Utility of a fusion protein T-cell co-stimulation blocker Belatacept in heart transplant recipients: Real world experience from a high volume center.

BACKGROUND: Belatacept (BTC), a fusion protein, selectively inhibits T-cell co-stimulation by binding to the CD80 and CD86 receptors on antigen-presenting cells (APCs) and has been used as immunosuppression in adult renal transplant recipients. However, data regarding its use in heart transplant (HT) recipients are limited. This retrospective cohort study aimed to delineate BTC's application in HT, focusing on efficacy, safety, and associated complications at a high-volume HT center. METHODS: A retrospective cohort study was conducted of patients who underwent HT between January 2017 and December 2021 and subsequently received BTC as part of their immunosuppressive regimen. Twenty-one HT recipients were identified. Baseline characteristics, history of rejection, and indication for BTC use were collected. Outcomes included renal function, graft function, allograft rejection and mortality. Follow-up data were collected through December 2023. RESULTS: Among 776 patients monitored from January 2017 to December 2021 21 (2.7%) received BTC treatment. Average age at transplantation was 53 years (± 12 years), and 38% were women. BTC administration began, on average, 689 [483, 1830] days post-HT. The primary indications for BTC were elevated pre-formed donor-specific antibodies in highly sensitized patients (66.6%) and renal sparing (23.8%), in conjunction with reduced calcineurin inhibitor dosage. Only one (4.8%) patient encountered rejection within a year of starting BTC. Graft function by echocardiography remained stable at 6 and 12 months posttreatment. An improvement was observed in serum creatinine levels (76.2% of patients), decreasing from a median of 1.58 to 1.45 (IQR [1.0-2.1] to [1.1-1.9]) over 12 months (p = .054). eGFR improved at 3 and 6 months compared with 3 months pre- BTC levels; however, this was not statistically significant (p = .24). Treatment discontinuation occurred in seven patients (33.3%) of whom four (19%) were switched back to full dose CNI. Infections occurred in 11 patients (52.4%), leading to BTC discontinuation in 4 patients (19%). CONCLUSION: In this cohort, BTC therapy was used as alternative immunosuppression for management of highly sensitized patients or for renal sparing. BTC therapy when combined with CNI dose reduction resulted in stabilization in renal function as measured through renal surrogate markers, which did not, however, reach statistical significance. Patients on BTC maintained a low rejection rate and preserved graft function. Infections were common during BTC therapy and were associated with medication pause/discontinuation in 19% of patients. Further randomized studies are needed to assess the efficacy and safety of BTC in HT recipients.

The utilization of molecular microscope in management of heart transplant recipients in the era of noninvasive monitoring.

INTRODUCTION: Monitoring for graft rejection is a fundamental tenet of post-transplant follow-up. In heart transplantation (HT) in particular, rejection has been traditionally assessed with endomyocardial biopsy (EMB). EMB has potential complications and noted limitations, including interobserver variability in interpretation. Additional tests, such as basic cardiac biomarkers, cardiac imaging, gene expression profiling (GEP) scores, donor-derived cell-free DNA (dd-cfDNA) and the novel molecular microscope diagnostic system (MMDx) have become critical tools in rejection surveillance beyond standard EMB. METHODS: This paper describes an illustrative case followed by a review of MMDx within the context of other noninvasive screening modalities for rejection. CONCLUSIONS: We suggest MMDx be used to assist with early detection of rejection in cases of discordance between EMB and other noninvasive studies.

Sleep Apnea as a Risk Factor for Diastolic Dysfunction: A Systematic Review and Meta-Analysis.

