Safety of drug-eluting stents in patients with left ventricular dysfunction undergoing percutaneous coronary intervention.

Recent studies have reported a higher incidence of late stent thrombosis in patients undergoing drug-eluting stent (DES). Reduced left ventricular (LV) ejection fraction (EF) is considered a risk factor for this complication after both bare-metal stent (BMS) and DES implantation. Therefore, the aim of this study was to evaluate the safety of DES on long-term follow-up in patients with LV dysfunction undergoing percutaneous coronary intervention. We retrospectively selected all patients with an EF <45% undergoing percutaneous coronary intervention with implantation of > or =1 sirolimus- or paclitaxel-eluting stent at our institution. The primary endpoint of the study was all-cause mortality, retrieved using both Social Security Database and hospital records. We also compared the results of this group with a historical cohort of patients with LV dysfunction undergoing BMS implantation; 121 patients who received > or =1 DES were enrolled. The mean LVEF was 36 +/- 8%, with 20 patients (16%) with a LVEF < or =25%; 36 patients (30%) had diabetes mellitus, and DES implantation was considered off-label in 100 patients (83%). Survival at 1-, 2-, and 3-year follow-up was 94% (95% confidence interval [CI] 88 to 100), 90% (95% CI 82 to 98) and 88% (95% CI 80 to 96), respectively. In conclusion, the favorable results of this study demonstrate the safety of DES in patients with LV dysfunction.

Relation of blood urea nitrogen to long-term mortality in patients with heart failure.

Patients with chronic kidney disease and heart failure (HF) have been shown to be at higher risk for major adverse cardiovascular events and death. Recent studies have demonstrated that blood urea nitrogen (BUN) might serve as a powerful predictor of mortality in acutely decompensated HF. The goal of this study was to determine the impact of BUN on long-term mortality in patients with stage B and C HF. Our retrospective analysis included patients undergoing percutaneous intervention with a calculated left ventricular ejection fraction < or =50%. Patients on dialysis or with technically inadequate left ventriculograms were excluded. Chart review was performed and mortality data were obtained. Our population included 444 patients with a mean ejection fraction of 38 +/- 10%, mean age of 59 +/- 11 years, median BUN of 14 mg/dl, and median glomerular filtration rate (GFR) of 81 ml/min/1.73 m(2); 31% had stage C HF, and 33% died during follow-up. Patients with increased BUN (> or =17 mg/dl) and decreased GFR (< or =69 ml/min/1.73 m(2)) had significantly increased long-term mortality on Kaplan-Meier analysis (8-year mortalities of 57% and 55%, respectively). In patients with stage C HF, mortalities at 8 years were 69% and 73% with abnormal BUN and GFR, respectively. Proportional hazard regression analysis demonstrated that BUN and stage C HF were independently associated with increased mortality, whereas GFR was not. In conclusion, we demonstrated that BUN is strongly associated with mortality in patients with stage B and C HF and may serve as a better biomarker than GFR for prognostication.

Effect of statins and white blood cell count on mortality in patients with ischemic left ventricular dysfunction undergoing percutaneous coronary intervention.

BACKGROUND: While morbidity and mortality were shown to be increased in the setting of an elevated white blood cell (WBC) count for patients with acute coronary syndrome, the impact of statin therapy on mortality for patients with an elevated WBC count is unknown in high-risk patients with coronary artery disease. HYPOTHESIS: The goal of this study was to determine whether statin therapy improved survival in patients with elevated WBC count undergoing percutaneous coronary intervention (PCI) with preexisting left ventricular (LV) dysfunction, a population at high risk for adverse outcomes. METHODS: We retrospectively evaluated consecutive patient procedures performed at our institution from 1996 through 1999. Patients had a technically adequate angiographic left ventriculogram with a calculated ejection fraction (EF) < or = 50%. Patients with prior coronary artery bypass graft were excluded. Mortality data were retrieved using the U.S. Social Security Death Index. Follow-up ranged from 3.5 to 6.5 years. Means are provided with +/- standard deviation, and p values < 0.05 were considered significant. RESULTS: Of the study population of 238 patients (average EF 39 +/- 9.8%, mean age 57.5 +/- 12 years, 68% men) 61% underwent PCI for a recent myocardial infarction, 68% received stents, and 65% were discharged on statins. Mean WBC count was 9,000 +/- 3,100 cells/mm3, with 28% of patients having a WBC > or = 10,000 cells/mm3. During follow-up, 27% of our population died. Patients with a WBC > or = 10,000 had worse survival than patients with WBC < 10,000 (1-year survival: 86 vs. 96%, p < 0.05; 3-year survival: 79 vs. 89%, p < 0.05). Survival was significantly improved in patients on statin therapy regardless of WBC count, but the greatest benefit tended to be in patients with WBC > or = 10,000 (WBC > or = 10,000; odds ratio [OR] 5.14, 95% confidence interval [CI] 1.44-19.0, WBC < 10,000; OR 2.79,95% CI 1.13-7.1). Proportional hazard regression analysis demonstrated that both statin therapy and WBC count predicted mortality. CONCLUSION: Patients undergoing PCI with LV dysfunction discharged on statins had improved survival regardless of WBC count, with a trend for greater improvement in patients with elevated WBC counts. In addition, WBC count predicts mortality in this high-risk population with LV dysfunction undergoing PCI.

