Clinical Trials
Optimal IVUS Guidance for Stent Placement: A Clear Winner? Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers: The ULTIMATE trial
The results of the ULTIMATE trial, presented at the TCT conference 2018, have shown that IVUS-guided PCI is superior to angiography-guided PCI in the prevention of target vessel failure in an all-comers population. The study findings have been simultaneously published in the Journal of the American College of Cardiology. Continue reading
How Accurate is the Fractional Flow Reserve Derived From Routine Coronary Angiography? Results from TCT 2018, FAST-FFR study: Accuracy of Fractional Flow Reserve Derived From Coronary Angiography
The FAST-FFR study conducted by Fearon and his colleagues, and presented at the annual TCT conference 2018, has shown that Fractional Flow Reserve (FFRangio) measured from the coronary angiogram alone has a high sensitivity, specificity and accuracy compared with pressure-wire derived Fractional Flow Reserve (FFR). The results of this study were published ahead of print in Circulation. Continue reading
Corevalve Evolut R (Medtronic) and Edwards Sapien 3 (Edward Lifesciences) Valves Reveal Equivalence in Transcatheter Aortic Valve Implantation (TAVI) in a Head-to-Head Comparison Results From The SOLVE-TAVI Trial Presented at the 30th Annual 2018 TCT Conference
Results from an open-label, multi-center, 2×2 factorial design randomized trial powered for equivalence, comparing the self-expanding Corevalve Evolut R valve to balloon expandable Edwards Sapien 3 valve, have shown that the two valves were equivalent to each other in terms of decreasing all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation (p=0.02). Trial results presented at the 2018 TCTMD conference held at San Diego, California, also showed equivalence in a comparison between general anesthesia vs local anesthesia (with conscious sedation) in terms of decreasing all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury (p=0.02). Continue reading
Landmark COAPT trial Demonstrates the Benefit of Transcatheter Mitral-Valve Repair Using MitraClip in Patients with Heart Failure TCT 2018: Findings of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial
The spectacular results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial, presented at TCT 2018, show that transcatheter mitral valve approximation using the MitraClip, on a background of maximally tolerated guideline-directed medical therapy (GDMT) was superior to GDMT alone in the reduction of Heart Failure (HF) hospitalization and mortality in symptomatic HF patients with grade 3-4+ Mitral regurgitation (MR). These landmark findings were simultaneously published today in the New England Journal of Medicine. Continue reading
Polymer-Free Amphilimus-Eluting stents: A Novel Elution Technology Results of the ReCre8 study, TCT 2018
Polymer-free amphilimus-eluting stents (PF-AES) are non-inferior to permanent-polymer zotarolimus-eluting stents (PP-ZES) in terms of target-lesion failure at 12 months, according to the results of the ReCre8 study, presented by Pieter R. Stella, MD, Ph.D. (University Medical Center, Utrecht, the Netherlands) at TCT 2018. The results for the first RCT comparing PF-AES versus latest generation PP ZES in an all-comers PCI population were simultaneously published in Circulation. Continue reading
Polymer coated sustained-release Eluvia DES outshines non-polymer coated Zilver DES for femoropopliteal artery stenosis Clinical outcomes at 1 year presented at TCTMD 2018
A randomized global, prospective, multi-center, single-blind trial comparing the Eluvia paclitaxel-eluting stent (Boston Scientific) to Zilver PTX paclitaxel-eluting stent (Cook Medical) has shown that the Eluvia stent outperformed Zilver in terms of efficacy, which was defined as primary patency at 12 months. These findings, published in The Lancet, were presented by Dr. William Gray at the annual TCT 2018 conference held in San Diego today. Continue reading
SORT-OUT and BIONYX Successfully Demonstrate Non-Inferiority in the World of Drug-Eluting Stents Results from the 30th Annual TCT Conference 2018, San Diego
Findings from the SORT-OUT trial, presented at the 30th annual Transcatheter Cardiovascular Therapeutics (TCT) conference 2018 held at San Diego, showed that at 12 months, polymer free Biolimus A9-coated BioFreedom stent was non-inferior to the thin strut, biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population. Continue reading
Biodegradable Polymer Sirolimus- Eluting Stent Proven Non-Inferior to Durable-Polymer, Everolimus-Eluting Stent BIOSCIENCE 5 Year Outcomes: Results from ESC 2018
