Biomedical subjects

Eugenia Nikolsky

Publications and source records attributed to Eugenia Nikolsky.

At least 19 recordsLinked to original sources

PubMed2006

Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial.

Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter <3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p <0.001; 45.9%, p <0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to <0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis.

Angioplasty, Balloon, Coronary↗

PubMed2006

Drug-eluting stents in the treatment of intermediate lesions: pooled analysis from four randomized trials.

OBJECTIVES: To address the safety and efficacy of drug-eluting stents (DES) in the treatment of intermediate lesions, we performed a pooled analysis of four randomized DES versus bare-metal stent (BMS) trials and assessed outcomes among patients with intermediate lesions. BACKGROUND: Before the introduction of DES, intermediate coronary lesions were commonly managed based on physiologic or anatomic assessment of lesion severity. The DES may challenge this paradigm. METHODS: The study population involved 167 of 2,478 randomized patients (6.7%) with intermediate lesions (diameter stenosis <50% [mean 44%] by quantitative coronary angiography) from the Sirolimus-coated Bx Velocity Balloon Expandable Stent in the Treatment of Patients with De Novo Coronary Artery Lesions (SIRIUS), TAXUS-IV, and the First and Second First Use to Underscore Restenosis Reduction with Everolimus (FUTURE-I and -II) trials. End points examined included early (in-hospital and 30-day) and late (1-year) major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis, and follow-up angiographic restenosis. RESULTS: Patients with intermediate lesions randomized to DES versus BMS had low rates of 30-day MACE (1.1% vs. 4.0% respectively; p = 0.22). At one-year follow-up, patients treated with DES versus BMS had similar rates of cardiac death (0% vs. 2.7%, respectively; p = 0.11) and MI (3.4% vs. 5.4%; p = 0.49) but markedly lower rates of TVR (3.4% vs. 20.3%; p = 0.0004), MACE (5.6% vs. 25.4%; p = 0.0003), and binary angiographic restenosis (1.8% vs. 34.0%; p < 0.0001). No patient in either group developed stent thrombosis. CONCLUSIONS: Compared with BMS, treatment of intermediate lesions with DES appears safe and results in a marked reduction in clinical and angiographic restenosis. The efficacy of DES may require a reevaluation of current treatment paradigms for intermediate lesions.

Coronary Restenosis↗

PubMed2006

Carotid artery stenting in surgical high-risk patients.

Recent studies have shown that carotid artery angioplasty and stenting may offer a viable alternative for symptomatic and asymptomatic patients with carotid artery stenosis, especially in high-risk patients. We report the results of a prospective single-center registry designed to evaluate the feasibility and safety of carotid artery angioplasty and stenting with and without distal protection devices in high-risk patients. A total of 116 consecutive patients underwent 126 procedures and 127 stents were deployed successfully in 130 lesions. The majority of patients (63%) had restenosis after a prior carotid endarterectomy; 31% were considered to be ineligible for carotid endarterectomy by both the vascular surgeons and the interventional cardiologist and 9% were considered ineligible for surgery due to hostile neck anatomy. Periprocedural and follow-up evaluation included a thorough independent clinical and neurological assessment. Distal embolic protection devices were used in 44% of all cases. Procedural success was achieved in 122 procedures (97%). The overall rate of in-hospital major adverse cerebrovascular events (death, stroke, and myocardial infarction) was 2.6%. Event rates in patients with prior carotid endarterectomy were comparable to patients with de novo lesions with 5.2% vs. 2.4% death/stroke at 30 days and 8.3% and 6.6% stroke/death rates at 1 year, respectively. When distal protection devices were used, death/stroke rates were 0% as compared to 4.5% when distal protection was not used (P = NS). However, minor embolic phenomena were observed in both primary and secondary lesions independent of the use of distal protection. These results support the use of carotid artery angioplasty and stenting in high-risk patients with significant primary or secondary carotid artery stenosis. In both types of lesions, acceptable results justify its use as a valid revascularization method. While clinical embolic events occur in a minority of patients in both lesion types, they are not entirely prevented by distal protection.