Improved survival for stenting vs. balloon angioplasty for the treatment of coronary artery disease in patients with ischemic left ventricular dysfunction.

While earlier studies of balloon angioplasty (BA) in patients with left ventricular (LV) dysfunction suggested high late mortality, a study directly comparing coronary stenting and BA has not been performed. Since stenting provides a more durable revascularization, we sought to compare long-term survival in patients undergoing stenting vs BA in patients with decreased left ventricular ejection fractions (LVEF). We evaluated consecutive patient procedures performed in our institution from 1996 through 1999. Patients were considered part of the stent group if they received at least one stent. To be included, patients had to have a technically adequate angiographic LV gram with a calculated LVEF

Six-month outcomes after single- and multi-lesion percutaneous coronary intervention: results from the ROSETTA registry.

BACKGROUND: The American College of Cardiology/American Heart Association exercise testing guidelines suggest that routine functional testing may benefit patients at high risk of restenosis, such as those undergoing multi-lesion percutaneous coronary intervention (PCI). OBJECTIVES: To compare the six-month post-PCI clinical and procedural outcomes in patients following single- and multi-lesion PCI, and to examine the use of routine functional testing (ie, in all patients) versus selective functional testing (ie, only in those with recurrent symptoms) following multi-lesion PCI. METHODS: Six-month outcomes among 562 patients after single-lesion PCI and 229 patients after multi-lesion PCI were examined. All patients were enrolled in the Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) registry, a prospective, multicentre registry examining the use of functional testing after successful PCI. RESULTS: For single- versus multi-lesion PCI patients, respectively, rates of death (1.8% versus 2.2%, P=0.7) and myocardial infarction (0.7% versus 2.6%, P=0.03) were low in both groups. Rates of unstable angina (12.0% versus 11.7%, P=0.9) and the composite clinical end point of death, myocardial infarction or unstable angina (13.5% versus 13.9%, P=0.9) were similar. Multi-lesion PCI patients had a higher number of repeat PCI procedures (6.6% versus 13.4%, P=0.02) but there was no difference in the rates of coronary artery bypass graft surgery (3.0% versus 2.6%, P=0.7). A routine functional testing strategy was used in 28.0% of single-lesion and 31.6% of multi-lesion patients. In a multivariate analysis of the multi-lesion patients, routine functional testing was not associated with a significant reduction in the composite clinical event rate (odds ratio 0.5, 95% CI 0.2 to 1.7, P=0.27). CONCLUSIONS: During the six-month period following successful PCI, clinical event rates were similar among patients undergoing single- or multi-lesion PCI. Routine functional testing was not associated with a statistically significant benefit in patients after multi-lesion PCI. However, additional study is required to better define the role of routine functional testing in this subgroup of patients.

Utility of routine functional testing after percutaneous transluminal coronary angioplasty: results from the ROSETTA registry.

BACKGROUND: There is little consensus regarding the use of functional testing after percutaneous transluminal coronary angioplasty (PTCA). Some physicians employ a routine functional testing strategy, and others employ a symptom-driven strategy. OBJECTIVE: To examine the effects of routine post-PTCA functional testing on the use of follow-up cardiac procedures and clinical events. METHODS: The Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) Registry is a prospective multicenter observational study examining the use of functional testing after PTCA. A total of 788 patients (pts) were enrolled in the ROSETTA Registry at 13 clinical centers in 5 countries. The frequencies of functional testing, cardiac procedures and clinical events were examined during the first 6 months following a successful PTCA. RESULTS: Patients were predominantly elderly men (mean age, 61+/-11 years; 76% male) who underwent single-vessel PTCA (85%) with stent implantation (58%). During the 6-month follow-up, a total of 237 pts were observed to undergo a routine functional testing strategy (100% having functional testing for routine follow-up), while 551 pts underwent a selective (or clinically-driven) strategy (73% having no functional testing and 27% having functional testing for a clinical indication). Patients in the routine testing group underwent a total of 344 functional tests compared with 165 tests performed in the selective testing group (mean, 1.45 tests/patient versus 0.3 tests/patient; p<0.0001). There was little difference in the rates of follow-up cardiac procedures among the pts undergoing the routine and selective testing strategies [cardiac catheterization, 13.9% versus 17.5% (p=NS); percutaneous coronary intervention (PCI), 8.4% versus 8.7% (p=NS); coronary artery bypass graft surgery, 2.1% versus 3.3% (p=NS)]. However, clinical events were less common among pts who underwent routine functional testing, e.g., unstable angina (6.1% versus 14.4%; p=0.001), myocardial infarction (0.4% versus 1.6%; p=NS), death (0% versus 2.2%; p=0.02) and composite clinical events (6.3% versus 16.3%; p<0.0001). After controlling for baseline clinical and procedural differences, routine functional testing had a persistent independent association with a reduction in the composite clinical event rate (odds ratio, 0.45; 95% confidence interval, 0.24-0.81; p=0.008). CONCLUSION: Routine functional testing after PTCA is associated with a reduction in the frequency of follow-up clinical events. This association may be attributable to the early identification and treatment of pts at risk for follow-up events, or it may be due to clinical differences between pts who are referred for routine and selective functional testing.

