Percutaneous coronary intervention at centers with and without on-site surgery: a meta-analysis.

CONTEXT: Percutaneous coronary interventions are performed at centers without onsite surgery, despite current guidelines discouraging this. OBJECTIVE: To assess literature comparing rates of in-hospital mortality and emergency coronary artery bypass grafting surgery at centers with and without on-site surgery. DATA SOURCES: A systematic search of studies published between January 1990 and May 2010 was conducted using MEDLINE, EMBASE, and Cochrane Review databases. STUDY SELECTION: English-language studies of percutaneous coronary intervention performed at centers with and without on-site surgery providing data on in-hospital mortality and emergency bypass were identified. Two study authors independently reviewed the 1029 articles originally identified and selected 40 for analysis. DATA EXTRACTION: Study title, time period, indication for angioplasty, and outcomes were extracted manually from all selected studies, and quality of each study was assessed using the strengthening the reporting of observational studies in epidemiology (STROBE) checklist. DATA SYNTHESIS: High-quality studies of percutaneous coronary interventions performed at centers with and without on-site surgery were included. Pooled-effect estimates were calculated with random-effects models. Analyses of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction of 124,074 patients demonstrated no increase in in-hospital mortality (no on-site surgery vs on-site surgery: observed risk, 4.6% vs 7.2%; odds ratio [OR], 0.96; 95% CI, 0.88-1.05; I(2) = 0%) or emergency bypass (observed risk, 0.22% vs 1.03%; OR, 0.53; 95% CI, 0.35-0.79; I(2) = 20%) at centers without on-site surgery. For nonprimary percutaneous coronary interventions (elective and urgent, n = 914,288), the rates of in-hospital mortality (observed risk, 1.4% vs 2.1%; OR, 1.15; 95% CI, 0.93-1.41; I(2) = 46%) and emergency bypass (observed risk, 0.17% vs 0.29%; OR, 1.21; 95% CI, 0.52-2.85; I(2) = 5%) were not significantly different at centers without or with on-site surgery. CONCLUSION: Percutaneous coronary interventions performed at centers without on-site surgery, compared with centers with on-site surgery, were not associated with a higher incidence of in-hospital mortality or emergency bypass surgery.

Chronic kidney disease and dipstick proteinuria are risk factors for stent thrombosis in patients with myocardial infarction.

BACKGROUND: Kidney failure (stage 5 chronic kidney disease [CKD]) is an independent risk factor for stent thrombosis (ST). Moderate (stage 3-4) CKD and proteinuria are both associated with adverse cardiovascular events, including worse outcomes after myocardial infarction (MI). Whether moderate CKD and proteinuria increase the risk of ST after MI is not known. This study evaluated the risk of ST associated with moderate CKD and dipstick proteinuria. METHODS: We retrospectively analyzed clinical and laboratory data from 956 non-stage 5 CKD patients who were admitted with MI and received intracoronary stenting. Clinical follow-up was collected at 1 year for definite or probable ST, as well as for all-cause mortality, nonfatal MI or death, and target vessel revascularization or coronary artery bypass graft surgery. RESULTS: After adjustment for multiple clinical and biochemical covariates, patients with both estimated glomerular filtration rate (GFR) of 15 to 59 mL min(-1) 1.73 m(-2) and > or =30 mg/dL dipstick proteinuria had increased cumulative incidence of ST (hazard rate [HR] 3.69, 95% CI 1.54-8.89), all-cause mortality (HR 2.68, 95% CI 1.34-5.37), and nonfatal MI or death (HR 3.20, 95% CI 1.77-5.81) at 1 year. In addition, estimated GFR of 15 to 59 mL min(-1) 1.73 m(-2) was a significant independent predictor of ST (HR 2.61, 95% CI 1.33-5.10). Dipstick proteinuria > or =30 mg/dL was associated with a trend toward increased risk for all outcomes. CONCLUSIONS: In an acute MI population, moderate CKD was identified as a novel prognostic marker for ST. In addition, patients with both decreased GFR and proteinuria had higher incidences of all-cause mortality and nonfatal MI or death than patients with either condition alone.

Derived fibrinogen compared with C-reactive protein and brain natriuretic peptide for predicting events after myocardial infarction and coronary stenting.

