Effects of on-pump and off-pump surgery in the Arterial Revascularization Trial.

OBJECTIVES: The Arterial Revascularization Trial (ART) is a randomized comparison of bilateral internal mammary artery (BIMA) versus single internal mammary artery (SIMA) grafting in coronary artery bypass graft (CABG) surgery and is one of the largest randomized trials of surgery ever conducted. ART is also one of the largest studies of contemporary CABG with a high proportion of off-pump surgeries (41%). The objective of this post hoc analysis was to evaluate the surgical process and 1-year outcomes for surgery performed on-pump compared with off-pump. METHODS: ART randomized 3102 patients with multivessel coronary artery disease (CAD) to SIMA or BIMA grafts to determine if BIMA grafts have an additional survival advantage at 10 years. The 1-year interim analysis showed an overall very low mortality and major morbidity rate irrespective of whether the procedure was with an SIMA or BIMA. The surgical process and 1-year outcomes were analysed according to whether surgery was performed on-pump or off-pump. RESULTS: Baseline variables were not statistically significantly different between on- and off-pump surgery within each treatment group after taking account of the effects of clustering by individual surgeons. At both 30 days and 1 year, there was a low incidence of death (1.2%, 2.3%), stroke (1.1%, 1.7%), myocardial infarction (MI) (1.4%, 1.9%), repeat revascularization (0.5%, 1.5%) and wound reconstruction (1.2%). A similar average number of grafts were performed with on- and off-pump surgery (median = 3), but the duration of surgery was 20-30 min and ventilation time ∼ 2 h shorter with off-pump surgery. Blood loss and platelet transfusions were lower in the off-pump group, with no difference in the need for balloon pump or renal support. Sternal wound reconstruction was similar with off-pump surgery in the SIMA group (0.5 vs 0.6%) and lower with off-pump surgery in the BIMA group (1.4 vs 2.2%). Repeat revascularization was marginally higher in off-pump patients at 30 days (0.8 vs 0.3%) and at 1 year (1.7 vs 1.3%). CONCLUSIONS: The outcomes of contemporary CABG are excellent with low mortality, stroke, myocardial infarction and need for wound reconstruction and repeat revascularization whether performed on-pump or off-pump. CLINICAL TRIAL REGISTRATION: Controlled-trials.com (ISRCTN46552265).

Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery.

BACKGROUND: ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. METHODS: The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query) and "dirty" (any incomplete, inconsistent or illegible data). The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent) and time delay (in days) between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India) and "Developed" (Italy, UK, Austria and Australia). RESULTS: There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month). The time interval for the receipt of data was longer for "Developing" countries (median:37 days) compared to "Developed" ones (median:11 days) (p < 0.001). The median number of data queries was 23% in "Developed" countries compared to 19% in "Developing" ones (p = ns). CONCLUSIONS: In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. TRIAL REGISTRATION: ISRCTN46552265.

High risk of peripheral arterial disease in the United Kingdom: 2-year results of a prospective registry.

We report a prospective 2-year, multicenter study of patients presenting with intermittent claudication (IC; ankle brachial blood pressure index, ABPI ≤ 0.9). Mean age of the 473 patients enrolled was 68 years, 20% were diabetics, 30% had prior symptomatic coronary heart disease (CHD), 7% had prior stroke, and 39% were current smokers. At baseline, 26.2% of patients had BP ≤ 140/85 mm Hg or lower and at 2 years this figure was 32.5% (P = .01). Current smokers had fallen to 27% (from 39%) at 2 years (P < .001). Use of antiplatelet agents, statins, and angiotensin converting enzyme inhibitors increased significantly during the course of the study as did claudication distance. Death and the composite of death, stroke or myocardial infarction (MI), occurred in 8.4% and 11.6% of patients, respectively. Prognosis was worse in patients with prior history of CHD, older age, those with diabetes and a lower ABPI.

Randomized trial to compare bilateral vs. single internal mammary coronary artery bypass grafting: 1-year results of the Arterial Revascularisation Trial (ART).