BACKGROUND: This meta-analysis assessed the relationship between obstructive sleep apnea (OSA) and echocardiographic parameters of diastolic dysfunction (DD), which are used in the assessment of heart failure with preserved ejection fraction. METHODS: We searched the databases including Ovid MEDLINE, Ovid Embase, Scopus, Web of Science, Google Scholar, and EBSCO CINAHL from inception up to December 26, 2020. The search was not restricted to time, publication status, or language. Two independent investigators screened the identified studies and extracted the data in duplicate. We conducted a meta-analysis using RevMan v.5. The risk of bias was assessed using Cochrane collaboration tools. Comparisons were made between patients with OSA, diagnosed in-laboratory polysomnography or home sleep apnea testing, and patients without OSA in relation to established markers of DD. RESULTS: Primary search identified 2,512 studies. A total of 18 studies including 2,509 participants were included. The two groups were free of conventional cardiovascular risk factors. Significant structural changes were observed between the two groups. Patients with OSA exhibited greater left atrial volume index (LAVI) (3.94 95% CI [0.8, 7.07]; p = 0.000) and left ventricular mass index (11.10 95% CI [2.56, 19.65]; p = 0.000) as compared to control group. The presence of OSA was also associated with more prolonged deceleration time (10.44 ms 95% CI [0.71, 20.16]; p = 0.04), isovolumic relaxation time (IVRT) (7.85 ms 95% CI [4.48, 11.22]; p = 0.000), and a lower ratio of early to late mitral inflow velocities (E/A) ratio (-0.62 95% CI [-1, -0.24]; p = 0.001) suggestive of early DD. The early mitral inflow velocity to mitral annular early diastolic velocity (E/e') ratio (0.94 95% CI [0.44, 1.45]; p = 0.000) was increased. Linear correlation between severity of OSA and LAVI and IVRT parameters was observed but this association did not sustain for the E/A and E/e'. The ejection fraction was not significantly different between patients with OSA and healthy controls (-0.48 95% CI [-1.18, 0.23]; p = 0.18). CONCLUSION: An association between OSA and echocardiographic parameters of DD was detected that was independent of conventional cardiovascular risk factors. OSA may be independently associated with DD perhaps due to higher LV mass. Investigating the role of continuous positive airway pressure therapy in reversing or ameliorating DD is recommended.

One-year results of the ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) Study.

BACKGROUND: Long-term clinical outcomes after exposure to non-ionic iso-osmolar contrast medium (IOCM) or ionic low-osmolar CM (LOCM) in patients with chronic kidney disease (CKD) undergoing coronary angiography are unclear. METHODS: The ICON trial was a prospective, double-blinded, multicentre study that randomly assigned 146 patients with CKD undergoing coronary angiography with or without percutaneous coronary intervention to the non-ionic IOCM Iodixanol or the ionic LOCM Ioxaglate. We report the 1-year clinical outcomes. RESULTS: After randomization, baseline and procedural characteristics were well-matched between the two groups. At 1 year, three deaths (4.1%) occurred in the ioxaglate and nine deaths in the iodixanol group (13.6%, P = 0.07). The cardiac death rate at 1 year was 2.7% in the ioxaglate group and 9.1% in the iodixanol group (P = 0.07). There were no significant differences in the rates of myocardial infarction (1.4% vs. 1.5%; P = 1.00) and repeated revascularization (6.8% vs. 9.1%; P = 0.75). CONCLUSIONS: The use of ionic LOCM ioxaglate was associated with a numerically lower mortality at 1 year as compared to iodixanol in patients who underwent cardiac catheterization. Future studies evaluating long-term safety following exposure to different types of CM are warranted.

Resistant in-stent restenosis in the drug eluting stent era.

BACKGROUND: In the drug eluting stent (DES) era, repeat in-stent restenosis (ISR) of the same coronary lesion, despite percutaneous coronary intervention (PCI), is a rare but challenging problem that has not been reported. We aim to describe what we propose as the occurrence of "resistant"-ISR (R-ISR) in the DES era, including angiographic patterns and outcomes. METHODS: We defined R-ISR as the recurrence of an ISR episode after successful treatment of the same lesion. We identified 276 consecutive patients with 291 lesions who had R-ISR between May 2003 and June 2012. Quantitative coronary angiography (QCA) was performed for the first and second ISR episodes. Outcomes at one year, including death, myocardial infarction (MI), and target lesion failure (TLF), were analyzed. RESULTS: Patients with R-ISR had a high frequency of diabetes (62%), chronic kidney disease (39%), bifurcation lesions (51%), and moderate to severe calcified lesions (52%). The most common pattern of R-ISR was focal (77%). R-ISR lesions were treated with DES implantation (55%) or balloon-only strategy (45%). The mortality rate and TLF at 2-years were 9.3% and 51% respectively. The overall 2-year TLF rate did not vary with the originally implanted stent, angiographic pattern (focal versus diffuse), or revascularization strategy. CONCLUSIONS: R-ISR appears to consist predominantly of focal lesions and occurs in patients at high clinical and angiographic risk, conceivably owing to their unique diabetic and coronary calcification profile. Clinical outcomes are suboptimal irrespective of angiographic pattern or treatment strategy, indicating the recalcitrant nature of the disease, and need for aggressive treatment of cardiovascular risk factors and novel interventional approaches. © 2016 Wiley Periodicals, Inc.

