Mark S. Patterson

5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial.

OBJECTIVES The purpose of this study was to evaluate the long-term outcomes of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. BACKGROUND In primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction (STEMI), the use of drug-eluting stents (DES) is still controversial. Several randomized controlled trials of DES, compared with bare-metal stents (BMS), with short-term follow-up showed a reduction in target lesion revascularization (TLR), but no differences in rates of cardiac death or recurrent myocardial infarction. Moreover, the occurrence of (very) late stent thrombosis (ST) continues to be of major concern, and, therefore, long-term follow-up results are needed. METHODS We randomly assigned 619 patients presenting with STEMI to a paclitaxel-eluting stent (PES) or the similar BMS. The primary end point was the composite of cardiac death, recurrent myocardial infarction, or TLR. We performed clinical follow-up at 5 years. RESULTS At 5 years, the occurrence of the composite of cardiac death, recurrent myocardial infarction, or TLR was comparable at 18.6% versus 21.8% in PES and BMS, respectively (hazard ratio [HR]: 0.82, 95% confidence interval [CI]: 0.58 to 1.18, p = 0.28). The incidence of definite or probable ST was 12 (4.2%) in the PES group and 10 (3.4%) in the BMS group (HR: 1.19, 95% CI: 0.51 to 276, p = 0.68). CONCLUSIONS In the present analysis of PES compared with BMS in primary percutaneous coronary intervention for STEMI, no significant difference in major adverse cardiac events was observed. In addition, no difference in the incidence of definite or probable ST was seen, although very late ST was almost exclusively seen after the use of PES. (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation [PASSION]; ISRCTN65027270).

Routine use of the transradial approach in primary percutaneous coronary intervention: procedural aspects and outcomes in 2209 patients treated in a single high-volume centre

Objective To examine the feasibility of a routine transradial approach (TRA) in primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI). Design A single-centre observational study with prospective data collection. Setting A high-volume interventional centre in Amsterdam, The Netherlands. Patients Procedural data were analysed for 2209 consecutive patients presenting with STEMI without cardiogenic shock, between January 2001 and December 2008. Interventions PPCI routinely performed by the TRA. Main Outcome Measures The primary outcomes of interest were the need for crossover to another vascular access site, the achievement of procedural success and their trends over time. Secondary outcome measures were trends in total procedural duration, fluoroscopy times and use of equipment. Results In a total of 2209 procedures the radial artery was the primary access site, comprising 96.1% of all procedures performed during the study period. In 84 cases (3.8%) access site crossover was needed. Crossover rates decreased from 5.9% in 2001–2 to 1.5% in 2007–8 (p=0.001). The procedural success rate was 94.1%, which remained stable over the years. Despite an increased complexity of PPCI (more non-left anterior descending infarct-related arteries, thrombus aspiration and multivessel PPCI), total procedural duration decreased from 38 min (IQR 28–50) in 2001–2 to 24 min (18–33) in 2007–8, p<0.001 for trend. Conclusions Systematic use of the TRA in PPCI yields low access site crossover, high procedural success rates and excellent procedural performances. It can therefore represent the primary access site in the vast majority of STEMI patients.

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.

First direct in vivo comparison of two commercially available three-dimensional quantitative coronary angiography systems.

Aim: The in vivo comparison of the accuracy of two 3‐dimensional quantitative coronary angiography (QCA) systems. Methods: Precision‐drilled plexiglass phantoms with five different luminal diameters (0.5–1.9 mm) were percutaneously inserted into the coronary arteries of four Yorkshire pigs. Twenty‐one angiographic images of these stenotic phantoms were acquired for in vivo validation testing. Quantitative assessments of the minimum, maximum, and mean luminal diameters together with the minimum luminal area were determined using two 3D QCA systems, the CardiOp‐B® and CAAS 5. Results: The CardiOp‐B system significantly underestimated the minimum luminal diameter MLD whilst both systems significantly overestimated the maximum luminal diameter at the minimal luminal area (MLA) over the phantoms true value. The CAAS 5 system had a greater degree of accuracy/mm (mean difference = 0.01 vs. 0.03) and precision/mm (SD = 0.09 vs. 0.23) than the CardiOp‐B in assessing the minimal LD. An increased precision/mm (SD = 0.01 vs. 0.29) and accuracy/mm (mean difference = 0.03 vs. 0.11) in the mean LD was observed with the CAAS 5. In comparing the MLA/mm2 the CAAS 5 was more precise/mm2 (SD = 0.14 vs. 0.55) and accurate/mm2 (mean difference = 0.12 vs. 0.02) to the true phantom MLA compared to the CardiOp‐B system. Conclusions: In a 21 phantom study, the CAAS 5 3D QCA system had a greater degree of accuracy and precision in both the luminal and area measurements than the CardiOp‐B 3D QCA system.

