Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.

AIM: This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation. METHODS AND RESULTS: Patients (N = 1799) who had undergone placement of ≥1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009-January 2013). Patients (N = 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1:1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50-1.28; P = 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34-1.22; P = 0.18). Rates of major bleeding were identical (2.0%, P = 0.95). CONCLUSIONS: Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment. CLINICALTRIALSGOV NUMBER: NCT00822536.

Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial.

BACKGROUND: Dual antiplatelet therapy with aspirin and thienopyridine is required after placement of coronary drug-eluting stents (DES) to prevent thrombotic complications. Current clinical guidelines recommend at least 6 to 12 months of treatment after a DES implantation, but it may be beneficial to apply dual antiplatelet therapy for a longer duration. METHODS/DESIGN: The optimal dual antiplatelet therapy (OPTIDUAL) study aims to compare the benefits and risks of dual antiplatelet therapy applied for either 12 or 48 months. We will examine the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention with DES for the treatment of coronary lesions. The OPTIDUAL study is an open-label multicenter, randomized, national trial that will include 1,966 patients treated with DES. All patients will be treated with dual antiplatelet therapy for 12 months (+/- 3). Then, patients with no MACCE or major bleeding will be randomized to receive either 36 additional months of clopidogrel plus aspirin or aspirin only. The primary end-point is the combination of death from all causes, myocardial infarction, stroke and major bleeding. The secondary end points include the individual components of the primary end-point, stent thrombosis, repeat revascularization of the treated vessel and minor bleeding. DISCUSSION: This randomized trial is designed to assess the benefits and safety of 12 versus 48 months of dual antiplatelet therapy in patients that receive a DES. We aim to determine whether substantial prolongation of clopidogrel (a thienopyridine) after DES implantation offers an advantage over its discontinuation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00822536.

Multislice computed tomography to rule out coronary allograft vasculopathy in heart transplant patients.

BACKGROUND: This study assessed if invasive coronary angiogram (CA) could be replaced by multislice (64- or 256-row) computed tomography (MSCT) to systematically rule out coronary allograft vasculopathy in heart transplant patients. METHODS: Electrocardiogram-gated contrast-enhanced MSCT (64-row for the first 25 patients and 256-row for the others) was compared with CA. MSCT parameters, adapted to the patient's weight, included 120 kV, 800 mAs, 0.625-mm slice thickness, and 0.42/0.27-second rotation time. The primary end point was the negative predictive value (NPV) of MSCT for the detection of significant (>50%) coronary stenosis. Secondary end points were the comparison of X-ray (mSv) and iodine contrast agent (ml) exposures. RESULTS: The study prospectively included 102 patients (mean age, 53±14 years). Transplantation occurred 6±5 years before inclusion. At CA, 41.8% had stenosis ≤50% and 8% had stenosis>50%. Among the 1,308 angiographic coronary segments ≥1.5 mm, 1,250 (95.6%) were evaluable by MSCT. The NPV of MSCT was 96.6% by patient analysis and 99.7% by segment analysis. The positive predictive value (PPV) was 45.5%. The total volume of contrast agent was 139±43 vs 91±12 vs 56±19 ml (p<0.05) with 64-row MSCT, 256-row MSCT, and CA, respectively. The effective radiation dose was higher using retrospective gating (17.8±5.5 mSv, p<0.05), but similar with prospective gating (6.2±1.9 mSv, p = 0.571) compared with CA (6.0±3.5 mSv). CONCLUSION: Newer generations of MSCT (64- or 256-row) have a good NPV and may represent an alternative to invasive CA to rule out significant (>50%) coronary vasculopathy in heart transplant patients, despite a low PPV.

Accuracy of multislice computed tomography in the preoperative assessment of coronary disease in patients scheduled for heart valve surgery.

