Elective Percutaneous Coronary Intervention in Ambulatory Surgery Centers

ObjectivesThe aim of this study was to explore characteristics and outcomes of patients undergoing elective percutaneous coronary intervention (PCI) in ambulatory surgery centers (ASCs).BackgroundLittle is known about patients who underwent ASC PCI before Medicare reimbursement was instituted in 2020.MethodsUsing commercial insurance claims from MarketScan, adults who underwent hospital outpatient department (HOPD) or ASC PCI for stable ischemic heart disease from 2007 to 2016 were studied. Propensity score analysis was used to measure the association between treatment setting and the primary composite outcome of 30-day myocardial infarction, bleeding complications, and hospital admission.ResultsThe unmatched sample consisted of 95,492 HOPD and 849 ASC PCIs. Patients who underwent ASC PCI were more likely to be younger than 65 years, to live in the southern United States, and to have managed or consumer-driven health insurance. ASC PCI was also associated with decreased fractional flow reserve utilization (odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.20 to 0.48; p < 0.001). In unmatched, multivariate analysis, ASC PCI was associated with increased odds of the primary outcome (OR: 1.25; 95% CI: 1.01 to 1.56; p = 0.039) and bleeding complications (OR: 1.80; 95% CI: 1.11 to 2.90; p = 0.016). In propensity-matched analysis, ASC PCI was not associated with the primary outcome (OR: 1.23; 95% CI: 0.94 to 1.60; p = 0.124) but was significantly associated with increased bleeding complications (OR: 2.49; 95% CI: 1.25 to 4.95; p = 0.009).ConclusionsCommercially insured patients undergoing ASC PCI were less likely to undergo fractional flow reserve testing and had higher odds of bleeding complications than HOPD-treated patients. Further study is warranted as Medicare ASC PCI volume increases.     

Safety of Enoxaparin versus Unfractionated Heparin during Percutaneous Coronary Intervention

We sought to determine the safety and efficacy of enoxaparin versus unfractionated heparin during percutaneous coronary intervention (PCI). Four hundred ninety-three consecutive patients undergoing elective or emergency PCI received unfractionated heparin (70 U/kg, intravenously) or enoxaparin (1 mg/kg, intravenously). Patients who had received subcutaneous enoxaparin in the emergency department were given a supplementary 0.3-mg/kg intravenous dose. There was no crossover of therapies. All patients received oral antiplatelet therapy and eptifibatide. Primary safety outcomes were bleeding and a postprocedural hemoglobin decrease of ≥3 g/dL. Troponin I levels were considered a marker for myocardial injury.Two hundred twenty-two patients received enoxaparin, and 271 received unfractionated heparin. There were no thrombotic events or in-hospital deaths. Multivariate logistic regression analysis showed that, compared with unfractionated heparin, enoxaparin yielded a lower risk of bleeding (odds ratio [OR]=0.47; 95% confidence interval [CI], 0.21–1.05) and significantly fewer >3-g/dL decreases in hemoglobin (OR=0.45; 95% CI, 0.22–0.94). Enoxaparin also produced less of a decrease in mean platelet count (41 ± 34 vs 55 ± 63 ×10⁹/L; P = 0.02) and in platelets >30% from baseline (OR=0.56; 95% CI, 0.31–0.99). After elective PCI, fewer enoxaparin patients had troponin I levels ≥3 times the upper limit of normal (OR=0.40; 95% CI, 0.028–0.66).Compared with unfractionated heparin, enoxaparin entailed less bleeding during both elective and emergent PCI and less cardiac enzyme elevation in patients undergoing elective PCI. Therefore, we believe that intravenous enoxaparin is a safe alternative to unfractionated heparin in both settings.Key words: Angioplasty, transluminal, percutanous coronary; anticoagulants; enoxaparin/therapeutic use; catheterization; heparin/therapeutic use; heparin, low-molecular-weight; heparin, unfractionated; treatment outcomeUnfractionated heparin (UFH), a mainstay of antithrombotic therapy during percutaneous coronary intervention (PCI), is usually adjusted on the basis of the patient''s activated clotting time (ACT). However, UFH has numerous well-recognized limitations: its difficulty in achieving reliable levels of anticoagulation, because of its higher degree of protein binding; its inactivation by platelet factor 4; its tendency toward platelet activation¹; and its risk of heparin-induced thrombocytopenia.² The narrow therapeutic index of UFH has been revealed in numerous studies in which almost two thirds of UFH recipients did not reach therapeutic levels within the first 12 hours of treatment^3,4 and only about half of the patients were within the therapeutic range at any given time. In contrast, low-molecular-weight heparin (LMWH) has been shown to provide more reliable anticoagulation, to release less von Willebrand factor,⁵ and to have a minimal effect on platelet activation.¹Enoxaparin, an LMWH, has emerged as an important tool in the antithrombotic management of patients who present with acute coronary syndromes (ACSs); and randomized, controlled trials have shown this agent to be superior to UFH.^6–8 In the United States, the American College of Cardiology and American Heart Association (ACC/AHA) guidelines⁹ give both enoxaparin and UFH a Class IA recommendation for use in patients with non–ST-segment-elevation myocardial infarction (NSTEMI). In contemporary practice, early invasive management has been shown to be superior to a conservative approach in treating both high-risk^10–12 and medium-risk ACS patients.¹³ Consequent to the more widespread use of LMWH in ACS patients, interventional cardiologists are more likely to encounter patients in the cardiac catheterization laboratory who already have received subcutaneous or intravenous LMWH.The current study compares intravenous enoxaparin with UFH as an anticoagulant agent during elective and emergent PCI.     