Gender-specific outcomes after balloon aortic valvuloplasty: Inhospital and long-term outcomes.

BACKGROUND: Increasing numbers of balloon aortic valvuloplasty (BAV) are performed in the management of symptomatic aortic stenosis as bridge and therapeutic challenge in the work-up for transcatheter aortic valve replacement. However, the significance of gender in outcomes following BAV remains controversial. METHODS: We retrospectively reviewed 664 consecutive patients who underwent BAV from January 2005 to December 2012. Patients were stratified according to gender. Clinical and procedural characteristics as well as in-hospital outcomes and 1-year mortality were collected. Cumulative survival curves for women and men were constructed using the Kaplan-Meier method and were compared by the log-rank test. Cox regression analysis was performed to identify the independent effect of sex on 1-year mortality. RESULTS: Of the 664 patients, 333 (52%) were women. Women had lower body surface area, tended to be frailer and were less likely to have history of coronary artery disease. Women were more likely to present with heart failure whereas men presented more commonly with chest pain. In hospital death was significantly higher in women compared to men, mainly driven by the difference in cardiac death (8.1% vs 3.9%, P = .02 and 6.3% vs 2.6%, P = .02 respectively). One-year mortality rates were similar in women and men (25.4% vs 29.4%, P = .42) and after multivariate analysis gender had no association with 1-year mortality (HR = 0.9, P = .65). CONCLUSIONS: Significant differences exist in baseline characteristics and presentation between genders. Although in hospital mortality after BAV was significantly higher in women, 1-year mortality was similar between women and men.

Right heart failure after durable left ventricular assist device implantation.

INTRODUCTION: Right heart failure (RHF) is a well-known complication after left ventricular assist device (LVAD) implantation and portends increased morbidity and mortality. Understanding the mechanisms and predictors of RHF in this clinical setting may offer ideas for early identification and aggressive management to minimize poor outcomes. A variety of medical therapies and mechanical circulatory support options are currently available for the management of post-LVAD RHF. AREAS COVERED: We reviewed the existing definitions of RHF including its potential mechanisms in the context of durable LVAD implantation and currently available medical and device therapies. We performed a literature search using PubMed (from 2010 to 2023). EXPERT OPINION: RHF remains a common complication after LVAD implantation. However, existing knowledge gaps limit clinicians' ability to adequately address its consequences. Early identification and management are crucial to reducing the risk of poor outcomes, but existing risk stratification tools perform poorly and have limited clinical applicability. This is an area ripe for investigation with the potential for major improvements in identification and targeted therapy in an effort to improve outcomes.

Frequency of Comfort Care and Palliative Care Consultation after ST-elevation Myocardial Infarction.

INTRODUCTION: ST-elevation myocardial infarction (STEMI) remains a leading cause of death despite advances in revascularization and post-STEMI care. Especially for patients with a poor prognosis, there is increasing emphasis on comfort-focused care. METHODS: We conducted a single-center retrospective cohort study of patients with STEMI at a large tertiary care academic medical center, abstracting patient-level data, causes of death, and use of palliative care consultation from the medical records. We sought to investigate the frequency of comfort-focused approaches and palliative care consultation after STEMI. RESULTS: A total of 536 patients presented with or were transferred with STEMI from January 2010 to July 2018, of whom 61/536 (11.4%) died during index hospitalization. Among those who underwent percutaneous intervention (PCI), the in-hospital mortality rate was 6.8%. Median (IQR) and time to death was 2 (0-6) days. Among those who died, 25/61 (41%) were treated with mechanical circulatory support (MCS). A total of 25/61 (41%) patients died following transition to a comfort-focused approach. Rate of MCS utilization during hospitalization was higher in the group that was ultimately transitioned to comfort-focused measures than the group who received full treatment measures. Palliative care was consulted in the case of 6/61 (9.8%) patients. Median time to consultation was 5 (1-7) days and time to death was 6.5 (2-28) days. DISCUSSION: Transition to comfort-focused care before death after STEMI is common, particularly in those with cardiogenic shock and/or treated with MCS, highlighting the critical status of such patients. Although increasingly employed in recent years, palliative care consults remain rare and are often employed late in the hospitalization.

