Prognostic impact of blood transfusion after primary angioplasty for acute myocardial infarction: analysis from the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) Trial.

OBJECTIVES: We sought to determine the relationship between red blood cell (RBC) transfusion and clinical outcomes in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). BACKGROUND: The implications of RBC transfusion in patients undergoing primary PCI for AMI have not been evaluated. METHODS: Clinical outcomes of patients from the prospective, randomized CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) trial were analyzed by administration of in-hospital RBC transfusion not related to coronary artery bypass surgery. RESULTS: Of 2,060 randomized patients, 82 (3.98%) received RBC transfusion during the index hospitalization, including 33 (1.60%) with moderate/severe bleeding and 49 (2.38%) without overt major bleeding. Transfusion was independently associated with baseline anemia (odds ratio [95% confidence interval]: 4.44 [2.60 to 7.58], p < 0.0001), older age (1.03 [1.01 to 1.06], p = 0.002), triple-vessel disease (2.54 [1.47 to 4.38], p = 0.0008), and female sex (1.04 [1.02 to 1.06], p = 0.0008). Patients transfused versus not transfused had significantly higher rates of 1-year mortality (23.9% vs. 3.4%), disabling stroke (2.5% vs. 0.5%), reinfarction (7.0% vs. 2.2%), and composite major adverse cardiac events (41.0% vs. 16.6%) (all p values < 0.01). After multivariable adjustment for potential confounders including transfusion propensity, RBC transfusion was independently associated with mortality at 30 days (hazards ratio: 4.71, p = 0.0005) and 1 year (hazards ratio: 3.16, p = 0.0005). CONCLUSIONS: An RBC transfusion after primary PCI in AMI may be harmful, which is consistent with the findings from other studies after PCI in the noninfarct setting. Alternatively, RBC transfusion may be a marker of markedly increased risk. Randomized studies are warranted to determine the optimal threshold for RBC transfusion in patients with AMI undergoing mechanical reperfusion therapy.

Impact of in-hospital acquired thrombocytopenia in patients undergoing primary angioplasty for acute myocardial infarction.

Thrombocytopenia that develops after percutaneous coronary intervention (PCI) may result in hemorrhagic complications, requirement for blood product transfusions, and potentially thrombotic or ischemic complications. The incidence and prognostic significance of thrombocytopenia, in patients with acute myocardial infarction (AMI) who undergo primary PCI have not been evaluated. In the CADILLAC trial 2,082 patients who had AMI within 12 hours of onset without shock were prospectively randomized to receive balloon angioplasty with or without abciximab versus stenting with or without abciximab. Acquired thrombocytopenia, defined as a nadir platelet count <100 x 10(9)/L in patients who did not have baseline thrombocytopenia, developed in 50 of 1,975 qualifying patients (2.5%) after primary PCI. By multivariate analysis, acquired thrombocytopenia developed more frequently in patients who had non-insulin-requiring diabetes mellitus (odds ratio 3.88 [OR], p = 0.0002), previous statin administration (OR 3.28, p = 0.002), and use of abciximab (OR 2.06, p = 0.02) and less frequently in patients who had previous aspirin use (OR 0.26, p = 0.002), a higher baseline platelet count (OR 1.20, p < 0.0001), and greater body mass index (OR 0.90, p = 0.006). Patients who developed thrombocytopenia versus those who did not had higher in-hospital rates of major hemorrhagic complications (10.0% vs 2.7%, p = 0.01), greater requirement for blood transfusions (10.0% vs 3.9%, p = 0.05), longer hospital stay (median 4.8 vs 3.6 days, p = 0.008), and increased costs (median dollar 14,466 vs dollar 11,629, p = 0.001). All-cause mortality was markedly increased at 30 days (8.0% vs 1.6%, p = 0.0008) and at 1 year (10.0% vs 3.9%, p = 0.03) in patients who developed thrombocytopenia. In conclusion, thrombocytopenia that develops after primary PCI for AMI, although uncommon, is associated with increased hemorrhagic complications and decreased survival.

Impact of mild or moderate chronic kidney disease on the frequency of restenosis: results from the PRESTO trial.