AIMS: Observational data suggest that the use of bilateral internal mammary arteries (BIMA) during coronary artery bypass graft surgery provides superior revascularization to a single internal mammary artery (SIMA), but concerns about safety have prevented the widespread use of BIMA. The Arterial Revascularisation Trial (ART) is a randomized trial of BIMA vs. SIMA, with a primary outcome of survival at 10 years. This paper reports mortality, morbidity, and resource use data at 1 year. METHODS AND RESULTS: Coronary artery bypass graft patients were enrolled in 28 hospitals in seven countries. Three thousand one hundred and two patients were randomly assigned to SIMA (n = 1554) or BIMA (n = 1548). The mean number of grafts was 3 for both groups. Forty per cent of the SIMA procedures and 42% of the BIMA were performed off-pump. Mortality at 30 days was 18 of 1548 (1.2%) for SIMA and 19 of 1537 (1.2%) for BIMA, and at 1 year was 36 of 1540 (2.3%) and 38 of 1529 (2.5%), respectively. The rates of stroke, myocardial infarction, and repeat revascularization were all ≤2% at 1 year and similar between the two groups. Sternal wound reconstruction was required in 0.6 and 1.9% of the SIMA and BIMA groups, respectively. CONCLUSION: Data from ART demonstrate similar clinical outcomes for SIMA and BIMA at 1 year but BIMA grafts are associated with a small absolute increase (1.3%) in the need for sternal wound reconstruction. The results suggest that the use of BIMA grafts is feasible on a routine basis. The 10-year results of the ART will confirm whether BIMA grafting results in lower mortality and the need for repeat intervention. TRIAL REGISTRATION: Controlled-trials.com (ISRCTN46552265).

Randomized, controlled trial of coronary artery bypass surgery versus percutaneous coronary intervention in patients with multivessel coronary artery disease: six-year follow-up from the Stent or Surgery Trial (SoS).

BACKGROUND: The Stent or Surgery Trial is a randomized, controlled trial comparing percutaneous coronary intervention with coronary artery bypass grafting (CABG) for patients with multivessel disease. Initial results at a median follow-up of 2 years showed a survival advantage for patients randomized to CABG. This article reports survival outcome at a median follow-up of 6 years. METHODS AND RESULTS: A total of 988 (n=488 percutaneous coronary intervention, n=500 CABG) patients were randomized at 53 centers during the period from 1996 to 1999. Investigators established survival status from hospital or community medical records or national databases or by direct contact with patients and their relatives. All-cause mortality was compared with hazard ratios and confidence intervals calculated from Cox proportional hazards models. Prespecified subgroup analyses for diabetes mellitus, angina grade, and angiographic severity of coronary disease at baseline were performed with tests for interaction. At a median follow-up of 6 years, 53 patients (10.9%) died in the percutaneous coronary intervention group compared with 34 (6.8%) in the CABG group (hazard ratio 1.66, 95% confidence interval 1.08 to 2.55, P=0.022). Little evidence was found that the treatment effect on mortality differed between subgroups according to baseline angina grade (interaction test P=0.52), the severity of coronary disease (P=0.92), or diabetic status (P=0.15). CONCLUSIONS: At a median follow-up of 6 years, a continuing survival advantage was observed for patients managed with CABG, which is not consistent with results from other stent-versus-CABG studies.

Coronary calcium measurement improves prediction of cardiovascular events in asymptomatic patients with type 2 diabetes: the PREDICT study.

AIMS: The PREDICT Study is a prospective cohort study designed to evaluate coronary artery calcification score (CACS) as a predictor of cardiovascular events in type 2 diabetes (T2DM). METHODS AND RESULTS: A total of 589 patients with no history of cardiovascular disease and with established T2DM had CACS measured, as well as risk factors, including plasma lipoprotein, apolipoprotein, homocysteine and C-reactive protein concentrations, homeostasis model assessment insulin resistance (HOMA-IR), and urine albumin creatinine ratio. Participants were followed for a median of 4 years and first coronary heart disease (CHD) and stroke events were identified as primary endpoints. There were 66 first cardiovascular events (including 10 strokes). CACS was a highly significant, independent predictor of events (P < 0.001), with a doubling in CACS being associated with a 32% increase in risk of events (29% after adjustment). Hazard ratios relative to CACS in the range 0-10 Agatston units (AU) were: CACS 11-100 AU, 5.4 (P = 0.02); 101-400 AU 10.5 (P = 0.001); 401-1000 AU, 11.9 (P = 0.001), and >1000 AU, 19.8 (P < 0.001). Only HOMA-IR predicted primary endpoints independently of CACS (P = 0.01). The areas under the receiver operator characteristic curve for United Kingdom Prospective Diabetes Study (UKPDS) risk engine primary endpoint risk and for UKPDS risk plus CACS were 0.63 and 0.73, respectively (P = 0.03). CONCLUSION: Measurement of CACS is a powerful predictor of cardiovascular events in asymptomatic patients with T2DM and can further enhance prediction provided by established risk models.

