Outcomes With Limus- vs Paclitaxel-Coated Balloons for Percutaneous Coronary Intervention: Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Randomized controlled trials (RCTs) examining the outcomes with limus drug-coated balloons (DCBs) vs paclitaxel DCBs were small and underpowered for clinical endpoints. OBJECTIVES: This study sought to compare the angiographic and clinical outcomes with limus DCBs vs paclitaxel DCBs for percutaneous coronary intervention (PCI). METHODS: An electronic search of Medline, EMBASE, and Cochrane databases was performed through January 2024 for RCTs comparing limus DCBs vs paclitaxel DCBs for PCI. The primary endpoint was clinically driven target lesion revascularization (TLR). The secondary endpoints were late angiographic findings. Summary estimates were constructed using a random effects model. RESULTS: Six RCTs with 821 patients were included; 446 patients received a limus DCB, and 375 patients received a paclitaxel DCB. There was no difference between limus DCBs and paclitaxel DCBs in the incidence of TLR at a mean of 13.4 months (10.3% vs 7.8%; risk ratio [RR]: 1.32; 95% CI: 0.84-2.08). Subgroup analysis suggested no significant interaction among studies for de novo coronary lesions vs in-stent restenosis (Pinteraction = 0.58). There were no differences in the risk of major adverse cardiovascular events, cardiac mortality, or target vessel myocardial infarction between groups. However, limus DCBs were associated with a higher risk of binary restenosis (RR: 1.89; 95% CI: 1.14-3.12), late lumen loss (mean difference = 0.16; 95% CI: 0.03-0.28), and a smaller minimum lumen diameter (mean difference = -0.12; 95% CI: -0.22 to -0.02) at late follow-up. In addition, late lumen enlargement occurred more frequently (50% vs 27.5%; RR: 0.59; 95% CI: 0.45-0.77) with paclitaxel DCBs. CONCLUSIONS: Among patients undergoing DCB-only PCI, there were no differences in the risk of clinically driven TLR and other clinical outcomes between limus DCBs and paclitaxel DCBs. However, paclitaxel DCBs were associated with better late angiographic outcomes. These findings support the need for future trials to establish the role of new-generation limus DCBs for PCI.

Angiographic Characteristics and Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention: Insights From the cVAD PROTECT III Study.

BACKGROUND: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI). METHODS: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization). RESULTS: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR ≥60 mL/min per 1.73 m2, 190 with eGFR ≥45 to <60, 105 with eGFR ≥30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m2 or on dialysis. CONCLUSIONS: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392.

Acute coronary syndromes in patients with cancer: Recent advances.

Coronary artery disease is presently one of the leading causes of death among cancer survivors. Due to the number of cancer survivors projected to reach 26 million by 2040 managing coronary disease in this population presents a unique challenge. Cancer patients face an elevated risk of atherosclerotic disease due to shared cardiovascular risk factors and the cardiotoxic effects of cancer therapies, predisposing them to acute coronary syndromes. Challenges in treating cancer patients presenting with acute coronary syndromes include atypical presentations, obscured symptoms, and the impact of cancer-related processes on traditional biomarkers. This review explores the complexities of acute coronary syndrome management in cancer patients, addressing challenges involved, recent advances in percutaneous strategies, pharmacology, and considerations for these high-risk individuals. This review discusses a balance between invasive vs. medical strategy, technical advances in multimodal imaging, intravascular physiology, intracoronary imaging, and evolving stent options, highlighting the need for tailored approaches in this complex patient population.

Clinical characteristics and outcomes of patients requiring prolonged mechanical circulatory support after high-risk percutaneous coronary intervention.

BACKGROUND: There are limited data on the clinical characteristics and outcomes of patients who require prolonged mechanical circulatory support (MCS) after Impella-supported high-risk percutaneous coronary intervention (HR-PCI). AIMS: The aim of this study is to describe the contemporary clinical characteristics, outcomes, and predictors associated with prolonged MCS support after assisted HR-PCI. METHODS: Patients enrolled in the prospective, multicentre, clinical endpoint-adjudicated PROTECT III study who had undergone HR-PCI using Impella were evaluated. Patient and procedural characteristics and outcomes for those who received prolonged MCS beyond the duration of their index procedure were compared to those in whom MCS was successfully weaned and explanted at the conclusion of the index PCI. RESULTS: Among 1,155 patients who underwent HR-PCI with Impella between 2017 and 2020 and had sufficient data to confirm the duration of Impella support, 16.5% received prolonged MCS (mean duration 25.2±31.1 hours compared with 1.8±5.8 hours for those who only received intraprocedural MCS). Patients receiving prolonged support presented with more urgent indications (e.g., acute coronary syndromes [ACS], lower ejection fraction [EF], elevated baseline heart rate and lower systolic blood pressure). Use of the Impella CP, intraprocedural complications, periprocedural complications and in-hospital mortality were all more common amongst the prolonged MCS group. Prolonged MCS was associated with increased rates of major adverse cardiovascular and cerebrovascular events, cardiovascular death, and all-cause mortality at 90-day follow-up. CONCLUSIONS: Patients receiving prolonged MCS after Impella-supported HR-PCI presented with more ACS, reduced EF and less favourable haemodynamics. Additionally, they were more likely to experience intraprocedural and periprocedural complications as well as increased in-hospital and post-discharge mortality.

