Top 10 Cardiology Stories of 2015 - The Cardiology Advisor

Top 10 Cardiology Stories of 2015

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  • 8. Blood Pressure Revised Guidelines

    8. Blood Pressure Revised Guidelines

    The United States Preventive Services Task Force (USPSTF) revised their guidelines this year to recommend that adults aged 18 years and older be screened for high blood pressure, and that patients obtain measurements outside of the clinic setting to confirm a hypertension diagnosis.

    Adults aged 40 years or older who have high-normal blood pressure (130-139/85-89 mm Hg) should be screened annually. Adults aged 18 to 39 years of age with normal blood pressure should be screened every 3 to 5 years.

    –from “USPSTF Revises Blood Pressure Screening Guidelines” by Lauren Grygotis, published on 10/12/15.

  • 2. TAVR Updates

    2. TAVR Updates

    Several devices used in transcatheter aortic valve replacement (TAVR), including SAPIEN XT, SAPIEN 3, and the CoreValve systems, showed improvements in clinical outcomes in 2015.

    Results from the 1-year PARTNER II trial of high-risk patients who received the SAPIEN XT valve-in-valve device for TAVR revealed that these patients had a 13.4% all-cause mortality rate and an 8.9% rate of cardiac mortality. One-year stroke rate was 3.7% and the rehospitalization rate was 11.8%. These promising findings led to the recent FDA approval of the SAPIEN XT expanded indication to include patients with surgical bioprosthetic aortic valve failure at high or greater risk for open surgical therapy.

    –from “TAVR: Current and Emerging Approaches” by Batya Swift Yasgur, published 12/14/15.

  • 2015 saw a great leap forward in the development and use of PCSK9 (proprotein convertase subtilisin/kexin) inhibitors. This past July, the FDA approved alirocumab (Praluent, Regeneron), followed 1 month later by the approval of a second PCSK9 inhibitor evolocumab (Repatha, Amgen). The drugs were approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or those with clinical atherosclerotic cardiovascular disease requiring additional LDL-C lowering. A third drug, bococizumab (Pfizer), is currently in development. Data from large, long-term randomized controlled outcomes trials—ODYSSEY Outcomes (alirocumab), FOURIER (evolocumab), and SPIRE (bococizumab)—are anticipated to provide clear answers as to the drugs' impact on cardiovascular events and safety profiles. –from "The Promise of PSCK9 Inhibitors by Brian Ellis,” published 11/9/15.

    1. PCSK9 Inhibitors: Newly Approved & In Pipeline

    2015 saw a great leap forward in the development and use of PCSK9 (proprotein convertase subtilisin/kexin) inhibitors.

    This past July, the FDA approved alirocumab (Praluent, Regeneron), followed 1 month later by the approval of a second PCSK9 inhibitor evolocumab (Repatha, Amgen). The drugs were approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or those with clinical atherosclerotic cardiovascular disease requiring additional LDL-C lowering. A third drug, bococizumab (Pfizer), is currently in development.

    Data from large, long-term randomized controlled outcomes trials—ODYSSEY Outcomes (alirocumab), FOURIER (evolocumab), and SPIRE (bococizumab)—are anticipated to provide clear answers as to the drugs' impact on cardiovascular events and safety profiles.

    –from "The Promise of PSCK9 Inhibitors by Brian Ellis,” published 11/9/15.

  • 4. S-ICD Therapy

    4. S-ICD Therapy

    Subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy could be continued after intervention in a majority of patients with a complication, according to a recent study published in the Journal of the American College of Cardiology: Clinical Electrophysiology.

    Complication-free survival at 1 year was 91.8% and at 2 years, 90.6%. There were 8 cases that required surgical intervention due to infectious complications: 5 from device infection and 3 from pocket erosion. The S-ICD systems were extracted and were later re-implanted. A wearable cardioverter defibrillator (WCD) was used as bridge therapy, lasting from 6 weeks to 3 months.

    –from “S-ICD Therapy Produces Positive Outcomes” by Britt Gambino, published 12/4/15.

  • The IVUS-XPL clinical trial examined rates of major adverse cardiac events (MACE) among patients requiring drug-eluting stent (DES) implantation for long coronary lesions. Compared with angiography guidance, intravascular ultrasound (IVUS) guidance reduced the rate of MACE at 1 year, due mainly to lowering the risk for target lesion revascularization.Rates of 1-year MACE were 2.9% in the IVUS-guided arm compared with 5.8% in the angiography-guided arm. This difference was primarily driven by a reduction in the rate of ischemia-driven target lesion revascularization in the IVUS-guided cohort. The rates of cardiac death and target lesion-related MI did not significantly differ between groups.–from “IVUS-Guided DES Implantation Outperformed Angiography-Guided Implantation”, by Brian Ellis, published on 11/11/15.