Aged↗

PubMed2006

Impact of body mass index on outcomes after primary angioplasty in acute myocardial infarction.

BACKGROUND: The prognostic importance of obesity after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) is unknown. We therefore sought to investigate the impact of body mass index (BMI) in patients with AMI undergoing primary PCI. METHODS: In the CADILLAC trial, 2082 patients of any age with AMI within 12 hours onset undergoing primary PCI were randomized to balloon angioplasty versus stenting, each +/-abciximab. Outcomes were stratified by baseline BMI. RESULTS: Baseline BMI was measured in 2035 (98%) randomized patients; 552 (27%) patients have normal weight (BMI < 25 kg/m2), 915 (45%) were overweight (> or = 25 to < 30 kg/m2), and 568 (28%) were obese (> or = 30 kg/m2). Compared with normal-weight patients, obese patients were younger and more frequently had diabetes, hyperlipidemia, hypertension, non-anterior myocardial infarction, and higher creatinine clearance. Obese patients were less likely to develop thrombocytopenia (1.8% vs 4.2%), moderate hemorrhagic complications (1.4% vs 3.3%), or required blood product transfusions (3.2% vs 6.3%) (all P < or = .04). Obese compared with normal-weight patients had lower inhospital mortality (0.9% vs 2.7%, P = .03) at 30 days (1.1% vs 3.8%, P = .02) and 1 year (1.8% vs 7.5%, P < .0001). Independent predictors of 30-day and 1-year mortality included lower ejection fraction, advanced age, 3-vessel disease, anterior AMI, and lower creatinine clearance, but not BMI. CONCLUSIONS: Obese patients with AMI have an improved prognosis after primary PCI compared with normal-weight patients, a finding attributable to AMI onset at younger age, with better renal function and less anterior infarction.

Aged↗

PubMed2006

[Percutaneous carotid artery stenting in high-risk patients].

UNLABELLED: Recent studies have shown that percutaneous carotid artery angioplasty and stenting can be safely performed in patients with carotid artery stenosis, especially those considered to be at high-risk for surgery. AIM: We evaluated the safety and feasibility of carotid artery angioplasty and stenting, with and without distal protection devices in patients at high-risk for surgical endarterectomy. METHODS: A total of 169 consecutive patients underwent 185 procedures and 189 stents were deployed successfully in 195 lesions. The majority of patients (51%) had restenosis after a prior carotid endarterectomy, 40% were considered to be ineligible for carotid endarterectomy by both the vascular surgeons and the interventional cardiologist and 7% were considered ineligible for surgery due to hostile neck anatomy. RESULTS: Distal embolic protection devices were used in 52% of all cases. Procedural success was achieved in 181 of 185 procedures (98%). The overall rate of in-hospital major adverse cerebrovascular events (death, major stroke, and myocardial infarction) was 2.4%. In-hospital event rates in patients with prior carotid endarterectomy were comparable to patients with de novo lesions with 3.3% vs. 1.1% death/ stroke at 30 days, and 3.3% and 3.3% stroke/death rates at 30 days, respectively. When distal protection devices were used death/stroke rates were 0% as compared to 4.7% when distal protection was not used (p = NS). However, minor embolic phenomena were observed in both primary and secondary lesions independent of the use of distal protection. CONCLUSIONS: These results support the use of carotid artery angioplasty and stenting in high-risk patients with significant primary or secondary carotid artery stenosis. In both types of lesions, acceptable results justify its use as a valid revascularization method. While clinical embolic events occur in a minority of patients in both lesion types, they are not entirely prevented by distal protection devices.

Aged↗

PubMed2006

Five-year clinical follow up after intracoronary radiation for the prevention of in-stent restenosis.

