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Biomedical subjects

Luis Gruberg

Publications and source records attributed to Luis Gruberg.

At least 55 records · Page 3Linked to original sources
PubMed2003

Comparison of two platelet glycoprotein IIb/IIIa inhibitors, eptifibatide and abciximab: outcomes, complications and thrombocytopenia during percutaneous coronary intervention.

BACKGROUND: Platelet glycoprotein IIb/IIIa inhibitors have significantly reduced the incidence of 30-day ischemic events during percutaneous coronary interventions (PCI). However, each of the three currently available agents has different pharmacological characteristics, safety, efficacy and costs. There has not been a direct comparison between eptifibatide and abciximab in the rates of major adverse cardiac events, major complications and thrombocytopenia. METHODS: A total of 642 consecutive patients underwent PCI at our institution between January 2000 and December 2001 and were treated with either eptifibatide (n = 342) or abciximab (n = 300) during the procedure. The selection of the IIb/IIIa inhibitor was arbitrary and left to the discretion of the operator. Complete blood counts were performed by routine protocol on all patients 2 and 4 hours after initiation of the drug. We analyzed the in-hospital clinical outcomes and the incidence of thrombocytopenia in this cohort. RESULTS: Baseline clinical and angiographic characteristics and concomitant drug treatment were similar between the 2 groups, except for a higher incidence of diabetes in the eptifibatide group. The rates of in-hospital death (1.2% eptifibatide group versus 1.0% abciximab group; p = 0.7), stroke (0% for both groups), target vessel revascularization (1.2% eptifibatide group versus 1.0% abciximab group; p = 0.8) and major bleeding complications (1.7% eptifibatide group versus 0.7% abciximab group; p = 0.2) were similar between the 2 groups. Thrombocytopenia was more frequent in the abciximab-treated patients (6%, versus 0% in the eptifibatide group; p < 0.001), including 5 patients who developed profound thrombocytopenia (< 20,000 cells/mm3). CONCLUSION: Both agents, eptifibatide and abciximab, proved to have the same rates of in-hospital major adverse cardiac events, bleeding and vascular complications. Abciximab therapy was associated with a significantly higher incidence of thrombocytopenia within 4 hours of drug initiation, which prompted immediate drug discontinuation, but was not associated with increased risk of bleeding, vascular or other complications.

Abciximab↗
PubMed2003

Comparison of bypass surgery and stenting for the treatment of multivessel disease: results from the ARTS trial in Israel.

BACKGROUND: The Arterial Revascularization Therapies Study was a multicenter, randomized trial designed to compare percutaneous coronary intervention with stenting versus coronary artery bypass graft surgery in 1,205 patients with multivessel coronary artery disease. The most appropriate type of treatment for these patients is still a matter of considerable debate. OBJECTIVES: To evaluate the clinical characteristics of patients enrolled in the ARTS trial in Israel in comparison to those worldwide, and to assess the 1 year outcome in these patients. METHODS: Between April 1997 and June 1998, a total of 1,205 patients with multivessel coronary artery disease, who were considered to be equally treatable with both modalities, were randomized to either stenting (n = 600) or CABG (n = 605) at 67 centers around the world. In Israel, 53 patients at four participating medical centers were randomized to either PCI with stents (n = 27) or CABG (n = 26). RESULTS: Clinical and angiographic characteristics were similar in the two groups, except for a significantly higher incidence of diabetic patients in Israel who were randomized to CABG, compared to those worldwide (35% vs. 16%, P = 0.01). Also, there were more patients with unstable angina in Israel (63 vs. 37%, P = 0.006). At 1 year follow-up, overall mortality and cerebrovascular accident rates were similar between the two groups and equivalent to results obtained around the world. There was a significantly higher incidence of myocardial infarction rates in patients randomized to stenting in Israel compared to patients worldwide (7.4 vs. 5.3%, P = 0.01) or to patients randomized to CABG in Israel (7.4 vs. 0%, P = 0.006). Similar to the overall ARTS results, there was a higher incidence of repeat revascularization procedures in patients assigned to the PCI with stenting arm (22.2 vs. 3.8%, P = 0.004) compared to those randomized to CABG, respectively. CONCLUSIONS: The results of this analysis of the Israeli ARTS population indicate that coronary stenting and bypass surgery yield similar findings with regard to mortality and stroke and are comparable to those obtained in the whole study group. Likewise, coronary stenting was associated with an increased incidence of repeat revascularization procedures as compared to CABG. However, patients in Israel randomized to stenting had a higher rate of myocardial infarction as compared to the overall results and to patients who underwent CABG in Israel. The present analysis provides important data for the safety and efficacy of either stenting or bypass surgery in treating patients with multivessel disease in Israel.