OBJECTIVES: The goal of this study was to determine if restenosis is increased in mild and moderate chronic kidney disease (CKD) patients after percutaneous coronary intervention (PCI). BACKGROUND: Mortality is increased in CKD after PCI. Restenosis may contribute to increased late mortality. METHODS: We analyzed 11,187 patients with a creatinine <1.8 mg/dl from the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial, grouped by estimated creatinine clearance (CrCl) (<60, 60 to 89, >89 ml/min). The Cox proportional hazards models investigated the association between CrCl group and death, myocardial infarction, and target vessel revascularization (TVR). Generalized estimating equation regression models determined the association between CrCl group and lesion-specific restenosis. RESULTS: At 30 days, there was no difference in myocardial infarction, death, or TVR between the CrCl groups. At nine months, mortality was higher in the lowest CrCl group (2.2%, 1.2%, 0.8%; p < 0.001), which was no longer significant after adjusting for confounding variables. Myocardial infarction and TVR were not different between the groups. In patients undergoing protocol follow-up angiography, restenosis (>/=50%) was not increased with CKD (32%, 32%, 37%; p = 0.02). CONCLUSIONS: Mortality nine months after PCI is mildly increased in mild or moderate CKD patients. However, restenosis is not and does not account for the increased mortality.

Magnitude and impact of treatment delays on weeknights and weekends in patients undergoing primary angioplasty for acute myocardial infarction (the cadillac trial).

In 2,082 patients in the CADILLAC trial, the outcomes of patients presenting during peak hours were compared with those presenting during peak hours (Monday to Friday 8a.m. to 8 p.m., n = 1,047, 51%) were compared with those of patients presenting during off-peak hours (weeknights from 8 p.m. to 8 a.m. and weekends, n = 989, 49%). Although treatment times to percutaneous coronary intervention (PCI) were delayed approximately 21 minutes, in patients with acute myocardial infarctions occurring on weeknights and weekends, this modest delay did not adversely affect procedural success, myocardial recovery, or survival after PCI.

Does lowering pulmonary arterial pressure eliminate severe functional tricuspid regurgitation? Insights from pulmonary thromboendarterectomy.

OBJECTIVES: Because pulmonary thromboendarterectomy (PTE) can result in an immediate reduction in pulmonary artery (PA) pressure, we sought to evaluate the effect of PTE on severe tricuspid regurgitation (TR) without tricuspid annuloplasty. BACKGROUND: Few data exist regarding the frequency and magnitude of functional TR improvement after reduction in PA pressure. METHODS: We identified 27 patients with severe TR, defined by a regurgitant index (RI) >33%, who underwent PTE. The RI, tricuspid annular diameter (TAD), apical displacement of leaflet coaptation, and estimated PA systolic pressure were determined on pre- and post-PTE echocardiograms. Patients were stratified based on resolution (RI < or =33%) or persistence (RI >33%) of severe TR. RESULTS: Comparing pre- and post-PTE echocardiography results, severe TR resolved in 19 of 27 (70%) patients. This group had a more effective PA systolic pressure reduction after PTE (49 +/- 20 mm Hg vs. 32 +/- 16 mm Hg by echocardiography, p = 0.075, and 37 +/- 16 mm Hg vs. 16 +/- 13 mm Hg by catheter measurement, p = 0.004). No difference was observed in TAD, apical displacement of the tricuspid valve, or other features compared with the group with persistent severe TR. There was a trend toward longer hospital stays in the group with persistent severe TR (19 +/- 15 days vs. 14 +/- 9 days; p = 0.55). CONCLUSIONS: After significant PA pressure reduction by PTE, severe functional TR with a dilated annulus may improve without annuloplasty despite dilated tricuspid annulus diameters.

Characteristics of cerebrovascular accidents after percutaneous coronary interventions.

OBJECTIVES: We sought to identify the incidence, predictors, and clinical implications of cerebrovascular accidents (CVAs) after percutaneous coronary interventions (PCIs). BACKGROUND: Cerebrovascular accidents after PCI, although rare, can be devastating. Limited information exists regarding the characterization of this complication. METHODS: The study population comprised 20,679 patients who underwent PCI between September 1993 and April 2002. A CVA was defined as a composite of transient ischemic attack (TIA) and stroke. The characteristics of those who had a periprocedural CVA were compared with those who did not. RESULTS: A CVA occurred in 92 patients (0.30% of procedures). Of these, TIA occurred in 13 patients (0.04%) and stroke in 79 patients (0.25%). On multivariate analysis, patients with this complication more frequently had diabetes mellitus (adjusted odds ratio [OR] 1.8, 95% confidence interval [CI] 1.1 to 3.0; p = 0.013), hypertension (OR 1.9, 95% CI 1.1 to 3.3; p = 0.033), previous CVA (OR 2.3, 95% CI 1.3 to 4.0; p = 0.0059), and creatinine clearance < or =40 ml/min (OR 3.1, 95% CI 1.8 to 5.2; p < 0.0001). They underwent urgent or emergent procedures (OR 2.7, 95% CI 1.3 to 5.5; p = 0.0092) with more thrombolytic (OR 4.7, 95% CI 2.3 to 9.7; p < 0.0001) and intravenous heparin (OR 1.9, 95% CI 1.1 to 3.4; p = 0.030) use before PCI, and they more often required emergent intra-aortic balloon pump placement (OR 2.2, 95% CI 1.1 to 4.3; p = 0.028). On multivariate analysis, CVA was independently associated with in-hospital death (OR 7.8, 95% CI 4.2 to 14.7; p < 0.0001), acute renal failure (OR 2.8, 95% CI 1.4 to 5.7; p = 0.0042), and new dialysis (OR 3.73, 95% CI 1.01 to 13.8; p = 0.049) after PCI. CONCLUSIONS: Cerebrovascular accidents after PCI, although rare, are associated with high rates of in-hospital death and acute renal failure, often requiring dialysis.