Intracoronary radiation therapy (IRT), utilizing both gamma- and beta-emitting radiation sources, is considered to be a safe and effective treatment for in-stent restenosis (ISR). Although no longer in clinical use, a significant number of patients were treated in the past with IRT, and their long-term outcomes have not been well documented. The aim of the present analysis was to document the long-term outcomes of all patients who underwent IRT at our institution for the prevention of recurrence of ISR. Data were collected from 132 patients (148 irradiated lesions) treated with IRT at our institution between March 1999 and January 2004. Clinical and angiographic data were collected over a 5-year period. Patients were divided into 2 groups: those with failed IRT (n = 65), defined as a procedure that resulted in a major adverse cardiac event: death, myocardial infarction, target lesion revascularization, target vessel revascularization or coronary artery bypass graft surgery at any time during the follow-up period, and patients with successful IRT (n = 67). Both groups were identical regarding baseline clinical and angiographic characteristics, with the exception of a higher percentage of multivessel disease and diffuse restenosis in patients who failed IRT (p = 0.01). At 1-year follow up, slightly less than half (43%) of those patients in the failure group experienced a major adverse cardiac event. During the long-term follow up period, half of all patients who underwent IRT at our institution experienced a major adverse cardiac event, 61 patients (46%) either died or underwent a revascularization procedure, 16 patients (24%) had a myocardial infarction or died, and 55 patients (42%) required repeat coronary revascularization. The average time to develop a major adverse cardiac event was 14.6 +/- 15 months. Therefore, during long-term follow up following IRT for the prevention of ISR, half of all patients developed a major cardiovascular event, mainly due to the need for repeat revascularization procedures.

Aged↗

PubMed2005

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.

Abciximab↗

PubMed2005

Prediction of mortality after primary percutaneous coronary intervention for acute myocardial infarction: the CADILLAC risk score.

OBJECTIVES: We sought to develop a simple risk score for predicting mortality after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). BACKGROUND: Accurate risk stratification after primary PCI is important. Previous risk scores after reperfusion therapy have incorporated clinical +/- angiographic variables but have not considered baseline left ventricular function. Moreover, prior studies have not been validated against independent databases or studies. METHODS: The databases from the two largest multicenter, randomized AMI trials of primary PCI were utilized for score derivation (the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications [CADILLAC] trial, n = 2,082) and subsequent validation (the Stent-Primary Angioplasty in Myocardial Infarction [Stent-PAMI] trial, n = 900). Logistic regression and the jackknife procedure were used to select correlates of one-year mortality that were subsequently weighted and integrated into an integer scoring system. RESULTS: Seven variables selected from the initial multivariate model were weighted proportionally to their respective odds ratio for one-year mortality (age >65 years [2 points], Killip class 2/3 [3 points], baseline left ventricular ejection fraction <40% [4 points], anemia [2 points], renal insufficiency [3 points], triple-vessel disease [2 points], and post-procedural Thrombolysis In Myocardial Infarction flow grade [2 points]). Three strata of risk were defined (low risk, score 0 to 2; intermediate risk, score 3 to 5; and high risk, score >/=6) with excellent prognostic accuracy for survival in the derivation and validation sets (c statistics = 0.83 and 0.81 for 30-day mortality and 0.79 and 0.78 for 1-year mortality, respectively). CONCLUSIONS: In AMI patients treated with primary PCI, seven risk factors readily available at the time of intervention accurately predict short- and long-term mortality. Of note, measurement of baseline left ventricular function is the single most powerful predictor of survival and should be incorporated into risk score models.

Aged↗

PubMed2005

Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes: analysis from the TAXUS-IV trial.

OBJECTIVES: We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). BACKGROUND: Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown. METHODS: In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome. RESULTS: Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04). CONCLUSIONS: The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.

Antineoplastic Agents↗

PubMed2005

Impact of obesity on revascularization and restenosis rates after bare-metal and drug-eluting stent implantation (from the TAXUS-IV trial).