Results of the BIOSCIENCE study that were presented at the ESC Annual Congress by Dr. Thomas Pilgrim, University Clinic for Cardiology, Bern, Switzerland, show that the 5-year risk of target lesion failure among patients undergoing percutaneous coronary intervention (PCI) is similar after implantation of the ultrathin-strut, biodegradable-polymer sirolimus-eluting stents as compared with thin-strut, durable-polymer, everolimus-eluting stents. However, higher incidence of all-cause and non-cardiovascular mortality in patients treated with the biodegradable polymer sirolimus-eluting-stents as compared with the durable-polymer stents eluting everolimus warrant careful scrutiny in ongoing clinical trials. The announcement of the results of this trial at the ESC was accompanied by a publication in the Lancet. Continue reading
Coronary Microvascular Dysfunction: A Promising Therapeutic Target in Heart Failure with Preserved EF? PROMIS-HFpEF: Results from ESC 2018
PROMIS-HFpEF (PRevalence Of MIcrovascular dySfunction in Heart Failure with Preserved Ejection Fraction) is an echocardiographic trial showcasing a high prevalence of coronary microvascular dysfunction (CMD) in HFpEF and its association with systemic endothelial dysfunction (RHI, UACR) and markers of HF severity (NT-proBNP and RV dysfunction). The results of the trial were recently published in the European Heart Journal. Continue reading
Lorcaserin proven safe as weight loss agent in obese patients CAMELLIA-TIMI 61 trial: Results from ESC 2018, Munich
The selective serotonin 2c receptor agonist, Lorcaserin has been proven to be effective in the promotion of sustained weight loss through appetite suppression in obese and overweight patients, with no increase in cardiovascular events, according to the CAMELLIA-TIMI 61 (Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients–Thrombolysis in Myocardial Infarction 61) trial, presented at the ESC conference in Munich. Continue reading
Transcatheter Interatrial shunt device appears safe at 1 year for heart failure with preserved ejection fraction ESC 2018: REDUCE LAP HF-1, 1 year results from phase 2
The 1-year results of a phase 2, sham-controlled RCT have confirmed the safety of a transcatheter interatrial shunt device (IASD; Corvia Medical) with no significant cardiovascular or renal events as compared to those receiving sham control treatment. It has also confirmed the long-term patency of the device. The findings were presented at the ESC and have also been simultaneously published in JAMA Cardiology. Continue reading
Omega-3 fatty acid Supplements Show No Benefit in Cardiovascular Prevention in Diabetes Says ASCEND, the largest and longest placebo controlled trial of omega-3 fatty acids
A randomized trial in patients with diabetes without evidence of cardiovascular disease has shown there to be no significant difference in the risk of serious cardiovascular events in those administered omega−3 fatty acids as compared to placebo. Continue reading
Aspirin Vs Placebo In Cardiovascular Event Reduction In Diabetes ESC 2018: ASCEND trial
A randomized 15,480 patient strong UK based trial comparing Aspirin (ASA) versus placebo in diabetics has shown that the absolute reduction in cardiovascular events from aspirin is offset by a similar absolute increase in major bleeding. Continue reading
Conservative Management Should be First Line Therapy for SCAD ESC 2018: Canadian SCAD study
Spontaneous coronary artery dissection (SCAD) is an underdiagnosed, poorly misunderstood condition. The predisposing causes and management of this condition are still unclear. To throw light on this, the CANADIAN SCAD cohort study was a large, prospective, multicenter, observational, natural history study that enrolled 750 non-atherosclerotic SCAD patients from 22 centers (20 from Canada and 2 from the US). The key study objective was the analysis of cardiovascular outcomes within the hospital and long-term. Secondary outcomes included the assessment of clinical and angiographic characteristics of patients presenting with SCAD. Continue reading
Low Dose Rivaroxaban Plus Aspirin Reduces Major Adverse Limb Events in COMPASS A COMPASS subgroup analysis
According to a new subgroup analysis of the COMPASS trial published in the Journal of the American College of Cardiology, the prevention of Major Adverse Limb Events (MALE) is of utmost importance in patients with lower extremity Peripheral Arterial Disease (PAD) due to its poor prognosis. Additionally, it has been found that the aspirin and rivaroxaban 2.5mg twice daily combination leads to a significant reduction of Major Adverse Limb Events (MALE) in these patients.
