A recent meta-analysis of clinical trials with more than 100,000 patients has shown that the carotid intima-media thickness (cIMT) progression can be used as a surrogate marker for cardiovascular risk in the clinical trials. The results of this study published in Circulation. According to Dr. Willeit, the assessment of cIMT progression can provide a link for the development and license of new therapies for cardiovascular disease. Continue reading
A recent study by Dr. O’Donoghue, published in Circulation, shows that early aspirin discontinuation with continued P2Y12 inhibitor monotherapy, after the percutaneous coronary intervention (PCI), was associated with a significant reduction in major bleeding compared to dual antiplatelet therapy. This study did not show a significant increase in major adverse cardiovascular events (MACE) after aspirin discontinuation in the participants.
A recent study by Dr. Julinda Mehilli, M.D., published in Circulation journal, has shown that in patients undergoing elective percutaneous coronary intervention (PCI), pretreatment strategy with the intensified prasugrel loading does not differ from standard clopidogrel loading dose in terms of Safety and Efficacy. According to the trial, both strategies can be safely applied among patients undergoing elective PCI.
A trial led by Dr. Holger Thiele showed that there was no difference in outcomes by 30 days when comparing the use of self-expandable and balloon-expandable valves in transcatheter aortic valve implantation (TAVI). The findings of this study published in the European Heart Journal suggest that both can be safely used in the majority of the population.
In an original investigation by Dr. Alexander R. van Rosendael et al recently published in JAMA Cardiology, it was found that the higher-density calcified plaque, referred to as 1K plaque was associated with a reduced risk for future Acute Coronary Syndromes (ACS). The authors also support the hypothesis of plaque stabilization with coronary calcium with the results of this analysis of Incident Coronary Syndromes Identified by Computed Tomography (ICONIC) study and are considerate of different risk stratifications that can be detected in atherosclerotic plaque beyond its burden. Continue reading
A post-hoc analysis of the Drug-Eluting Stents Versus Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) trial was recently published in Circulation: Cardiovascular Interventions. The study led by Dr. Faisal Latif showed that in patients undergoing percutaneous coronary intervention (PCI) of a de novo saphenous vein graft lesion, there was no difference in target vessel failure at 12 months between the stent-only and balloon-stent group. However, stent thrombosis and target vessel myocardial infarction (MI) rates were lower in the stent-only group over a longer duration of follow up.
A recent study by Dr. Kilic, published in the American Heart Association Journal, showed similar adverse outcomes in the 1-year survival, rejection rates, and complications of patients who received a heart transplant using hepatitis C-positive (HCV+) donors whereas those using hepatitis C-negative donors.
A randomized controlled trial led by Dr. Seung-Yul Lee published in Circulation: Cardiovascular Intervention showed that in patients who required percutaneous coronary intervention, the use of optical coherence tomography (OCT) to help guide bioresorbable vascular scaffold (BVS) implantation did not reduce the incidence of nonoptimal deployment as compared to angiography guided BVS implantation.
The study by Dr. Ajijola, published in JAMA Cardiology, found that elevated coronary sinus neuropeptide Y (NPY) level is associated with adverse cardiovascular events in stable patients with chronic heart failure and therefore, it may have prognostic value in this population.
Increased cardiac sympathetic signaling has been associated with adverse cardiovascular outcomes. Biomarkers of the sympathetic system are of significant interest in the assessment of cardiovascular outcomes. NPY is one of the circulating catecholamines, which may predict the risk of death in patients with chronic heart failure.
Dr. Ajijola and his colleagues conducted a prospective observational cohort study at a single-center, tertiary care hospital. They observed 105 patients with stable heart failure undergoing elective cardiac resynchronization therapy (CRT) device implantation between 2013 and 2015. Patients with NYHA class I, severe aortic stenosis, cardiac surgery within prior 90 days, severe obstructive pulmonary disease requiring oxygen or with recent decompensation (< 30 days), current pregnancy, primary pulmonary hypertension, continuous intravenous drug infusion for heart failure, and life expectancy under 6 months were excluded from the study. At the time of the intervention, the coronary sinus blood sample was taken and checked for the NPY levels. Patients were evaluated for major adverse cardiovascular events (MACE) as well as responses to CRT. Composite endpoint was defined as death, cardiac transplant (OHT), or ventricular assist device (VAD) placement.
The results of the study showed that NPY levels of coronary sinus were associated with prognostic implications in patients with heart failure. 20 out of 105 (19%) patients showed composite endpoints at a median follow-up of 29 months. Also, the NPY levels of greater than 130 pg/mL were associated with worse outcomes compared with those with lower levels (HR, 8.9; 95% CI, 3.1 – 25.7; P < 0.001). The results remained significant even after adjusting for age, eGFR, and LVEF (HR, 9.5; 95% CI, 2.92 – 30.5; P < 0.001). According to Dr. Ajijola, “Coronary sinus NPY levels may identify patients in whom close clinical monitoring and more aggressive interventions are needed to prevent adverse events. It may also identify those in whom CRT is likely to be ineffective, and such patients may be considered sooner for OHT or VAD.”