The progress of coronary heart disease in Type 2 diabetes as measured by coronary calcium score from electron beam computed tomography (EBCT): the PREDICT study.

Coronary calcification score (CACS) measured by electron beam tomography is well established in the evaluation of cardiovascular risk in general populations. The PREDICT study aims to evaluate prediction of cardiovascular events by CACS in Type 2 diabetic subjects without previous clinical cardiovascular disease. In the present PREDICT sub-study, the rate of progression of CACS and factors influencing this rate were assessed. CACS was measured at baseline and after a mean interval of 4.0 (range of 2.1-5.0) years in the 202 PREDICT participants who agreed to have a second scan. Participants also had a range of conventional and novel biochemical risk factors measured at baseline. Progression of calcification was apparent in 170 (84%), while in 32 (16%) there was regression or no progression. Those showing progression had a significantly more adverse risk factor profile. Rate of change in CACS was strongly related to baseline CACS (p<0.0001). Rate of change also correlated with, waist:hip ratio (p=0.004), male gender (p=0.009), age (p=0.04), use of antihypertensive drugs (p=0.03) and statins (p=0.05) and, independently of baseline CACS, systolic blood pressure (p=0.0006), waist circumference (p=0.001) and urine albumin:creatine ratio (p=0.04). Most subjects with Type 2 diabetes showed progression of CACS. The absence of a relationship between progression and lipid risk factors and the positive relationship with statin and antihypertensive drug use may reflect earlier risk factor exposure. Independent relationships between progression and established calcification, blood pressure, central adiposity and urine albumin:creatinine ratio suggest areas for risk factor modification that could be especially relevant in Type 2 diabetes.

The impact of age on outcomes after coronary artery bypass surgery versus stent-assisted percutaneous coronary intervention: one-year results from the Stent or Surgery (SoS) trial.

BACKGROUND: Relative outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) may differ between younger and older patients. There are no data comparing the age-related CABG versus PCI outcomes in the stent era. METHODS: The SoS trial compared CABG (n = 500) and stent-assisted PCI (n = 488). The impact of treatment assignment on 1-year outcomes was evaluated by age < or = 65 years (n = 295, CABG; n = 298, PCI) and > 65 years (n = 205, CABG; n = 190, PCI). RESULTS: One-year procedural outcomes were similar between treatment groups regardless of age, with the exception of more repeat revascularizations after PCI (age < or = 65, 16.1% vs 4.8%; age > 65, 19.5% vs 3.4%; both P < .001). Six and 12-month Seattle Angina Questionnaire scores improved from baseline in both age and treatment groups. However, CABG was associated with greater improvement in physical limitation, angina frequency, and quality of life in younger patients at 6 and 12 months (12-month difference in improvement between CABG and PCI: 5.6, 4.8, and 3.9 points for 3 domains), whereas in the elderly a significant benefit of CABG observed at 6 months did not persist at 12 months (12-month difference: 0.9, 1.9, and 1.4). One-year costs were significantly higher after CABG regardless of age. CONCLUSIONS: Although PCI and CABG result in similar rates in clinical outcomes irrespective of age, younger patients reported more health status benefits from CABG as compared with PCI, whereas in older patients the 2 approaches resulted in similar 1-year health status benefits.

Early versus periprocedural administration of abciximab for primary angioplasty: a pooled analysis of 6 studies.

BACKGROUND: The 2004 ACC/AHA guidelines on ST-elevation myocardial infarction state that it is reasonable to start treatment with abciximab as early as possible before primary percutaneous coronary intervention (PCI). We investigated the potential benefit of early use of abciximab by pooling data from all the available studies. METHODS: Six prospective studies were identified that had allocated 260 patients to receive early abciximab (either prehospital or soon after the patient arrived in hospital) and 342 to receive late abciximab (at the time of PCI). RESULTS: TIMI flow grade 2 or 3 was present in 42% of the early group compared with 29% in the late group (P = .001). After PCI, 59% of patients in the early group showed ST-resolution >or = 70%, compared with 41% in the late group (P = .003). The composite clinical outcomes death, new myocardial infarction, or repeat target vessel revascularization at 30 days occurred in 7.3% of the early group compared with 9.7% in the late group (odds ratio 0.73, 95% CI 0.41-1.32) and death alone occurred in 2.7% versus 4.7%, respectively (odds ratio 0.56, 95% CI 0.23-1.39). CONCLUSIONS: Early administration of abciximab improves epicardial patency (TIMI flow) before PCI and results in better myocardial tissue perfusion (ST-resolution) after the procedure. The promising effects on clinical outcomes need to be tested in larger studies.