BACKGROUND: Coronary angiography (CA), an invasive and expensive procedure, is still recommended in most patients referred for elective valve surgery. Multislice computed tomography (MSCT) is a promising alternative technique to rule out significant coronary artery lesions. AIM: To evaluate MSCT in detecting significant coronary artery lesions in patients referred for elective valve surgery. METHODS: Between August 2007 and December 2010, patients referred for elective valve surgery were identified prospectively and underwent 64-slice MSCT and CA. We compared significant coronary stenoses, defined as a reduction of luminal diameter ≥ 50%, to establish the diagnostic accuracy of MSCT. All coronary segments were analysed and uninterpretable lesions were scored positive. RESULTS: Forty-eight patients were included (62.5% male; mean age 65 ± 12 years), the majority had aortic insufficiency (37.7%) or aortic stenosis (32.0%). The prevalence of significant coronary artery stenoses was 27.1%. The sensitivity, specificity, positive and negative predictive values of MSCT were 77%, 89%, 71% and 91%, respectively, in a patient-based analysis; 82%, 86%, 64% and 94% in a revascularization-based analysis; 67%, 94%, 52% and 97% in a vessel-based analysis; and 65%, 98%, 52% and 99% in a segment-based analysis. Overall, CA could have been avoided in 65% of patients. CONCLUSION: In patients referred for elective valve surgery, MSCT had a high diagnostic accuracy to rule out significant coronary stenoses. However, larger multicenter studies in an unselected population of patients are needed to determine its place within the range of diagnostic tool in the preoperative assessment of valvular heart disease.

One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents.

OBJECTIVES: We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. BACKGROUND: Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR. METHODS: Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. RESULTS: 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. CONCLUSIONS: In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end-point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow-up MLD and immediate and net gain favored SES.

[Medical progress exemplified by improvements in the safety coronary angioplasty]. / Le progrès médical à la lumière de l'amélioration de la sécurité de l'angioplastie coronaire.

The significant decrease in complications associated with coronary angioplasty is a model of medical progress. Breakthroughs are achieved through individual initiatives, whereas incremental progress results from occasional, anonymous improvements. The two types of improvement are complementary, as pointed out by Claude Bernard as early as 1864.

One-year clinical outcomes in patients with chronic renal failure treated by percutaneous coronary intervention with drug-eluting stent.

BACKGROUND: It is unknown whether the efficacy and safety of drug-eluting stents (DES) apply in patients with chronic renal failure (CRF). AIMS: To compare DES with bare metal stents (BMS) for percutaneous coronary intervention (PCI) in CRF patients. PATIENTS AND METHODS: Consecutive patients treated by PCI were allocated to four groups according to type of stent used (DES versus BMS) and creatinine clearance (CrCl). CRF was defined as CrCl less than 60 mL/minute. Cardiovascular death, major adverse cardiac events (MACE, defined as cardiovascular death, myocardial infarction, stroke and target lesion revascularization [TLR]), TLR and definite stent thrombosis (ST) were recorded at 1 year. RESULTS: We note that 1376 consecutive patients underwent PCI with stent within 18 months: 534 (39%) and 492 (36%) patients without CRF and 224 (16%) and 126 (9%) patients with CRF were treated with BMS and DES, respectively. In the entire cohort, patients treated with DES had a higher restenosis risk profile. BMS were predominantly (87%) used for ST-segment elevation myocardial infarction. At 1 year, 6.2% had cardiovascular death, 15.8% MACE, 7.3% TLR and 1.5% ST. Cardiovascular death and MACE occurred less frequently in DES groups. The TLR rate was not significantly different in the CRF groups (BMS 9.8% vs DES 7.1%; P=0.44). No excess of ST was observed in the DES groups and use of DES was independently associated with absence of MACE and TLR. CONCLUSIONS: In patients with CRF, DES appear to be at least as effective as BMS--despite a higher restenosis risk profile--with no excess of ST at 1 year.

Long-term outcome after bare-metal or drug-eluting stenting for allograft coronary artery disease.