This study is limited by some points. First, although NPY levels were irrespective of CRT response, the presence of CRT devices limits the external validity of the study. Second, the sample size was small for formal statistical validation of the study including the NPY thresholds. Future studies are warranted to further validate the results of this study and to clarify the prognostic value of NPY levels.
A cross-sectional observational study enrolling 223 patients with 3-vessel coronary artery disease, has shown that compared to conventional invasive coronary angiography, a noninvasive physiology assessment using fractional flow reserve CT scanning (FFRCT or multi-slice CT scanning) changed heart team’s treatment decision-making and procedural planning in 1/5th of the patients.
The SYNTAX III REVOLUTION Trial was a randomized, multi-center study which randomized two heart teams to make a treatment decision between percutaneous coronary interventions (PCI) and coronary artery bypass grafting (CABG) using either coronary computed tomography angiography (CTA) or conventional invasive angiography while blinded to the other imaging modality. The study included patients with complex coronary artery disease, defined as, left main (isolated, or associated with 1, 2 or 3 vessel disease) or de novo 3-vessel coronary artery disease (DS ≥50%), who were able to receive cardiac CT with a multi-slice CT scanner. Coronary CTA was performed with the GE Revolution CT scanner that has a nominal spatial resolution of 230 microns along the X–Y planes, a rotational speed of 0.28 s, and a Z-plane coverage of 16 cm enabling to image the heart in one heartbeat. Patients with concomitant atrial fibrillation, cardiac valve disease and prior history of PCI or CABG were excluded from the study. The primary outcome was the inter-rater agreement (assessed by Cohen’s Kappa Kappa; a value of 0.82) on revascularization strategy of two heart teams by employing the use of either an “Angio-first” algorithm or a “CT First” algorithm 1 to 2 weeks after patient enrollment. The addition of FFRCT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%. With conventional angiography as a reference, FFRCT assessment resulted in reclassification of 14% of patients from intermediate and high to low SYNTAX score tertile.
The American and European guidelines recommend a heart team based approach for the decision-making process regarding the revascularization strategy and recommend the evaluation of the anatomical complexity using the SYNTAX score. Patients with SYNTAX scores >34 have been found to do much better with bypass surgery than those with lower SYNTAX scores. The SYNTAX scores can be divided into three tertiles. Higher scores signify complex conditions and indicate greatest risks to patients undergoing PCI. Calculation of the SYNTAX score takes into account complex lesions including bifurcations, chronic total occlusions, thrombus, calcification, and small diffuse disease with a total of 11 measures of lesion complexity. The score ranges from 0 to greater than 60 in very complex coronary anatomy.
Previously validated SYNTAX II score utilizes SYNTAX I score and then combines it with clinical prognostic variables such as age, creatinine clearance, gender, left main vessel involvement, left ventricular ejection fraction, chronic obstructive pulmonary disease (COPD) and peripheral vascular disease (PVD) in order to guide selection between PCI and CABG for patients with multivessel coronary disease. The results of the SYNTAX III Trial suggest the potential feasibility of a treatment decision-making and planning that stems from a non-invasive imaging modality and clinical information.
In an autopsy-based, histopathological analysis of stented coronary lesions, severe calcification was an independent risk factor for delayed strut coverage and healing after newer-generation DES. The report of the study led by Torri was recently published in the European Heart Journal.
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.
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.
A registry-based cohort study including 72,660 Medicare patients with and without atrial fibrillation (AF) who underwent non-apical transcatheter aortic valve replacement (TAVR) from 2014 to 2016, has shown that, TAVR patients with new-onset AF have the highest rate of all-cause mortality (32%) compared to patients with pre-existing or no AF (23.3% and 12.8%, respectively). New-onset AF was also associated with an increased risk of bleeding, stroke and heart failure (HF) hospitalizations.
A randomized, double blind, placebo-controlled, phase II clinical trial studying the effect of a novel protein proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis inhibitor (inclisiran) on serum low density lipoprotein cholesterol (LDL-C) levels has shown that twice a year subcutaneous injections of inclisiran leads to a sustained dose-dependent reduction in serum LDL-C levels over a period of 1 year.
New findings from the COAPT study were just published in Circulation and presented at TCT 2019 by Dr. Suzanne J. Baron. The findings of the study suggest that in patients with symptomatic heart failure and secondary mitral regurgitation, transcatheter mitral valve repair (TMVr) increases life expectancy and quality-adjusted life years (QALY) as compared with guideline-directed medical therapy.
Findings from the ongoing PARTNER 3 trial were published in the Journal of the American College of Cardiology and presented at TCT 2019 by Dr. Suzanne J. Baron. The findings of this study further support the use of transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement (SAVR).
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 results of a randomized controlled trial led by Dr. Gregg W. Stone presented at TCT 2019 and published in the New England Journal of Medicine showed that in patients with left main coronary artery disease of low or intermediate complexity, there was no significant difference in the composite endpoint of death, stroke, or myocardial infarction at 5 years in patients who received either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
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.