BACKGROUND: After myocardial infarction (MI), biomarkers can be helpful to identify patients who might benefit from more intensive therapies. The prothrombin time-derived fibrinogen (PTDF) assay is widely available and relatively inexpensive. We determined whether PTDF predicts events in patients with MI and compared this assay with brain natriuretic peptide (BNP) and C-reactive protein (CRP). METHODS: We retrospectively analyzed data from 915 patients admitted with MI. Follow-up was collected at 1 year for major adverse cardiac events (MACE) defined as death from any cause, nonfatal MI or death, target vessel revascularization, or coronary artery bypass grafting. RESULTS: Patients in the fourth quartile of PTDF were older and had more risk factors but fewer ST-elevation MI and lower peak troponin values. The fourth quartiles of PTDF, CRP, and BNP were associated with increased MACE compared with the first quartiles with hazard ratios of 2.08 (1.30-3.33), 1.94 (1.22-3.07), and 2.56 (1.57-4.18), respectively, findings that remained significant after adjustment. When outcomes by strata of PTDF were examined, CRP failed to add additional prognostic value. Higher BNP levels predicted MACE in the upper but not lower stratum of PTDF. CONCLUSION: In patients with MI, PTDF is a predictor of MACE at 1 year, with equivalent value compared to BNP and CRP. With low PTDF levels, neither BNP nor CRP adds prognostic value. At elevated PTDF values, higher BNP, but not CRP, identifies a higher-risk population. Therefore, PTDF can be substituted for CRP, with BNP being useful in the presence of elevated PTDF.

Coronary artery stents: Part I. Evolution of percutaneous coronary intervention.

The subspecialty of interventional cardiology has made significant progress in the management of coronary artery disease over the past three decades with the development of percutaneous coronary transluminal angioplasty, atherectomy, and bare-metal and drug-eluting stents (DES). Bare-metal stents (BMS) maintain vessel lumen diameter by acting as a scaffold and prevent collapse incurred by angioplasty. However, these devices cause neointimal hyperplasia leading to in-stent restenosis and requiring reintervention in more than 20% of patients by 6 mo. DES (sirolimus and paclitaxel) prevent restenosis by inhibiting neointimal hyperplasia. However, DESs also delay endothelialization, causing the stents to remain thrombogenic for an extended, yet unknown, period of time. Late stent thrombosis is associated with a 45% mortality rate. Premature discontinuation of antiplatelet therapy, particularly clopidogrel, is the strongest predictor of stent thrombosis. Sixty percent of patients receive stents for off-label (unapproved) indications, which also increases the frequency of stent thrombosis. Clopidogrel and aspirin are the cornerstone of therapy in the prevention of stent thrombosis in both BMS and DES. Recommendations pertaining to the optimal duration of dual-antiplatelet therapy have been debated. Both the Food and Drug Administration and the American Heart Association/American College of Cardiologists, in association with other major societies, have made recommendations to extend the duration of dual-antiplatelet therapy in patients with DES to 1 yr. The 6-wk duration of dual-antiplatelet therapy in patients with BMS remains unchanged. All patients with coronary stents must remain on life-long aspirin monotherapy. Since the introduction of percutaneous transluminal coronary angioplasty for the treatment of coronary atherosclerosis, the practice of percutaneous coronary intervention has undergone a dramatic transformation from simple balloon dilation catheters to sophisticated mechanical endoprostheses. These advancements have impacted the practice of perioperative medicine. In this series of two articles, in Part I we will review the evolution of percutaneous coronary intervention and discuss the issues associated with percutaneous transluminal coronary angioplasty and coronary stenting; in Part II we will discuss perioperative issues and management strategies of coronary stents during noncardiac surgery.

Coronary artery stents: II. Perioperative considerations and management.