Angioplasty, Balloon, Coronary↗
PubMed2002

Stroke complicating percutaneous coronary interventions: incidence, predictors, and prognostic implications.

BACKGROUND: Stroke associated with percutaneous coronary intervention (PCI) is an infrequent although devastating complication. We investigated the incidence, predictors, and prognostic impact of periprocedural stroke in unselected patients undergoing PCI. METHODS AND RESULTS: A total of 9662 patients who underwent 12 407 PCIs between January 1990 and July 1999 were retrospectively studied. Stroke was diagnosed in 43 patients (0.38% of procedures). Patients with stroke were older (72+/-11 versus 64+/-11 years, P<0.001), had lower left ventricular ejection fraction (42+/-12 versus 46+/-13%, P=0.04) and more diabetes (39.5% versus 27.2%, P=0.07), and experienced a higher rate of intraprocedural complications necessitating emergency use of intra-aortic balloon pump (IABP) (23.3% versus 3.3%, P<0.001). In-hospital mortality (37.2% versus 1.1%, P<0.001) and 1-year mortality (56.1% versus 6.5%, P<0.001) were higher in patients with stroke. Compared with hemorrhagic stroke, patients with ischemic stroke had higher rate of in-hospital major adverse cardiac events (57.1% versus 25%, P=0.037). Multivariate logistic regression analysis identified emergency use of IABP as the strongest predictors for stroke (OR=9.6, CI 3.9 to 23.9, P<0.001), followed by prophylactic use of IABP (OR=5.1), age >80 years (OR=3.2, compared with age <50 years), and vein graft intervention (OR=2.7). CONCLUSIONS: Stroke associated with contemporary PCI is associated with substantial increased mortality. Elderly patients who experience intraprocedural complications necessitating the use of IABP are at particularly high risk.

Aged↗
PubMed2002

The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with diabetes mellitus.

OBJECTIVES: The purpose of this study was to examine the effect of intracoronary radiation therapy (IRT) in diabetic patients with in-stent restenosis (ISR). BACKGROUND: Diabetic patients are at an increased risk for restenosis, repeat revascularization procedures and late mortality after percutaneous coronary interventions and stenting. Intracoronary radiation therapy, utilizing both gamma and beta-emitters, has been shown to reduce the rate of ISR. METHODS: The study group consisted of 749 consecutive patients with ISR who were treated with either IRT or placebo in randomized trials and registries at our center. Diabetic patients (252 radiation and 51 placebo) were compared with nondiabetic patients (371 radiation and 75 placebo). RESULTS: In-hospital outcomes were similar between diabetic and nondiabetic patients treated with and without radiation. At six-month clinical and angiographic follow-up, there was a significant reduction in the binary restenosis (63.8% vs. 15.7%, p < 0.0001), target lesion revascularization (66.7% vs. 17.6%, p < 0.0001) and target vessel revascularization (TVR) (70.6% vs. 22.9%, p < 0.0001) rates in diabetic patients treated with radiation compared to placebo. Comparisons between the placebo arms detected a trend towards higher restenosis (63.8% vs. 48.4% p = 0.13) and TVR (70.6% vs. 56.0%, p = 0.14) in diabetic versus nondiabetic patients. In contrast, diabetic and nondiabetic patients treated with IRT experienced similar restenosis (15.6% vs. 10.7% p = 0.33) and TVR (22.9% vs. 28.2% p = 0.41) rates. CONCLUSIONS: In diabetic patients with ISR, intracoronary radiation significantly reduced the recurrence of ISR compared to placebo. Additionally, similar rates of restenosis and revascularization procedures were achieved in irradiated diabetic and nondiabetic patients. In view of these results, IRT should be considered as a valuable therapeutic alternative in all diabetic patients with ISR.