Medical therapy in patients undergoing percutaneous coronary intervention: results from the ROSETTA registry.

BACKGROUND: Previous studies have examined medication use among patients with coronary artery disease who have suffered an acute myocardial infarction (MI). However, little is known about medication use among patients with coronary artery disease who undergo percutaneous coronary intervention (PCI). OBJECTIVE: To examine the patterns of use of medical therapy among patients who undergo PCI; and to examine the determinants of medical therapy in these patients. METHODS: The Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) registry is a prospective multicentre study examining the use of functional testing after PCI. The medication use was examined among 787 patients who were enrolled in the ROSETTA registry at 13 clinical centres in five countries. RESULTS: Most patients were men (mean age 61+/-11 years, 76% male) who underwent single vessel PCI (85%) with stent implantation (58%). At admission, discharge and six months, rates of acetylsalicylic acid use were 77%, 96% and 93%, respectively (discharge versus six months, P<0.0001). Rates of use of other oral antiplatelet agents were 11%, 59% and 2% (P=0.02). For individual anti-ischemic medications, rates of use were as follows: beta-blockers 49%, 58% and 59% (P<0.0001); calcium antagonists 34%, 43% and 42% (P<0.0001); and nitrates 42%, 56% and 43% (P<0.0001). Rates of use of combination anti-ischemic medications were as follows: triple therapy 7%, 9% and 9% (P<0.0001); double therapy 34%, 47% and 38% (P<0.0001); monotherapy 36%, 36% and 41% (P<0.0001); and no anti-ischemic therapy 23%, 8% and 12% (P<0.0001). Rates of use of angiotensin-converting enzyme inhibitors were 25%, 33% and 32% (P<0.0001), and rates of use of lipid lowering agents were 41%, 52% and 61% (P<0.0001). CONCLUSIONS: Trials and guidelines statements have favourably affected the rates of use of acetylsalicylic acid and other antiplatelet agents after PCI. However, in spite of patients undergoing a successful revascularization procedure, physicians do not reduce the use of anti-ischemic medical therapy.

Comparison of event and procedure rates following percutaneous transluminal coronary angioplasty in patients with and without previous coronary artery bypass graft surgery [the ROSETTA (Routine versus Selective Exercise Treadmill Testing after Angioplasty) Registry].

To compare 6-month post-percutaneous transluminal coronary angioplasty (PTCA) outcomes and cardiac procedure use among patients with and without prior coronary artery bypass graft (CABG) surgery, we examined 791 patients who were enrolled in the Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) Registry. The ROSETTA Registry is a prospective, multicenter registry that examines the use of functional testing after successful PTCA. Most patients were men (76%, mean age 61 +/- 11 years) who underwent single-vessel PTCA (85%) with stent implantation (58%). Baseline and procedural characteristics differed between patients with a prior CABG (n = 131) and patients with no prior CABG (n = 660), including Canadian Cardiovascular Society angina class III to IV (60% vs 49%, respectively, p = 0.03) and stenosis involving the proximal left anterior descending coronary artery (10% vs 22%, p = 0.004). Event rates among patients with prior CABG were higher than among patients with no prior CABG, including unstable angina (19% vs 11%, p = 0.02), myocardial infarction (2% vs 1%, p = 0.2), death (4% vs 2%, p = 0.08), and composite clinical events (22% vs 12%, p = 0.003). Furthermore, patients with prior CABG had higher rates of follow-up cardiac procedures, including angiography (24% vs 14%, p = 0.008) and PTCA (13% vs 7%, p = 0.04), but not repeat CABG (2% vs 3%, p = 0.8). A multivariate analysis that included baseline clinical and procedural characteristics demonstrated that prior CABG was a significant independent predictor of clinical events and cardiac procedure use (odds ratio 2.3, 95% confidence interval 1.5 to 3.5, p = 0.0001). Within the prior CABG group, patients with a PTCA of a bypass graft had a higher composite clinical event rate than patients with a PTCA of a native vessel (32% vs 17%, p = 0.05). In contrast, patients with a PTCA of a native vessel had event rates similar to those of patients with no prior CABG (17% vs 12%, p = 0.2). Thus, post-CABG patients have an increased risk of developing a cardiac event or needing a follow-up cardiac procedure during the 6 months after PTCA.