The management of patients with coronary artery stents during the perioperative period is one of the most important patient safety issues clinicians confront. Perioperative stent thrombosis is a life-threatening complication for patients with either bare-metal or drug-eluting stents. Noncardiac surgery appears to increase the risk of stent thrombosis, myocardial infarction, and death, particularly when patients undergo surgery early after stent implantation. The incidence of complications is further increased when dual-antiplatelet therapy is discontinued preoperatively. It is generally agreed that aspirin must be continued throughout the perioperative period, except in circumstances when the risk of bleeding significantly outweighs the benefit of continued anticoagulation, such as procedures performed in a closed space. We present considerations for regional anesthesia, as well as postoperative recommendations as the occurrence of perioperative stent thrombosis appears to be greatest during this period. Immediate percutaneous coronary intervention is the definitive treatment for perioperative stent thrombosis, and 24-h access to an interventional cardiology suite should be readily available. Algorithms for perioperative management of patients with bare-metal and drug-eluting stents are proposed.

Utilization of distal embolic protection in saphenous vein graft interventions (an analysis of 19,546 patients in the American College of Cardiology-National Cardiovascular Data Registry).

In clinical trials, the use of a distal embolic protection device (EPD) during saphenous vein graft (SVG) percutaneous intervention (PCI) decreases the incidence of major adverse events. However, the frequency of EPD use during SVG PCI in clinical practice is unknown. We evaluated 19,546 SVG PCI procedures in the American College of Cardiology-National Cardiovascular Data Registry from January 1, 2004, through March 30, 2006. EPD use was the primary outcome. Univariate and multivariable analyses were used to assess for characteristics associated with EPD use and to determine the association between EPD use and 2 outcomes: no-reflow and in-hospital mortality. EPDs were used in 22% of patients who underwent SVG PCI. Characteristics independently associated with EPD use were age (odds ratio [OR] 1.04, p = 0.03), male gender (OR 1.12, p = 0.02), older grafts (p <0.001 for the group), longer lesions (OR 1.16, p <0.001), and American College of Cardiology/American Heart Association class C lesions (OR 1.41, p <0.001). Patients were less likely to receive an EPD if they had class <3 grade flow according to Thrombolysis in Myocardial Infarction classification (p <0.001) or previously treated lesions (OR 0.55, p <0.001). There was a weak correlation between annual hospital PCI volume and EPD use (r = 0.2, p <0.001). Nineteen percent of centers did not use EPDs and 41% used them in <10% of cases. EPD use was independently associated with a lower incidence of no-reflow (OR 0.68, p = 0.032), but not in-hospital mortality (1.0% vs 0.9%, p = NS). In conclusion, in current practice, EPDs are used in <25% of SVG PCI procedures.

Frequency of percutaneous coronary interventions at facilities without on-site cardiac surgical backup--a report from the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR).

The practice of performing percutaneous coronary intervention (PCI) in centers without on-site cardiac surgical backup is controversial. Using data from facilities that participated in the American College of Cardiology/National Cardiovascular Data Registry, the incidence of PCI without on-site surgical backup was evaluated. From January 1, 2001 through December 31, 2004, 39 of 449 (8.7%) centers were identified as sites that performed PCI without on-site surgical backup. By the end of 2005, 75 of 463 (16%) participating facilities were performing PCI without on-site backup. By using standardized data element definitions, it was possible to differentiate between patients who underwent elective PCI and those who had urgent nonelective PCI for acute ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction. This analysis showed that the number of elective and nonelective PCI procedures with or without on-site surgical backup per quarter had increased significantly (p <0.0001) from 2001 to 2004. The number of PCI procedures performed without on-site surgical backup continued to increase in 2005. In conclusion, the significant increase in elective PCIs performed at facilities without on-site surgical backup occurred despite national guidelines that state elective PCI should not be done in centers without on-site cardiac surgery.

Comparison of drug-eluting versus bare metal stents on later frequency of acute myocardial infarction and death.

In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.

PCI with and without abciximab after upstream eptifibatide use: outcomes in high-risk patients.