Aged↗
PubMed2002

The impact of lesion length and reference vessel diameter on angiographic restenosis and target vessel revascularization in treating in-stent restenosis with radiation.

OBJECTIVES: The study assessed the influence of lesion length and reference vessel diameter (RVD) on recurrent restenosis after gamma intracoronary radiation therapy (ICRT) for in-stent restenosis (IRS). BACKGROUND: Intracoronary radiation therapy reduces angiographic and clinical restenosis in patients with ISR. The impact of ICRT on challenging subgroups, such as long lesions and small vessels, has not been established. METHODS: Six-month quantitative coronary angiography and clinical follow-up were conducted to evaluate the influence of lesion length and RVD in patients with ISR treated with ICRT who were enrolled in gamma radiation trials. Angiographic binary restenosis (>50% diameter stenosis) and clinical events were assessed in 311 patients treated with gamma ICRT and 105 patients who received placebo. RESULTS: Baseline demographic, angiographic and procedural details were similar in the two treatment groups. The ICRT group had reduced binary restenosis in vessels of all sizes (30% vs. 66%, p < 0.001), with the most benefit seen in small vessels. A trend toward reduced restenosis with ICRT was found across all lesion lengths. At six months, major adverse cardiac events (MACE) were reduced in the ICRT group compared to placebo (34% vs. 71%, p < 0.0001), driven by reduced target vessel revascularization (27% vs. 71%, p < 0.0001). The independent predictors of angiographic restenosis include ICRT (OR [odds ratio] 0.16; CI [confidence interval] 0.10 to 0.28, p < 0.001), lesion length (OR 1.03; CI 1.01 to 1.05, p = 0.004) and RVD (OR 0.40; CI 0.23 to 0.67, p < 0.001). CONCLUSIONS: Intracoronary radiation therapy, compared to placebo, results in a significant reduction of angiographic restenosis across all vessel sizes, with a trend toward reduction of angiographic restenosis across all lesion lengths; this effect is seen predominantly in small vessels and diffuse lesions.

Aged↗
PubMed2002

The impact of obesity on the short-term and long-term outcomes after percutaneous coronary intervention: the obesity paradox?

OBJECTIVES: The purpose of this study was to assess the impact of body mass index (BMI) on the short- and long-term outcomes after percutaneous coronary intervention (PCI). BACKGROUND: Obesity is associated with advanced coronary artery disease (CAD). However, the relation between BMI and outcome after PCI remains controversial. METHODS: We studied 9,633 consecutive patients who underwent PCI between January 1994 and December 1999. Patients were divided into three groups according to BMI: normal, BMI between 18.5 and 24.9 (n = 1,923); overweight, BMI between 25 and 30 (n = 4,813); and obese, BMI >30 (n = 2,897). RESULTS: Obese patients were significantly younger and had consistently worse baseline clinical characteristics than normal or overweight patients, with a higher incidence of hypertension, diabetes, hypercholesterolemia and smoking history (p < 0.0001). Despite similar angiographic success rates among the three groups, normal BMI patients had a higher incidence of major in-hospital complications, including cardiac death (p = 0.001). At one-year follow-up, overall mortality rates were significantly higher for normal BMI patients compared with overweight or obese patients (p < 0.0001). Myocardial infarction and revascularization rates did not differ among the three groups. By multivariate Cox regression analysis, diabetes, hypertension, age, BMI and left ventricular function were independent predictors of long-term mortality. CONCLUSIONS: In patients with known CAD who undergo PCI, very lean patients (BMI <18.5) and those with BMI within the normal range are at the highest risk for in-hospital complications and cardiac death and for increased one-year mortality.

Age Factors↗
PubMed2002

Prognostic value of cardiac troponin I elevation after percutaneous coronary intervention in patients with chronic renal insufficiency: a 12-month outcome analysis.