经皮冠状动脉介入治疗术后阿司匹林应用剂量的研究进展

自冠状动脉支架应用于临床以来,经皮冠状动脉介入治疗后阿司匹林的剂量一直是人们争论的问题.国外多项大规模的临床研究表明：经皮冠状动脉介入治疗后服用小剂量阿司匹林（75-100 mg/d）、较大剂量阿司匹林（≥300 mg/d）并不增加不良心血管事件,而且明显减少出血并发症.我们对中国人经皮冠状动脉介入治疗术后阿司匹林不同剂量的有效性和安全性研究较少,有待国内展开大规模的临床试验,为临床合理用药提供循证依据.     

A Randomized Trial of Creatine‐kinase Leak After Rosuvastatin in Elective Percutaneous Coronary Intervention (CLEAR‐PCI)

Objectives

To determine the impact of percutaneous coronary intervention (PCI) performed at the same time of the peak concentration of rosuvastatin to reduce periprocedural myocardial infarction (PMI).

Background

Prior studies suggest that a high dose of statin before PCI reduce periprocedural myocardial infarction. However, there is no information regarding the elective PCI performed at the time of the peak of statin concentration to reduce PMI.

Methods

From 2001 to 2013, at a single center in Brazil we enrolled 544 patients who underwent elective PCI and after exclusions for baseline biases in clinical and angiographic characteristics, yielding 528 patients, we prospectively randomly assigned them to either a high loading dose of Rosuvastatin before PCI (n = 264) or standard treatment (n = 264). After exclusions for biases in procedural characteristics a total of 487 patients underwent to end points analysis. The primary outcome was the incidence of MB fraction of creatine kinase (CK‐MB) greater than three times the upper limit of normal.

Results

The primary end point occurred in 7.6% in the rosuvastatin and 4.8% in the control group (P = 0.200). There was a higher incidence in elevation of CK‐MB than normal baseline in the rosuvastatin (67.1% vs 59.2%, P = 0.701). There was no difference in major adverse event (0% in the rosuvastatin group vs 0.8% in control).

     

Overcoming Aspirin Resistance with Loading Clopidogrel Earlier in Elective Percutaneous Coronary Intervention

We aimed to analyze the clinical effect of clopidogrel loading time on adverse cardiovascular events among patients with aspirin resistance. Recurrent adverse events may still occur despite dual antiplatelet therapy after coronary stenting. Aspirin resistance is one of the possible reasons of this trouble. Optimal antiplatelet strategy for coronary stenting is unknown among patients with aspirin resistance. A total of 980 patients scheduled for elective coronary stenting were enrolled and allocated into two groups according to the loading time of clopidogrel more or less than 6 hours before coronary intervention (early- or late-loaded groups, respectively). Aspirin resistance was determined according to the urinary levels of 11-dehydrothromboxane B2. Overall 240 patients who were allocated to early- and late-loaded groups were identified as aspirin resistant according to the urinary levels of 11-dehydrothromboxane B2. After a follow-up period of 12 months major adverse cardiac events were observed among 16 patients (13.9%) in the early-loaded group and 30 patients (25.8%) in the late-loaded group (p = 0.02). Early loading of clopidogrel was an independent predictor of lower rate of cardiac events (hazard ratio = 0.46 [0.32–0.76, 95% confidence interval], p = 0.001). The rates of bleeding events and periprocedural myocardial infarction were similar in early- and late-loaded groups. The current study demonstrated that loading of clopidogrel earlier than 6 hours before elective coronary stenting among aspirin-resistant patients was associated with increased benefits for ischemic events with similar bleeding rates.     

