A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes

Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.

Start Date01 Feb 2002

Sponsor / Collaborator-

100 Clinical Results associated with Manidipine Hydrochloride/Delapril Hydrochloride

100 Translational Medicine associated with Manidipine Hydrochloride/Delapril Hydrochloride

100 Patents (Medical) associated with Manidipine Hydrochloride/Delapril Hydrochloride

Literatures (Medical) associated with Manidipine Hydrochloride/Delapril Hydrochloride

01 Sep 2010·European cytokine networkQ4 · MEDICINE

The rise and fall of intermittent interleukin-2 therapy in HIV infection.

Q4 · MEDICINE

Article

Author: Guido Poli ; Giuseppe Tambussi ; Giulia Della Chiara ; Claudio Fortis

In 1995, a breakthrough paper showed that intermittent cycles of interleukin-2 (IL-2), together with suboptimal ART, caused an unprecedented, stable increase in CD4+ T cell counts, without altering the steady state levels of viremia. At the time, this was somewhat obscured by the first successes of combination antiretroviral therapy (cART). However, since then, numerous studies have confirmed this basic finding, opening up a new perspective in the long-term management of chronic HIV infection. One of the benchmarks of this experimental treatment is the expansion of CD4+CD25+ T lymphocytes probably including T regulatory cells (Tregs). Based on these encouraging findings, two major phase III clinical trials, ESPRIT and SILCAAT, involving thousands of patients worldwide, were launched and continued over several years. Unfortunately, they both resulted in the highly unexpected, yet unequivocal, outcome of a lack of a protective effect of IL-2-expanded CD4+ T cells on HIV disease progression towards the acquired immunodeficiency syndrome (AIDS) or death. In addition, there was the suggestion of an increase in certain deleterious effects on treated patients in terms of cardiovascular and inflammatory events. While IL-2 therapy is unlikely to be studied any further in the context of HIV infection, other cytokines, such as IL-7, are still being tested in the hope of more promising results.

01 Mar 2010·Journal of HIV therapy

SILCAAT and ESPRIT: taking stock.

Communications

Author: Gazzard, Brian

01 Jan 2004·American journal of cardiovascular drugs : drugs, devices, and other interventionsQ4 · MEDICINE

Therapeutic Use of Intravenous Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention

Q4 · MEDICINE

Review

Author: Juan F. Granada ; Neal S. Kleiman

Eptifibatide, a molecule isolated from the venom of the southeastern pygmy rattlesnake, selectively inhibits the platelet receptor IIb/IIIa. The safety and clinical efficacy of eptifibatide in patients undergoing percutaneous coronary intervention (PCI) was first evaluated in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) trial. In this study, the primary combined endpoint (composite of death, myocardial infarction [MI] or target vessel revascularization [TVR] at 30 days) occurred in 9.6% of the patients assigned to eptifibatide bolus followed by the 4-hour infusion versus 12.2% in the placebo group (p = 0.67). In the IMPACT-II trial, two different eptifibatide dosages were studied in 4011 patients undergoing elective PCI. The primary endpoint (death, MI, TVR or stent placement for threatened vessel closure at 30 days) occurred in 11.6% in the placebo group versus 9.1% in the 135/0.5 eptifibatide group (p = 0.035) and 10% in the 135/0.75 eptifibatide group (p = 0.18). The Enhanced Suppression of Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial studied a dose of eptifibatide 3- to 4-fold higher than that used in IMPACT II trial in patients undergoing non-emergent coronary artery stenting (two 180 microg/kg bolus doses 10 minutes apart). The 6-month composite endpoint (death, MI, TVR and 'bailout' eptifibatide use) occurred in 18.3% of patients in the placebo group versus 14.2% in the eptifibatide group (p = 0.008) and was maintained at 12 months (22.1% in the placebo group vs 17.5% in the eptifibatide group, p = 0.0068). The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) study in 10 948 patients was designed to study the effect of eptifibatide in the treatment of acute coronary syndromes (ACS) using two different dosages (180 microg/kg bolus followed by an infusion of either 1.3 microg/kg/min or 2 microg/kg/min. The primary endpoint, a composite of death or MI at 30 days, occurred in 15.7% of placebo-treated patients and 14.2% of eptifibatide-treated patients (p = 0.042). This difference was maintained at 7 days (11.6% in the placebo group vs 10.1% in the eptifibatide group, p = 0.016) and at 30 days (15.7% in the placebo group vs 14.2% in the eptifibatide group). In the eptifibatide studies, the rates of major bleeding were 0.7% (0.5% in the control group) in ESPRIT and 2.1% (1.3% in the placebo group) in PURSUIT. The incidence of intracranial bleeding was 0.2% in ESPRIT (0.1% in the placebo group) and 0.7% in PURSUIT (0.8% in the placebo group). Significant thrombocytopenia (platelet count <20 000/microL) was reported in 0.2% of the patients receiving eptifibatide in the ESPRIT trial (0% in the placebo group) and in <1% in PURSUIT (<1% in the placebo group). In summary, several clinical trials have demonstrated a clear-cut reduction in a variety of ischemic events in patients receiving eptifibatide as adjunctive pharmacotherapy during PCI.

