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STITCH TRIAL |
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| Problem | LV dysfunction |
| Format | Multi-center open-label RCT |
| Treatment | SVR & CABG OR CABG |
| Control | Medical therapy alone |
| Population | 1212 patients |
| Inclusion criteria | Coronary artery disease that was amenable to CABG Ejection fraction of 35% or less Patients assessed to determine whether they were candidates for any of three possible therapeutic options: medical therapy alone, medical therapy plus CABG, or medical therapy plus CABG and surgical ventricular reconstruction. 1) Patients were eligible for medical therapy alone if they did not have a stenotic lesion leading to loss of 50% or more of the diameter of the left main coronary artery and if they did not have Canadian Cardiovascular Society class III or IV angina while receiving medical therapy. 2) Patients were eligible for surgical ventricular reconstruction if they had dominant anterior left ventricular akinesia or dyskinesia. N.B. All patients were eligible for CABG Inserted into one of 3 strata: -Stratum A included patients who were eligible for either medical therapy alone or medical therapy plus CABG -Stratum B included patients who were eligible for any of the three treatment options -Stratum C included patients who were eligible for either medical therapy plus CABG or medical therapy plus CABG and surgical ventricular reconstruction |
| Exclusion criteria | Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support Plan for percutaneous intervention of CAD Recent acute MI judged to be an important cause of left ventricular dysfunction History of more than 1 prior coronary bypass operation Noncardiac illness with a life expectancy of less than 3 years Noncardiac illness imposing substantial operative mortality Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode) Previous heart, kidney, liver, or lung transplantation Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device |
| Follow-up | Median 56 months |
| Primary endpoint | Rate of death from any cause |
| Secondary endpoint(s) | Rate of death from cardiovascular causes Rate of death from any cause or hospitalization for cardiovascular causes |
| Details | . |
| Brief summary: | CABG for CCF only reduced mortality when analysed by as-treated; high cross-over |
| PAPER: Coronary-Artery Bypass Surgery in Patients with Left Ventricular Dysfunction | |
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| Date | 28 Apr 2011 |
| Journal | N Engl J Med. 2011 Apr 28;364(17):1607-16. |
| Information | Ejection fraction of 35% or less & coronary disease: CABG + medical therapy vs. medical therapy alone -No significant difference to all-cause mortality (p=0.12, favouring CABG) --Became significant when adjusting for baseline statistics (p=0.039) -Early risk of death as a result of the surgical intervention itself --Disappeared within 2 years -Significant reduction in death from any cause or hospitalization for CV causes N.B. An as-treated analysis showed significant mortality benefit (p<0.001) |