News
Three Million Patient Study Shows Patients With Cancer At Higher Risk of Dying from Cardiovascular Disease As Compared to the General Population
A study led by Dr. Kathleen Sturgeon published in the European Heart Journal showed that in patients diagnosed with cancer, the majority of cardiovascular deaths in the United States occur in patients diagnosed with breast, prostate or bladder cancer. Additionally, the investigators demonstrated that patients with cancer are at a higher risk of dying from cardiovascular disease as compared to the general population.
COMPLETE Trial OCT Substudy: Non-Culprit Lesions with Vulnerable Plaque Morphology Found In Half of Patients with STEMI and Multivessel Disease
The results of the COMPLETE Optical Coherence Tomography Substudy were presented by Dr. Natalia Pinilla-Echeverri at the American Heart Association 2019 meeting. The substudy found that in patients with an ST-elevation myocardial infarction and multivessel coronary artery disease, half of the patients had a non-culprit lesion with vulnerable plaque morphology.
The COMPLETE trial previously demonstrated that routine angiography guided staged a percutaneous coronary intervention (PCI) of non-culprit lesions reduced the composite endpoint of cardiovascular death or myocardial infarction by 26%. However, whether the benefit of routine PCI of non-culprit lesions is, as a result, the non-culprit lesions having characteristics that were consistent with a vulnerable plaque is not known. Optical coherence tomography (OCT) is a form of intracoronary imaging that is able to identify vulnerable plaques. OCT is able to recognize thin cap fibroadenoma (TCFA), an indicator of a vulnerable plaque that is at risk of rupturing. The investigators wanted to identify the prevalence of TCFA in obstructive compared to non-obstructive non-culprit lesions.
In the COMPLETE trial, patients with a STEMI and multivessel disease who underwent successful PCI of the culprit lesion were randomized to either routine staged PCI of all suitable non-culprit lesions with the goal of complete revascularization regardless of whether there were clinical symptoms or evidence of ischemia or culprit-lesion revascularization only. Patients were deemed to have multivessel disease if they had angiographically significant non-culprit vessel disease of a vessel that was at least 2.5mm in diameter. A lesion was considered angiographically significant if it had at least 70% stenosis of the vessel diameter or 50-69% stenosis with a fractional flow reserve of less than 0.8. In this substudy, STEMI patients with stenosis of at least one non-culprit vessel with more than 70% stenosis that was suitable for OCT were identified. After randomization, multivessel OCT imaging was performed on vessels with non-culprit lesions that underwent PCI, additional vessels with or without target non-culprit lesions for PCI, and STEMI vessels with segments more than 50mm that were unstented.
A total of 93 patients and 425 lesions were included in this substudy. The baseline characteristics in the main study were similar to this imaging study. The average age was 61.3, 82.8% were male, 12.9% had diabetes, 64% had 1 residual diseased vessel and 36% had two or more residual diseased vessels. The non-culprit lesions were classified according to whether they had significant stenosis and whether they had a TCFA. Of the lesions with greater than 70% obstruction, 58 (38.7%) had a TCFA and 92 did not. Of the lesions with less than 70% obstruction, 74 (23.2%) had a TCFA and 201 did not. When assessing the prevalence of TCFAs per patient, the investigators found that half of the patients with TCFA had an obstructive non-culprit lesion that contained vulnerable plaque.
In an interview with Dr. Arzu Kalayci, Dr. Pinilla-Echeverri discussed the implications of the study. She said, “this is very important in the STEMI population because we believe the STEMI population has higher rates of future cardiovascular events. IT may all be related to the inflammatory response that is behind [this]. This is telling us that these patients had a definitely higher risk because they had vulnerable plaques far from the culprit segment. This is reassuring that acute coronary syndrome implies a diffuse pathophysiology with vulnerable plaque not only in the culprit segment but in places far away from the culprit lesion. These results support the findings in the COMPLETE trial.” However, this study does have its limitations. The substudy was observational and is affected by confounding and bias. The substudy was not powered to link clinical evens to morphology. Regardless, the findings of this study could potentially explain the benefit of routine PCI of obstructive non-culprit lesions in patients with STEMI and multivessel disease.