BACKGROUND: Percutaneous coronary intervention (PCI) with bare-metal stenting (BMS) has been reported to be associated with high rates of target-lesion revascularization (TLR) in heart transplant recipients. We aimed to assess the outcome of successful PCI with BMS or drug-eluting stenting (DES) in such patients. METHODS: Ninety-four consecutive heart transplant recipients with successful PCI of de novo lesions with BMS (n = 53) or DES (n = 60) were prospectively followed-up for 3.7 +/- 2.5 years after PCI. An angiographic lesion-based analysis at 12-month follow-up and a long-term, patient-based survival analysis were performed. RESULTS: The lesion-based analysis within 12 months after PCI showed a reduction of TLR rates with the use of DES (6.6% vs 26.4%, p < 0.01). DES were associated with better preservation of left ventricular function at this time-point. The patient-based, long-term analysis showed sustained local benefit of DES (hazard ratio 4.5 [1.4 to 14.5] for BMS vs DES), but no effect on mortality, remote-site PCI and total revascularization rates. Anti-hypertensive (hazard ratio 0.2 [0.1 to 0.5]) and aspirin (hazard ratio 0.3 [0.1 to 0.8]) therapy, and left ventricular ejection fraction (0.96 [0.94 to 0.98] per percent) were the only correlates of long-term mortality. CONCLUSIONS: Compared with BMS, DES are associated with a sustained reduction in rates of TLR and could safely be used in heart transplant recipients with coronary artery disease. Despite excellent local effects, DES use failed to reduce mortality. Anti-hypertensive and anti-platelet therapy, and left ventricular function preservation, may be considered as aims of treatment to improve long-term survival in such patients.

Long-term follow-up of patients with sirolimus-eluting stents for treatment of bare-metal in-stent restenosis.

BACKGROUND: Limited data is available on the long-term outcome after sirolimus-eluting stent (SES) implantation for in-stent restenosis. METHODS: In 3 centers, consecutive patients (n=100) with percutaneous coronary intervention (PCI) for in-stent restenosis (n=110) were treated with SES: 28 lesions were focal, 40 diffuse, 17 proliferative, and 15 totally occluded (reference vessel diameter: 3.0+/-0.2 mm, lesion length: 13.8+/-5.7 mm). RESULTS: SES implantation was successful in all patients. The mean follow-up was 50+/-12 months. The main univariate predictive factor of definite (4%) or probable (4%) SES thrombosis was revascularization without SES in a non-target site during the initial procedure (p<0.01). Repeated target lesion revascularization (TLR) was performed in 8 patients (8%) at 1 year, in 10 patients (10%) at 4 years. A cardiac event related to the SES occurred in 14 patients (14%) at one year, 17 patients (17%) at 4 years, and were associated with unstable angina (p<0.05), multivessel disease (p<0.02) and revascularization without SES in another site of the target vessel during the initial procedure (p<0.01). CONCLUSIONS: SESs are effective at 4 years in the treatment of high risk patients with complex in-stent restenosis, with a low risk of TLR but a high risk of stent thrombosis. Most of cardiac events related to the target vessel occur during the first year, and are associated to a revascularization without SES in another site during the first procedure.

Percutaneous coronary intervention in anticoagulated patients via radial artery access.

OBJECTIVES: To assess safety and feasibility of using radial artery access for percutaneous coronary intervention (PCI) in patients on oral anticoagulation without interrupting therapy. BACKGROUND: The radial artery approach for PCI is intuitively attractive for patients receiving chronic oral anticoagulation with vitamin K antagonists (VKAs) but little data exist concerning feasibility or safety of this approach in this population. The main advantage of this strategy would be to avoid bridging therapy with heparin that increases risk of thrombotic and bleeding events. METHODS: In this prospective observational study, 50 consecutive patients referred for coronary angiography underwent PCI without interrupting oral anticoagulant therapy. The main outcome measures were bleeding and thrombotic complications. RESULTS: The indications for permanent oral anticoagulation were as follows: atrial fibrillation in 62%, mechanical prosthesis in 24%, and venous thromboembolism in 14%. Seventy-two percent were elective cases and 28% presented with acute coronary syndromes. PCI was performed with an INR range of 1.4-3.4 with mean of 2.2 +/- 0.6. Seventy-six percent of the patients were on dual antiplatelet therapy before the procedure. No thrombotic events or excess bleeding were observed at 1 month. Only one patient had a minor hemorrhage 8 days after procedure. CONCLUSIONS: This series suggests that for patients treated with VKAs, the use of radial artery access is feasible and safe for PCI on dual antiplatelet therapy without interrupting oral anticoagulant treatment.

Intensive cardiovascular risk factors therapy and prevalence of silent myocardial ischaemia in patients with type 2 diabetes.

