Guideline-Directed Medical Therapy
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1 Guideline-Directed Medical Therapy Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation
2 OPTIMAL THERAPY (As defined in Appendix A of the Protocol) Subjects with current or prior symptoms of heart failure and reduced LVEF should be on stable optimally uptitrated medical therapy recommended according to current guidelines (J Am Coll Cardiol Jun 5. doi:pii: S (13) ) as standard of care for heart failure therapy in the United States. Stable is defined as no more than a 100% increase or a 50% decrease in dose. This minimally includes an ACE-inhibitor (ACE-I) at stable doses for 30 days prior to subject registration in the trial, if tolerated, and a beta blocker (carvedilol, sustained release metoprolol succinate, or bisoprolol) for 90 days prior to subject registration in the trial, if tolerated, with a stable up-titrated dose for 30 days prior to subject registration in the trial. This also includes an Angiotensin II Receptor Blocker (ARB) at stable doses for 30 days prior to subject registration in the trial, if tolerated, when ACE-I is not tolerated. If the subject is intolerant to ACE-I, ARB, or beta blockers, documented evidence must be available. In those intolerant to both ACE-I and ARB, combination therapy with hydralazine and oral nitrate should be considered. Therapeutic equivalence for ACE-I substitutions is allowed within the trial registration stability timelines. are recommended in patients with NYHA class II-IV heart failure and who have LVEF of 35% or less, unless contraindicated, to reduce morbidity and mortality. Patients with NYHA class II should have a history of prior cardiovascular hospitalization or elevated plasma natriuretic peptide levels to be considered for aldosterone receptor antagonists. If aldosterone inhibitor therapy is to be administered, it must be initiated and optimized at least 30 days prior to trial registration. Stability criteria are the same as for other neurohormonal antagonists. Eplerenone requires dosage stability for 30 days prior to subject registration in the trial similar to the other agents. Diuretics may be used as necessary to keep the subject euvolemic. All heart failure therapeutics and dosages should be documented in the electronic case report forms. Aldosterone receptor antagonists [or mineralocorticoid receptor antagonists]
3 OPTIMAL THERAPY It is recognized that approximately two-thirds of patients with HF have underlying CAD (ischemic cardiomyopathy). Therefore, it is imperative that appropriate treatment for CAD be used in COAPT, according to the ACC/AHA Guidelines for Heart Failure. Specific recommendations listed in those guidelines are listed as follows: Use of nitrates and beta blockers for the treatment of angina, Coronary revascularization according to recommended guidelines in patients who have both HF and angina, Patients with coronary artery disease and HF should be treated in accordance with recommended guidelines for chronic stable angina and Use of antiplatelet agents for prevention of MI and death in patients with HF who have underlying coronary artery disease. Subjects registered in COAPT should be treated with ICD and or CRT, as per the following guidelines, prior to subject registration in the trial: An implantable cardioverter-defibrillator is recommended as secondary prevention to prolong survival in subjects with current or prior symptoms of HF and reduced LVEF who have a history of cardiac arrest, ventricular fibrillation, or hemodynamically destabilizing ventricular tachycardia. Implantable cardioverter-defibrillator therapy is recommended for primary prevention of sudden cardiac death to reduce total mortality in subjects with non-ischemic dilated cardiomyopathy or ischemic heart disease at least 40 days post-mi, a LVEF less than or equal to 35%, and NYHA functional class II or III symptoms while receiving chronic optimal medical therapy, and who have reasonable expectation of survival with a good functional status for more than 1 year Subjects with LVEF of less than or equal to 35%, sinus rhythm, left bundle branch block (LBBB), a QRS duration of 150 ms, and NYHA functional class III or ambulatory class IV symptoms despite recommended optimal medical therapy, should receive cardiac resynchronization therapy, with or without an ICD, unless contraindicated In addition, revascularization (i.e., percutaneous coronary intervention, etc.) should occur prior to subject registration in the trial as applicable.
4 Table 1. Please refer to this table for guideline dosages and potential reasons why the maximum dosages may not be prescribed. QD = once daily; BID = twice daily; TID = three times daily; QID = four times daily Drug Class ACE-Inhibitors (ACE-I): (must be > 30d prior to registration, if tolerated, & stable dose for 30d) Angiotensin-Receptor Blocker (ARB): (must be > 30d prior to registration, if tolerated, when ACE-I is not tolerated) Aldosterone Antagonists: (If Aldosterone inhibitor therapy is to be administered in NYHA Class II, III or IV subjects, it must be initiated and optimized at least 30 days prior to registration.) Drug Name INITIAL Daily Dose MAXIMUM Daily Dose(s) Captopril 6.25 mg TID 50 mg TID Enalapril 2.5 mg BID 10 to 20 mg BID Fosinopril 5 to 10 mg QD 40 mg QD Lisinopril 2.5 to 5 mg QD 20 to 40 mg QD Perindopril 2 mg QD 8 to 16 mg QD Quinapril 5 mg BID 20 mg BID Ramipril 1.25 to 2.5 mg QD 10 mg QD Trandolapril 1 mg QD 4 mg QD Candesartan 4 to 8 mg QD 32 mg QD Losartan 25 to 50 mg QD 50 to 150 mg QD Valsartan 20 to 40 mg BID 160 mg BID Spironolactone 12.5 to 25 mg QD 25 mg QD or BID Eplerenone 25 mg QD 50 mg QD Acceptable reason(s) for subject not being on a guideline directed drug or dosage angioedema; cough; orthostatic), dizziness, lightheadedness; hyperkalemia; worsening renal function; other (provide narrative) angioedema; hypotension (resting or lightheadedness; hyperkalemia; worsening renal function; other (provide narrative) lightheadedness; hyperkalemia; worsening renal function; breast tenderness and/or gynecomastia; other (provide narrative) Beta-Blockers: (must be > 90d prior to registration, if tolerated, with a stable up-titrated dose for 30d prior to registration) Vasodilators (nitrate and hydralazine): Bisoprolol 1.25 mg QD 10 mg QD Carvedilol mg BID 25 mg BID if subject is <85kgs 50 mg BID if subject is >85kgs Carvedilol Controlled Release 10 mg QD 80 mg QD Metoprolol succinate extended release Fixed dose combination (424) Hydralazine + isosorbide dinitrate (429) 12.5 to 25 mg QD 37.5 mg hydralazine / 20 mg isosorbide dinitrate TID Hydralazine: 25 to 50 mg (TID or QID) + isosorbide dinitrate: 20 to 30 mg (TID or QID) 200 mg QD 75 mg hydralazine / 40 mg isosorbide dinitrate TID Hydralazine: 300 mg (QD in divided doses) + isosorbide dinitrate: 120 mg (QD in divided doses) lightheadedness; bradycardia; depression; gastrointestinal side effects (nausea, vomiting, diarrhea); intolerable fatigue; COPD with wheezing or other evidence of reactive airway disease; other (provide narrative) lightheadedness; headache; skin rash; hydralazine-induced lupus; other Hydralazine + isosorbide dinitrate (429) (provide narrative) Source: 2013 ACCF/AHA Guideline for the Management of Heart Failure
5 Abbott Vascular 3200 Lakeside Dr., Santa Clara, CA USA, Tel: COAPT address CAUTION: Investigational device. Limited by federal (U.S.) law to investigational use only. CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, it is important to read the package insert thoroughly for Instructions for Use, Warnings, and Potential Complications associated with use of this device. MitraClip is a registered trademark of the Abbott Group of Companies Abbott. All rights reserved.
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