Local intramural delivery of 60% ethyl alcohol for treatment of recalcitrant in-stent restenosis.

We report a case of recalcitrant in-stent restenosis after intracoronary brachytherapy failure that was successfully treated with a novel and experimental technique of local intramural delivery of 60% ethyl alcohol.

Impact of renal insufficiency in patients undergoing primary angioplasty for acute myocardial infarction.

BACKGROUND: The prognostic importance of renal insufficiency (RI) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) has not been well characterized. METHODS AND RESULTS: PCI was performed in 2082 AMI patients without shock presenting within 12 hours of symptom onset in a prospective, multicenter randomized trial. RI was defined as a calculated (Cockroft-Gault) creatinine clearance (CrCl) < or =60 mL/min. RI at baseline was present in 18% of patients. Compared with patients without RI, patients with RI were older and were more likely to be female; to have hypertension, peripheral vascular disease, or cerebrovascular disease; and to present in heart failure. Mortality was markedly increased in patients with versus without baseline RI both at 30 days (7.5% versus 0.8%, P<0.0001) and at 1 year (12.7% versus 2.4%, P<0.0001). Mortality rates increased incrementally for every 10-mL/min decrease in baseline CrCl. By multivariate analysis, reduced baseline CrCl was a powerful independent predictor of 30-day mortality (hazard ratio, 5.77; P<0.0001) and remained associated with reduced survival at 1 year (hazard ratio, 1.98; P=0.08). Hemorrhagic complications and transfusion requirements were also increased more than 2-fold in patients with RI, as were severe restenosis (diameter stenosis > or =70%; 20.6% versus 11.8%, P=0.024) and infarct artery reocclusion (14.7% versus 7.3%, P=0.02). CONCLUSIONS: Baseline RI in patients with AMI undergoing primary PCI is associated with a markedly increased risk of mortality, as well as bleeding and restenosis. Novel approaches are needed to improve the otherwise poor prognosis of patients with RI and AMI.

Frequency, determinants, and clinical implications of residual intracoronary thrombus following primary angioplasty for acute myocardial infarction.

The presence of intracoronary thrombus after percutaneous coronary intervention (PCI) worsens clinical outcomes. We performed this study to assess the incidence of intracoronary thrombus after primary angioplasty for acute myocardial infarction (AMI) and the clinical impact of nonocclusive thrombus. In 2,148 patients enrolled in the Primary Angioplasty in Myocardial Infarction (PAMI)-2, Stent PAMI, and PAMI No-Surgery-On-Site trials, we compared clinical and angiographic characteristics of 131 patients (6%) who had angiographically visible thrombus after PCI with those who did not (n = 2,017). In the subset of 2,115 patients with post-PCI Thrombolysis In Myocardial Infarction (TIMI) 2 or 3 flow, we assessed the impact of post-PCI thrombus (n = 110) on in-hospital, 1-month, and 1-year outcomes (reinfarction, ischemic target vessel revascularization [I-TVR], death, and major adverse cardiovascular events [MACEs] [i.e., death, reinfarction, or I-TVR]). Lack of stent use, presence of thrombus before PCI, and no history of PCI were independent correlates of post-PCI thrombus. Patients with nonocclusive thrombus after PCI had more reinfarctions during the index hospitalization (5.5% vs 2.0%, p = 0.03) and at 1 month (6.8% vs 2.3%, p = 0.01) and had nonsignificantly higher I-TVR (during hospitalization 5.5% vs 2.8%, p = 0.13; at 1 month 5.9% vs 3.4%, p = 0.17), but similar mortality and MACE rates as those without post-PCI thrombus. In multivariate analysis, post-PCI thrombus was not a significant predictor of in-hospital or 1-month reinfarction. At 1 year, clinical outcomes were similar between patient groups (reinfarction 8.3% vs 4.7%, p = 0.14; I-TVR 12.5% vs 12.1%, p = 0.91; death 5.9% vs 5.0%, p = 0.68; and MACEs 21% vs 18%, p = 0.54). We conclude that residual intracoronary thrombus after primary angioplasty is relatively uncommon. In patients who achieve TIMI 2 or 3 flow after PCI, intracoronary thrombus is associated with worse cardiovascular outcomes. However, differences in outcomes between patients with and without residual thombus are related to baseline clinical differences rather than thrombus per se.