    6. IVUS-Guided Stenting

    The IVUS-XPL clinical trial examined rates of major adverse cardiac events (MACE) among patients requiring drug-eluting stent (DES) implantation for long coronary lesions. Compared with angiography guidance, intravascular ultrasound (IVUS) guidance reduced the rate of MACE at 1 year, due mainly to lowering the risk for target lesion revascularization.

    Rates of 1-year MACE were 2.9% in the IVUS-guided arm compared with 5.8% in the angiography-guided arm. This difference was primarily driven by a reduction in the rate of ischemia-driven target lesion revascularization in the IVUS-guided cohort. The rates of cardiac death and target lesion-related MI did not significantly differ between groups.

    –from “IVUS-Guided DES Implantation Outperformed Angiography-Guided Implantation”, by Brian Ellis, published on 11/11/15.

  • SPRINT trial results introduced the cardiology world to a new standard of blood pressure targeting. A lower systolic blood pressure target of less than 120 mm Hg, as compared with the currently recommended 140 mm Hg, was associated with lower rates of mortality and adverse cardiovascular events in high-risk patients.A total of 9361 participants were randomly assigned to intensive treatment with a target systolic blood pressure of less than 120 mm Hg or standard treatment with a target of less than 140 mm Hg. Results revealed a significantly lower rate of the primary composite outcome in the intensive treatment arm vs the standard treatment arm.–from “Lower Blood Pressure Target Demonstrates Significant Benefits” by Melissa Foster, published 12/2/15.

    9. SPRINT Trial Results

    SPRINT trial results introduced the cardiology world to a new standard of blood pressure targeting.

    A lower systolic blood pressure target of less than 120 mm Hg, as compared with the currently recommended 140 mm Hg, was associated with lower rates of mortality and adverse cardiovascular events in high-risk patients.

    A total of 9361 participants were randomly assigned to intensive treatment with a target systolic blood pressure of less than 120 mm Hg or standard treatment with a target of less than 140 mm Hg. Results revealed a significantly lower rate of the primary composite outcome in the intensive treatment arm vs the standard treatment arm.

    –from “Lower Blood Pressure Target Demonstrates Significant Benefits” by Melissa Foster, published 12/2/15.

  • 10. Reversal Agent for Anticoagulants

    10. Reversal Agent for Anticoagulants

    Andexanet alfa administered as a bolus plus infusion rapidly reversed the anticoagulant activity of the factor Xa inhibitor rivaroxaban in older healthy patients, without producing clinical toxic effects. Mark A. Crowther, MD, MSc, of McMaster University, Hamilton, Ontario, presented findings from 1 of the 2 ANNEXA-R studies at the 2015 American Heart Association Scientific Sessions.

    Results revealed that patients given andexanet bolus plus infusion experienced significant reductions in anti-factor Xa activity and unbound rivaroxaban concentration compared with placebo. Furthermore, thrombin activity was fully restored in 100% of andexanet patients compared with 0% of placebo patients.

    –from “Andexanet alfa Reversed Anticoagulant Effects of Rivaroxaban” by Brian Ellis, published 11/16/15.

  • A 20-year government study on aging and heart disease revealed that exercising later in life can still reduce the risk of heart failure. Investigators from Johns Hopkins University School of Medicine in Baltimore examined the exercise habits of about 11 000 American men and women. Activity levels were assessed on 2 consecutive visits over a period of 6 years.Compared to those who were inactive at both visits, people who met or exceeded recommended physical activity levels of 150 minutes of moderate exercise or 75 minutes of vigorous exercise per week were 33% less likely to develop heart failure. Those who consistently got modest amounts of exercise still had a 20% lower risk.“…Every little bit of movement matters and that picking up exercise later in life is decidedly better than not moving at all,” Roberta Florido, MD, a cardiology fellow at Hopkins, said.–from “Exercise Late in Life Can Still Reduce HF Risk," published on 11/20/15.

    7. Preventive Cardiology

    A 20-year government study on aging and heart disease revealed that exercising later in life can still reduce the risk of heart failure. Investigators from Johns Hopkins University School of Medicine in Baltimore examined the exercise habits of about 11 000 American men and women. Activity levels were assessed on 2 consecutive visits over a period of 6 years.

    Compared to those who were inactive at both visits, people who met or exceeded recommended physical activity levels of 150 minutes of moderate exercise or 75 minutes of vigorous exercise per week were 33% less likely to develop heart failure. Those who consistently got modest amounts of exercise still had a 20% lower risk.

    “…Every little bit of movement matters and that picking up exercise later in life is decidedly better than not moving at all,” Roberta Florido, MD, a cardiology fellow at Hopkins, said.

