Methods and progress in the study.
Randomized, double-blind, placebo-controlled trial of PREVENT IV was conducted in 107 centers in the U.S... In 2002-2003 been included 3,000 patients with a planned CS with the imposition of at least 2 coronary conduits. The main exclusion criteria were previously transferred KS, planned intervention on the valve of the heart, not with coronary atherosclerosis, concomitant diseases, which limits life expectancy by five years.
The primary endpoint of the study was the frequency of the composite outcome - death and disease (stenosis ≥ 75%) shunt according to quantitative coronary angiography (CAG) performed 12-18 months after surgery. Clinical outcomes (death, myocardial infarction, repeat revascularization) were traced every year within three years of observation.
Multivariate Cox analysis was performed with adjustment for age, sex, race, severity of coronary artery disease, research center, congestive heart failure and its class, creatinine clearance, recent myocardial infarction, body mass index, hypertension, smoking, lung disease, diabetes mellitus, peripheral arterial disease.
EZ graft was performed in 1,753 patients, KS - in 1247 patients. 2913 (97%) participants completed the 3-year observation. Of 2400 patients with a planned re-coronary angiography study was performed in 1817 (75.7%) patients at a mean of 12.6 months. The total number of venous grafts was 4290.
Baseline clinical and demographic characteristics of groups of Ez and OZ were comparable. In the angiographic cohort of individuals with KS shunts had higher creatinine clearance (91 ml / minimum vs. 87 ml / minimum in a group EZ, p = 0.04), less likely to suffer heart failure III - IV class NYHA (22% vs. 30%, respectively; p <0,001). After surgery, CABG in grothe group frequently administered clopidogrel (25.2% versus 17.3% in theOZ,p <0,001).When the control of CAGina largernumberof patients with shuntsEZ mettheir failure (46.7%versus38.0% for OZ, p <.001)and occlusion(42.6% vs. 33.8%, respectively, p <0,001). Under EZ compared with OZ noted more stenosed grafts (27.2% vs. 22.6%, p<0,001), including theirocclusion(24.2% vs. 19.4%, p <0,001).During the 3-year follow-up among patients with EZ conduits noted higher mortality, myocardial infarction and repeat revascularization (20.2% vs. 17.4%, odds ratio [OR] - odd's,p = 0,04), myocardial 0, 04),tion and total mortality (9.3% vs7.6%, OR = - 1.38,p = 0.01) and total mortality (7.4% vs5.8%, OR - 1.52; p= 0,005). However, t0, 005).tween-group differences in outcome were observed onlyafter 12-18 monthsaftersurgery.
Subgroup analysis in general confirmed the results obtained. Among the patients subjected to the control of CAG, the link between EZ shunts c worse clinical outcomes (death, myocardial infarction and revascularization) persisted (OR - 1.34, p = 0.01). The same pattern was observed among patients in selected centers, performing both way's fence shunts (OR - 1.30, p = 0.03).
Secondary analysis of PREVENT IV study showed that the EZ grafts for CABG compared with OZ is accompanied by more frequent failure conduits within 12-18 months after surgery and, more importantly, significantly worse clinical outcomes, including mortality within three years of observation.
Probable cause less long-term effectiveness of EZ may have a greater traumatic venous graft during manipulation. However, the exact mechanism of the possible adverse effects of endoscopic method of preparation of vein grafts requires further study.
The obtained results require confirmation in a randomized clinical trial. Until then, physicians should weigh the established short-term benefit of EZ with the remote risk of adverse clinical outcomes.
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