Influence of left ventricular ejection fraction in patients undergoing contemporary pLVAD-supported high-risk PCI.

BACKGROUND: Left ventricular (LV) systolic dysfunction worsens outcomes in patients undergoing percutaneous coronary intervention (PCI). The objective of this study, therefore, was to evaluate outcomes of pLVAD-supported high-risk PCI (HRPCI) patients according to LV ejection fraction (LVEF). METHODS: Patients from the PROTECT III study undergoing pLVAD-supported HRPCI were stratified according to baseline LVEF: severe LV dysfunction (LVEF <30%), mild and moderate LV dysfunction (LVEF ≥30% to <50%), or preserved LV function (LVEF ≥50%). Major adverse cardiovascular and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization), and PCI-related complications were assessed at 90 days and mortality was assessed at 1-year. RESULTS: From March 2017 to March 2020, 940 patients had evaluable baseline LVEF recorded in the study database. Patients with preserved LV function were older, more frequently presented with myocardial infarction, and underwent more left main PCI and atherectomy. Immediate PCI-related coronary complications were infrequent (2.7%, overall), similar between groups (P = 0.98), and not associated with LVEF. Unadjusted 90-day MACCE rates were similar among LVEF groups; however, as a continuous variable, LVEF was associated with both 90-day MACCE (adj.HR per 5% 0.89, 95% CI [0.80, 0.98], P = 0.018) and 1-year mortality (adj.HR per 5% 0.84 [0.78, 0.90], P <0.0001). CONCLUSIONS: Patients who underwent pLVAD-supported HRPCI exhibited low incidence of PCI-related complications, regardless of baseline LVEF. However, LVEF was associated with 90-day MACCE and 1-year mortality.

Early Utilization of Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: The National Cardiogenic Shock Initiative.

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with significant morbidity and mortality. Mechanical circulatory support (MCS) devices increase systemic blood pressure and end organ perfusion while reducing cardiac filling pressures. METHODS AND RESULTS: The National Cardiogenic Shock Initiative (NCT03677180) is a single-arm, multicenter study. The purpose of this study was to assess the feasibility and effectiveness of utilizing early MCS with Impella in patients presenting with AMI-CS. The primary end point was in-hospital mortality. A total of 406 patients were enrolled at 80 sites between 2016 and 2020. Average age was 64±12 years, 24% were female, 17% had a witnessed out-of-hospital cardiac arrest, 27% had in-hospital cardiac arrest, and 9% were under active cardiopulmonary resuscitation during MCS implantation. Patients presented with a mean systolic blood pressure of 77.2±19.2 mm Hg, 85% of patients were on vasopressors or inotropes, mean lactate was 4.8±3.9 mmol/L and cardiac power output was 0.67±0.29 watts. At 24 hours, mean systolic blood pressure improved to 103.9±17.8 mm Hg, lactate to 2.7±2.8 mmol/L, and cardiac power output to 1.0±1.3 watts. Procedural survival, survival to discharge, survival to 30 days, and survival to 1 year were 99%, 71%, 68%, and 53%, respectively. CONCLUSIONS: Early use of MCS in AMI-CS is feasible across varying health care settings and resulted in improvements to early hemodynamics and perfusion. Survival rates to hospital discharge were high. Given the encouraging results from our analysis, randomized clinical trials are warranted to assess the role of utilizing early MCS, using a standardized, multidisciplinary approach.

Prevalence and outcomes of type 2 myocardial infarction in patients with cancer: A retrospective analysis from the National Inpatient Sample dataset.