BACKGROUND: Screening for silent myocardial ischaemia (SMI) is a controversial strategy undergoing intensive risk factor therapy. AIMS: To assess the prevalence of SMI and coronary artery disease (CAD) in asymptomatic type 2 diabetic patients at high cardiovascular risk (two additional risk factors or more) and undergoing long-term intensive risk factor therapy and tight glycaemic control. METHODS: SMI screening, using isotopic or echographic stress tests, was carried out in 122 asymptomatic type 2 diabetic patients at high cardiovascular risk and undergoing long-term intensive risk factor therapy. Coronary angiography was proposed if SMI was detected. Long-term follow-up data on death, myocardial infarction and revascularization were obtained by telephone call or clinical review. RESULTS: The mean age was 65+/-6 years and 74% of patients were men. The mean duration of diabetes was 15+/-9 years. The mean number of additional risk factors was 2.9, 32% of patients had microalbuminuria and 12% had peripheral arterial disease. SMI was detected in 20 (16%) patients. Seven (6%) patients had significant CAD treated successfully by angioplasty (n=6) or bypass surgery (n=1). The positive predictive value of the non-invasive screening test for the diagnosis of significant CAD (stenosis>50%) was 39%. The event rate was very low (1.6%) at 2-year follow-up. CONCLUSION: Long-term intensive risk factor therapy in high-risk patients with type 2 diabetes is associated with low prevalence of SMI and detected CAD. Optimal medical therapy and revascularization of significant CAD are associated with a low cardiovascular event rate at two years.

Predictive factors of cardiac events after implantation of sirolimus-eluting stents for treatment of in-stent restenosis.

BACKGROUND: The factors associated with recurrent restenosis after SES implantation for in-stent restenosis are unknown. This study aimed to assess the clinical outcome and to analyse predictive factors of cardiac events in patients with in-stent restenosis treated with Sirolimus-eluting stent (SES). METHODS: In 3 centers, consecutive patients (n = 100) with elective indication to percutaneous coronary intervention (PCI) for in-stent restenosis (n = 110) were treated with SES: 28 lesions were focal, 40 diffuse, 17 proliferative, and 15 showed total occlusion. RESULTS: SES implantation was successful in all patients, without complication during the first hospital stay. The mean follow-up was 15 (10-24) months. A cardiac event related to the target vessel occurred in 24 (24%) patients, and was associated with dialysis status (p < 0.05), lower ejection fraction (p < 0.05) and revascularization without SES in another site (p < 0.0001). A cardiac event related to the SES occurred in 11 (11%) patients, secondary to an acute or sub-acute thrombosis of the SES (2%), to a late occlusion of the target vessel (4%) or to a non-occlusive restenosis of the SES (5%), and was associated with unstable angina (p < 0.01), multivessel disease (p < 0.03) and revascularization without SES in another site (p < 0.03). No cardiac event related to the SES occurred in patients with direct stenting. Target lesion revascularization for in-SES restenosis or occlusion of the target vessel was performed in 7 (7%) patients, and was associated with unstable angina (p < 0.01) and revascularization without SES in another site (p < 0.01). Target vessel revascularization was needed in 20 patients (20%), related to dialysis status (p < 0.01) and a revascularization without SES in another site (p < .0001). CONCLUSIONS: SESs are effective in the treatment of high risk patients with complex in-stent restenosis. Most of cardiac events during follow-up are related to a revascularization without SES in another site.

Long-term outcome after coronary angioplasty in renal transplant and hemodialysis patients.

