Safety and Efficacy of Bivalirudin for Percutaneous Coronary Intervention with Rotational Atherectomy

Background: Although bivalirudin use in percutaneous coronary intervention (PCI) results in less bleeding compared to unfractionated heparin (UFH) use, its safety in patients undergoing rotational atherectomy (RA) is unknown. Methods: A cohort of 503 patients who underwent PCI with RA from 2000 to 2009 was studied. Patients receiving bivalirudin (n = 322) were compared to those (n = 181) treated with UFH ± glycoprotein IIb/IIIa inhibitor (GPI) as PCI anticoagulation. Safety was assessed by the frequency of major bleeding (hematocrit drop ≥15%, intracerebral or gastro‐intestinal bleeding) and need for transfusion. Efficacy was assessed by a composite end‐point of in‐hospital death, Q wave myocardial infarction (MI) or urgent coronary artery bypass graft (CABG). Results: Those in the bivalirudin group were older, more hypertensive, and had greater body mass index. The UFH group was more likely to have prior MI, prior CABG, and an acute coronary syndrome at baseline. GPI was used in 93 patients (52%) of the UFH group. No difference was found between groups for the composite of death/Q wave MI/urgent CABG (1.9% vs. 1.7%, respectively, in bivalirudin vs. UFH group; P = 0.2). The frequency of major bleeding (2.2% vs. 1.7%; P = 0.8) or transfusion (5.6% vs. 8.7%; P = 0.9) was also similar between groups. After adjustment, bivalirudin use was not associated with a reduction in death/Q wave MI/urgent CABG, major bleeding, or transfusion compared to UFH. Conclusion: Bivalirudin use seems to be as safe and effective as UFH in patients undergoing RA. (J Interven Cardiol 2010;23:223–229)     

The Feasibility and Safety of Same-Day Discharge for All Comers after Elective Percutaneous Coronary Interventions

BackgroundThe safety of same day discharge (SDD) after percutaneous coronary interventions (PCI) has been demonstrated in several studies. However, SDD was only allowed in patients meeting strict criteria. We aimed to evaluate the feasibility and safety of SDD following elective-PCI in all comers.MethodsIn 2012, we implemented a strategy of SDD for all elective PCI (no exclusion) but admissions were allowed at the discretion of the treating physician. We assessed the feasibility and safety of this approach in consecutive patients who underwent elective PCI at WVU.ResultsOut of 3355 patients who underwent PCI between 2012 and 2016, 691 (21%) presented electively. Radial access was utilized in 480 (69.5%). Same day discharge was achieved in 539/691 (78%), and there was no difference between patients who had SDD and those who were admitted with regards to the 30-day major adverse cardiovascular and cerebrovascular events (3.2% vs. 3.5% respectively, P = 0.195). Predictors of SDD failure were procedural complications (OR 12.08, 95%CI 2.20–57.8. P = 0.002), use of Glycoprotein IIB-IIIA inhibitors (OR 3.45, 95%CI 1.067–11.41, P = 0.039), femoral access (OR 2.067, 95%CI 1.25–3.419, p = 0.005), anemia (OR 1.80, 95%CI 1.06–3.04, P = 0.029), home distance ≥60 miles (OR 1.68, 95%CI 1.03–2.72, P = 0.037).ConclusionSDD is feasible in the majority of all-comers after elective PCI, and is not associated with increase in adverse events at 30-days. Certain procedural and patient's characteristics predict SDD failure. If validated in prospective studies, these factors can possibly be integrated in a predictive tool to aid in triaging patients, post-elective PCI.     

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.     

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.     