BACKGROUND: This study aimed to investigate the prevalence, clinical characteristics and outcomes of type 2 myocardial infarction (T2AMI) in patients with versus without cancer. METHODS: All hospitalizations with a primary discharge diagnosis of T2AMI were stratified according to cancer status (secondary diagnosis of any-cancer vs cancer-free) using data from the US National Inpatient Sample (2016-2019). The primary outcome was in-hospital all-cause mortality while secondary outcomes were in-hospital major adverse cardiovascular and cerebrovascular events (MACCE). RESULTS: Among 61,305 included hospitalizations with primary diagnosis of T2AMI, 3745 (6.1%) were associated with a diagnosis of cancer. Patients with T2AMI and cancer presented more frequently with acute respiratory failure (23.2% vs 18.1%), acute pulmonary embolism (3.7% v 1.3%), major bleeding (6.8% vs 4.1%) and renal failure (51.0% vs 46.8%), compared to patients without. On adjusted analysis, diagnosis of cancer was associated with lower odds of invasive coronary angiography (aOR 0.75, 95% CI 0.60 to 0.93, p = 0.009) but greater odds of mortality (aOR 1.95, 95% C.I. 1.26-2.99 p = 0.002). Among the different types of cancer, adjusted risk of all-cause mortality was higher in patients with colorectal (aOR 4.17 95% CI 1.68-10.32, p = 0.002), lung (aOR 3.63, 95% CI 1.83-7.18, p < 0.001) and haematologic (aOR 2.48, 95% CI 1.22-5.05, p = 0.001) cancer. CONCLUSIONS: Patients with cancer presenting with T2AMI have lower odds of management with invasive diagnostic coronary angiography and have higher rates of in-hospital all-cause death. Further studies are warranted to improve overall care and outcomes of cancer patients and cardiovascular diseases.

Outcomes with catheter-directed thrombolysis vs. catheter-directed embolectomy among patients with high-risk pulmonary embolism: a nationwide analysis.

AIMS: To examine the shot-term outcomes with catheter-directed thrombolysis (CDT) vs. catheter-directed embolectomy (CDE) for high-risk pulmonary embolism (PE). METHODS AND RESULTS: The Nationwide Readmissions Database was utilized to identify hospitalizations with high-risk PE undergoing CDE or CDT from 2016 to 2019. The main outcome was all-cause in-hospital mortality. Propensity score matching was used to compare the outcomes in both groups. Among 3216 high-risk PE hospitalizations undergoing catheter-directed interventions, 868 (27%) received CDE, 1864 (58%) received CDT, and 484 (15%) received both procedures. In the unadjusted analysis, the rate of all-cause in-hospital mortality was not different between CDE and CDT (39.6% vs. 34.2%, P = 0.07). After propensity score matching, there was no difference in the incidence of in-hospital mortality [adjusted odds ratio (aOR): 1.28, 95% confidence interval (CI): 0.95, 1.72, P = 0.10], intracranial haemorrhage (ICH) (adjusted OR 1.57, 95% CI: 0.75, 3.29, P = 0.23), or non-ICH bleeding (aOR: 1.17, 95% CI: 0.85, 1.62, P = 0.33). There were no differences in the length of stay, cost, and 30-day unplanned readmissions between both groups. CONCLUSION: In this contemporary observational analysis of patients admitted with high-risk PE undergoing CDT or CDE, the rates of in-hospital mortality, ICH, and non-ICH bleeding events were not different.

Trends and Outcomes of Interhospital Transfer for High-Risk Acute Pulmonary Embolism: A Nationwide Analysis.

Background: Data on outcomes of patients with high-risk acute pulmonary embolism (PE) transferred from other hospitals are scarce. Methods: We queried the Nationwide Readmissions Database for admissions who were ≥18 years old, and with a primary discharge diagnosis of acute high-risk PE between the years 2016 and 2019. The main outcome of interest was the difference in all-cause in-hospital mortality between patients admitted directly to small/medium hospitals; patients admitted directly to large hospitals; and patients transferred to large hospitals. Results: Among 11,341 weighted hospitalizations with high-risk PE, 631 (5.6%) patients were transferred to large hospitals. There was no significant change in the rates of transfer during the study period. Transferred patients were younger and had a higher prevalence of comorbidities. They were more likely to present with saddle PE and cor pulmonale and were more likely to receive advanced therapies. In-hospital mortality was not different between patients transferred to large hospitals and those admitted directly to large hospitals (adjusted odd ratio [OR] 1.11, 95% confidence interval [CI] 0.81, 1.54) as well as between patients transferred to large hospitals and those admitted directly to small/medium hospitals (aOR 1.28, 95% CI 0.92, 1.76). The rates of major bleeding and cardiac arrest were higher among transferred patients. Admissions for transferred patients were associated with higher cost and longer length of stay. Conclusion: Transferred patients with high-risk PE were more likely to receive advanced therapies. There was no difference in-hospital mortality rates compared with patients admitted directly to the large or small/medium hospitals.