Randomized comparison of stentless versus stented valves for aortic stenosis: effects on left ventricular mass.

BACKGROUND: Aortic valve replacement (AVR) is the established treatment for severe aortic stenosis. In response to the long-term results of aortic homografts, stentless porcine valves were introduced as an alternative low-resistance valve. We conducted a randomized trial comparing a stentless with a stented porcine valve in adults with severe aortic stenosis. METHODS AND RESULTS: The primary outcome was change in left ventricular mass index (LVMI) measured by transthoracic echocardiography and, in a subset, by cardiovascular MR. Measurements were taken before valve replacement and at 6 and 12 months. Patients undergoing AVR with an aortic annulus < or =25 mm in diameter were randomly allocated to a stentless (n=93) or a stented supra-annular (n=97) valve. There were no significant differences in mean LVMI between the stentless versus stented groups at baseline (176+/-62 and 182+/-63 g/m2, respectively) or at 6 months (142+/-49 and 131+/-45 g/m2, respectively), although within-group changes from baseline to 6 months were highly significant. Changes in LVMI measured by cardiovascular MR (n=38) were consistent with the echo findings. There was a greater reduction in peak aortic velocity (P<0.001) and a greater increase in indexed effective orifice area (P<0.001) in the stentless group than in the stented group. There were no differences in clinical outcomes between the 2 valve groups. CONCLUSIONS: Despite significant differences in indexed effective orifice area and peak flow velocity in favor of the stentless valve, there were similar reductions in left ventricular mass at 6 months with both stented and stentless valves, which persisted at 12 months.

The impact of acute coronary syndrome on clinical, economic, and cardiac-specific health status after coronary artery bypass surgery versus stent-assisted percutaneous coronary intervention: 1-year results from the stent or surgery (SoS) trial.

BACKGROUND: Data are limited regarding the impact of acute coronary syndromes (ACSs) on the relative benefits of coronary artery bypass grafting (CABG) versus stent-assisted percutaneous coronary intervention (PCI). METHODS: The SoS trial compared patients with multivessel disease who were randomly assigned to CABG (n = 500) or stent-assisted PCI (n = 488). The impact of treatment on 1-year outcomes was compared in ACS (n = 126, CABG; n = 116, PCI) and non-ACS (n = 374, CABG; n = 372, PCI) subgroups. RESULTS: Baseline characteristics were similar between treatment groups within ACS and non-ACS groups, as was the 1-year composite incidence of mortality and myocardial infarction (ACS, 5.2% for PCI vs 5.6% for CABG, P = .89; non-ACS, 7.0% vs 8.3%, P = .50). The need for repeat revascularizations was higher after PCI versus CABG within each subgroup (ACS, 15.5% vs 7.1%, P = .04; non-ACS, 18.0% vs 3.2%, P < .001). At 6 and 12 months, scores on the Seattle Angina Questionnaire improved significantly in patients with and without ACS. In patients without ACS, CABG was associated with greater improvement in physical limitation, angina frequency, and quality of life at 6 and 12 months. In patients with ACS, there was only a nonsignificant slight trend toward greater improvement with CABG at 1 year. The total 1-year costs for PCI and CABG in patients without ACS were 5760 pound sterling and 8509 pound sterling (Delta = 2749 pound sterling, 95% CI 1890 pound sterling - 3409 pound sterling), and in patients with ACS, 8014 pound sterling and 10080 pound sterling (Delta = 2066 pound sterling, 95% CI -690 pound sterling to 3487 pound sterling). CONCLUSIONS: In patients with and without ACS, CABG had similar clinical outcomes, less need for repeat revascularization and higher costs compared to PCI. The benefit of CABG relative to PCI in improving patients' health status tended to be greater in patients without ACS than in patients with ACS.

Neuropsychological outcome after percutaneous coronary intervention or coronary artery bypass grafting: results from the Stent or Surgery (SoS) Trial.