Serum cardiac troponin I (cTnI) is a highly specific marker for myocardial damage in patients with chronic renal insufficiency (CRI), unlike creatine kinase myocardial band fraction (CK-MB), which may be elevated in the absence of myocardial injury in patients with CRI. We studied 116 consecutive CRI patients (serum creatinine +/- 1.8 mg/dL, not on dialysis) with normal baseline cTnI levels who underwent successful percutaneous coronary intervention (PCI). Patients were divided into two groups: group 1, elevated postprocedural cTnI (n = 50), and group 2, normal cTnI (n = 66). Patients with elevated cTnI were older and had a higher incidence of postinfarction angina and lower creatinine clearance compared to patients who did not have cTnI elevation. Atheroablative devices (rotational and directional atherectomy and excimer laser coronary angioplasty) were more frequently used in group 1 patients (27.1% vs. 18.5%; P = 0.04). In-hospital mortality, cardiac mortality, and Q-wave myocardial infarction rates did not differ between the two groups. At 12-month follow-up, total mortality rates were significantly higher in group 1 (28.0% vs. 9.9%; P = 0.002). Multivariate analysis showed that cTnI was an independent predictor of late mortality (OR = 2.26; CI = 1.07-4.77; P = 0.03). Thus, in patients with CRI, elevated cTnI levels after successful PCI is an important predictor of poor long-term outcome. Our data suggest that patients with cTnI elevation > 3 times above normal values are particularly at higher risk.

Age Factors↗
PubMed2002

Clinical outcome following percutaneous coronary interventions in patients with chronic renal failure.

The clinical outcome of patients with chronic renal failure (CRF) who undergo percutaneous coronary intervention (PCI) has not been systematically evaluated in a large cohort of patients. We retrospectively analyzed the in-hospital and 1-year clinical outcomes of 10,076 consecutive patients who underwent PCI between January 1994 and December 1997. A total of 95 patients (0.9%) had end-stage renal disease (ESRD) on dialysis, 786 patients (7.8%) had CRF, and 9,125 patients (90.6%) had normal renal function. Despite an angiographic success rate of 97% in all three groups, in-hospital mortality was significantly higher among patients with renal disease, whether they were on dialysis or not, when compared to patients without renal dysfunction (6.8% vs. 4.2% vs. 0.9%; P < 0.0001). At 1-year follow-up, mortality rate was 48.8% for ESRD, 25.7% for patients with CRF, and 5.5%, for patients without renal dysfunction (P < 0.0001). By multivariate analysis, high left ventricular ejection fraction and creatinine clearance were associated with decreased late mortality (OR = 0.84 and 0.95; P < 0.0001), whereas ESRD (OR = 3.65; P = 0.0002), non-Q-wave myocardial infarction (OR = 2.21; P < 0.0001), diabetes mellitus (OR = 1.99; P < 0.0001), and CRF (OR = 1.74; P = 0.003) were independent correlates of increased late mortality. Therefore, PCI in patients with impaired renal function, whether on dialysis or not, is associated with poor in-hospital and 1-year survival.

Aged↗
PubMed2002

Staged versus one-step approach for multivessel percutaneous coronary interventions.

BACKGROUND: Percutaneous coronary interventions (PCIs) in patients with multivessel coronary artery disease (CAD) may be staged or performed in a single session. No data exist about the relative safety and efficacy of these 2 strategies. Our aim was to compare short-term and long-term outcomes of patients with multivessel CAD who underwent PCI in 1 versus 2 sessions. METHODS AND RESULTS: The study included 264 consecutive patients who underwent treatment in our center during 1997 and 1998. PCI was conducted in a single session in 129 patients and was staged in 135 patients. The mean interval between the sessions in the staged group was 45.6 +/- 22.3 days. The rates of major adverse cardiac events (MACEs) during in-hospital stay did not differ significantly between the staged (combined for both stages) and nonstaged groups (2.2% vs 4.6%; P =.28). A trend for lower event rates at 30-day (2.9% vs 6.9%; P =.13) and 1-year follow-up (26.1 vs 35.9; P =.08) favored the staged arm. Diameter stenosis > or =50% was found in 17% of patients in the staged group in the second session and was successfully retreated in most of them. No MACE occurred between the sessions. Multivariate analysis identified staging of the procedure as a single independent predictor of MACE at 1-year follow-up (P =.05). CONCLUSION: Our results suggest that a practical staging strategy within 4 to 8 weeks is safe and allows for identification and treatment of potential excessive proliferative response in the previously intervened lesions during the second procedure.