In order to determine how renal transplantation modifies in hospital and long-term outcome after coronary angioplasty, we compared dialysis and renal transplant patients with control patients without renal failure. Seventy-five consecutive dialysis patients (group D) and 37 renal transplant patients (group T) undergoing coronary angioplasty, were compared with two control groups (groups control D and control T, respectively) matched 1:1 with groups D and T for clinical and angiographic characteristics. The mean follow-up was 50 months. The rate of angiographic success was high and comparable in the four groups (P=0.7). Renal transplant patients were younger than dialysis non-transplant patients (P=0.004). The risk of 4-year cardiac death and nonfatal myocardial infarction was higher in dialysis compared to control dialysis patients (OR 2.6, 95% CI 1.35--5.01, P=0.004), in transplant patients compared to control transplant patients (OR 9.93, 95% CI 1.17--84.04, P=0.03), and there was a trend toward a higher risk in dialysis than in renal transplant patients (OR 1.6, 95% CI 0.8--3.19, P=0.08). The risk of 4-year mortality was higher in dialysis patients than in the other three groups (31% in group D versus 19% in group T, 13% in group control D, and 0% in group control T, P<0.001). After adjusting for age, diabetes, and multivessel disease, long-term mortality risk was similar in dialysis and renal transplant patients. On multivariate analysis, renal function (P=0.002), age (P=0.005), and tobacco consumption (P=0.005) were independently associated with 4-year cardiac death. In patients with end-stage renal disease who undergo coronary angioplasty, renal transplantation was not independently associated with a lower long-term mortality compared to dialysis treatment. Both dialysis and renal transplant patients show lower survival rates compared to matched control patients.

Assessment of biventricular remodeling by magnetic resonance imaging after successful primary stenting for acute myocardial infarction.

Inferior acute myocardial infarction (AMI) is associated with a better outcome compared with anterior AMI, even in the presence of comparable infarct size. Whether left ventricular remodeling, a major predictor of poor outcome, and right ventricular (RV) remodeling depend on the site of an AMI remains unknown. Biventricular volumes were assessed by magnetic resonance imaging 7 +/- 2 days and 3.4 +/- 0.3 months after successful primary stenting in 51 consecutive patients with inferior or anterior AMI. This study documents RV involvement and biventricular reverse remodeling in patients with inferior AMI in the absence of RV infarction, as opposed to those with anterior AMI who show progressive biventricular remodeling.

Routine breath-hold gradient echo MRI-derived right ventricular mass, volumes and function: accuracy, reproducibility and coherence study.

Right ventricular (RV) dysfunction is a predictor of poor outcome in patients with heart disease. Conventional imaging modalities fail to assess RV volumes accurately. We sought to assess the accuracy and reproducibility of routine breath-hold gradient echo magnetic resonance imaging (MRI)-derived RV mass, volumes and function. We assessed: (1) The accuracy of in vivo MRI-derived RV mass in comparison to the RV weight in 9 minipigs. (2) Intra- and inter-observer reproducibility of RV mass, end-diastolic (EDV) and end-systolic (ESV) volumes and ejection fraction (EF) in 15 normal volunteers and 10 patients with heart disease. (3) Inter-study reproducibility of the former parameters in 25 coronary artery disease patients. (4) The correlation between right and left ventricular stroke volumes in the total population. Strong statistically significant correlations were found between: (1) MRI-derived RV mass and RV weight (r = 0.98, bias = 2.5 g), (2) Intra-observer measurements of RV mass (r = 0.96, bias = 0.5 g), EDV (r = 0.99, bias = -1.5 ml), ESV (r = 0.98, bias = 0.1 ml) and EF (r = 0.92, bias = -1.4%), (3) Inter-observer measurements of RV mass (r = 0.95, bias = 1.1 g), EDV (r = 0.98, bias = -1.1 ml), ESV (r = 0.98, bias = 1.2 ml) and EF (r = 0.87, bias = -1.9%), (4) Inter-study measurements of RV mass (r = 0.91, bias = -0.1 g), EDV (r = 0.96, bias = 3.8 ml), ESV (r = 0.98, bias = 0.3 ml) and EF (r = 0.90, bias = 0.9%), (5) MRI-derived right and left ventricular stroke volumes (r = 0.87). The assessment of the RV mass, volumes and function by routine breath-hold gradient echo MRI is accurate and highly reproducible. The correlation between left and RV MRI-derived stroke volumes indicates excellent coherence of simultaneous bi-ventricular volume measurements.

Comparison of short- and long-term outcomes of coronary angioplasty in patients with and without diabetes mellitus and with and without hemodialysis.