The effect of obesity on repeat coronary revascularization and restenosis in patients who undergo stent implantation has not been reported. We therefore examined the database from the multicenter randomized TAXUS-IV trial to determine the effect of body mass index (BMI) on outcomes after bare-metal and drug-eluting stent implantation. In TAXUS-IV, patients were randomized to receive a slow-release, polymer-based, paclitaxel-eluting stent or a bare-metal stent. Outcomes were stratified by baseline BMI. Of the 1,307 randomized patients who had documented BMI, 233 (17.8%) had normal weight (BMI <25 kg/m2), 531 (40.6%) were overweight (BMI < or =25 to 30 kg/m2), and 543 (41.5%) were obese (BMI > or =30 kg/m2). Patients who had been assigned to receive bare-metal stents and were overweight and obese compared with those who had normal weight had higher rates of 9-month binary restenosis (29.2% and 30.5% vs 9.3%, respectively; p = 0.01) and 1-year major adverse cardiac events (20.8% and 23.2% vs 11.1%, respectively; p = 0.02), whereas rates of these events did not differ significantly among those who received a paclitaxel-eluting stent (7.6% and 9.3% vs 4.9%, respectively for binary restenosis; p = 0.65; 11.3% and 10.4% vs 10.1%, respectively; p = 0.82 for major adverse cardiac events). By multivariate analysis, BMI > or =30.0 kg/m2 independently predicted binary restenosis (hazard ratio 4.26, p = 0.005), 1-year target vessel revascularization (hazard ratio 1.95, p = 0.04), and major adverse cardiac events (hazard ratio 1.95, p = 0.004) in patients who received bare-metal stents but not paclitaxel-eluting stents. In conclusion, obesity is an important risk factor for clinical and angiographic restenosis and for composite major adverse cardiac events in patients who receive bare-metal stents. Paclitaxel-eluting stents attenuate the increased risk associated with obesity, such that the intermediate-term prognosis after percutaneous coronary intervention is independent of weight.

Aged↗

PubMed2005

Contrast-induced nephropathy after percutaneous coronary interventions in relation to chronic kidney disease and hemodynamic variables.

We previously found that contrast-induced nephropathy (CIN) complicating percutaneous coronary intervention adversely affects patients with chronic kidney disease (CKD). Therefore, we further investigated whether the predictors and outcome of CIN after percutaneous coronary intervention differ among patients with versus without CKD. Among 7,230 consecutive patients, CIN (>or=25% or >or=0.5 mg/dl increase in preprocedure serum creatinine 48 hours after the procedure) developed in 381 of 1,980 patients (19.2%) with baseline CKD (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73 m(2)) and in 688 of 5,250 patients (13.1%) without CKD. Decreased eGFRs, periprocedural hypotension, higher contrast media volumes, lower baseline hematocrit, diabetes, pulmonary edema at presentation, intra-aortic balloon pump use, and ejection fraction <40% were the most significant predictors of CIN in patients with CKD. Apart from intra-aortic balloon pump use, predictors of CIN in patients without CKD were the same as mentioned, plus older age and type of contrast media. Regardless of baseline renal function, CIN correlated with longer in-hospital stay and higher rates of in-hospital complications and 1-year mortality compared with patients without CIN. By multivariate analysis, CIN was 1 of the most powerful predictors of 1-year mortality in patients with preexisting CKD (odds ratio 2.37, 95% confidence interval 1.63 to 3.44) or preserved eGFR (odds ratio 1.78; 95% confidence interval 1.22 to 2.60). Thus, regardless of the presence of CKD, baseline characteristics and periprocedural hemodynamic parameters predict CIN, and this complication is associated with worse in-hospital and 1-year outcomes.

Aged↗

PubMed2005

Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial).

The purpose of this study was to report the angiographic findings of the first human evaluation of the everolimus-eluting stent (EES) for the treatment of noncomplex coronary lesions. Forty-two patients with de novo coronary lesions (2.75 to 4.00 mm vessels; lesion length, <18 mm) were prospectively randomized in a 2:1 ratio to receive either the EES (n = 27) or a metallic stent (n = 15). Baseline clinical and angiographic characteristics were similar among both groups. At 6-month follow-up, EES had a lower in-stent late lumen loss (0.10 +/- 0.22 vs 0.85 +/- 0.32 mm, p <0.0001) and in-segment diameter stenoses (20.7 +/- 12.3% vs 37.0 +/- 15.8%, p = 0.002). There was no in-stent restenosis with EES; however, 1 focal distal edge restenosis was present. There was 1 in-stent and 1 in-segment (proximal edge) restenosis in the metallic stent group. There was no stent thrombosis or aneurysm formation at follow-up in either group.