DASH-HF Study: A Pragmatic Quality Improvement Randomized Implementation Trial for Patients With Heart Failure With Reduced Ejection Fraction.

BACKGROUND: Heart failure is a prevailing diagnosis of hospitalization and readmission within 6 months, and nearly a quarter of these patients die within a year. Guideline-directed medication therapies reduce risk of mortality by 73% over 2 years; however, the implementation of these therapies to their target dose in clinical practice continues to be challenging. In 2020, the Veterans Affairs (VA) Health Care System developed a HF dashboard to monitor and improve outpatient HF management. The DASH-HF (Dashboard Activated Services and Telehealth for Heart Failure) study is a randomized, pragmatic clinical trial to evaluate proactive dashboard-directed telehealth clinics to improve the use and dosing of guideline-directed medication therapy for patients with heart failure with reduced ejection fraction not on optimal guideline-directed medication therapy within the VA. METHODS: Three hundred veterans with heart failure with reduced ejection fraction met inclusion criteria with an optimization potential score (OPS) of 5 or less out of 10, representing nonoptimal guideline-directed medication therapy. The primary outcome was a composite score of guideline-directed medical therapy, the OPS, 6 months after the end of the intervention. Secondary outcomes included active prescriptions for each individual guideline-directed medical therapy class, HF-related hospitalizations, deaths, and clinician time per patient during the intervention clinics. RESULTS: There was no significant difference between the intervention arm and usual care group in the primary outcome (OPS, 2.9; SD=2.1 versus OPS, 2.6, SD=2.1); adjusted mean difference 0.3 (95% CI, -0.1 to 0.7) or in the prespecified secondary outcomes for hospitalization and all-cause mortality for the intervention of proactive dashboard-based clinics. CONCLUSIONS: A dashboard-based clinic intervention did not improve the OPS or secondary outcomes of hospitalization and all-cause mortality. There remains a larger opportunity to better target patients and provide more intensive follow-up to further evaluate the utility of proactive dashboard-based clinics for HF management and quality improvement. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT05001165.

Coronary physiologic assessment based on angiography and intracoronary imaging.

Despite the current evidence supporting clinical benefits of fractional flow reserve (FFR), its uptake in the cardiac catheterization laboratory has been slow due to procedural cost and increased time with the need for maximum hyperemia. Recently, novel physiological indices derived from coronary angiography and intracoronary imaging have emerged to overcome issues with a wire-based FFR. Angiography-based FFR can be measured without vessel instrumentation and has shown excellent diagnostic performance using wire-based FFR as the reference standard. Thus, angiography-based FFR may facilitate coronary functional assessment before and after percutaneous coronary intervention (PCI). Angiography-based index of microcirculatory resistance (IMR) is another new computational index for assessing the coronary microcirculation. Although angiography-derived IMR remains in an early phase of development and requires further validation, its less-invasive nature may help broaden the adoption of microvascular functional assessment in various conditions such as myocardial infarction and cardiac allograft vasculopathy. Lastly, computational FFR based on intravascular ultrasound and optical coherence tomography allows detailed lesion assessment from both morphological and functional standpoints. Given a growing interest in physiology-guided PCI optimization strategies, intravascular imaging-based FFR may become the main assessment tool to confirm successful PCI.

The design of the Dashboard Activated Services and Telehealth for Heart Failure (DASH-HF) study: A pragmatic quality improvement randomized implementation trial for patients with heart failure with reduced ejection fraction.

