Recurrent Myocardial Infarction After Primary Percutaneous Coronary Intervention in Multivessel Coronary Disease Is Primarily Related to Stent Failure: Post-Hoc Analysis of the PASSION Trial.

OBJECTIVES: Our aim was to investigate the risk of events related to non-culprit lesions after primary percutaneous coronary intervention (PCI) in patients with multivessel coronary disease (MVD). BACKGROUND: In patients undergoing primary PCI for ST-elevation myocardial infarction (STEMI) who are diagnosed with MVD, the optimal treatment strategy is currently under debate. Although observational data exposed an increased risk of multivessel PCI in the acute phase of STEMI, 2 recently published randomized controlled trials showed a reduction of death or recurrent myocardial infarction (MI) after preventive PCI of non-culprit lesions when compared with culprit-lesion PCI only. METHODS: We performed a post-hoc analysis of 279 patients with MVD included in the Paclitaxel-Eluting Stent versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation (PASSION) trial. We analyzed the incidence and cause of recurrent MI. Recurrent MI due to stent failure was assumed in the event of definite or probable stent thrombosis. RESULTS: After 5 years, 14 patients (5.7%) with MVD had a recurrent MI versus 17 (5.4%) patients with 1-vessel disease (HR 1.06, 95%CI 0.52-2.15, P = 0.87). The majority of events was attributable to stent failure, while of the remaining 6 events, only 1 was proven to originate from a lesion that was judged significant at enrolment. CONCLUSIONS: In this post-hoc analysis of the PASSION trial, recurrent MI in patients with MVD was mainly related to stent failure rather than a new event originating from a significant stenosis in a non-culprit coronary artery.

A randomized comparison of manual versus mechanical thrombus removal in primary percutaneous coronary intervention in the treatment of ST-segment elevation myocardial infarction (TREAT-MI).

OBJECTIVES: The objective of this study was to compare the efficacy and long-term clinical outcome of manual thrombus aspiration with the Export catheter (Medtronic, Minneapolis, MN) versus mechanical thrombus cutting/aspiration with the X-sizer system (eV3, White Bear Lake, MN) in primary percutaneous coronary intervention (PPCI). BACKGROUND: In PPCI for acute ST-segment elevation myocardial infarction (STEMI), markers of myocardial reperfusion are improved with adjunctive thrombectomy. Previous studies of different devices showed a variability in performance, suitability, and short-term clinical outcome. In current literature, no direct comparison is available. METHODS: We prospectively randomized 201 patients admitted for PPCI for STEMI to either the Export catheter or the X-sizer prior to stent deployment. Technical success in advancing to and across the lesion, improvement of flow, reduction of thrombus, and the effect on ST-segment resolution were examined. The primary endpoint of the follow-up study was the combined endpoint of cardiac death, recurrent myocardial infarction (MI), or target-vessel revascularization (TVR) at 3 years. RESULTS: Although the Export catheter was more successfully deployed, other procedural parameters were similar with a trend toward better ST-segment resolution (56.6% vs. 44%; P = 0.06) as compared to the X-sizer system. The occurrence of the primary clinical endpoint at 3 years was 22.2% and 18.6%, respectively (HR 1.20; 95% CI 0.65-2.22; P = 0.35). CONCLUSION: Despite shorter procedural times, better lesion crossing, and fewer complications, both surrogate endpoints as well as 3-year clinical follow-up were similar with the use of the Export catheter as compared to the X-sizer system.

Use of the Stereotaxis Niobe magnetic navigation system for percutaneous coronary intervention: results from 350 consecutive patients.