News (Medical) associated with Manidipine Hydrochloride/Delapril Hydrochloride

18 Jul 2024

·www.prnewswire.com

Abbott Reports Second-Quarter 2024 Results and Raises Full-Year Guidance

Sales of $10.4 billion driven by strong underlying base business performance Reported sales growth of 4.0 percent; organic sales growth for underlying base business of 9.3 percent1, led by double-digit growth in Medical Devices Continues to strengthen portfolio with new product approvals ABBOTT PARK, Ill., July 18, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced financial results for the second quarter ended June 30, 2024. Second-quarter GAAP diluted EPS of $0.74 and adjusted diluted EPS of $1.14, which excludes specified items. Abbott raised its full-year 2024 EPS guidance range. Abbott projects full-year diluted EPS on a GAAP basis of $3.30 to $3.40 and projects adjusted diluted EPS of $4.61 to $4.71. Abbott narrowed its full-year 2024 organic sales growth guidance range, excluding COVID-19 testing-related sales, to 9.5% to 10.0%, which represents an increase at the midpoint of the range2. In April, Abbott announced U.S. Food and Drug Administration (FDA) approval of the Esprit™ below-the-knee (BTK) system, a breakthrough innovation for people living with peripheral artery disease. This system is designed to keep arteries open and deliver a drug to support vessel healing prior to completely dissolving. In June, Abbott announced U.S. FDA clearance for two new over-the-counter continuous glucose monitoring systems — Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology3. In June, Abbott obtained CE Mark for its AVEIR® dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pacemaker system that treats people with abnormal or slow heart rhythms. During the first half of 2024, Abbott announced 10 new growth opportunities coming from the company's highly productive R&D pipeline. These include a combination of new product approvals and new treatment indications. "We achieved another quarter of strong growth in our underlying base business," said Robert B. Ford, chairman and chief executive officer, Abbott. "We have a lot of positive momentum heading into the second half of the year and are raising our full-year guidance." SECOND-QUARTER BUSINESS OVERVIEW Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, the impact of discontinuing the ZonePerfect® product line in the Nutrition business, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI) during the first year post-acquisition, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests. Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates. Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue. *Reflects the impact of discontinuing the ZonePerfect® product line in the Nutrition business in March 2024 and the acquisition of CSI on April 27, 2023. Organic sales growth excludes the impact of the acquired business from January through April 2024. Worldwide Nutrition sales increased 3.5 percent on a reported basis and 7.5 percent on an organic basis in the second quarter. In Pediatric Nutrition, global sales increased 3.4 percent on a reported basis and 5.0 percent on an organic basis. Sales in the U.S. reflect continued market share gains in the infant formula business. In Adult Nutrition, global sales increased 3.7 percent on a reported basis and 9.9 percent on an organic basis, which was led by strong growth of Ensure®, Abbott's market-leading complete and balanced nutrition brand. As expected, Diagnostics sales growth in the second quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales4. Worldwide COVID-19 testing sales were $102 million in the second quarter of 2024 compared to $263 million in the second quarter of the prior year. Excluding COVID-19 testing-related sales, global Diagnostics sales increased 1.8 percent on a reported basis and 5.9 percent on an organic basis. Excluding COVID-19 testing-related sales, global Core Laboratory Diagnostics sales increased 3.0 percent on a reported basis and 8.8 percent on an organic basis, led by continued strong adoption of Abbott's Alinity® family of diagnostics systems and testing portfolios. Established Pharmaceuticals sales increased 0.6 percent on a reported basis and 8.1 percent on an organic basis in the second quarter. Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott's branded generics product portfolio. Sales in these geographies decreased 0.2 percent on a reported basis and increased 8.8 percent on an organic basis, led by growth in several geographies and therapeutic areas, including cardiometabolic, gastroenterology, and central nervous system/pain management. Worldwide Medical Devices sales increased 10.2 percent on a reported basis and 12.1 percent on an organic basis in the second quarter, including double-digit organic growth in both the U.S. and internationally. Sales growth was led by double-digit growth in Diabetes Care, Electrophysiology, and Structural Heart. Several recently launched products and new indications contributed to the strong performance, including Amplatzer® Amulet®, Navitor®, TriClip®, and AVEIR®. In Electrophysiology, sales grew 13.3 percent on a reported basis and 16.7 percent on an organic basis, which included double-digit growth in catheters and cardiac mapping-related products, and double-digit growth in all major geographic regions. In Diabetes Care, FreeStyle Libre sales were $1.6 billion, which represents sales growth of 18.4 percent on a reported basis and 20.4 percent on an organic basis. ABBOTT'S EARNINGS-PER-SHARE GUIDANCE Abbott projects full-year 2024 diluted earnings per share under GAAP of $3.30 to $3.40. Abbott forecasts specified items for the full-year 2024 of $1.31 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $4.61 to $4.71 for the full-year 2024. Abbott projects third-quarter 2024 diluted earnings per share under GAAP of $0.85 to $0.89. Abbott forecasts specified items for the third-quarter 2024 of $0.33 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $1.18 to $1.22 for the third quarter 2024. ABBOTT DECLARES 402ND CONSECUTIVE QUARTERLY DIVIDEND On June 14, 2024, the board of directors of Abbott declared the company's quarterly dividend of $0.55 per share. Abbott's cash dividend is payable Aug. 15, 2024, to shareholders of record at the close of business on July 15, 2024. Abbott has increased its dividend payout for 52 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years. About Abbott: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and YouTube. Abbott will live-webcast its second-quarter earnings conference call through its Investor Relations website at at 8 a.m. Central time today. An archived edition of the webcast will be available later in the day. — Private Securities Litigation Reform Act of 1995 — A Caution Concerning Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended Dec. 31, 2023, and are incorporated herein by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Specified items reflect intangible amortization expense of $471 million and other net expenses of $278 million associated with restructuring actions, acquisitions, a divestiture and other net expenses. See table titled "Details of Specified Items" for additional details regarding specified items. Specified items reflect intangible amortization expense of $498 million and other net expenses of $68 million associated with restructuring actions, costs associated with acquisitions and other net expenses. See table titled "Details of Specified Items" for additional details regarding specified items. Specified items reflect intangible amortization expense of $943 million and other net expenses of $405 million associated with restructuring actions, acquisitions, a divestiture and other net expenses. See table titled "Details of Specified Items" for additional details regarding specified items. Specified items reflect intangible amortization expense of $989 million and other net expenses of $125 million associated with restructuring actions, costs associated with acquisitions and other expenses. See table titled "Details of Specified Items" for additional details regarding specified items. A reconciliation of the second-quarter tax rates for 2024 and 2023 is shown below: A reconciliation of the year-to-date tax rates for 2024 and 2023 is shown below: SOURCE Abbott