BACKGROUND: Abciximab is often used to treat high-risk patients during percutaneous coronary intervention (PCI). Recent data indicate, however, that upstream and postprocedural treatment with low-dose glycoprotein (GP) IIb/IIIa inhibitors may be more beneficial than abciximab during and after PCI. Whether abciximab can be used safely or effectively during PCI for high-risk patients after upstream treatment with eptifibatide in patients with acute coronary syndromes (ACS) is not known. METHODS: Clinical outcomes were evaluated in 289 patients with ACS who had upstream treatment with eptifibatide, and abciximab (EA) during PCI, and compared to 560 ACS patients who had both upstream and interventional treatment with eptifibatide (EE). RESULTS: Bleeding and vascular complications of the two groups were similar. Overall, 1-year major adverse cardiac event (MACE) rates were similar: 26.0% in the EA group and 25.2% in the EE group; p = 0.82. In patients with unstable angina, the hazard of MACE at 1 year was higher with EA than EE, 1.98 (1.23-3.18), due to significantly higher rates of repeat revascularization in the EA group. In patients with myocardial infarction (MI), the hazard of MI or death at 1 year was lower in the EA than the EE group, 0.50 (0.27-0.93). CONCLUSION: In this single-center observational study, the use of abciximab for PCI after upstream use of eptifibatide for ACS was safe. Abciximab was of no benefit in patients with unstable angina, but was associated with lower MI or death in patients with MI. These observations are consistent with recent findings indicating that abciximab is of benefit in patients with NSTEMI, but not lower-risk patients.

Relationship between procedure indications and outcomes of percutaneous coronary interventions by American College of Cardiology/American Heart Association Task Force Guidelines.

BACKGROUND: An American College of Cardiology/American Heart Association (ACC/AHA) Task Force periodically revises and publishes guidelines with evidence-based recommendations for appropriate use of percutaneous coronary intervention (PCI). Some studies have suggested that closer adherence to guidelines can reduce variations in care, can improve quality, and may ultimately result in better outcomes, but this finding is incompletely understood. Guidelines themselves must change to be responsive to continuously evolving clinical practice. Our goal here was to investigate whether any relationship existed between the most recent ACC/AHA recommended indications for PCI and short term in-hospital outcomes. METHODS AND RESULTS: We analyzed the ACC National Cardiovascular Data Registry for the period of January 1, 2001, through March 31, 2004. We excluded PCI procedures performed for acute myocardial infarction (ST-segment elevation myocardial infarction); all others were grouped by their indications according to the standard ACC/AHA scheme: Class I, evidence and/or agreement that PCI is useful and effective; Class IIa, conflicting evidence and/or divergent opinions, weight is in favor; Class IIb, usefulness/efficacy is less well established; and Class III, evidence and/or agreement that PCI is not useful or effective and may be harmful. Clinical success was defined as angiographic success (<20% residual stenosis) at all lesions attempted without the adverse events of myocardial infarction, same-admission bypass surgery, or death. There were 412 617 PCI procedures included in the analysis. Frequency of indications was as follows: Class I, 64%; Class IIa, 21%; Class IIb, 7%; and Class III, 8%. Clinical success declined across the indications classes (92.8%, 91.7%, 89%, and 85.5%, respectively; P<0.001), whereas adverse events increased. CONCLUSIONS: In this large survey of contemporary PCI practice, most procedures were performed for Class I indications. A significant relationship between evidence-based indications recommended by the ACC/AHA Task Force and in-hospital outcomes was noted.

Preprocedural white blood cell count and major adverse cardiac events late after percutaneous coronary intervention in saphenous vein grafts.

Elevation of white blood cells (WBCs) is associated with worse outcomes in patients with coronary artery disease (CAD), including patients undergoing percutaneous coronary intervention (PCI) of native coronary arteries, but this relation has not been studied in patients with saphenous vein graft disease undergoing PCI. A total of 530 patients who underwent PCI of saphenous vein grafts from May 1997 to July 2002 were followed for >3 years. Major adverse coronary events (MACEs) were assessed as a composite of death, myocardial infarction, or revascularization during follow-up (mean 2.7 years). Patients with MACEs (n = 287) were younger and had more thrombotic and ostial lesions (p < 0.05) than those without MACEs (n = 243). The preprocedural WBC count was also significantly higher in the MACE group than in the non-MACE group (8.1 x 10(3)/mul, range 6.6 to 10.1, vs 7.0 x 10(3)/mul, range 5.6 to 8.2; p < 0.001). After adjusting for covariates, multiple logistic regression analysis revealed the preprocedural WBC count to be an independent predictor for MACEs (odds ratio 1.2; 95% confidence interval 1.1 to 1.3, p < 0.001). Patients in the highest quartile of the preprocedural WBC level had a significantly increased risk of MACEs (lowest vs highest quartile, 41.3% vs 72.4%; odds ratio 3.7; 95% confidence interval 2.2 to 6.3). Thus, an elevated preprocedural WBC count is associated with increased risk of MACEs in patients undergoing PCI for saphenous vein graft lesions.