Low Molecular Weight Heparin Therapy for Percutaneous Coronary Intervention: A Practice in Evolution

Unfractionated heparin (UFH) remains the principal antithrombotic agent during percutaneous coronary intervention (PCI) but is associated with significant limitations including an unpredictable anticoagulation dose response, the requirement for frequent monitoring, and transient rebound hypercoagulability. Low molecular weight heparin (LMWH) represents an attractive alternative due to its predictable dose response relationship, superior antithrombotic efficacy and potential for improved clinical safety, and has been used increasingly in patients with acute coronary syndromes prior to coronary angiography. The rationale and existing data regarding the use of LMWH in PCI is summarized and reviewed. Preliminary clinical guidelines for the use of LMWH in the transition from medical stabilization of patients with acute coronary syndromes to invasive management in the catheterization laboratory are presented.     

Same-Day Discharge After Elective Percutaneous Coronary Intervention: Insights From the British Cardiovascular Intervention Society

ObjectivesThe aim of this study was to evaluate national temporal trends in same-day discharge (SDD) and compare clinical outcomes with those among patients admitted for overnight stay undergoing elective percutaneous coronary intervention (PCI) for stable angina.BackgroundOvernight observation has been the standard of care following PCI, with no previous national analyses around changes in practice or clinical outcomes from health care systems in which SDD is the predominant practice for elective PCI.MethodsData from 169,623 patients undergoing elective PCI between 2007 and 2014 were obtained from the British Cardiovascular Intervention Society registry. Multiple logistic regressions and the British Cardiovascular Intervention Society risk model were used to study the association between SDD and 30-day mortality.ResultsThe rate of SDD increased from 23.5% in 2007 to 57.2% in 2014, with center SDD median prevalence varying from 17% (interquartile range: 6% to 39%) in 2007 to 66% (interquartile range: 45% to 77%) in 2014. The largest independent association with SDD was observed for radial access (odds ratio: 1.69; 95% confidence interval: 1.65 to 1.74; p < 0.001). An increase in 30-day mortality rate over time for the SDD cases was observed, without exceeding the predicted mortality risk. According to the difference-in-differences analysis, observed 30-day mortality temporal changes did not differ between SDD and overnight stay (odds ratio: 1.15; 95% confidence interval: 0.294 to 4.475; p = 0.884).ConclusionsSDD has become the predominant model of care among elective PCI cases in the United Kingdom, in increasingly complex patients. SDD appears to be safe, with 30-day mortality rates in line with those calculated using the national risk prediction score used for public reporting. Changes toward SDD practice have important economic implications for health care systems worldwide.     

术前血浆D-二聚体含量对择期经皮冠状动脉介入治疗术后心肌损伤的预测价值

目的:探讨经皮冠状动脉介入治疗术前血浆D-二聚体含量对术后心肌损伤的预测价值.方法:68例择期行经皮冠状动脉介入治疗的患者,根据术后12～24 h肌钙蛋白Ⅰ(cTnI)是否≥1.0 ng/ml而分为肌钙蛋白阳性组及肌钙蛋白阴性组.采用酶联免疫吸附法测定手术前、后血浆D-二聚体含量,并进行两组间的比较.结果:肌钙蛋白阳性组血浆D-二聚体含量术后即刻及术后12～24 h均高于术前(P＜0.05),在各时间点的血浆D-二聚体含量均高于肌钙蛋白阴性组(P＜0.05).多变量逐步Logistic回归分析表明术前及术后即刻血浆D-二聚体含量、术前血管狭窄程度是术后cTnI升高的独立预测指标(P＜0.05).ROC曲线分析显示预测术后cTnI升高的最佳界值为术前血浆D-二聚体含量≥0.345 mg/L.结论:术前血浆D-二聚体含量是术后心肌损伤的独立预测因素,术前血浆D-二聚体含量≥0.345 mg/L者应视为术后cTnI升高的高危患者.     

