Month: September 2019
EXCEL Trial: Five-Year Data Suggests PCI Non-Inferior to CABG in Patients with Left Main Coronary Artery Disease
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 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.
AUGUSTUS Trial: Dual Therapy with P2Y12 Inhibitor and Apixaban Safer Than Triple Therapy or Dual Therapy with Warfarin in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
The results of a randomized controlled trial led by Dr. Renato Lopes presented at TCT 2019 and published in the New England Journal of Medicine showed that in patients with atrial fibrillation and a recent acute coronary syndrome or percutaneous coronary intervention who are treated with a P2Y12 inhibitor, an antithrombotic regimen that consists of apixaban without aspirin led to lower rates of bleeding and fewer hospitalizations without a significant difference in ischemic events as compared to a regimen that consists of two antiplatelet agents or a vitamin K inhibitor or both.
New 1,500 Patient Study Demonstrates Favorable 1-Year Mortality Rate in Mitral Valve-In-Valve Implantation in Patients With Failed Mitral Valve Surgery
The results of a combined analysis of the STS/ACC/TVT Registry and the Centers for Medicare and Medicare Services (CMS) were presented by Dr. Mayra Guerrero, an interventional cardiologist and Professor of Medicine at Mayo Clinic Hospital, at TCT 2019. The analysis suggests that a transcatheter mitral valve-in-valve implantation may be preferable to repeat mitral surgery and should be the standard of care in patients with favorable anatomy.
SCOPE I: ACURATE Neo (Self-Expanding TAVR System) Struggles to Have An Edge On SAPIEN 3 (Balloon-Expandable TAVR System)
Results of a randomized trial presented at TCT 2019 and simultaneously published in The Lancet, showed that TAVR with the self-expanding ACURATE neo (Boston Scientific) did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 (Edwards Lifesciences) in terms of early safety and clinical efficacy outcomes.
Novel Subcutaneously Administered GpIIb/IIIa Inhibitor (RUC-4) Exhibits Promising Potential As The First Point-of-Contact Therapy of STEMI First human use of a novel subcutaneous platelet GPIIb/IIIa inhibitor (RUC-4) for STEMI point of care treatment
Results of a new ongoing phase 1 study, presented at Transcatheter Cardiovascular Therapeutics (TCT) 2019 San Francisco, showed that as a first point-of-contact therapy for ST-elevation myocardial infarction (STEMI), a novel subcutaneous (SC) GpIIb/IIIa inhibitor, RUC-4, can achieve 80% of platelet inhibition within 15 minutes of the administration.
TWILIGHT Trial: Single Anti-Platelet Therapy (SAPT) Using Ticagrelor Reduces Bleeding Risk And Preserves Ischemia Prevention Post-PCI Following 3 months of dual anti-platelet therapy (DAPT) post-PCI, continuation of anti-ischemic pharmacotherapy with ticagrelor alone safer than extended DAPT
A randomized, double-blinded, placebo-controlled trial which enrolled 7119 high risk patients with coronary artery disease who had undergone recent percutaneous coronary intervention (PCI) has shown that, after 3 months of dual anti-platelet therapy (DAPT) using a P2Y12 receptor blocker (ticagrelor) and aspirin, continuing secondary prevention with a single anti-platelet therapy (SAPT) with ticagrelor alone reduces bleeding as compared to extended DAPT.
New Study Shows Levels of Circulating Cardiovascular Biomarkers Are Different in Men and Women
A study led by Dr. Emily Lau published in the Journal of the American College of Cardiology showed that there were significant differences in circulating biomarkers in men and women. These differences in biomarker levels may reflect the distinct pathways implicated in the pathogenesis of cardiovascular disease in men and women.
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.
Positive Correlation Found Between Combined Life-time Exposure of Decreased LDL-C and Low Systolic BP in Lowering the Risk of Cardiovascular Disease Mendelian randomization analyses involving approximately half a million participants reveals the association of lifelong genetic exposure to lower levels of low-density lipoprotein cholesterol and lower systolic blood pressure with lower cardiovascular risk
A recent study by Brian A. Ference et al. based on a UK Biobank study, published in JAMA, has shown that life-time exposure to decreased low-density lipoprotein cholesterol (LDL-C) levels and low systolic blood pressure (SBP) leads to a decreased lifetime risk of cardiovascular disease. Nonetheless, these findings do not constitute the quantified benefit of treating these risk factors in decreasing the life-time cardiovascular disease risk.
This randomized study included the data from 438, 952 individuals who were the participants of the UK Biobank study with the mean age of 65.2 years (range: 40.4 – 80.0 years) and 54.1% female participants. Participants were divided into a total of 4 groups, and 4 x 4 factorial reasoning was carried out. First participants were divided into 2 groups based on having a genetic LDL-C score being equal to or lower than, or higher than the median value. Second, they were further subdivided into 2 groups based on having their genetic systolic BP score being equal to, or lower than, or higher than the median value. The reference group further included 3 groups with each individual group having a higher LDL-C genetic score than the median, higher SBP scores than the median, and combined LDL-C and SBP genetic scores higher than the median, respectively. Differences in the plasma LDL-C, SBP, and cardiovascular event rates between the groups were compared to evaluate the correlations with the lifetime cardiovascular disease risk. The primary outcome included major coronary events which were characterized as a composite of coronary death, coronary revascularization, or nonfatal myocardial infarction. The key secondary outcomes were major cardiovascular events defined as the occurrence of a major coronary event or ischemic stroke.