Click here to view the study slides.
Click here to listen to Dr. Kalayci and Dr. Pinilla-Echeverri.
Interim Results of The EVAPORATE Trial Indicate No Change in Low Attenuation Plaque Volume But A Reduction in Total Plaque Volume Following Treatment with Icosapent Ethyl
The interim results of EVAPORATE trial, a study on the effect of Icosapent Ethyl on coronary plaque progression in statin-treated patients with elevated Triglyceride (TG) level (200-499mg/dl), were presented by Dr. Matthew Budoff at the American Heart Association 2019 meeting. Dr. Budoff and his team found that in patients with coronary atherosclerosis treated with statins, the addition of Icosapent Ethyl (Vascepa) was not associated with a change in low attenuation plaque volume but was associated with a decrease in total plaque volume. However, these are preliminary findings and the trial is set for completion at 18 months.
Icosapent Ethyl, a high‐purity eicosapentaenoic acid (EPA) derivative, has been approved as an adjunct to diet for the reduction of TG levels in adults with elevated TG levels. Its utility has been associated with an increase in serum EPA levels, a lower serum TG level as well as a decrease in inflammatory markers. A prior trial investigated the effect of long-term eicosapentaenoic acid (1.8 g/d) on more than 18000 statin-treated patients, in Japan, showed a significant reduction (19%) in the relative risk of major coronary events.
In the EVAPORATE trial, statin-treated patients with coronary atherosclerosis (defined by narrowing≥20% in 1 coronary artery by either invasive angiography or multidetector computed tomography angiography (MDCTA)) and elevated serum TG levels (135-499mg/dl) were enrolled. Exclusion criteria included severe heart failure, hypersensitivity to contrast or fish and renal insufficiency. The primary endpoint of the study was progression rates of low attenuation coronary plaques as measured by MDCTA. The secondary endpoints were the quantitative changes in plaque morphology, inflammatory markers and the relationship between plaque vulnerability and these changes.
A total of 80 individuals participated in the study (40 randomized to receive Icosapent Ethyl and 40 to receive the placebo). Participants were evaluated at baseline, 3 and 9 months of the study. At baseline, each participant underwent a cardiac computed tomography angiography (CCTA) to evaluate plaque morphology and volume as well as its composition. At 9 months, compared to placebo, Icosapent Ethyl slowed low attenuation coronary plaque progression by 21% (p=0.469). Although the primary outcome was statistically insignificant, the study continues until 18 months. Secondary outcomes of the study were promising, including a reduction in total non-calcified plaque volume by 19% (p = 0.01) and a 42% (p <0.0004) reduction in total plaque volume.
In an interview with Dr. C. Michael Gibson, Dr. Budoff discussed the primary findings of the trial. He noted that the increase in serum EPA levels significantly increased in those receiving Icosapent Ethyl and this increase was associated with a coronary plaque regression as well as an anti-inflammatory effect.
This study limited by some points. First, the follow-up duration was shorter than prior studies. Second, the primary endpoint was not statistically significant at the interim time point. The ultimate result of this trial may further define the potential clinical benefits of Icosapent Ethyl on atherosclerotic disorders.
Click here to view the study slides.
Click here to listen to Dr. Budoff and Dr. Gibson discuss the findings of the study.
ISCHEMIA CKD: No Difference In Outcomes Between Medical and Invasive Approaches to Ischemia in Patients with End Stage Renal Disease
The results of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches – Chronic Kidney Disease were presented by Dr. Sripal Bangalore at the American Heart Association 2019 meeting. Dr. Bangalore and his team showed that in patients with moderate ischemia and end-stage renal disease, an initial invasive strategy with catheterization and possibly percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) did not lead to an improvement in clinical outcomes.