Aged↗

PubMed2005

An Internet-based registry examining the efficacy of heparin coating in patients undergoing coronary stent implantation.

BACKGROUND: Heparin coating is an attractive alternative to counterbalance intrinsic stent thrombogenicity and to decrease the incidence of stent thrombosis. METHODS: We compared, based on the data of an international multicenter prospective registry, the rates of stent thrombosis after percutaneous coronary interventions in native coronary arteries using a Bx VELOCITY heparin-coated stent versus a bare metal stent of the same design in a total of 3098 patients at high risk for stent thrombosis. Most patients in both groups underwent percutaneous coronary intervention for unstable angina (48.4% vs 47.5%, respectively) with > 25% of the patients treated for acute myocardial infarction (30.8% and 28.1%, respectively). RESULTS: Procedural success was high and very similar in patients with heparin-coated and bare metal stents (99.3% vs 98.8%, respectively, P = .11). The primary end point, a 30-day stent thrombosis, occurred in 0.6% of the 1417 patients treated with the heparin-coated stent and 0.9% of the 1681 patients treated with the bare metal stent (relative risk reduction 33%, P = .41). The rates of cardiac death, myocardial infarction, and target lesion revascularization did not differ significantly between the groups. By multivariate analysis, variables independently associated with 30-day stent thrombosis included the evidence of thrombus at baseline (odds ratio [OR] 3.0, 95% CI 1.29-7.0, P = .01), small vessel stenting (OR 2.41, 95% CI 1.01-5.74, P = .05), and target left anterior descending artery (OR 2.32, 95% CI 1.00-5.38, P = .05). CONCLUSION: This large-scale registry comparing the use of heparin-coated stent versus bare metal stent in the reality of daily practice showed no significant difference in stent thrombosis in patients with a high-risk profile for thrombotic complications.

Angina, Unstable↗

PubMed2005

Low hematocrit predicts contrast-induced nephropathy after percutaneous coronary interventions.

BACKGROUND: The relationship between low hematocrit and contrast-induced nephropathy has not been investigated. METHODS: Of 6,773 consecutive patients treated with percutaneous coronary intervention, contrast-induced nephropathy (an increase of >/=25% or >/=0.5 mg/dL in preprocedure serum creatinine, at 48 hours postprocedure) occurred in 942 (13.9%) patients. RESULTS: Rates of contrast-induced nephropathy steadily increased as baseline hematocrit quintile decreased (from 10.3% in the highest quintile to 23.3% in the lowest quintile) (chi(2) for trend, P < 0.0001). Stratification by baseline estimated glomerular filtration rate (eGFR) and baseline hematocrit showed that the rates of contrast-induced nephropathy were the highest (28.8%) in patients who had the lowest level for both baseline eGFR and hematocrit. Patients with the lowest eGFR but relatively high baseline hematocrit values had remarkably lower rates of contrast-induced nephropathy (15.8%, 12.3%, 17.1%, and 15.4% in 2nd, 3rd, 4th, and 5th quintiles of baseline hematocrit, respectively) (P < 0.0001). The rates of contrast-induced nephropathy increased with increment in change in hematocrit. Patients in the lowest quintile of baseline hematocrit with absolute hematocrit drop >5.9% had almost doubled rates of contrast-induced nephropathy compared with patients with hematocrit change <3.4% (38.1% vs. 18.8%, respectively) (P < 0.0001). By multivariate analysis, lower baseline hematocrit was an independent predictor of contrast-induced nephropathy; each 3% decrease in baseline hematocrit resulted in a significant increase in the odds of contrast-induced nephropathy in patients with and without chronic kidney disease (11% and 23%, respectively). When introduced into the multivariate model instead of baseline hematocrit, change in hematocrit also showed a significant association with contrast-induced nephropathy. CONCLUSION: Lower hematocrit is an important risk factor for contrast-induced nephropathy. Whether correcting the hematocrit prepercutaneous coronary intervention might decrease the rates of contrast-induced nephropathy should be addressed in a prospectively designed trial.