AcquisitionFinancial Statement

29 Apr 2024

·www.prnewswire.com

Abbott's Breakthrough Dissolving Stent Receives FDA Approval for Arteries Below the Knee

More than 20 million people in the U.S. are living with peripheral artery disease (PAD) yet there have been limited treatment options The first-of-its-kind Esprit™ BTK Everolimus Eluting Resorbable Scaffold dissolves over time after it has opened blocked arteries below the knee (BTK) The Esprit BTK System is a dissolving stent that offers the possibility of better outcomes for people with the most severe form of PAD ABBOTT PARK, Ill., April 29, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK). The Esprit BTK System is designed to keep arteries open and deliver a drug (Everolimus) to support vessel healing prior to completely dissolving. Until today, there were no stents or drug-coated balloons approved for use below the knee in the U.S. The standard of care has been balloon angioplasty, which relies on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow. However, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many instances the vessels become blocked again, requiring additional treatment. The Esprit BTK System is a first-of-its-kind dissolvable stent and is comprised of material similar to dissolving sutures. The device is implanted during a catheter-based minimally invasive procedure via a small incision in the leg. Once the blockage is open, the Esprit BTK scaffold helps heal the vessel and provides support for approximately three years until the vessel is strong enough to remain open on its own. "The FDA approval of Abbott's Esprit BTK System marks a significant milestone in our fight against peripheral artery disease below the knee and should usher in a new era of improved outcomes for people worldwide," said Sahil A. Parikh, M.D., Columbia University Irving Medical Center, and one of the principal investigators of the LIFE-BTK trial. "By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy." The LIFE-BTK trial, which evaluated Abbott's Esprit BTK System, was presented in October 2023 as a late-breaking clinical trial at the 35th Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco and simultaneously published in the New England Journal of Medicine. The results of the trial demonstrated that the Esprit BTK System reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current standard of care. PAD is highly prevalent, yet many people have never heard of the condition. More than 20 million people in the U.S. are living with this painful disease and only 10% of those people have been diagnosed.1,2 CLTI is a serious form of PAD that occurs when arteries become clogged with plaque, preventing blood flow and oxygen from reaching the lower leg and foot. People living with CLTI often experience extreme pain, open wounds that don't heal and, in some cases, may have to resort to amputation. Over a five-year period, CLTI has a lower survival rate than breast, colorectal and prostate cancer combined.3 "At Abbott, we've recognized the significant burden of disease and limited treatment options available for people living with the most severe form of PAD. That's why we're revolutionizing treatments with resorbable scaffold technology below the knee," said Julie Tyler, senior vice president of Abbott's vascular business. "Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives." As part of Abbott's continued commitment to helping all people live healthier lives, PAD and CLTI education information can be found at . Physicians can find more information at . For U.S. important safety information on Esprit BTK System, visit: . About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and YouTube. 1 Fowkes, F.G., et al., Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet, 2013. 382(9901): p. 1329-40–––. 2 Nehler, M.R., et al., Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J Vasc Surg, 2014. 60(3): p. 686-95 e2. 3 Li J, Varcoe R, Manzi M, Kum S, Iida O, Schmidt A, Shishehbor MH. Below-the-Knee Endovascular Revascularization: A Position Statement. JACC: Cardiovascular Interventions. 2024; ISSN 1936-8798 SOURCE Abbott