Saphenous Vein Graft Intervention.

Even though saphenous vein grafts (SVGs) are the most commonly used surgical conduits, their long-term patency is limited by accelerated atherosclerosis often resulting in acute coronary syndrome or asymptomatic occlusion. SVG intervention is associated with 2 significant challenges: a significant risk of distal embolization with resultant periprocedural myocardial infarction in the short-term and restenosis in the long-term. Several individual trials have compared bare metal stents with drug-eluting stents for SVG intervention. This review article discusses the pathophysiology of SVG lesions, indications for SVG intervention, and the challenges encountered, and also technical considerations for SVG intervention and the supporting evidence.

Contemporary Management of Severely Calcified Coronary Lesions.

Coronary artery calcification is increasingly prevalent in our patient population. It significantly limits the procedural success of percutaneous coronary intervention and is associated with a higher risk of adverse cardiovascular events both in the short-term and long-term. There are several modalities for modifying calcified plaque, such as balloon angioplasty (including specialty balloons), coronary atheroablative therapy (rotational, orbital, and laser atherectomy), and intravascular lithotripsy. We discuss each modality's relative advantages and disadvantages and the data supporting their use. This review also highlights the importance of intravascular imaging to characterize coronary calcification and presents an algorithm to tailor the calcium modification therapy based on specific coronary lesion characteristics.

Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Cardiogenic shock is defined as persistent hypotension, accompanied by evidence of end organ hypo-perfusion. Percutaneous ventricular assist devices (PVADs) are used for the treatment of cardiogenic shock in an effort to improve hemodynamics. Impella is currently the most common PVAD and actively pumps blood from the left ventricle into the aorta. PVADs unload the left ventricle, increase cardiac output and improve coronary perfusion. PVADs are typically placed in the cardiac catheterization laboratory under fluoroscopic guidance via the femoral artery when feasible. In cases of severe peripheral arterial disease, PVADs can be implanted through an alternative access. In this article, we summarize the mechanism of action of PVAD and the data supporting their use in the treatment of cardiogenic shock.

Percutaneous coronary intervention in patients with cancer and readmissions within 90 days for acute myocardial infarction and bleeding in the USA.

AIMS: The post-discharge outcomes of patients with cancer who undergo PCI are not well understood. This study evaluates the rates of readmissions within 90 days for acute myocardial infarction (AMI) and bleeding among patients with cancer who undergo percutaneous coronary intervention (PCI). METHODS AND RESULTS: Patients treated with PCI in the years from 2010 to 2014 in the US Nationwide Readmission Database were evaluated for the influence of cancer on 90-day readmissions for AMI and bleeding. A total of 1 933 324 patients were included in the analysis (2.7% active cancer, 6.8% previous history of cancer). The 90-day readmission for AMI after PCI was higher in patients with active cancer (12.1% in lung, 10.8% in colon, 7.5% in breast, 7.0% in prostate, and 9.1% for all cancers) compared to 5.6% among patients with no cancer. The 90-day readmission for bleeding after PCI was higher in patients with active cancer (4.2% in colon, 1.5% in lung, 1.4% in prostate, 0.6% in breast, and 1.6% in all cancer) compared to 0.6% among patients with no cancer. The average time to AMI readmission ranged from 26.7 days for lung cancer to 30.5 days in colon cancer, while the average time to bleeding readmission had a higher range from 38.2 days in colon cancer to 42.7 days in breast cancer. CONCLUSIONS: Following PCI, patients with cancer have increased risk for readmissions for AMI or bleeding, with the magnitude of risk depending on both cancer type and the presence of metastasis.

Outcomes of percutaneous coronary interventions in cancer patients.

Introduction: There are numerous shared risk factors in the etiopathogenesis of coronary artery disease (CAD) and cancer both at epidemiologic and molecular level. Additionally, different modalities of treatment of cancer such as radiation, chemotherapy, immunotherapy, and hormonal therapies further increase the risk of CAD and acute coronary syndrome. Most large database analysis and single-center experiences have shown that cancer patients undergoing PCI are at an increased risk of in-hospital mortality, bleeding, repeat revascularization.Areas covered: In this review article the authors discuss the associations between CAD and cancer, challenges for PCI in cancer patients and outcome data.Expert opinion: Interventionists performing PCI on cancer patients should be cognizant of the heightened risk of bleeding, thrombosis, possible need for interruption of dual-antiplatelet therapy, and the increased risk of target lesion revascularization in this cohort. These risks may be partially mitigated by utilization of best practices such as the use of radial artery access, intravascular imaging for lesion assessment and stent optimization and avoidance of complex stenting strategies. Finally, it is of paramount importance to have a multidisciplinary approach consisting of the treating cardiologist, medical and/or surgical oncologist, and palliative medicine, and involve the patient and their family in making informed decisions.