BACKGROUND: Coronary artery bypass surgery (CABG) has been associated with a range of neurological and neuropsychological complications from stroke to cognitive problems such as memory and problem solving disturbance. However, little is known about the impact of percutaneous coronary intervention (PCI) on neuropsychological outcome. METHODS AND RESULTS: In the Stent or Surgery Trial (SoS), 988 patients were randomized in equal proportions between PCI supported by stent implantation and CABG. As a substudy of this trial, we undertook an evaluation of neurological and neuropsychological outcomes after intervention. A clinical examination and neuropsychological assessment consisting of 5 tests (Digit Span Forwards and Backwards, Visual Reproduction, Bourdon, and Block Design) were performed at baseline and 6 and 12 months after the procedure. A total of 145 patients were included in the substudy analysis: 77 in the PCI group and 68 in the CABG group. One patient in the PCI arm had a stroke. There was no significant difference between treatment groups at 6 and 12 months for any of the 5 tests. The mean change from baseline was also similar in both groups. CONCLUSIONS: We were not able to demonstrate an important and significant difference in neuropsychological outcome in patients treated with different revascularization strategies. This important finding needs to be examined in further research.

Relative benefit of coronary artery bypass grafting versus stent-assisted percutaneous coronary intervention for angina pectoris and multivessel coronary disease in women versus men (one-year results from the Stent or Surgery trial).

Information on the relative benefit of coronary artery bypass grafting (CABG) versus stent-assisted percutaneous coronary intervention (PCI) for improvement of cardiac-related health status in women and how it compares with men is limited. The Stent or Surgery trial compared randomly assigned CABG and stent-assisted PCI in 206 women and 782 men with multivessel disease. We examined longitudinal changes at 6 and 12 months from baseline by gender and treatment in 3 subscales of the Seattle Angina Questionnaire (SAQ): physical limitation, angina frequency, and quality of life. At the time of revascularization, women were older, more severely ill, and tended to have lower SAQ scores than men. At 6 months, SAQ scores after both procedures improved significantly in both genders, with greater improvement achieved with CABG. After adjustment for other factors, in men, CABG was associated with a 54.7% greater improvement in physical limitation compared with PCI, 31.3% greater improvement in angina frequency, and 18.3% greater improvement in quality of life. In women, these relative differences were 11.6%, 43.2%, and 39.3%, respectively. At 1 year, men continued to show greater improvement with CABG in all 3 dimensions (50.6%, 19.7%, and 15.3%, respectively), but in women the relative differences decreased substantially (1.6%, 11.1%, and 0.6%, respectively) due to a greater later improvement after PCI (p = 0.049 for the interaction among treatment, gender, and follow-up for the quality of life domain). Although CABG may be superior to PCI in men, in women, at 1 year after intervention, both procedures appear equally effective.

Disease-specific health status after stent-assisted percutaneous coronary intervention and coronary artery bypass surgery: one-year results from the Stent or Surgery trial.

BACKGROUND: Functional status and quality of life are important outcomes in the evaluation of revascularization approaches for symptomatic coronary artery disease. Few data are available regarding the comparative improvement in disease-specific health status after CABG versus percutaneous coronary intervention (PCI) in the era of coronary stenting. METHODS AND RESULTS: Cardiac-specific health status was evaluated at baseline and at 6 and 12 months after intervention with the Seattle Angina Questionnaire (SAQ) in patients randomized to stent-assisted PCI (n=488) versus CABG (n=500) in the Stent or Surgery trial. Scores for physical limitation, angina frequency, and quality of life improved significantly for both treatment groups at 6 months (range of improvement from 13.6 to 34.7 points) and 12 months (14.3 to 38.2 points; all P<0.001). CABG patients had greater improvement than those assigned to PCI, although the magnitude of the difference decreased over time (difference at 6 months, 4.03 to 6.48 points; 12 months, 2.05 to 2.93 points). A component of this reduction is accounted for by PCI-arm patients who required repeat intervention. Differences between treatment groups were greatest for the 6-month angina frequency scores (difference=6.48 points; 95% CI 3.96 to 8.99). Overall, treatment satisfaction was high and did not differ significantly between groups. CONCLUSIONS: Both CABG and stent-assisted PCI dramatically improved cardiac-related health status in patients with multivessel disease at 6- and 12-month follow-up. During the first postprocedure year, patients' angina burden and physical limitations were alleviated to a greater extent with CABG.