INTRODUCTION: The Stereotaxis Niobe magnetic navigation system (MNS; Stereotaxis, St. Louis, MO) facilitates precise vector based navigation of magnetically-enabled guidewires for percutaneous coronary intervention (PCI) by using two permanent magnets located on opposite sides of the patient table to produce a controllable magnetic field. The objective of this study is to describe the results of a large patient series using this system, to compare the results with a historical control group, and to detail the MNS learning curve. METHODS: We prospectively collected data on 439 lesions in 350 consecutive PCI patients using the MNS predominantly using the radial approach. All data were entered into a customized database to capture the key parameters and then compared with a previously collected stent registry from the same center. RESULTS: In 410/439 lesions (93%) the wire crossed the lesion successfully using the MNS. Twenty-five of the 35 failures were chronic total occlusions. No wire perforations or dissections occurred in this population. Lesion crossing time was 81 +/- 168 sec (mean +/- SD), and fluoroscopy time was 64 +/- 123 sec. A clear learning curve was evident after the first 80 patients. Contrast use was reduced when compared with a historical control group. Procedural and fluoroscopy times were similar. CONCLUSIONS: Use of the MNS may enable the successful performance of more complex procedures in the cardiac catheterization laboratory with an improvement in time efficiency.

Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial.

BACKGROUND: The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months. METHODS AND RESULTS: Patients (n = 1197) treated for single coronary artery stenosis were enrolled in a prospective, randomized, double-blind study and randomly assigned to receive the Endeavor zotarolimus-eluting phosphorylcholine polymer-coated stent (n = 598) or the same bare metal stent but without the drug or the polymer coating (n = 599). The 2 groups were well matched in baseline characteristics. Diabetes was present in 20.1% of patients; the mean reference vessel diameter was 2.75 mm; and the mean lesion length was 14.2 mm. The primary end point of target vessel failure at 9 months was reduced from 15.1% with the bare metal stent to 7.9% with the Endeavor (P = 0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (P = 0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (P = 0.0001). The rate of stent thrombosis was 0.5% with the Endeavor, which was not significantly different from 1.2% with the bare metal stent. In 531 patients submitted to angiographic follow-up, late loss was reduced from 1.03 +/- 0.58 to 0.61 +/- 0.46 (P < 0.001) in stent and from 0.72 +/- 0.61 to 0.36 +/- 0.46 (P < 0.001) in segment. The rate of in-segment restenosis was reduced from 35.0% to 13.2% with Endeavor (P < 0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malapposition by intravascular ultrasound imaging. Differences in clinical outcome were maintained at 12 and 24 months (P < 0.0001). CONCLUSIONS: Compared with bare metal stents, the Endeavor stent is safe and reduces the rates of clinical and angiographic restenosis at 9, 12, and 24 months.

Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial.

BACKGROUND: The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. METHODS AND RESULTS: This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. CONCLUSIONS: Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.

Early angioplasty in acute coronary syndromes without persistent ST-segment elevation improves outcome but increases the need for six-month repeat revascularization: an analysis of the PURSUIT Trial. Platelet glycoprotein IIB/IIIA in Unstable angina: Receptor Suppression Using Integrilin Therapy.

OBJECTIVES: We explored the effect of timing of percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS) without persistent ST-segment elevation on the need for repeat revascularization, and we related this effect to other events. BACKGROUND: Percutaneous coronary intervention is widely used to treat ACS without persistent ST-segment elevation. Moreover, restenosis and subsequent revascularization after PCI are more frequent in ACS than in stable angina. The optimal timing of PCI in ACS without persistent ST-segment elevation is unknown. METHODS: In the Platelet glycoprotein IIB/IIIA in Unstable angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) database, patients were stratified by the time of PCI. In the PURSUIT trial, 9,461 patients received a platelet glycoprotein IIb/IIIa inhibitor, eptifibatide or placebo for 72 h. The investigators decided on other treatments. RESULTS: A total of 2,430 patients underwent PCI within 30 days. Repeat revascularization (during 165 days) was notably higher for PCI within 24 h of enrollment (n = 620 [19%]) than for PCI at 24 to 72 h (n = 624 [16.7%]), 3 to 7 days (n = 614 [13.2%]), or 8 to 30 days (n = 561 [7.7%]; p < 0.001), regardless of eptifibatide use. This gradual reduction in the revascularization rate for later PCI was also observed after multivariate analysis correcting for baseline characteristics and with time as a continuous variable. CONCLUSIONS: Percutaneous coronary intervention within 24 is associated with improved outcome (other analysis) but more repeat revascularization. Prospective analyses are needed to test the hypothesis that rapid PCI in ACS with a platelet glycoprotein IIb/IIIa receptor antagonist reduces myocardial infarction (and possibly death) and is therefore most suited for patients at highest risk of infarction, despite a higher need for repeat revascularization.