Angina Pectoris↗
PubMed2002

Non-surgical myocardial reduction in hypertrophic obstructive cardiomyopathy.

BACKGROUND: Percutaneous transluminal septal ablation was recently introduced as an alternative to surgical treatment of hypertrophic obstructive cardiomyopathy. In this procedure, alcohol is injected into a proximal septal artery to create a localized myocardial infarction. OBJECTIVES: To characterize the immediate and medium-term results following PTSMA. METHODS: Of 13 patients referred for PTSMA, 8 were found suitable for the procedure. Hemodynamic parameters were evaluated prior to and following the procedure, and clinical and echo-Doppler parameters at 2 weeks and 9 months later. RESULTS: The procedure was technically successful in all patients. Resting left ventricular outflow gradient at rest (by Doppler) fell from 82 +/- 37 to 15 +/- 8 mmHg (P < 0.001) 9 months later. Late post-procedural gradient after the Valsalva maneuver was 2 +/- 24 mmHg. The degree of mitral regurgitation fell from 2.0 +/- 0 to 1.5 +/- 0.5 (P < 0.05). New York Heart Association class for dyspnea improved from 2.8 +/- 0.5 to 1.8 +/- 0.8 (P < 0.01) and Canadian Cardiovascular Society class for angina from 2.0 +/- 1.3 to 1.3 +/- 1.2 (P = 0.08). Complete right bundle branch block developed in six patients, temporary complete atrioventricular block in three, and persistent block requiring permanent pacing in one. No flow in the distal left anterior descending coronary artery (presumably due to spilling of alcohol) was seen in one (with development of a small antero-apical infarction) and ventricular fibrillation 2 hours post-procedure in one. None of the patients died. CONCLUSION: PTSMA provided a substantial reduction in left ventricular outflow gradient associated with an improvement in symptomatology. Serious complications are not uncommon. Long-term follow-up is unknown.

Adult↗
PubMed1999

Deferring angioplasty in intermediate coronary lesions based on coronary flow criteria is safe: comparison of a deferred group to an intervention group.

The decision for revascularization in patients with intermediate coronary lesions remains a challenging topic, particularly when objective data of reversible ischemia are lacking. In some of the patients, coronary revascularization is performed or deferred without definitive evidence on the clinical significance of the coronary stenosis. We investigated the usefulness of coronary flow reserve (CFR) measurements in 28 patients with intermediate coronary lesions. We compared 20 patients who underwent angioplasty based on Doppler-wire-derived CFR with 8 patients for whom angioplasty was deferred (diameter stenosis of 50.7 +/- 2.0% versus 46.5 +/- 3.1%, P < 0.0001 and CFR of 1.80 +/- 0.32 versus 2.65 +/- 0.11, P = 0.002, respectively). Angioplasty resulted in normalization of the CFR to 2.57 +/- 0.53 (P < 0.0001, versus the baseline value). During a follow-up period of 58.1 weeks (range 23-149 weeks), eight patients in the revascularization group were readmitted to the hospital, one of them with a myocardial infarction in the territory of the target vessel, compared with only one admission in the deferred group. Target-vessel revascularization was performed in three patients (a fourth patient declined it) in the former group, compared with only one in the latter. Symptomatic improvement or no change in clinical status was observed in the majority of patients in both groups (90% in the revascularization group and 87.5% in the deferred group). We conclude that in a selected group of patients with intermediate coronary lesions, measurement of CFR may be a useful tool in determining the need for revascularization based on its physiologic significance. Importantly, deferring PTCA in patients with intermediate lesions and normal CFR values seems to be safe.

Journal Article↗