, percutaneous coronary intervention (PCI) has assumed a more prominent role in the treatment of LMS disease. With the advent of newer drug-eluting stents (DES) with an improved risk factor profile, better intravascular imaging modalities and careful patient selection, the use of PCI in this cohort is expanding. We review the current data to support this and discuss the on-going trials that will hopefully shed more light into the management of this complex disease.
| S-EPMC5808470 | biostudies-literature
Project description:ImportanceDespite a rapid increase in percutaneous coronary intervention (PCI) procedures in China, little is known about patient-reported health status before and after PCI in patients without acute myocardial infarction (AMI).ObjectiveTo describe self-perceived angina-specific health status prior to PCI and 1 year after the procedure in patients without AMI in China.Design, setting, and participantsThe China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI was a population-based, multicenter cohort study of a consecutive sample of 1611 patients without AMI undergoing elective PCI. Participants were enrolled from 40 hospitals in 18 provinces in China from December 2012 to August 2014. Participants were eligible if they underwent PCI for stable and unstable angina and did not have AMI. Participants were excluded if they died in hospital, withdrew from follow-up, or had missing data on self-reported health status at baseline or at 1 year after PCI. The date of the analysis was September 15, 2018.ExposuresPercutaneous coronary intervention for ischemic heart disease.Main outcomes and measuresAngina frequency and angina-related quality of life were assessed with the Seattle Angina Questionnaire (SAQ) immediately prior to PCI and 1 year after the procedure. Either (1) an increase in the SAQ Angina Frequency score of 10 or more points or (2) an increase in the SAQ Quality-of-Life score of 10 or more points was considered to represent clinically significant improvement.ResultsOf 1611 patients, 520 (32.3%) were women; mean (SD) age was 61.3 (9.8) years. Among these patients, 443 (27.5%) had stable coronary artery disease and 1168 (72.5%) had unstable angina. One hundred fourteen of 443 patients undergoing PCI for stable coronary artery disease (25.7%) and 175 of 1168 undergoing PCI for unstable angina (15.0%) had no reported angina symptoms at the time of the procedure (SAQ Angina Frequency score = 100). Moreover, 18% of all patients (290) had minimal angina symptoms (SAQ Angina Frequency score >90) and, thus, no potential for substantial clinical improvement. Patients with smaller clinical improvements in angina symptom burden at 1 year following PCI had significantly higher baseline SAQ scores for all scales than patients with greater clinical improvement, but generally similar sociodemographic and procedural characteristics.Conclusions and relevanceIn this study, 25.7% of patients undergoing PCI for stable coronary artery disease had no reported angina symptoms at the time of the procedure. Patients with smaller clinical improvements in angina symptom burden had higher baseline SAQ scores, which highlights the importance of ascertaining impairment from angina among patients without AMI prior to performing PCI.
| S-EPMC6324328 | biostudies-literature
Project description:BACKGROUND:The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies. METHODS:A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness. RESULTS:Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400-1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful. CONCLUSIONS:Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.
| S-EPMC7074513 | biostudies-literature
Project description:Percutaneous coronary intervention (PCI), especially coronary stent implantation, has been shown to be an effective treatment for coronary artery disease. However, in-stent restenosis is one of the longstanding unsolvable problems following PCI. Although stents implanted inside narrowed vessels recover normal flux of blood flows, they instantaneously change the wall shear stress (WSS) distribution on the vessel surface. Improper stent implantation positions bring high possibilities of restenosis as it enlarges the low WSS regions and subsequently stimulates more epithelial cell outgrowth on vessel walls. To optimize the stent position for lowering the risk of restenosis, we successfully established a digital three-dimensional (3-D) model based on a real clinical coronary artery and analysed the optimal stenting strategies by computational simulation. Via microfabrication and 3-D printing technology, the digital model was also converted into in vitro microfluidic models with 3-D micro channels. Simultaneously, physicians placed real stents inside them; i.e., they performed "virtual surgeries". The hydrodynamic experimental results showed that the microfluidic models highly inosculated the simulations. Therefore, our study not only demonstrated that the half-cross stenting strategy could maximally reduce restenosis risks but also indicated that 3-D printing combined with clinical image reconstruction is a promising method for future angiocardiopathy research.