Lack of efficacy of clopidogrel pre-treatment in the prevention of myocardial damage after elective stent implantation.

OBJECTIVES: The object of this study was to determine the effect of pre-treatment with clopidogrel in patients undergoing elective stent implantation. BACKGROUND: The treatment of patients with adenosine diphosphate receptor blockers after percutaneous coronary intervention (PCI) with stent implantation has been shown to decrease the incidence of subacute stent thrombosis. Furthermore, non-randomized studies on pre-treatment with clopidogrel among patients undergoing stent implantation have suggested a reduction in myocardial damage and clinical events. The effect of pre-treatment with clopidogrel has been studied in only a few randomized trials. METHODS: In a randomized trial, three days of pre-treatment with clopidogrel was compared with standard post-procedural treatment in 203 patients undergoing elective stent implantation. The primary end point was a rise in troponin I or creatine kinase-MB fraction (CK-MB) serum levels at 6 to 8 and 16 to 24 h after PCI. Secondary end points were death, stroke, myocardial infarction, coronary bypass grafting, repeated PCI, and subacute stent thrombosis at one and six months after PCI. RESULTS: No difference was found between non-pre-treated and pre-treated patients in the post-procedural elevation of troponin I (42 [43.3%] vs. 48 [51.1%], respectively, p = 0.31) or CK-MB (6 [6.3%] vs. 7 [7.4%], respectively, p = 0.78). Adjustment for possible confounding factors did not change these findings. Patient follow-up at one and six months showed no significant difference between the treatment groups in death, stroke, myocardial infarction, coronary artery bypass grafting, repeated PCI, or subacute stent thrombosis. CONCLUSIONS: In this randomized study, no beneficial effect of pre-treatment with clopidogrel on post-procedural elevation of troponin I and CK-MB or on clinical events after one and sixth months could be demonstrated. The study suggests that among patients with stable coronary syndromes in whom coronary stent implantation is planned, pre-treatment may not be beneficial in reducing early myocardial damage.

Dynamics in N-terminal pro-brain natriuretic peptide concentration in patients with non-ST-elevation acute coronary syndrome.

BACKGROUND: Although there is growing evidence that N-terminal pro-brain natriuretic peptide (NT-proBNP) can be used as a powerful tool in risk prediction in patients with non-ST-elevation acute coronary syndrome (NSTEACS), the dynamic variation of serum concentrations in time is poorly understood. To gain insight into the dynamics of NT-proBNP, a study was performed using serial serum samples in patients admitted with NSTEACS. METHODS: A total of 24 patients admitted with NSTEACS was included in this study. Serial samples were taken at baseline, 8 hours, 16 hours, 24 hours, and 36 hours after admittance. RESULTS: A highly dynamic pattern in serial measurements of NT-proBNP was observed. Although an increase in NT-proBNP serum levels already existed 8 hours after admittance, it did not reach significance as compared with baseline. The samples obtained 16, 24, and 36 hours after admission were all significantly increased as compared with the values at admission (P < .01), generally leading to a > 2-fold increase with peak values at 16 to 24 hours after admittance. Furthermore, considerable differences in NT-proBNP concentrations between patients were observed. CONCLUSIONS: It was shown that NT-proBNP is a highly dynamic cardiac peptide. Strategic sampling at 16 to 24 hours after admittance could prove representative regarding the assessment of risk prediction and subsequent clinical decision making.

Complete versus culprit vessel percutaneous coronary intervention in multivessel disease: a randomized comparison.