BACKGROUND: Gaps in the receipt and dosing of guideline-directed medical therapy (GDMT) persist for patients with heart failure with reduced ejection fraction (HFrEF) [1]. In 2020, the Veterans Affairs (VA) developed a heart failure (HF) specific population dashboard to monitor care quality and performance on standard HFrEF performance measures [2]. METHODS: The Dashboard Activated Services and Telehealth for HF (DASH-HF) study is a pragmatic randomized quality improvement study designed to evaluate the utility of proactive population management clinics using the VA's HF dashboard to optimize GDMT for patients with HFrEF. Panel management telemedicine clinics incorporated multidisciplinary clinicians to perform chart review and impromptu telephone encounters to evaluate current HFrEF management and opportunities to optimize GDMT. The study will evaluate the efficacy of proactive panel management to usual care at 6 months as quantified by the GDMT optimization potential score. Secondary outcomes include hospitalizations, mortality, and clinician time per intervention. The study completed enrollment and randomization of 300 participants. The intervention was performed from September to December 2021. CONCLUSION: DASH-HF will contribute to the literature by evaluating use of the existing VA dashboard to identify HF patients with the lowest adherence to GDMT and proactively target this group for the intervention. REGISTRATION: https://clinicaltrials.gov/. Unique identifier: NCT05001165.

Meta-Analysis of Randomized Controlled Trials of Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Left Main Coronary Artery Disease.

Few randomized controlled trials (RCTs) and observational studies had shown acceptable short-term efficacy and safety of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) in selected patients with left main coronary artery disease (LMCAD). We aimed to evaluate long-term outcomes of PCI using DES compared with CABG in patients with LMCAD. On November 1, 2016, we searched available databases for published RCTs directly comparing DES PCI with CABG in patients with LMCAD. Odds ratios (ORs) were used as the metric of choice for treatment effects using a random-effects model. I-squared index was used to assess heterogeneity across trials. Prespecified end points were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stroke, and repeat revascularization at maximal available follow-up. We identified 5 RCTs including a total of 4,595 patients, with a median follow-up of 60 months. The risk of all-cause mortality (OR 1.01; 95% confidence interval [CI] 0.76 to 1.34) and cardiovascular mortality (OR 1.02; 95% CI 0.73 to 1.42) were comparable between PCI with DES and CABG. Similarly, there were no statistically significant differences between PCI with DES and CABG for MI (OR 1.45; 95% CI 0.87 to 2.40) and stroke (OR 0.87; 95% CI 0.38 to 1.98). Conversely, repeat revascularization was significantly higher with PCI compared with CABG (OR 1.82; 95% CI 1.51 to 2.21). In conclusion, in patients with LMCAD, PCI with DES appears to be a viable alternative to CABG at long-term follow-up, with similar risks of ischemic adverse events (mortality, MI, and stroke) but a higher risk of repeat revascularization.

Quantitative angiographic characterisation of coronary artery disease in patients with human immunodeficiency virus (HIV) infection undergoing percutaneous coronary intervention.

AIMS: Patients with human immunodeficiency virus (HIV) infection have an increased risk of acute myocardial infarction (MI), and 6.5-15% of mortality in this population is attributable to cardiovascular disease. However, the angiographic pattern of coronary artery disease (CAD) in patients with HIV undergoing percutaneous coronary intervention (PCI) remains unknown. We sought to assess and describe the angiographic features and burden of CAD in patients with HIV as compared to those without HIV infection. METHODS AND RESULTS: This is a retrospective, single-centre study comparing 93 patients with HIV infection who underwent PCI between 2003 and 2011 with 93 control patients without HIV infection matched for age (±3 years), gender, diabetes, and year of PCI (±2 years). Quantitative coronary angiography (QCA) was performed for all treated lesions at baseline and following PCI in both groups. One-year clinical outcomes post PCI were also analysed and compared. The mean age for both study populations was 57 years; patients with HIV were more likely to present with ST-segment elevation myocardial infarction (STEMI). Patients had a similar extent of CAD as measured by the presence of multivessel disease as well as SYNTAX score; however, patients with HIV were more likely to have lesions in the proximal segment of the respective coronary artery. While both groups mostly displayed none/mild calcified lesions, HIV+ patients had longer and fewer stenotic lesions. Clinical outcomes at one year were similar. CONCLUSIONS: While HIV+ patients were more likely to present with STEMI, detailed coronary angiographic analysis revealed less complex lesions and favourable anatomy. This paradox may suggest alterations in genesis and progression of atherosclerosis in this clinical setting.

Acute cholecystitis and myocardial infarction: a case study with coronary involvement.

Possible links between inflammatory stimuli and atherothrombotic disease in the context of gallbladder pathology are not well understood. Our case demonstrates that clinical suspicion of cardiac disease after a diagnosis of acute cholecystitis should remain high in light of the dire consequences of a missed diagnosis.

Balancing the Risk of Bleeding and Stroke in Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (from the AVIATOR Registry).

Patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) are at elevated risk for bleeding and thromboembolic ischemic events. Currently, guidelines on antithrombotic treatment for these patients are based on weak consensus. We describe patterns and determinants of antithrombotic prescriptions in this population. The Antithrombotic Strategy Variability in Atrial Fibrillation and Obstructive Coronary Disease Revascularized with PCI Registry was an international observational study of 859 consecutive patients with AF who underwent PCI from 2009 to 2011. Patients were stratified by treatment at discharge with either dual antiplatelet therapy (DAPT; aspirin plus clopidogrel) or triple therapy (TT; warfarin plus DAPT). Bleeding and thromboembolism risks were assessed by the HAS-BLED and CHADS2 scores, respectively, and predictors of TT prescription at discharge were identified. Major adverse cardiovascular events and clinically relevant bleeding (Bleeding Academic Research Consortium score ≥2) at 1-year follow-up were compared across antithrombotic regimens. Compared with patients on DAPT (n = 488; 57%), those given TT (n = 371; 43%) were older, with higher CHADS2 scores, lower left ventricular ejection fraction, and more often had permanent AF, single-vessel coronary artery disease, and bare-metal stents. In multivariate analysis, increasing thromboembolic risk (CHADS2) was associated with a higher rate of TT prescription at discharge (intermediate vs low CHADS2: odds ratio 2.2, 95% confidence interval [CI] 2.0 to 3.3, p <0.01; high vs low CHADS2: odds ratio 1.6, 95% CI 2.6 to 4.3, p <0.01 for TT). However, there was no significant association between bleeding risk and TT prescription in the overall cohort or within each CHADS2 risk stratum. The rates of major adverse cardiovascular events were similar for patients discharged on TT or DAPT (20% vs 17%, adjusted hazard ratio 0.8, 95% CI 0.5 to 1.1, p = 0.19), whereas the rate of Bleeding Academic Research Consortium ≥2 bleeding was higher in patients discharged on TT (11.5% vs 6.4%, adjusted hazard ratio 1.8, 95% CI 1.1 to 2.9, p = 0.02). In conclusion, the choice of the intensity of antithrombotic therapy correlated more closely with the risk of ischemic rather than bleeding events in this cohort of patients with AF who underwent PCI.

Comparison of provisional 1-stent and 2-stent strategies in diabetic patients with true bifurcation lesions: the EES bifurcation study.

BACKGROUND: Percutaneous coronary intervention (PCI) of true bifurcation lesions (Medina classification 1, 1, 1; 1, 0, 1; or 0, 1, 1) is challenging and may involve either a 1-stent strategy with provisional side branch stenting, or a 2-stent strategy. Diabetes mellitus is associated with greater atherosclerotic burden and higher incidence of bifurcation lesions, and unfavorable outcomes after PCI. It is unknown whether use of newer everolimus-eluting stent (EES) implantation impacts relative outcomes of 1-stent and 2-stent strategies in patients with diabetes. METHODS: We performed a retrospective analysis of consecutive patients with diabetes mellitus and complex true bifurcation lesions (side branch diameter >2.0 mm) who underwent PCI with EES between February 2010 and December 2011. We grouped subjects based on initial treatment to a 1-stent (n = 81) or 2-stent (n = 54) strategy, and compared baseline characteristics, quantitative coronary angiography, and 1-year major adverse cardiovascular event (MACE) rates, defined as death, myocardial infarction, target lesion revascularization (TLR), or target vessel revascularization (TVR). RESULTS: Baseline characteristics were well matched. A 2-stent strategy was associated with larger side-branch reference vessel diameter at baseline and post PCI. In-hospital events included 1 periprocedural myocardial infarction in each group and no deaths. At 1 year, there was no significant difference between 1-stent and 2-stent strategies in TVR rates (6.2% vs 3.7%; P=.53), TLR (both 3.7%; P>.99), or MACE (7.4% vs 3.7%; P=.37). CONCLUSION: In this series of diabetic patients undergoing complex bifurcation PCI using EES implantation, there was no difference between 1-stent and 2-stent strategies with respect to ischemic events at 1 year.

Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions).

OBJECTIVES: This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes. BACKGROUND: Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up. METHODS: We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis. RESULTS: At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other). CONCLUSIONS: In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel.