Randomized trial of warfarin, aspirin, and clopidogrel in patients with chronic heart failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial.

BACKGROUND: Chronic heart failure remains a major cause of mortality and morbidity. The role of antithrombotic therapy in patients with chronic heart failure has long been debated. The objective of this study was to determine the optimal antithrombotic agent for heart failure patients with reduced ejection fractions who are in sinus rhythm. METHODS AND RESULTS: This prospective, randomized clinical trial of open-label warfarin (target international normalized ratio of 2.5 to 3.0) and double-blind treatment with either aspirin (162 mg once daily) or clopidogrel (75 mg once daily) had a 30-month enrollment period and a minimum of 12 months of treatment. We enrolled 1587 men and women >/=18 years of age with symptomatic heart failure for at least 3 months who were in sinus rhythm and had left ventricular ejection fraction of

Outcomes in patients having vitreous presentation during cataract surgery who lack capsular support for a nonsutured PC IOL.

PURPOSE: The study's purpose was to determine the effect that lack of capsular support for a nonsutured posterior chamber (PC) intraocular lens IOL has on 1-year postoperative vision in patients suffering vitreous presentation (VP) during extracapsular cataract surgery. DESIGN: The study was a prospective, long-term clinical trial. METHODS: The study was conducted at 19 Department of Veterans Affairs medical centers. Patients having VP during cataract surgery with sufficient capsular support for a nonsutured PC IOL were randomized to receive either a PC IOL (230 patients) or an anterior chamber (AC) IOL (208 patients). Patients having insufficient capsular support (ICS) for a nonsutured PC IOL (143 patients) were prospectively followed in the same fashion. Best-corrected visual acuity (BCVA) at 1 year was obtained by a masked, certified examiner. RESULTS: The ICS group had considerably fewer patients with BCVA of 20/40 or better at 1 year (P < .0001) than the randomized PC IOL group (66.7% vs 91.1%) with a trend (P = .04) for having fewer patients than the randomized AC IOL group (66.7% vs 79.0%). The ICS group had significantly poorer rating of vision at 1 year by study raters, and the patients themselves than either of the randomized VP groups. CONCLUSIONS: The lack of capsular support for the placement of a nonsutured PC IOL after VP during extracapsular cataract surgery or the severity of the complication of VP associated with lack of capsular support would appear to cause visual problems beyond that related to the type of intraocular lens implanted.

The effect of vitreous presentation during extracapsular cataract surgery on the postoperative visual acuity at one year.

PURPOSE: The purpose of this study was to determine the effects that vitreous presentation (VP) during extracapsular cataract surgery has on patients' 1-year postoperative vision. DESIGN: The study was a prospective, long-term, clinical trial. METHODS: The study took place at 19 Department of Veterans Affairs medical centers. Patients having VP during cataract surgery and receiving a posterior chamber (PC) intraocular lens (IOL) (230 patients) were prospectively compared with a 5% random sample of nonvitreous presentation (NVP) cataract surgery patients (521 patients). Best-corrected visual acuity (BCVA) at 1 year was obtained by a masked, certified examiner. RESULTS: There was no statistical difference (P = .089) between the VP patients receiving PC IOL and the NVP patients in percentage of patients having BCVA of 20/40 or better at 1 year (91.1% vs 94.9%). There were significantly more PC IOL VP patients than NVP patients with BCVA of 20/50 or worse at some time during the first postoperative year (21.6% vs 10.9%; P = .0003), significantly fewer with BCVA of 20/20 or better at 1 year (27.8% vs 38.8%; P = .013), and significantly more with cystoid macular edema (11.5% vs 3.6%; P = .0002), retinal detachment (4.3% vs 0.2%; P = .0002), and uveitis (3.4% vs 0.6%; P = .012). The NVP patients rated their vision as very good or excellent significantly more often than the VP patients (71% vs 58%; P = .025). CONCLUSIONS: Vitreous presentation during extracapsular cataract surgery leads to somewhat worse overall outcomes in patients, although the majority of patients with VP do reasonably well.

The Warfarin and Antiplatelet Therapy in Heart Failure trial (WATCH): rationale, design, and baseline patient characteristics.

BACKGROUND: The role of anticoagulation in patients with chronic heart failure has long been an area of interest and controversy. Traditionally the goal of anticoagulation has been to prevent embolic events, but recent trials also demonstrated that oral anticoagulation also prevents vascular events in patients with prior myocardial infarction, who constitute the majority of heart failure patients. Although antiplatelet agents also reduce postinfarction vascular events, few data are available in heart failure patients, and some evidence suggests that aspirin may also have the potential to worsen heart failure morbidity and mortality, possibly by interfering with the effects of angiotensin-converting enzyme inhibitors. Methods and results The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial was undertaken to determine the optimal antithrombotic agent for heart failure patients. WATCH was a prospective-randomized trial in which symptomatic heart failure patients in sinus rhythm with ejection fractions < or =35% taking angiotensin-converting enzyme inhibitors (unless not tolerated) and diuretics were randomized to open-label warfarin (target International Normalized Ratio 2.5-3.0) or double-blind antiplatelet therapy with aspirin 162 mg or clopidogrel 75 mg. Two primary comparisons were specified: anticoagulation with warfarin versus antiplatelet therapy with aspirin and antiplatelet therapy with clopidogrel versus antiplatelet therapy with aspirin. The primary outcome is the composite of death from all causes, nonfatal myocardial infarction, and nonfatal stroke analyzed as time to first event using the intent-to-treat approach. The secondary endpoint was the broader composite of death from all causes, nonfatal myocardial infarction, non-fatal stroke, and hospitalizations for worsening heart failure, unstable angina pectoris, and systemic or pulmonary artery embolic events. Additional prespecified analyses include heart failure events, coronary events, and resource utilization. CONCLUSIONS: Although the trial was designed to enter 4500 patients, it was terminated 18 months prematurely in June 2003 by the VA Cooperative Study Program because of poor enrollment with a resulting reduction of its power to achieve its original objective. This manuscript describes the study rationale, protocol design, and the baseline characteristics of the 1587 patients who were entered into the study. The WATCH trial will help define the optimal approach to antithrombotic therapy in the contemporary management of patients with chronic heart failure resulting from left ventricular systolic dysfunction.

A comparison of anterior chamber and posterior chamber intraocular lenses after vitreous presentation during cataract surgery: the Department of Veterans Affairs Cooperative Cataract Study.

PURPOSE: To compare the efficacy and safety of anterior chamber (AC) intraocular lenses (IOLs) and posterior chamber (PC) IOLs implanted after vitreous presentation during extracapsular cataract extraction (ECCE). DESIGN: The study was a prospective, long-term, randomized clinical trial conducted at 19 Department of Veterans Affairs medical centers across the United States. METHODS: There were 438 eyes (438 patients) that met preliminary eligibility criteria, suffered vitreous presentation during ECCE (phacoemulsification or classical extracapsular technique), and had sufficient capsular support for a PC IOL without sutures after anterior vitrectomy randomized to either a PC IOL (230 patients) or an AC IOL (208 patients). Patients were examined at 3, 6, and 12 months post-surgery and yearly thereafter. Minimum follow-up was 1 year. The primary outcome measure of best-corrected visual acuity at 1 year was obtained by a masked certified examiner. RESULTS: More PC IOL patients (91%) achieved visual acuity of 20/40 or better at 1 year than AC IOL patients (79%), a highly significant difference (P =.003). There was no significant difference between the two groups for patient's rating of vision or adverse events. Over 84% of the PC IOL patients and over 77% of the AC IOL patients rated their vision as good or better at 1 year as opposed to only 7% giving such ratings before surgery. For at least one rating period during the first year, 13.2% of the combined study patients had cystoid macular edema, 8.5% had posterior capsule opacification, 5.7% had glaucoma, and 3.7% had retinal detachment. CONCLUSION: In the presence of sufficient capsular support, a PC IOL should be implanted after vitreous presentation during ECCE.