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement

BackgroundCoronary artery disease (CAD), often with severe calcification, is present in up to 75% of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). Management of CAD in such patients is challenging. Orbital atherectomy (OA) is an effective treatment of severely calcified coronary lesions prior to stent implantation. However, there is limited data on the use of OA for percutaneous coronary intervention (PCI) to treat calcific CAD patients prior to TAVR (OA PCI + TAVR).MethodsRetrospective analysis of patients with moderate/severe calcific CAD and moderate/severe AS who underwent staged OA PCI + TAVR at one high-volume institution. Data were analyzed to assess the 1-year major adverse cardiac events after index OA PCI [MACE: death, target lesion revascularization (TLR), and myocardial infarction (MI)].ResultsThere were 18 patients (mean age of 82) treated with staged OA PCI + TAVR, and of those, 10 (56%) were male, 7 (39%) Caucasian, and 11 (61%) Hispanic/Latino. The average left ventricular ejection fraction was 49% and congestive heart failure was present in 12 patients (67%). There were no angiographic complications (0%), stent thrombosis (0%), or stroke events (0%). The 30-day and 1-year MACE rates were 5.6% (0% death, 0% TLR, 5.6% MI) and 17% (0% death, 11% TLR, and 17% MI [all non-Q-wave MI]), respectively.ConclusionsIn this single-center observational cohort series, patients with heavily calcified coronary lesions treated with OA prior to TAVR had low rates of MACE at 30 days and 1 year. The results demonstrate the feasibility and safety of OA for the treatment of complex calcific coronary lesions prior to TAVR. An up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD is also provided.Table of contents summaryThere is limited data on the use of orbital atherectomy (OA) for percutaneous coronary intervention (PCI) to treat calcific coronary artery disease (CAD) patients prior to transcatheter aortic valve replacement (TAVR). Our primary aim was to evaluate the feasibility, safety, and 1-year outcome of OA PCI pre-TAVR in patients with complex CAD and severe aortic stenosis (AS). We also aimed to provide a brief up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD. This retrospective cohort study found that OA is feasible and safe for the treatment of severely calcified coronary lesions before TAVR, resulting in acceptable 30-day and 1-year outcomes.     

Comparison of Rotational with Orbital Atherectomy During Percutaneous Coronary Intervention for Coronary Artery Calcification: A Systematic Review and Meta-Analysis

BackgroundPercutaneous coronary intervention (PCI) outcomes for patients with significant calcification have been consistently inferior compared to patients without significant calcification. Procedural success and long-term outcomes after PCI have been worse in patients with severe coronary calcium.ObjectiveA Bayesian meta-analysis of outcomes comparing rotational atherectomy (RA) with orbital atherectomy (OA) was performed.MethodsPubMed, Embase, and Cochrane Library databases were searched through 30th November 2018 and identified 4 observational studies.ResultsThe primary end-point, Major Adverse Cardiac Event (MACE) composing of death, MI and stroke at 1 year was more likely with RA (OR = 1.61; 95% CI: 1.11–2.33; p = 0.01) as compared to OA. The driver of the difference in MACE between the two groups was a statistically significant difference in mortality favoring OA (OR = 4.65; 95% CI: 1.36–15.87; p = 0.01). Peri-procedural MI, the other component of the primary end-point was 1.3 times more likely in the RA arm (OR = 1.35; 95% CI 0.95–1.92; p-0.09) and was not statistically different between the groups. The odds of a vascular complication were not different in the two groups (OR = 1.26; 95% CI: 0.73–2.17; p = 0.41).In an adjusted Bayesian analysis, mortality (OR = 3.69; 95% CI: 0.30–38.51), MACE (OR = 1.68; 95% CI: 0.55–5.49), MI (OR = 1.42; 95% CI: 0.50–4.29) and dissections/perforations (OR = 0.38; 95% CI: 0.10–1.38) were not different in RA and OA groups.ConclusionOur study is the first published Bayesian meta-analysis comparing MACE and peri-procedural outcomes in RA compared to OA. These findings lay the foundation for a randomized comparison between the two competing technologies.     

Zwolle Risk Score for Safety Assessment of Same-day Discharge after Primary Percutaneous Coronary Intervention

ObjectivesThe Zwolle risk score (ZRS) has been considered to be a useful tool for the systematic evaluation of patients for early discharge after primary percutaneous coronary intervention (PCI). Therefore, aim of this study was to evaluate the clinical utility of ZRS for the same-day discharge strategy after primary PCI at a tertiary care cardiac center of Karachi, Pakistan.MethodsThis study was conducted at a tertiary care cardiac center between August 2019 and July 2020. Patients discharged within 24 h (same-day) of the primary PCI procedure were included. Patients were stratified as high- and low-risk based on ZRS score; low-risk (≤3) and high-risk (≥4). All patients were followed during 30-days post-procedure period for major adverse cardiac events (MACE).ResultsOut of 487 patients, 83.2% (405) were male and mean age was 54.6 ± 10.87 years. Mean ZRS was 2.34 ± 1.64 with 16.0% (78) patients in high-risk (≥4) group. 30-days MACE rate was observed to be 5.3% (26) with significantly higher rate among high-risk patients as compared to low-risk patients 12.8% (10) vs. 3.9% (16); p = 0.004 respectively with OR of 3.61 [1.57–8.29]. The area under the curve (AUC) of ZRS for prediction of 30-day MACE was 0.67 [95% CI: 0.58–0.77], ZRS ≥4 had sensitivity of 38.5% and specificity of 85.2% with AUC of 0.62 [95% CI: 0.50–0.74] for prediction of 30-day MACE.ConclusionZRS showed moderate discriminating potential in identifying patients with high-risk of MACE at 30-day after same-day discharge after primary PCI.     