Analysis of Subjective and Objective Screening Techniques as Predictors of Safety for Radial Artery Intervention.

BACKGROUND: There is no currently accepted standard in safety evaluation for radial artery intervention. We sought to compare the accuracy of various subjective and objective screening techniques in predicting safety for radial artery intervention. METHODS: Fifty-four patients in a prospective cohort study at a single institution underwent subjective Allen's test, objective Barbeau test, and several objective hand ultrasound techniques to assess safety for radial artery intervention. These results were then compared to the gold standard of conventional hand angiography to document complete palmar arch. Statistical analysis including sensitivity, specificity, positive predictive values, negative predictive values, and accuracy were calculated. RESULTS: Compared to hand angiography, the subjective Allen's test and the objective Princeps Pollicis Artery ultrasound demonstrated the comparable levels of sensitivity (100% vs. 96.7%, respectively), specificity (100% vs. 100%, respectively), and accuracy (97.2% vs. 97.1%, respectively). The objective Barbeau test demonstrated similar results (sensitivity of 100%, accuracy of 98.2%) with the exception of a lower specificity (50%). CONCLUSIONS: There is no currently accepted standard in safety evaluation for radial artery intervention. However, preliminary data suggest that certain subjective and objective techniques such as Allen's testing, Princeps Pollicis artery ultrasound, and Barbeau testing are comparable options in predicting palmar arch patency.

Utility of the guideliner catheter for percutaneous coronary interventions in patients with prior transcatheter aortic valve replacement.

The safety and utility of GuideLiner catheters in complex percutaneous coronary interventions (PCI) has been well established. Patients with prior trans-catheter aortic valve replacement especially with CoreValve, who present for PCI, pose a unique set of challenges. Not only does the operator often encounter difficulty with selective engagement of coronary ostia through the struts of the CoreValve, but also the complex nature of the underlying CAD in this high-risk population. We present a case series to illustrate the use of GuideLiner catheter as an adjunctive tool for PCI in this patient population.

Multimodality Intravascular Imaging to Evaluate Sex Differences in Plaque Morphology in Stable CAD.

OBJECTIVES: The aim of this study was to evaluate sex differences in plaque morphology in stable coronary artery disease (CAD) patients using a multimodality intravascular imaging approach. BACKGROUND: Differences in atherosclerotic burden and plaque morphology between men and women is a focus of treatment and preventative measures. METHODS: We retrospectively analyzed data from 383 patients with stable CAD who were referred for angiography and underwent optical coherence tomography. Among them, 128 also underwent intravascular ultrasound (IVUS)/near infrared spectroscopy. RESULTS: Of the 383 patients included in the study, 268 were men and 115 were women. Women tended to be older (66 ± 10 years of age vs. 62 ± 11 years of age; p = 0.002) and have more comorbidities including hypertension (97% vs. 90%; p = 0.031), diabetes with insulin use (18% vs. 10%; p = 0.043), obesity (body mass index 30 kg/m2 vs. 28 kg/m2; p = 0.022), and lower estimated glomerular filtration rate (88 ml/min/1.73 m2 vs. 98 ml/min/1.73 m2; p = 0.001). Optical coherence tomography data demonstrated that there was no sex difference in plaque morphology as characterized by maximum lipid arc, lipid length, lipid volume index, minimum cap thickness, incidence of thin cap fibroatheroma, microvessels, macrophages, and calcification. There was also no difference in maximal lipid core burden index at the 4-mm maximal segment as seen on near infrared spectroscopy. Plaque characteristics by IVUS were similar between men and women except for an increase in plaque burden in men compared to women in the reference segment (44.4 vs. 39.3; p = 0.031). After adjusting for age, body mass index, percutaneous coronary intervention history, and clinical risk factors, sex was not found to be an independent predictor of severe plaque burden by IVUS. CONCLUSION: Among men and women with stable CAD referred for coronary angiography, there was no difference in plaque characteristics as assessed by multimodality imaging. These findings, which are hypothesis generating, suggest that equally aggressive primary and secondary preventive efforts irrespective of sex must be undertaken.