BACKGROUND: The purpose of this study was to compare the safety, efficacy, and costs of complete versus "culprit" vessel revascularization in multivessel coronary artery disease treated with percutaneous coronary interventions (PCI). METHODS: Patients with multivessel disease and an identified culprit vessel were randomly assigned to complete revascularization of vessels > or =50% stenoses (n = 108) versus revascularization limited to the culprit vessel (n = 111). The primary end point, major adverse cardiac events (MACE), were defined as cardiac or noncardiac death, myocardial infarction, need for coronary artery bypass graft surgery, and repeat PCI up to 1 year. RESULTS: Despite equal MACE at 24 hours (6.3% vs 7.4%), strategy success was higher in the culprit vessel than in the complete revascularization group (93.7% vs 81.5%, P =.007). MACE rates at 1 month (14.4% vs 9.3%), 1 year (32.4% vs 26.9%), and 4.6 +/- 1.2 years (40.4% vs 34.6%) were similar in both groups. Repeat PCI was performed more often in the culprit vessel group (31.2% vs 21.2%, P =.06). A lower consumption of medical material was associated with lower procedural costs in the culprit vessel group (5784 vs 7315 Euros; P <.001). However, between 1 year and the end of follow-up, costs had equalized in both groups. CONCLUSIONS: Complete versus culprit vessel revascularization in multivessel coronary disease treated with PCI was associated with a lower strategy success rate, similar MACE rates, and initially higher costs. However, over the long term, more repeat PCIs were conducted in patients treated by culprit revascularization only, mostly because of the need to treat lesions initially left untreated. As a consequence, incremental costs had equalized within 1 year. The decision of whether to perform culprit vessel or complete revascularization can be made on an individual basis.

Long-term follow-up of the randomised controlled trial to evaluate the safety and efficacy of the zotarolimus-eluting driver coronary stent in de novo native coronary artery lesions: five year outcomes in the ENDEAVOR II study.

AIMS: We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor(tm) zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions. METHODS AND RESULTS: Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (>1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years. CONCLUSIONS: After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease.

Overview of the transradial approach in percutaneous coronary intervention.

Thirteen years have passed since the first percutaneous coronary intervention was performed at Onze Lieve Vrouwe Gasthuis in Amsterdam using the transradial approach (TRA). Since then TRA has spread through the interventional community and many centres have now adopted TRA as the arterial access of choice. This review is focused on the hot issues and the latest developments in this field. The following subjects will be addressed and discussed: drawbacks and learning curve, procedural technique, indications (with particular attention to acute coronary patients), complications, contraindications, nurse workload, patient management, and economics.

NT-ProBNP serum levels reflect severity and extent of ischemia in patients admitted with non-ST-elevation acute coronary syndrome.

OBJECTIVE: To explore the relationship between NT-proBNP elevation and prognosis in patients with NSTEACS. BACKGROUND: High NT-proBNP levels are related to a worse prognosis in patients with ACS. The precise mechanism by which is not clear. METHODS: Serial sampling of NT-proBNP, Troponin T and CK-MB was performed in 23 patients admitted with NSTEACS. Using coronary angiography in each patient a culprit lesion was identified. Proximal lesions were located before or at the first major branch of the parent artery. All other lesions localizations were considered distal. To evaluate the influence of left ventricular systolic function on NT-proBNP levels WMSI was measured by echocardiography. RESULTS: Proximal culprit lesion localization was associated with significant higher baseline (mean 506 ng/l, SD 440 ng/l) and peak NT-proBNP levels (mean 1055 ng/l; SD 236 ng/l), as compared to patients with a distal lesion localization. (Baseline: 139 ng/l, SD 140 ng/l, peak: 381 ng/l; SD 64 ng/l). (P = 0.01) NT-proBNP levels were highly correlated to Troponin T and CK-MB peak serum levels. Adjustments for left ventricular dysfunction did not alter these associations. CONCLUSIONS: High peak NT-proBNP levels are independently associated with both proximal culprit localization and elevated biochemical markers of myocardial damage. These findings suggest that NT-proBNP levels reflect the amount of jeopardized myocardium and could signify the integral of the extent and severity of an ischemic event.

Oral administration of glycine in the prevention of restenosis after coronary angioplasty. A double blind placebo controlled randomized feasibility trial evaluating safety and efficacy of glycine in the prevention of restenosis after angioplasty.