Adult↗

PubMed2005

Vascular closure devices: a review of their use after invasive procedures.

In the endovascular procedure setting, vascular closure devices (VCD) have emerged as an alternative to mechanical compression in order to achieve vascular hemostasis after puncture of the femoral artery. VCD are categorized based primarily on the principle mechanism of hemostasis, which includes biodegradable plug, suture, staples, or ultrasound. While VCD offer advantages over mechanical compression (shorter time to hemostasis and patient ambulation, high rate of patient satisfaction, and greater cost-effectiveness) complications related to the site of femoral access are still present. Efficacy and safety of VCD have been evaluated in a number of clinical trials, but to date there is still a lack of randomized clinical trials with sample sizes large enough to reveal superiority or non-inferiority of VCD compared with mechanical compression. Mechanical compression and VCD are effective and well tolerated in the setting of diagnostic procedures and procedures that do not use anticoagulation. For both methods, success rates are lower, and complication rates higher, in the setting of interventional procedures and when anticoagulation medications are used. Regardless of the device type, deployment failure is the major drawback of VCD. However, overall, meta-analysis data demonstrated that complications and success rates are not significantly different between mechanical compression and VCD. Current data suggest that the correct answer on whether or not to use VCD still remains in the operator domain where integration of clinical data and familiarity with a particular closure device plays a key role in achieving successful hemostasis and avoiding access site complication.

Case-Control Studies↗

PubMed2004

Impact of anemia on outcomes of patients undergoing percutaneous coronary interventions.

Of 6,929 consecutive patients who were treated with percutaneous coronary intervention, 1,708 (24.6%) had anemia according to criteria of the World Health Organization. Compared with patients who did not have anemia, those who did have anemia were older, more frequently women and African-American, had a smaller body mass index, and higher frequencies of cardiovascular risk factors and co-morbid conditions. Patients who had anemia compared with those who did not have anemia had significantly (p <0.0001) higher mortality rates during hospitalization (1.9% vs 0.4%) and at 1 year (12.8% vs 3.5%). After adjustment for potential confounders, baseline hematocrit remained a significant predictor of a 1-year mortality rate (hazard ratio 0.93 per 1% increase in hematocrit, 95% confidence interval 0.91 to 0.95).

Aged↗

PubMed2004

A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation.

OBJECTIVES: We sought to develop a simple risk score of contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI). BACKGROUND: Although several risk factors for CIN have been identified, the cumulative risk rendered by their combination is unknown. METHODS: A total of 8,357 patients were randomly assigned to a development and a validation dataset. The baseline clinical and procedural characteristics of the 5,571 patients in the development dataset were considered as candidate univariate predictors of CIN (increase >or=25% and/or >or=0.5 mg/dl in serum creatinine at 48 h after PCI vs. baseline). Multivariate logistic regression was then used to identify independent predictors of CIN with a p value <0.0001. Based on the odds ratio, eight identified variables (hypotension, intra-aortic balloon pump, congestive heart failure, chronic kidney disease, diabetes, age >75 years, anemia, and volume of contrast) were assigned a weighted integer; the sum of the integers was a total risk score for each patient. RESULTS: The overall occurrence of CIN in the development set was 13.1% (range 7.5% to 57.3% for a low [ or=16] risk score, respectively); the rate of CIN increased exponentially with increasing risk score (Cochran Armitage chi-square, p < 0.0001). In the 2,786 patients of the validation dataset, the model demonstrated good discriminative power (c statistic = 0.67); the increasing risk score was again strongly associated with CIN (range 8.4% to 55.9% for a low and high risk score, respectively). CONCLUSIONS: The risk of CIN after PCI can be simply assessed using readily available information. This risk score can be used for both clinical and investigational purposes.

Aged↗

PubMed2004

Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis.

OBJECTIVES: This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures. BACKGROUND: Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. METHODS: Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. RESULTS: A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79). CONCLUSIONS: In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.

Angioplasty, Balloon, Coronary↗