Trends in Use and Outcomes of Same-Day Discharge Following Elective Percutaneous Coronary Intervention

ObjectivesThe aims of this study were to describe trends and hospital variation in same-day discharge following elective percutaneous coronary intervention (PCI) and to evaluate the association between trends in same-day discharge and patient outcomes.BackgroundInsights on contemporary use of same-day discharge following elective PCI are limited.MethodsIn a sequential cross-sectional analysis of 819,091 patients undergoing elective PCI at 1,716 hospitals in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009, to December 31, 2017, overall and hospital-level trends in same-day discharge were assessed. Among the 212,369 patients who linked to Centers for Medicare and Medicaid Services data, the association between same-day discharge and 30-day mortality and rehospitalization was assessed.ResultsA total of 114,461 patients (14.0%) were discharged the same day as PCI. The proportion of patients with same-day discharge increased from 4.5% in the third quarter of 2009 to 28.6% in the fourth quarter of 2017. From 2009 to 2017, the rate of same-day discharge increased from 4.3% to 19.5% for femoral-access PCI and from 9.9% to 39.7% for radial-access PCI. Hospital-level variation in the use of same-day discharge persisted throughout (median odds ratio adjusted for year and radial access: 4.15). Risk-adjusted 30-day mortality did not change over time, while risk-adjusted rehospitalization decreased over time and more quickly for same-day discharge (P for interaction <0.001).ConclusionsIn the past decade, a large increase in the use of same-day discharge following elective PCI was not associated with worse 30-day mortality or rehospitalization. Hospital-level variation in same-day discharge may represent an opportunity to reduce costs without compromising patient outcomes.     

Bivalirudin versus Unfractionated Heparin during Percutaneous Coronary Intervention in Patients at High Risk for Bleeding

Low/medium-bleeding-risk populations undergoing percutaneous coronary intervention (PCI) show significantly less bleeding with bivalirudin (BIV) than with unfractionated heparin (UFH), but this has not been established for high-risk patients. We performed a randomized double-blind prospective trial comparing efficacy and safety of BIV versus UFH combined with dual antiplatelet therapy during PCI among 100 high-risk patients with non-ST elevation myocardial infarction (NSTEMI) or angina pectoris. The baseline characteristics were similar in both treatment arms. A radial approach was used in 84% of patients with a higher rate in the BIV group (90 vs. 78%, p < 0.05). Study end points were: major and minor bleeding, port-of-entry complications, major adverse cardiac events (MACE) in-hospital, and at long-term follow-up. There was one case of major gastrointestinal bleeding in the BIV group and 7% minor bleeding complications in both categories. Rate of periprocedural myocardial infarction (PPMI) in the BIV group was twice that in the UFH group (20 vs. 10%, p < 0.16). In-hospital MACE rate was higher in BIV patients as well (12 vs. 2%, p = 0.1). By univariate analysis, the femoral approach was the predictor of PPMI and in-hospital MACE. In a multivariate model, the independent predictor of PPMI was previous MI (odds ratio, 7.7; p < 0.0158). PPMI was 49.7 times more likely with the femoral approach plus BIV than the nonfemoral approach plus UFH (p < 0.0021). At 41.5 ± 14 months'' follow-up, end points did not significantly differ between the groups. In patients at high risk for bleeding undergoing PCI, BIV was not superior to UFH for bleeding complications, and early and late clinical outcomes.     

Impact of Periprocedural Myocardial Biomarker Elevation on Mortality Following Elective Percutaneous Coronary Intervention

ObjectivesThis study sought to explore the association between biomarker elevation, with creatine kinase–myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) and mortality in patients undergoing PCI for stable angina with normal baseline values.BackgroundSeveral studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated.MethodsPatient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB.ResultsA total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB <5 × ULN and cTn <35 × ULN. Among patients with CK-MB ≥5 × ULN (n = 315), 212 (67.3%) also had cTn ≥35 × ULN. Conversely, 390 of patients (64.8%) who had cTn ≥35 × ULN did not have CK-MB ≥5 × ULN. A total of 259 patients (1.9%) died at 1 year; 20 (7.7%) had CK-MB ≥5 × ULN, and 23 (8.8%) had cTn ≥35 × ULN. In the Cox multivariate analysis, in which the CK-MB and cTn ratios post-procedure were forced into the model, age, prior myocardial infarction, lesion complexity, hyperlipidemia, and CK-MB ratio (≥10) post-procedure were associated with increased 1-year mortality.ConclusionsFollowing elective PCI in patients in stable condition treated with second-generation drug-eluting stent, CK-MB and cTn elevations remain common. After multivariate adjustment, there was an increased mortality rate with elevation of CK-MB after PCI, whereas cTn elevation was not independently associated with mortality at 1 year.