OBJECTIVES: Evaluation of safety, feasibility, and efficacy of oral administered glycine in prevention of angiographic restenosis six months after percutaneous coronary intervention (PCI). BACKGROUND: The amino acid glycine modulates immunological response and enhances the production of endothelial derived nitric oxide (EDNO) factor. This factor has been shown to possess anti-atherosclerotic properties, actions of which are thought to reduce neo-intimal hyperplasia. Furthermore, glycine significantly elevates arginine serum levels. This amino acid has been extensively studied for its effects on the endothelium, nitric oxide (NO) metabolism and effects on several biochemical pathways interfering with the process of restenosis after PCI. METHODS: A prospective double blind placebo controlled randomized study evaluated safety and feasibility of chronic oral administration of glycine. In addition, the efficacy was determined by evaluation of six months angiographic restenosis rates. RESULTS: 214 patients scheduled for elective PCI were randomized to receive glycine or placebo. At follow-up, there was no significant difference in side effects and in major adverse cardiac events (MACE) between both groups. Six-month angiograms revealed similar restenosis rates for the glycine group (17.5%) and for the placebo group (20.2%) (P = 0.82). CONCLUSION: Chronic oral administration of glycine was safe and feasible and had similar side effects compared to placebo. However, chronic oral administration of glycine did not lead to a significant reduction in restenosis rates at six months after elective PCI.

Early discharge is feasible following primary percutaneous coronary intervention with transradial stent implantation under platelet glycoprotein IIb/IIIa receptor blockade. Results of the AGGRASTENT Trial.

BACKGROUND: Primary percutaneous coronary intervention (PCI) with stent implantation demonstrated to be superior to both PCI with balloon angioplasty and to thrombolysis for acute ST-elevation myocardial infarction (STEMI). The use of glycoprotein (GP) IIb-IIIa blockers in this setting may be beneficial. However, GP IIb-IIIa receptor blocker treatment is frequently accompanied by femoral entry site-related bleeding complications, resulting in additional morbidity and prolonged hospitalization. These complications are minimized by using the transradial approach (TRA). METHODS: This study prospectively explored the feasibility of early discharge (within 4 days) following primary PCI with transradial stent implantation under GP IIb-IIIa blockade with tirofiban in the setting of STEMI. One-hundred patients with STEMI eligible for PCI were included. RESULTS: Of these 100 patients, 62% received treatment according to the protocol, e.g., TRA, successful PCI with stent implantation, full-dose GP IIb/IIIa receptor blocker infusion and early discharge. The PCI was successful in 95%. Early discharge was achieved in 75 patients of the total study population. Major adverse cardiac and cerebral events (MACCE) did not occur in the early discharge group, with a 1-year event-free survival rate of 91%. The combined MACCE rates in the total study population at 1, 6, and 12 months were 8%, 15% and 20%, respectively. CONCLUSION: Early discharge is feasible following primary PCI with stent implantation via the radial artery under GP IIb-IIIa blockade for STEMI, however a larger study is needed to prove the efficacy of this strategy.

A prospective multicentre registry of the procedural and long-term clinical and angiographic results of stent implantation using a Dylyn coated coronary stent system.

OBJECTIVES: A prospective registry was performed to evaluate the safety and efficacy of a Dylyn coated coronary stent. BACKGROUND: Diamond-like nanocomposite (Dylyn) stent coating is thought to be biocompatible, resulting in decreased thrombogenicity and decreased neointimal hyperplasia. METHODS: In a multicentre, open, prospective, clinical and angiographical registry, the Dylyn-coated stent system was evaluated in patients requiring percutaneous coronary intervention. The primary procedural and angiographical endpoint of the study was the sustained success of stent-implantation using a follow-up catheterisation at six months. The primary clinical endpoint of the study was the composite incidence of death, non-fatal myocardial infarction and revascularisation at six months after stent implantation. RESULTS: 127 Dylyn coated coronary stents were implanted in 121 patients. Procedural success was obtained in 100% of the cases. No episodes of acute stent thrombosis occurred. The number of patients within stent restenosis at six months was 29 (24%). The primary procedural, angiographical endpoint was achieved in 91 (70%) patients. The clinical results at six-month follow-up were favourable with a MACE-rate of 7.4%. CONCLUSIONS: A Dylyn coated coronary stent system is well tolerated and has excellent short-term results. The amount of angiographic restenosis at 6 months, however, is considerable, but comparable to other non-drug-eluting stent systems.

Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: a randomized double-blind comparison of coated and uncoated sheaths.

Radial artery spasm may cause severe discomfort during radial artery sheath removal. A hydrophilic-coated sheath may reduce the force required to remove a radial sheath. This force may be quantified using an automatic pullback device (APD). The objective of this study was to assess if a hydrophilic coating reduces the required force and discomfort associated with removal of a radial sheath following transradial coronary intervention. Ninety patients undergoing percutaneous coronary intervention via the radial artery were randomly assigned to two groups receiving either coated or uncoated introducer sheaths. Radifocus Introducer II (Terumo) 25 cm, 6 Fr radial sheaths and sheaths that were identical apart from the presence of the coating were used in all patients. The APD was used for sheath removal at the end of the procedure. Three patients (7%) in the coated group experienced discomfort during automatic sheath removal, compared to 12 patients (27%) in the uncoated group (P = 0.02). The maximum pullback force (MPF) was significantly lower in the coated compared to the uncoated group (0.24 +/- 0.31 vs. 0.44 +/- 0.33 kg; P = 0.003). Similarly, the mean pullback force was significantly lower in the coated group (0.14 +/- 0.23 vs. 0.32 +/- 0.24 kg; P < 0.001). Only one patient (2%) in each group had an MPF greater than 1.0 kg together with clinical evidence of radial artery spasm. Removal of the coated Terumo Radifocus sheath requires less force than an identical uncoated sheath. The coated sheath was also associated with less discomfort for the patient.

Impact of operator volume on overall major adverse cardiac events following direct coronary stent implantation versus stenting after predilatation.

OBJECTIVES: To determine the impact of operator experience on procedural, clinical and angiographic outcome after (direct) coronary stent implantation. BACKGROUND: Although for other forms of percutaneous coronary interventions an inverse relationship between operator volume and patient outcomes has been shown, the impact of operator volume on outcome after direct stenting has never been investigated. METHODS: A retrospective analysis was performed on data from a prospective randomized trial comparing direct stenting with that after predilatation. The trial consisted of 400 patients with stable and unstable angina pectoris and/or myocardial ischemia due to a coronary stenosis of a single native vessel eligible in 1999-2001 for direct stenting. For a single-center high-volume clinic (>1500 cases/year), the authors compared the most experienced operators (case load: >4000) with well trained practitioners (case load: 175). One hundred and fifteen patients were identified who were treated by high-volume and 180 who were treated by medium-volume operators. RESULTS: Baseline patient characteristics were evenly distributed among groups. High-volume, compared with medium-volume operators, were faster (30.8 versus 42.2 minutes, p < 0.001), needed less frequent postdilatation (15% versus 24%, p = 0.06) and had lower fluoroscopy times (7.5 versus 11.2 minutes, p < 0.001), lower contrast usage (180 versus 228 ml, p < 0.001), lower procedural costs (euro1982 versus euro2164, p = 0.05) and reduced rates of major adverse cardiac and cerebral event (MACCE) at six months (12.2 versus 21.1%, p = 0.03). The medium-volume operator group experienced higher angiographic binary restenosis rates after direct stenting compared with stenting after predilatation (31.5 versus 14.9%, p = 0.005). CONCLUSIONS: Stenting performed by high-volume operators resulted in a 50% reduction in MACCE as compared with medium-volume physicians, which also had twice as much restenosis when using direct stenting. Hence, the more demanding technique of direct stenting should not be performed by unsupervised operators who have not yet completed their training. Furthermore, prolonged training periods and even more intensive supervision by experienced operators seems mandatory.

Evaluation of a spasmolytic cocktail to prevent radial artery spasm during coronary procedures.