    –from “Exercise Late in Life Can Still Reduce HF Risk," published on 11/20/15.

  • The first case of computed tomography-guided percutaneous revascularization of coronary occlusion in man using a wearable, hands-free computer with a head-mounted display has been described. "We believe wearable computers have a great potential to optimize percutaneous revascularization, and thus favorably affect interventional cardiologists in their daily clinical activities." –from “Wearable Computers to Improve Percutaneous Revascularization,” published 11/23/15.

    3. Virtual Reality & Wearable Technology in Cardiology

    The first case of computed tomography-guided percutaneous revascularization of coronary occlusion in man using a wearable, hands-free computer with a head-mounted display has been described.

    "We believe wearable computers have a great potential to optimize percutaneous revascularization, and thus favorably affect interventional cardiologists in their daily clinical activities."

    –from “Wearable Computers to Improve Percutaneous Revascularization,” published 11/23/15.

  • In a single, nonrandomized arm of PARTNER II, TAVR with the SAPIEN 3 valve led to an overall 1-year survival of >85% among high-risk and inoperable patients with aortic stenosis, as well as a low rate of 30-day complications.“The combination of the new design features of SAPIEN 3, procedural improvements, operator experience, and improved patient selection have all contributed to a low rate of important adverse events (including stroke) and a high rate of 1-year survival in these high-risk and inoperable patients,” said Howard C. Herrmann, MD, study investigator.–from “TAVR With SAPIEN 3 Valve Demonstrates High 1-Year Survival Rate” by Brian Ellis, published 10/14/15.

    2. TAVR Updates (Continued)

    In a single, nonrandomized arm of PARTNER II, TAVR with the SAPIEN 3 valve led to an overall 1-year survival of >85% among high-risk and inoperable patients with aortic stenosis, as well as a low rate of 30-day complications.

    “The combination of the new design features of SAPIEN 3, procedural improvements, operator experience, and improved patient selection have all contributed to a low rate of important adverse events (including stroke) and a high rate of 1-year survival in these high-risk and inoperable patients,” said Howard C. Herrmann, MD, study investigator.

    –from “TAVR With SAPIEN 3 Valve Demonstrates High 1-Year Survival Rate” by Brian Ellis, published 10/14/15.

  • 2. TAVR Updates (Continued)

    2. TAVR Updates (Continued)

    Two-year data from the CoreValve US Pivotal Trial High Risk Study compared CoreValve to SAVR in the treatment of symptomatic severe aortic stenosis in high-risk and very high-risk patients. One-year survival rate for TAVR vs SAVR was 4.8% and 2-year survival rate was 6.4%. Researchers concluded that TAVR conferred superior survival at 2 years, as compared with SAVR.

    –from “TAVR: Current and Emerging Approaches” by Batya Swift Yasgur, published 12/14/15.

  • Results from both the IN.PACT.SFA and ISA-DESIRE 4 clinical trials demonstrated promising outcomes for drug-coated and scoring balloons.In the IN.PACT.SFA trial the use of drug-coated balloons in patients with peripheral artery disease demonstrated a significantly higher primary patency and reductions in repeat interventions compared with percutaneous transluminal angioplasty. In the ISAR-DESIRE 4 trial the use of a scoring balloon plus a paclitaxel-coated balloon demonstrated anigographical superiority compared with a paclitaxel-coated balooon alone for restenosis treatment. Percent diameter stenosis at follow-up angiography was 40.4% for the scoring balloon plus paclitaxel-coated balloon vs 35% for the paclitaxel-coated balloon alone group.–from, “Addition of Scoring Balloon Superior to Drug-Coated Balloon Alone for Restenosis” and “Drug-Coated Balloons Better than PTA in PAD Patients” published on 10/29/15 by Britt Gambino.

    5. Improvements in Anigioplasty Balloons

    Results from both the IN.PACT.SFA and ISA-DESIRE 4 clinical trials demonstrated promising outcomes for drug-coated and scoring balloons.

    In the IN.PACT.SFA trial the use of drug-coated balloons in patients with peripheral artery disease demonstrated a significantly higher primary patency and reductions in repeat interventions compared with percutaneous transluminal angioplasty.

    In the ISAR-DESIRE 4 trial the use of a scoring balloon plus a paclitaxel-coated balloon demonstrated anigographical superiority compared with a paclitaxel-coated balooon alone for restenosis treatment. Percent diameter stenosis at follow-up angiography was 40.4% for the scoring balloon plus paclitaxel-coated balloon vs 35% for the paclitaxel-coated balloon alone group.

    –from, “Addition of Scoring Balloon Superior to Drug-Coated Balloon Alone for Restenosis” and “Drug-Coated Balloons Better than PTA in PAD Patients” published on 10/29/15 by Britt Gambino.

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