When compared with the reference group, participants having LDL-C genetic scores higher than the median had 14.7-mg/dL lower LDL-C levels with an Odds ratio of 0.73 for major coronary events (95%CI: 0.70 – 0.75; P < 0.001). Participants with SBP genetic scores higher than the median had 2.9 mmHg lower SBP with an Odds ratio of 0.82 for major coronary events (95%CI: 0.79 – 0.85; P < 0.001). Finally, the participants in the group with both genetic scores higher than the median had 13.9 mg/dL lower LDL-C, 3.1 mmHg lower SBP, with an Odds ratio of 0.61 for major coronary events (95%CI: 0.59 – 0.64; P < 0.001). In a 4×4 factorial analysis, exposure to increasing genetic risk scores and lower LDL-C levels and SBP was associated with dose-dependent lower risks of major coronary events. In a meta-regression analysis, combined exposure to 38.67 mg/dL lower LDL-C and 10 mmHg lower SBP was associated with an Odds ratio of 0.22 for major coronary events (95%CI: 0.17 – 0.26; P < 0.001), and 0.32 for cardiovascular death (95%CI: 0.25 – 0.40; P < 0.001). These findings concluded the positive correlation of lifelong genetic exposure to lower LDL-C levels and lower SBP with the overall lower cardiovascular disease risk without any regard to the magnitude of benefit achieved after treating these risk factors.
There are several limitations to this study, including the lack of evaluation of risks and benefits of medications associated with lowering the LDL-C and SBP. Second, there is a lack of evidence proving that outcomes associated with naturally occurring lower LDL-C or SBP levels are the same as the outcomes associated with extrinsic drug treatment or other interventions to achieve similar plasma LDL-C or SBP levels. Hence, these study findings fail to quantify the amount of benefit gained from various treatments to lower LDL-C, SBP, or both.
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.
REVELATION Trial: Paclitaxel-Coated Balloon Angioplasty is Non-Inferior To The Routinely Conducted Drug-Eluting Stenting in STEMI Patients A 9 months follow-up Single-Centered Randomized Clinical Trial
According to a recent study based on the REVELATION Trial, conducted by Nicola S. Vos et al. and published in JACC, Paclitaxel-coated balloon angioplasty was documented to be non-inferior to the routine drug-eluting stenting (DES) in ST-segment elevation myocardial infarction (STEMI) patients.
HOPE 4: A Comprehensive Community-based Program Surpassing the Barriers in Improving BP Control and Associated Cardiovascular Disease Risk in 2 Middle Income Countries A successful 12-months follow-up open-labeled, cluster-randomized controlled trial
Significant improvement in blood pressure control and related cardiovascular disease (CVD) risk is seen as a result of a potentially effective and pragmatic comprehensive model of care conducted as HOPE 4 trial (Heart Outcomes and Prevention Evaluation-4) presented by Dr. JD Schwalm at the European Society of Cardiology (ESC) Congress 2019 and simultaneously published in The LANCET.
No significant association between myocardial viability & long-term survival benefit of CABG in patients with ischemic cardiomyopathy Results of a 10-year follow-up STICH trial & subsequent myocardial viability sub-study
According to a new study published in The New England Journal of Medicine (NEJM) based on a 10-year follow-up STICH trial, no association was found between myocardial viability as a long-term survival benefit of CABG in patients with ischemic cardiomyopathy.
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).
Dual Anti-thrombotic Therapy Safe For Patients with Atrial Fibrillation and Recent PCI:ENTRUST-AF PCI Results of the ENTRUST-AF PCI trial presented at the ESC Congress 2019
Results from a phase-IIIb, open-label, multi-center, randomized clinical trial comparing the safety of dual anti-thrombotic therapy (DAT) with triple anti-thrombotic therapy (TAT) for patients with atrial fibrillation who have undergone recent (4 hours – 5 days) percutaneous coronary intervention (PCI), have shown that the DAT regimen (Edoxaban plus a P2Y12 inhibitor) is non-inferior to Vitamin K antagonist(VKA) plus a P2Y12 inhibitor and aspirin or TAT regimen.
SYNTAXES Study: No Significant Difference In All-Cause Death At 10 Years Between PCI and CABG Results of a 10-year Follow-up Study presented at the European Society of Cardiology (ESC) Congress 2019
A follow-up of a multicenter, randomized controlled trial, the results of which were debuted at the European Society of Cardiology (ESC) Congress 2019, has shown that at 10 years, no statistically significant difference existed in all-cause mortality between percutaneous coronary intevention (PCI) using first-generation paclitaxel-eluting stents and coronary artery bypass grafting (CABG). However, CABG was shown to provide significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease.