GALILEO-4D: Rivaroxaban-Aspirin Based Anti-Thrombotic Therapy Post-TAVR Protects From Valve Leaflet Motion Abnormalities Rivaroxaban based strategy led to decreased prosthetic valve leaflet thickening and motion reduction following TAVR performed for severe aortic valve stenosis
An expanded analysis of 231 patients from the GALILEO trial comparing rivaroxaban-aspirin based anti-thrombotic therapy with clopidogrel-aspirin based dual anti-platelet therapy post transcatheter aortic valve replacement (TAVR), has shown that the rivaroxaban based regimen protects from valve leaflet motion abnormalities. The rivaroxaban based strategy led to decreased prosthetic valve leaflet thickening and motion reduction following TAVR performed for severe aortic valve stenosis. Continue reading
DAPA-HF: Dapagliflozin Improves Heart Failure Outcomes in Patients With HFrEF Regardless of Diabetic Status
Dr. John McMurray presented the results of the DAPA-HF trial at the American Heart Association 2019 Meeting. The study, which was published in the New England Journal of Medicine, showed that dapagliflozin, an SGLT-2 inhibitor, can potentially be used to treat heart failure with reduced ejection fraction (HFrEF) in patients with and without type 2 diabetes.
BETonMACE: Trial Shows Novel BET Protein Inhibitor Apabetalone Is Safe and Could Potentially Be Used To Improve Cardiovascular Outcomes
During the American Heart Association 2019 meeting, Dr. Kosh Ray presented the results of the BETonMACE trial. Dr. Ray and his teams showed apabetalone, a BET protein inhibitor was safe and well-tolerated and could potentially be used to reduce the risk of major adverse cardiovascular events (MACE).
Phase 1 Trial Shows RUC-4 (A Novel Subcutaneous GPIIb/IIIa Inhibitor) Achieves Safe, Rapid and Effective Platelet Inhibition
The results of a phase 1 trial that evaluated the safety of RUC-4, a novel subcutaneous GPIIb/IIIa inhibitor, were presented by Dr. Dean Kereiakes at the American Heart Association 2019 meeting. The study showed that in healthy volunteers and subjects on aspirin with stable coronary artery disease (CAD), RUC-4 provided rapid and high-grade platelet inhibition that resolved within 2 hours.
GALILEO: Rivaroxaban Based Anti-thrombotic Strategy Associated with Increased Risk of Death or Thromboembolic Events and Bleeding Compared to Antiplatelet Based Strategy in Patients with TAVR
The results of the GALILEO trial were presented by Dr. George Dangas at the American Heart Association 2019 meeting. The trial, which was stopped early, showed that in patients with a successful transcatheter aortic valve replacement (TAVR), a rivaroxaban-based strategy was associated with excessive ischemic and bleeding events.
ISCHEMIA: No Reduction in Cardiovascular Event in Patients with Stable Coronary Artery Disease Who Undergo Invasive Therapy
The results of the ISCHEMIA trial were presented by Dr. Judith Hochman at the American Heart Association 2019 meeting. The study demonstrated that in stable patients, there was no difference in cardiac event rates in patients who underwent invasive procedures as compared to those who were managed conservatively.
COLCOT: Colchicine Reduced Cardiovascular Events in Patients with Recent Myocardial Infarction
The results of the COLCOT trial were presented by Dr. Jean-Claude Tardif at the American Heart Association 2019 conference and published in the New England Journal of Medicine. The study showed that in patients with a recent myocardial infarction, colchicine led to a significantly lower risk of ischemic cardiovascular events than placebo.
Blinded Post-PCI Physiologic Assessment Detected Residual Ischemia After Angiographically Successful Result The DEFINE PCI Study
The result of a study, presented at ACC 2019 in March, 2019 and recently published in JACC Interventional Cardiology, showed that despite angiographically successful percutaneous coronary intervention (PCI), physiological assessment detected residual ischemia in 1 out of 4 patients after coronary stenting. The majority of the cases were due to inappropriate focal lesions which seem amenable to treatment with additional PCI.
Cardiac Rehabilitation Is Associated With Decreased Hospitalization and Mortality After Cardiac Valve Surgery
Cardiac rehabilitation after cardiac valve surgery is associated with lower hospitalizations and mortality at one year. A recent cohort study of Medicare beneficiaries, published in JAMA Cardiology, revealed.