Differences in baseline characteristics and in-hospital outcomes in patients with or without prior stroke undergoing percutaneous coronary intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used in patients with high-risk baseline characteristics. A prior stroke may identify patients who have a higher risk for post-PCI complications. However, no comparative data exist on post-PCI outcomes of patients with or without prior stroke. METHODS: Review of a PCI database of 9,088 consecutive PCIs from July 1997 to December 2002 identified 812 PCIs in patients with a history of prior stroke and 8,044 PCIs without prior stroke. RESULTS: Patients with prior stroke had high-risk baseline characteristics [diabetes, hypertension, hyperlipidemia, smoking, peripheral arterial disease, congestive heart failure, chronic renal failure, history of prior myocardial infarction and prior coronary artery bypass graft (CABG)] and high-risk coronary anatomy (p < 0.001 for each one). The triple composite (death, myocardial infarction and emergent CABG) and the triple composite plus post-PCI stroke were higher in patients with prior stroke (11.2% vs. 4.8%; p < 0.001; z = 7.617 and 12.1% vs. 5.0%; p < 0.001; z = 8.271, respectively. CONCLUSION: Patients with prior stroke constitute a high-risk PCI cohort with higher rates of in-hospital adverse events. A prior stroke history should be considered in evaluating potential candidates for PCI.

Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial.

OBJECTIVES: We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing stent implantation. BACKGROUND: Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel. METHODS: In the TAXUS-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting TAXUS stent or the bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin. RESULTS: Among patients with diabetes, the TAXUS stent, compared to the bare-metal stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p < 0.0001), and reduced the 12-month rates of target lesion revascularization by 65% (7.4% vs. 20.9%, p = 0.0008), target vessel revascularization by 53% (11.3% vs. 24%, p < 0.004), and composite major adverse cardiac events by 44% (15.6% vs. 27.7%, p = 0.01). The one-year rates of cardiac death (1.9% vs. 2.5%), myocardial infarction (3.2% vs. 6.4%), and subacute thrombosis (0.6% vs. 1.2%) were comparable between the paclitaxel-eluting and control stents, respectively. In the insulin-requiring subgroup, the TAXUS stent reduced angiographic restenosis by 82% (7.7% vs. 42.9%, p = 0.0065), and reduced the one-year rate of target lesion revascularization by 68% (6.2% vs. 19.4%, p = 0.07), a relative reduction similar to patients without diabetes. CONCLUSIONS: The site-specific delivery of paclitaxel after coronary stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.

Superior in-hospital and 30-day outcomes with abciximab versus eptifibatide: a contemporary analysis of 495 consecutive percutaneous coronary interventions.

BACKGROUND: Both abciximab (AB) and eptifibatide (EP) are approved for use during percutaneous coronary intervention (PCI) but comparative data between the 2 agents are limited. METHODS: We compared in-hospital and 30-day outcomes of contemporary 495 consecutive PCIs performed by a single operator between July 2001 and November 02 with AB and EP (242 with AB and 253 with EP). Cardiogenic shock patients who underwent a second procedure within 30 days from their first procedure were excluded. Selection of glycoprotein IIb/IIIa was at the operator's discretion. The initial 444 cases were performed with unfractionated heparin and the last 51 with bivalirudin. RESULTS: AB cases comprised a higher risk group with more patients with diabetes, peripheral vascular disease, ST-elevation myocardial infarction and renal failure (p<0.05 for each) and more rotablator use and longer lesions (p<0.01 for each). AB was associated with less in-hospital (4.6 versus 12.3%; OR: 0.34; 95% CI: 0.17-0.7; p=0.004) as well as 30-day (5.5 versus 14%; OR: 0.37; 95% CI: 0.19-0.71; p=0.003) major adverse cardiac events (sum of death, MI, urgent revascularization, all bleeding and stroke). CONCLUSION: Despite its use in higher risk PCI patients, AB resulted in superior short-term outcomes compared with EP. Our data suggest that significant efficacy differences may exist between these 2 agents and that a randomized comparison is warranted.