Excimer Laser Atherectomy in Percutaneous Coronary Intervention: A Contemporary Review

Excimer laser coronary atherectomy (ELCA) during percutaneous coronary intervention (PCI) has been in use for more than twenty years. While early experiences were not favorable over balloon angioplasty alone, with improvement in operator technique, patient selection and technology, ELCA has established its own niche in contemporary PCI as a safe and effective atherectomy strategy. With growing experience in complex coronary interventions worldwide, ELCA has become one of the essential atherectomy tools offering unique advantages over other atherectomy devices. In the modern era, ELCA is commonly used for patients with in-stent restenosis, stent under expansion, balloon uncrossable lesions and chronic total occlusions. Technical success rates are reported to be >80% in most situations while procedural complication rates such as vessel dissection and perforation among others are reported to average 9% over the past 25 years with improvement over time. In this review, we provide a comprehensive systematic review of the ELCA system, its practical use, indications, and procedural techniques in the contemporary PCI era.     

Safety and Feasibility of Same Day Discharge Strategy for Primary Percutaneous Coronary Intervention

Background:The strategy for early discharge after primary percutaneous coronary intervention (PCI) could have substantial financial benefits, especially in low-middle income countries. However, there is a lack of local evidence on feasibility and safety of the strategy for early discharge. Therefore, the aim of this study was to assess the safety of early discharge after primary PCI in selected low-risk patients in the population of Karachi, Pakistan.Methods:In this study 600 consecutive low-risk patients who were discharged within 48 hours of primary PCI were put under observation for major adverse cardiac events (MACE) after 7 and 30 days of discharge respectively. Patients were further stratified into discharge groups of very early (≤ 24 hours) and early (24 to 48 hours).Results:The sample consisted of 81.8% (491) male patients with mean age of 54.89 ± 11.08 years. Killip class was I in 90% (540) of the patients. The majority of patients (84%) were discharged within 24 hours of the procedure. Loss to follow-up after rate at 7 and 30 days was 4% (24) and 4.3% (26) respectively. Cumulative MACE rate after 7 and 30 days was observed in 3.5% and 4.9%, all-cause mortality in 1.4% and 2.3%, cerebrovascular events in 0.9% and 1.4%, unplanned revascularization in 0.9% and 1.2%, re-infarction in 0.3% and 0.5%, unplanned re-hospitalization in 0.5% and 0.5%, and bleeding events in 0.5% and 0.5% of the patients respectively.Conclusion:It was observed that very early (≤ 24 hours) discharge after primary PCI for low-risk patients is a safe strategy subjected to careful pre-discharge risk assessment with minimal rate of MACE after 7-days as well as 30-days.     

Safety and Feasibility of 48 h Discharge After Successful Primary Percutaneous Coronary Intervention

BackgroundThe aim of the current study is to determine the safety of early discharge (ED) within 48 hours (h) for ST-elevation myocardial infarction (STEMI) patients who underwent primary percutaneous coronary intervention (PPCI) and to define the criteria of low-risk patients that can be considered for ED.MethodsThis is a single-center retrospective study that took place at Mohammed bin Khalifa Cardiac Centre in the Kingdom of Bahrain. 301 patients who underwent PPCI between January 2018 and March 2019 were included. Endpoints at 30 days follow-up comprised cardiac re-admission, cardiovascular death, non-fatal myocardial infarction, stroke, and major adverse cardiovascular and cerebrovascular events.ResultsOf the 301 patients included in our study, 74 (24.5%) were discharged within 48 h (group 1) compared with 227 (75.5%) hospitalized for more than 48 h after PPCI (group 2) (<0.0001). In terms of baseline characteristics, group 2 had higher proportions of chronic kidney disease (P = 0.051), mean HbA1c (P = 0.016) and mean CPK (P < 0.0001) compared to their group 1 counterparts. The prevalence of anterior STEMI was twice as high among group 2 (P < 0.0001), with a significantly higher prevalence of left main stenting (P = 0.025). Additionally, larger proportion of group 2 required inotropic therapy (P = 0.031), oral anticoagulation (P = 0.005) and had a significantly lower ejection fraction (LVEF) (P < 0.0001) with more procedural complications (P = 0.005). LVEF exerts a large effect on ED, as reflected by a high deviance R² = 20.4%, and was able to correctly classify the subjects into their pertaining discharge group with an accuracy of 80.4%, a specificity of 82.7%, and a sensitivity of 71.2%. According to the fitted LVEF values using the logistic equation, each 1% increase in LVEF is associated with a 3.5% increase in the chance of ED. The two groups recorded fairly similar clinical outcomes at 30-day.ConclusionPreserved LV systolic function is a good predictor of early and safe discharge after successful PPCI. The presented data support the practice of ED, with length of stay even shorter than current guidelines recommendation in selected low-risk patients.     