In-hospital and long-term outcomes after coronary angioplasty in 28 dialysis diabetic and 84 dialysis nondiabetic patients were compared with clinical outcomes after coronary angioplasty in 28 nondialysis diabetic and 84 nondialysis, nondiabetic patients matched according to clinical and angiographic characteristics. The rate of angiographic success in diabetic dialysis patients was high and similar in the 4 groups. The risk of 4-year cardiac death and nonfatal myocardial infarction was higher in dialysis diabetics than in dialysis nondiabetics (odds ratio [OR] 1.88, 95% confidence interval [CI] 1.01 to 2.75, p <0.05), nondialysis diabetics (OR 4.27, 95% CI 2.87 to 5.67, p <0.008), and nondialysis nondiabetics (OR 5.2, 95% CI 4.17 to 6.23, p <0.0001).

Safety, efficacy, and cost advantages of combined coronary angiography and angioplasty.

AIM: The safety and efficacy of ad hoc PTCA has been previously reported and this approach is performed in many angioplasty centers as a routine procedure. The aim of this study is to examine whether this approach reduces the length, and cost of hospital stay. METHODS AND RESULTS: To determine the hospital costs we studied 2,440 PTCAs over 11 years in our institution (1990-2000). Urgent PTCA for acute coronary syndromes refractory to medical treatment were excluded. In 1809 patients (74%) angioplasty was performed immediately after coronary angiography, while separate procedures were performed in 631 patients. Indication for PTCA was unstable angina in 1342 patients (55%). In the ad hoc PTCA group, 92% of the culprit lesions were successfully treated; complications included myocardial infarction (2%), urgent bypass surgery (0.6%) and death (0.9%). The rate of combined procedure progressively increased from 54% in 1990 to 88% in 2000, with a significant decrease in the rate of complications. After adjusting for clinical and angiographic differences between combined and separate procedures, angiographic success and complication rates were not statistically different in the two groups. Mean length of hospital stay decreased all along the years, and was 45% less in the ad hoc PTCA group (11.4 +/- 6.9 vs 18.2 +/- 7.7 in 1990, 5.4 +/- 4.3 vs 10.8 +/- 5.7 in 2000, P < 0.0001). The cost was 40% lower in the ad hoc PTCA group. For patients with stable angina, the savings were 49%, and for those with unstable angina, they were 29%. CONCLUSION: In the era of coronary stenting, ad hoc PTCA can be performed in most of the patients as safely and successfully as a separate procedure. It reduces the length, and the cost of hospital stay in patients with stable or unstable angina.

Comparison of effects on markers of blood cell activation of enoxaparin, dalteparin, and unfractionated heparin in patients with unstable angina pectoris or non-ST-segment elevation acute myocardial infarction (the ARMADA study).

The low-molecular-weight heparins (LMWHs) enoxaparin and dalteparin have shown superior and equivalent efficacy, respectively, over unfractionated heparin (UFH) in patients with unstable angina pectoris (UAP) or non-ST-segment elevation myocardial infarction (NSTEMI). This study aimed to identify markers of blood cell activation that are independent predictors of outcomes at 1 month and to compare the effects of enoxaparin, dalteparin, and UFH on any such markers. In this multicenter, prospective, open-label study, 141 patients with UAP or NSTEMI were randomized to treatment for 48 to 120 hours with enoxaparin (n = 46), dalteparin (n = 48), or UFH (n = 47). Blood samples were taken at the time of randomization and after > or =48 hours of treatment but before catheterization. Multivariate analysis identified increased plasma levels of von Willebrand factor (vWF) and decreased platelet levels of glycoprotein Ib/IX complexes as independent predictors of 1-month adverse outcome (a composite of death, myocardial infarction, and recurrent ischemia). vWF release was strongly related to and may have been released by inflammation as measured by C-reactive protein. Both LMWHs reduced the release of vWF in plasma (as well as C-reactive protein) compared with UFH. Enoxaparin had a more favorable effect on glycoprotein Ib/IX complexes than either dalteparin or UFH. The incidence of the composite clinical efficacy end point was: 13% (enoxaparin), 19% (dalteparin), and 28% (UFH). vWF and its receptor glycoprotein Ib/IX play a key role in acute coronary syndromes. vWF is linked to inflammation and, like glycoprotein Ib/IX, is affected more favorably by the LWMHs than by UFH.