| S-EPMC4455241 | biostudies-literature
Project description:BACKGROUND:Assessments of healthcare value have largely focused on measuring outcomes of care at a given level of cost with less attention paid to appropriateness. However, understanding how appropriateness relates to outcomes and costs is essential to determining healthcare value. METHODS AND RESULTS:In a retrospective cohort study design, administrative data from fee-for-service Medicare patients undergoing percutaneous coronary intervention (PCI) in Michigan hospitals between June 30, 2010, and December 31, 2014, were linked with clinical data from a statewide PCI registry to calculate hospital-level measures of (1) appropriate use criteria scores, (2) 90-day risk-standardized readmission and mortality rates, and (3) 90-day risk-standardized episode costs. We then used Spearman correlation coefficients to assess the relationship between these measures. A total of 29 839 PCIs were performed at 33 PCI hospitals during the study period. A total of 13.3% were for ST-segment-elevation myocardial infarction, 25.0% for non-ST-segment-elevation myocardial infarction, 47.1% for unstable angina, 9.8% for stable angina, and 4.7% for other. The overall hospital-level mean appropriate use criteria score was 8.4±0.2. Ninety-day risk-standardized readmission occurred in 23.7%±3.7% of cases, 90-day risk-standardized mortality in 4.3%±0.6%, and mean risk-standardized episode costs were $26 159±$1074. Hospital-level appropriate use criteria scores did not correlate with 90-day readmission, mortality, or episode costs. CONCLUSIONS:Among Medicare patients undergoing PCI in Michigan, we found hospital-level appropriate use criteria scores did not correlate with 90-day readmission, mortality, or episode costs. This finding suggests that a comprehensive understanding of healthcare value requires multidimensional consideration of appropriateness, outcomes, and costs.
| S-EPMC7053780 | biostudies-literature
Project description:Fibrolase is the fibrinolytic enzyme isolated from Agkistrodon contortrix contortrix (southern copperhead snake) venom. The enzyme was purified by a three-step HPLC procedure and was shown to be homogeneous by standard criteria including reverse phase HPLC, molecular sieve chromatography and SDS-PAGE. The purified enzyme is a zinc metalloproteinase containing one mole of zinc. It is composed of 203 amino acids with a blocked amino-terminus due to cyclization of the terminal Gln residue. Fibrolase shares a significant degree of homology with enzymes of the reprolysin sub-family of metalloproteinases including an active site homology of close to 100%; it is rapidly inhibited by chelating agents such as EDTA, and by alpha2-macroglobulin (?2?). The enzyme is a direct-acting thrombolytic agent and does not rely on plasminogen for clot dissolution. Fibrolase rapidly cleaves the A(?)-chain of fibrinogen and the B(?)-chain at a slower rate; it has no activity on the ?-chain. The enzyme exhibits the same specificity with fibrin, cleaving the ?-chain more rapidly than the ?-chain. Fibrolase was shown to have very effective thrombolytic activity in a reoccluding carotid arterial thrombosis model in the canine. A recombinant version of the enzyme was made in yeast by Amgen, Inc. (Thousand Oaks, CA, USA) and called alfimeprase. Alfimeprase is identical to fibrolase except for a two amino acid truncation at the amino-terminus and the insertion of a new amino-terminal amino acid in the truncated protein; these changes lead to a more stable enzyme for prolonged storage. Alfimeprase was taken into clinical trials by Nuvelo, Inc. (San Carlos, CA), which licensed the enzyme from Amgen. Alfimeprase was successful in Phase I and II clinical trials for peripheral arterial occlusion (PAO) and central venous access device (CVAD) occlusion. However, in Phase III trials alfimeprase did not meet the expected end points in either PAO or CVAD occlusion and in a Phaase II stroke trial, and Nuvelo dropped further development in 2008.
| S-EPMC3153196 | biostudies-literature
Project description: Not available
| S-EPMC1768265 | biostudies-literature