Treatment with Statins, RAAS Inhibitors and Platelet Inhibitors After CABG is Essential, While the Use of Beta-blockers is Questionable: Swedish Study Secondary prevention medications after coronary artery bypass grafting and long-term survival: a population-based longitudinal study from the SWEDEHEART registry
In a recent study published in the European Heart Journal, Erik Björklund et al. found that the secondary prevention medications, such as statins and renin-angiotensin-aldosterone system (RAAS) inhibitors, and platelet inhibitors used after coronary artery bypass grafting (CABG) are essential while the use of B-blockers had no association with survival and is questionable.
New 21,000 PCI Study Shows Same-Day Discharge Associated with Reduced Costs But No Difference in Mortality or Readmission Rates in Patients Undergoing Elective PCI
A study led by Dr. Jennifer Rymer published in the American Heart Journal suggested that same-day discharge after an elective percutaneous coronary intervention (PCI) is being increasingly adopted and is associated with reduced costs without an increase in hospital readmission rates or mortality. The data presented in this study would further support the increased adoption of same-day discharge after elective PCI in some patients.
REMEDIAL III: Urine Flow Rate Guided Hydration Is Superior to Left Ventricular End‐Diastolic Pressure Guided Hydration for Preventing Renal And/Or Pulmonary Edema in Interventional Cardiology Renal insufficiency following contrast media administration trial III: Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Rationale and design.
Findings of an ongoing REMEDIAL (REnal Insufficiency Following Contrast MEDIA Administration triaL) III trial have been published recently in Catheter Cardiovasc Interventions and were presented by Dr. Carlo Briguori from Naples, Italy at the TCT-2019 in San Francisco. The study showed that urine flow rate (UFR) guided hydration is superior to left ventricular end‐diastolic pressure (LVEDP)-guided hydration for preventing contrast-induced acute kidney injury (CIAKI) and/or acute pulmonary edema.
The COMPLETE Timing Substudy: A Randomized Trial of Complete Staged Revascularization Vs. Infarct Artery PCI Alone in Patients With Acute Myocardial Infarction and Multivessel Disease – Importance of Revascularization Timing
The results of a substudy of the COMPLETE Trial were presented at TCT 2019 by Dr. David Wood, an interventional cardiologist, and Professor of Medicine at the University of British Columbia, Canada. The analyses revealed that compared with culprit-lesion only PCI, the timing of complete revascularization, whether performed early during the index hospitalization or after discharge have similar benefits on major cardiovascular events.
EWTOPIA 75 Trial: Lowering LDL-Cholesterol with Ezetimibe Prevents Cardiovascular Events in the Elderly
Individuals older than 75 years treated with ezetimibe had a significantly lower risk of atherosclerotic cardiovascular events over 4 years compared with standard care, according to the results of the EWTOPIA 75 trial recently published in Circulation.
Meta-analysis Shows Reduced 1-Year Mortality with TAVR in Low-Risk Severe AS Patients
In a meta-analysis of RCTs comparing TAVR (Transcatheter Aortic Valve Replacement) versus SAVR (Surgical Aortic Valve Replacement) in low-risk patients with severe AS, TAVR was associated with a significantly lower risk of all-cause and cardiovascular mortality at 1 year follow up. The study conducted by Kolte et.al was recently published in the Journal of American College of Cardiology.
ADRIFT Trial: Low-Dose Rivaroxaban is Superior to Dual Antiplatelet Therapy for Controlling Thrombin Generation after Left Atrial Appendage Closure in Atrial Fibrillation Patients Results of ADRIFT trial presented at the ESC Congress 2019
According to the results of Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban in Atrial Fibrillation Treated with Left Atrial Appendage Closure (ADRIFT) trial, recently presented at the European Society of Cardiology (ESC) Congress 2019 by Prof. Dr. Montalescot, from Pitié-Salpêtrière Hospital, Paris, low dose rivaroxaban is superior to dual antiplatelet therapy (DAPT) in controlling thrombin generation in patients undergoing Left Atrial Appendage Closure (LAAC).