Radial artery spasm is a frequent complication of the transradial approach for coronary angiography and angioplasty. Recently, we have been able to quantify spasm using the automatic pullback device. The objective of this study was to assess the efficacy of an intra-arterial vasodilating cocktail in reducing the incidence and severity of radial artery spasm. A hundred patients undergoing coronary procedures via the radial artery were divided into two groups of 50 each. Patients in group A received intra-arterial cocktail (5 mg of verapamil plus 200 micro g nitroglycerine in 10 ml of normal saline), while patients in group B did not receive any vasodilating drug. The pullback device was used for sheath removal at the end of the procedure. Seven (14%) patients in group A experienced pain (i.e., pain score of III-V) during automatic sheath removal, as compared to 17 (34%) in group B (P = 0.019). The mean pain score was significantly lower in group A than in group B (1.7 +/- 0.94 vs. 2.08 +/- 1.07; P = 0.03). The maximal pullback force (MPF) was also significantly lower for group A (0.53 +/- 0.52 kg; range, 0.10-3.03 kg) as compared to group B (0.76 +/- 0.45 kg; range, 0.24-1.99 kg; P = 0.013). Only 4 (8%) patients in group A had an MPF value greater than 1.0 kg, suggesting the presence of significant radial artery spasm, as opposed to 11 (22%) in group B (P = 0.029). Administration of an intra-arterial vasodilating cocktail prior to sheath insertion reduces the occurrence and severity of radial artery spasm.

Safe and effective direct implantation of a new stent through 5 F. guiding catheters with delivery from the radial artery: initial results of a prospective registry.

OBJECTIVES: To evaluate the safety and efficacy of the direct implantation of a new stent via the radial artery through a 5 F. guiding catheter. Background advances in the design of stents and stent delivery systems have facilitated the performance of direct stenting and the use of thinner guiding catheters. METHODS: This registry enrolled prospectively 125 patients (147 lesions, 20.4% AHA/ACC class B2/C) who underwent elective percutaneous coronary revascularization procedures for stable or unstable angina between November 2000 and March 2001. RESULTS: Cannulation of the radial artery was attempted in 92.7% and was successful in 91.0% of cases. Direct stenting was successful in 88.7% of lesions and procedural success was 99.3%. In-hospital major adverse cardiac events occurred in 1.6% of cases (one death, one semi-urgent coronary artery bypass operation). The final rate of successful stent implantation through 5 F. guiding catheters was 96.7%. There were no access-site-related complications. Failure to cross the lesion occurred in 10% of attempts. At a mean follow-up of 7 +/- 2.8 months after discharge from hospital, 79% of patients had remained free of angina, and 89% had remained free of ischemic events. CONCLUSIONS: Direct stenting with a new stent design was safe, effective, and could be accomplished through 5 F. guiding catheters with favorable long-term clinical outcomes.

The effect of ITF-1697 on reperfusion in patients undergoing primary angioplasty. Safety and efficacy of a novel tetrapeptide, ITF-1697.

AIM: ITF-1697 is a C-reactive protein-derived tetrapeptide that, based on pre-clinical studies, is thought to reduce reperfusion injury. We performed a dose-finding study to assess safety, preliminary efficacy and clinical outcome of prolonged i.v. infusion of ITF-1697 in patients with an acute myocardial infarction (AMI) who were eligible for percutaneous coronary intervention (PCI). METHODS AND RESULTS: This was a multicentre dose-finding study that was randomised, double blind, and placebo-controlled. Four hundred and two patients were enrolled. Intravenous infusion of four dosages of ITF-1697 (0.1, 0.5, 1.0 or 2.0 microg/kg/min) or placebo was started before PCI and continued for 24 h. After interim analysis of data from 242 patients the study continued with the 0.1 and 1.0 microg/kg/min ITF-1697 regimes. Analysis did not raise any safety concerns. Post-procedure perfusion, assessed by TIMI flow, corrected TIMI frame count, blushgrade and ST-segment resolution, was similar for the placebo, 0.1 and 1.0 microg/kg/min regimes. Furthermore, the results showed no differences between the treatment regimes in enzymatic infarct size or clinical outcome up to 30 days. CONCLUSION: ITF-1697 was well tolerated. However, neither a dose-relation nor improvement of perfusion, clinical outcome or reduction of myocardial damage could be demonstrated with ITF-1697 during and after primary PCI for AMI.