经皮冠状动脉介入治疗术后的无再流现象

无再流现象 (no reflowphenomenon)是指冠状动脉闭塞 ,血流中断后重新恢复血流 ,却无心肌组织的有效灌注的现象 ,可发生于溶栓治疗及经皮冠状动脉介入治疗 (PCI)术后。本文就PCI术后无再流现象的发生情况、机制、检测、预防和处理等方面的研究进展进行了综述。     

Economic Impact And SafetY of Same-Day Discharge Following Percutaneous Coronary Intervention: A Tertiary-Care Centre Experience From Northern India (EASY-SDD)

BackgroundThe literature about the safety and feasibility of same-day discharge (SDD) following complex percutaneous coronary intervention (PCI) and in acute coronary syndrome (ACS) is scarce. The economic impact of SDD has not been evaluated in this geographical region. We in the present study evaluated the safety, feasibility, and economic impact of SDD following PCI at a tertiary care centre of north India.MethodsIt was a single-centre, non-randomized, prospective study, in which all consecutive PCI patients during the study period of 15 months were evaluated for SDD using a “patient-centred” approach. The patients who were discharged on the next calendar day were included in the next day discharge (NDD) group. The baseline demographic data including coronary risk factors, clinical presentation, and management details were noted for all patients. All patients were followed up for 6 weeks. The Indian health system is only partially insured, hence most of the expendable costs are borne by patients. In the present study, we computed the total societal expenditure of each PCI which includes both the health system costs and the expenditure borne by the patients. A standardized tool and bottoms up costing method were used for recording out-of-pocket expenditure (OOPE) by the patients and health care expenditure respectively.ResultsOut of a total of 675 PCI patients, 617 patients were enrolled in the study, and 132/617 (21.39%) patients were discharged the same day. Sixty-five % of patients (86/132) in the SDD cohort and 70% of patients (337/485) in the NDD cohort presented with ACS. Baseline characteristics in the two cohorts were identical. A higher syntax score, greater number of stents, and longer stented segment predicted the NDD. The mean length of stay after PCI in patients with SDD and NDD was 8.71 ± 2.48 and 21.76 ± 2.42 h, respectively. In the SDD group, there were no readmissions or adverse events after discharge till 6 weeks of follow-up. The total mean cost of PCI (health care system and OOPE) for SDD and NDD was Indian Rupees (INR) 129,322.14 [United States dollar (US$) 1810.51] and INR 165500.71 [US$ 2317.01] respectively. An amount of INR 36178.57 (health system cost: INR 10242.76 and OOPE: INR 25935.71 was saved for each SDD. Besides 100 cardiac unit bed days including 85 intensive cardiac care bed days were saved with 21% SDD in the present cohort.ConclusionPost PCI SDD is safe and feasible in selected ACS/chronic stable angina patients using the “patient-centred” approach. Besides, decreasing OOPE for the patients, SDD also helps in the efficient use of scarce health system resources.     

西洛他唑在冠状动脉介入术后的应用

经皮冠状动脉介入治疗（PCI）广泛用于缺血性心脏病，其术后的再狭窄庭血栓高风险是导致心脑血管事件发生。PCI术后给予西洛他唑，具有抗血栓和扩张血管作用、抑制血管平滑肌细胞的增殖、调节血脂浓度、对抗血栓形成、减少心脑血管事件发生等应用。     

整合素与冠脉介入治疗后再狭窄

整合素是细胞表面介导细胞-细胞间以及细胞-细胞外基质间黏附作用的主要黏附分子。整合素通过介导血栓形成、炎症反应、血管平滑肌细胞迁移增殖等多种机制参与冠脉介入治疗后再狭窄的发生、发展和形成。拮抗整合素能抑制再狭窄的形成,这可能成为开发防治再狭窄新药的方向。