Drug ApprovalAHA

31 Oct 2023

·www.prnewswire.com

Second Round of Late-Breaking Clinical Trial Results Announced at VIVA23

LAS VEGAS, Oct. 31, 2023 /PRNewswire/ -- The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the second of four Late-Breaking Clinical Trial sessions at the VIVA23 conference, hosted at Wynn Las Vegas. VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of talks and live case presentations from clinical centers around the world. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this afternoon's 3 late-breaking clinical trial presentations. Wound Assessment and Outcomes in the LIFE-BTK Randomized Controlled Trial Evaluating the Esprit BTK™ Drug-Eluting Resorbable Scaffold Presented by: Raghu Kolluri, MD, MS Results from Abbott's LIFE-BTK randomized clinical trial (RCT) demonstrate that Esprit BTK (Abbott) reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current state of care. Abbott's landmark LIFE-BTK trial met its primary safety and efficacy endpoints, demonstrating that Esprit BTK offers significant advancements in opening blocked below-the-knee arteries and maintaining patency compared to balloon angioplasty alone. LIFE-BTK data underscore the profound impact that Esprit BTK, if approved, could have for the more than 200 million people worldwide with peripheral artery disease (PAD). LIFE-BTK is the first RCT that collected comprehensive wound data from the chronic limb-threatening ischemia (CLTI) population, people who have a serious form of PAD with severe blockage in the arteries of the lower extremities, which reduces blood flow. In the LIFE-BTK trial, wound assessment was not a prespecified powered primary or secondary endpoint but rather a prespecified descriptive endpoint. It is important for the trial as there is not much evidence from other trials assessing wounds. The trial offers the largest ischemic wound data set to date, collected systematically and adjudicated independently in a blinded fashion. Wound care is an important aspect of CLTI care, as CLTI can lead to nonhealing wounds due to the reduced blood flow to the affected limb. Wound care is critical to prevent infections, promote healing, prevent further tissue damage, and minimize amputation rates. The wound data were assessed by experts at the wound core laboratory. The healing of the index wounds showed improvement in both arms, and the occurrence of new wounds was comparable, with no statistical difference between arms. This result highlights the fact that revascularization is not the sole factor influencing wound healing. Additionally, it has been further demonstrated that the resorbable scaffold with an olimus-based antiproliferation drug was not associated with any disruption in wound healing over a period of time. RESOLV FIH 6-Month Results by Rutherford Classification Presented by: Marianne Brodmann, MD The Magnitude thin-strut 98-μm drug-eluting bioresorbable scaffold (BRS; R3 Vascular) offers the potential for higher vessel patency in the treatment of below-the-knee arteries. The 6-month results from an ongoing first-in-human study are presented for 30 treated patients, stratified by the baseline Rutherford classification. Patients included in the RESOLV study were Rutherford category 3 to 5, with lesions up to 12 cm in the tibioperoneal trunk, posterior tibial artery, anterior tibial artery, and peroneal artery. Angiography and intravascular ultrasound (IVUS) were used to identify vessel characteristics and morphology. At baseline, the Rutherford category 3 cohort (5/30, 17%) had a total of five lesions treated, a mean age of 76.8 (± 6.0) years, and a mean body mass index (BMI) of 23.9 (± 3.5) kg/m2. The mean proximal vessel diameter by IVUS was 4.1 mm, and the mean in-segment diameter stenosis was 80.1% prior to treatment, decreasing to 16.6% following scaffold implantation and increasing slightly to 23.0% at 6 months. Rutherford category 4 cohort (3/30, 10%), at baseline, had a total of three lesions treated, a mean age of 74.3 (± 6.3) years, and a mean BMI of 32.7 (± 3.7) kg/m2. The mean proximal vessel diameter by IVUS was 4.1 mm, and the mean in-segment diameter stenosis was 77.7% prior to treatment, decreasing to 7.9% following scaffold implantation and increasing slightly to 25.4% at 6 months. At screening, the Rutherford category 5 cohort (22/30, 73%) had a total 23 lesions treated, a mean age of 74.5 (± 5.8) years, and a mean BMI of 28.2 (± 5.8) kg/m2. The mean proximal vessel diameter by IVUS was 4.3 mm, and the mean in-segment diameter stenosis was 78.4% prior to treatment, decreasing to 14.8% following scaffold implantation and increasing slightly to 28.8% at 6 months. Overall, across severity of PAD by Rutherford class, significant improvement was seen following placement of the Magnitude BRS, with sustained patency by angiography at 6 months. IN.PACT AV Access Trial Thrombosis Predictors Presented by: Robert Lookstein, MD, MHCDL Thrombotic events in arteriovenous fistulas (AVFs) used for dialysis are associated with high rates of access loss, additional procedure cost, poor long-term patency, and higher mortality rates. However, patient, lesion, and procedural characteristics associated with thromboses are not well understood and are rarely reported in prospective randomized controlled trials (RCTs). This post hoc analysis reports differences in IN.PACT AV Access study participants who eventually had a thrombosis versus those who did not. The IN.PACT AV Access study is a multicenter, single-blinded RCT of end-stage kidney disease patients with de novo or obstructive native AVF from the United States, Japan, and New Zealand. Serious adverse events, including access circuit thrombosis, were independently adjudicated. A multivariable analysis was conducted to assess factors associated with access circuit thrombosis through 36 months. The cumulative incidence of access circuit thrombosis through 36 months in the IN.PACT AV Access study was 8.2% in the drug-coated balloon (DCB) group compared to 18.3% in the percutaneous transluminal angioplasty (PTA) group based on Kaplan-Meier estimates (log-rank P = .040). A post hoc multivariable analysis of all participants suggested that predictors of a higher risk of access circuit thrombosis were two or more reinterventions in the year prior to the index procedure, upper arm AVF type, higher preprocedural diameter stenosis of the target lesion, and treatment with PTA. In the IN.PACT AV Access trial, cumulative incidence of thrombosis through 36 months was lower in the DCB group compared to the PTA group. After conducting a multivariable analysis, four variables were retained and appear to be associated with higher access circuit thrombosis through 36 months. Due to the costs and patient impact associated with access circuit thrombosis as well as the post hoc approach, these results should be further studied in larger populations. About the VIVA Foundation The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about the VIVA Foundation, visit . SOURCE The VIVA Foundation

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100 Deals associated with Manidipine Hydrochloride/Delapril Hydrochloride

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