Percutaneous coronary interventions in octogenarians. glycoprotein IIb/IIIa receptor inhibitors' safety profile.

OBJECTIVES: This study was designed to evaluate the safety profile of glycoprotein IIb/IIIa receptor inhibitors (GPI) in octogenarians undergoing percutaneous coronary intervention (PCI). BACKGROUND: Patients > or =80 years old constitute the fastest growing segment of the U.S. population and have a high prevalence of coronary artery disease. Few data exist regarding the use of GPI during PCI in octogenarians, as these patients have been excluded from randomized clinical trials of GPI. METHODS: Consecutive patients > or =80 years old undergoing PCI between January 1998 and June 2001 were evaluated for clinical outcomes and bleeding complications. RESULTS: One thousand three hundred and ninety two of 14,308 patients (9.7%) undergoing PCI were > or =80 years old. Of these, 459 of 1,392 (33%) of the patients were treated with GPI. Octogenarians treated with GPI were more likely to present with acute coronary syndrome or infarction, receive stents, require an intra-aortic balloon pump, or undergo multi-vessel PCI. Glycoprotein receptor inhibitor use was associated with a higher rate of bleeding, but the transfusion rate was similar to that in patients who did not receive GPI (9.8% vs. 8.6%, p = NS). No cases of intracranial hemorrhage were observed. By multivariate analysis, GPI treatment was associated with longer hospitalization but did not independently predict the need for transfusion or affect mortality. CONCLUSIONS: Octogenarians have a high incidence of bleeding and need for transfusion after PCI. Although the use of GPI was associated with more access and non-access site bleeding and longer hospital stay, GPI treatment does not significantly increase the risk of transfusion or intracranial hemorrhage in this non-randomized cohort.

Percutaneous intervention of unprotected left main coronary artery.

Successful percutaneous intervention of unprotected left main coronary artery (LMCA) in lieu of surgical revascularization represents the next wave of challenges that the field of interventional cardiology will try to overcome. Significant LMCA stenosis, commonly secondary to atherosclerosis, is seen in about 4-10% of cases presenting to the cardiac catheterization laboratory. Currently, the vast majority of these patients undergo surgical revascularization unless there are prohibitive reasons for surgical revascularization. Several challenges of percutaneous revascularization have been overcome with stents, intravascular brachytherapy, and other technical improvements. Yet, several remaining limitations of percutaneous intervention, such as in-stent restenosis, have to be improved further before randomized clinical trials of surgical and percutaneous revascularization of unprotected LMCA disease can be contemplated to establish a new standard of care.

Correlation of left ventricular diastolic filling characteristics with right ventricular overload and pulmonary artery pressure in chronic thromboembolic pulmonary hypertension.

OBJECTIVES: This study was designed to determine a quantitative relationship between right ventricular (RV) pressure overload and left ventricular (LV) diastolic filling characteristics in patients with chronic thromboembolic pulmonary hypertension (CTEPH). BACKGROUND: Right ventricular pressure overload in patients with CTEPH causes abnormal LV diastolic filling. However, a quantitative relationship between RV pressure overload and LV diastolic function has not been established. METHODS: We analyzed pre- and postoperative diastolic mitral inflow velocities and right heart hemodynamic data in 39 consecutive patients with CTEPH over the age of 30 (55 +/- 11 years) with mean pulmonary artery pressure >30 mm Hg who underwent pulmonary thromboendarterectomy (PTE). RESULTS: After PTE, mean pulmonary artery pressure (mPAP) decreased from 50 +/- 11 to 28 +/- 9 mm Hg (p < 0.001) while cardiac output (CO) increased from 4.4 +/- 1.1 to 5.7 +/- 0.9 l/m (p < 0.001). Mitral E/A ratio (E/A) increased from 0.74 +/- 0.22 to 1.48 +/- 0.69 (p < 0.001). E/A was < 1.25 in all patients pre-PTE. After PTE, all patients with E/A >1.50 had mPAP <35 mm Hg and CO >5.0 l/min. E/A correlated inversely with mPAP (r = 0.55, p < 0.001) and directly with CO (r = 0.53, p < 0.001). CONCLUSIONS: E/A is consistently abnormal in patients with CTEPH and increases post-PTE. Moreover, E/A varies inversely with mPAP and directly with CO. Following PTE, E/A >1.5 correlates with the absence of severe pulmonary hypertension (mPAP >35 mm Hg) and the presence of normal cardiac output (> 5.0 l/m).