Technology Insight: magnetic navigation in coronary interventions

Magnetic navigation is rapidly emerging as a useful technology in the field of interventional cardiology. Precise control of the direction of a guide wire or a device in three-dimensional space offers a means to access vessels and areas of the heart that are often challenging to access with conventional methods. In this comprehensive Review, we detail the development of magnetic navigation technology and how this tool has been adapted for use during percutaneous coronary intervention. We aim to provide an up-to-date analysis of what is currently possible with this technology and an insight into what the future holds, particularly with respect to chronic occluded arteries and cell transplantation.

Two year follow-up after primary PCI with a paclitaxel-eluting stent versus a bare-metal stent for acute ST-elevation myocardial infarction (the PASSION trial): a follow-up study.

AIMS This follow-up study was performed to assess the long-term effects of paclitaxel-eluting stents (PES) compared with bare-metal stents (BMS) in patients who had undergone a percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS The PASSION trial randomly assigned 619 patients with STEMI to receive either a PES or BMS. The composite endpoint for the follow-up study was the occurrence of the combination of cardiac death, recurrent myocardial infarction, target lesion revascularisation (TLR) or stent thrombosis at two years. A trend towards a lower rate of the composite endpoint was observed in the PES compared to the BMS group (hazard ratio [HR] 0.70; 95% C.I. 0.45-1.09). This was driven by a reduced TLR in favour of PES (HR 0.60; 95% C.I. 0.34-1.09). Angiographically proven stent thrombosis at two years did not differ significantly between groups (2.1% in the PES group versus 1.4%; HR 1.48; 95% C.I. 0.42-5.23). CONCLUSIONS PES implantation for STEMI did not significantly improve clinical outcome at two years after the index event, although there was a trend towards a lower rate of target-lesion revascularisation. The rate of stent thrombosis did not differ significantly between groups.

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.

Magnetically navigated percutaneous coronary intervention in distal and/or complex lesions may improve procedural outcome and material consumption

AIMS Comparison of magnetic guidewire navigation in percutaneous coronary intervention (magnetic PCI) across distal and/or complex lesions versus conventional navigation (conventional PCI). METHODS AND RESULTS Forty-seven consecutive patients (age 61 +/- 10 yr) undergoing elective single vessel magnetic PCI for distal and/or complex lesions were matched by age and lesion location with 45 patients undergoing conventional PCI (age 63 +/- 10 yr). Technical success rate was defined as an intraluminal wire position distal to the stenosis. Procedural outcome and costs were evaluated. Baseline demographics and angiographic characteristics of the two groups were similar. The technical success rate did not differ between magnetic and conventional PCI (95.7 vs 97.8%; p = 1.00). Significantly shorter procedural and fluoroscopy time were observed for magnetic compared to conventional PCI (29.9 +/- 17.6 vs 41.1 +/- 21 min, p = 0.007; 7.5 +/- 7.3 vs 16.1 +/- 22.4 min, p = 0.02 respectively). Less contrast was used in the magnetic PCI group (58 ml/patient; P = 0.02). These advantages resulted in a mean estimated saving of 1400 euro per patient (P < 0.001). Advantages of procedural outcome were even more pronounced in the ACC/AHA lesion class C subgroup. CONCLUSIONS Magnetic compared to conventional PCI is an attractive novel technique that proved to be feasible and safe and might be faster in distal and especially complex lesions.

A randomized comparison of the magnetic navigation system versus conventional percutaneous coronary intervention.

Objective: A randomized comparison of the magnetic navigation system (MNS) to conventional guidewire techniques in percutaneous coronary interventions. Background: The MNS precisely directs a magnetized guidewire in vivo through two permanent external magnets. Methods: A total of 111 consecutive patients were enrolled. Crossing success, crossing‐/fluoroscopy times, and contrast usage were directly compared. Lesions were classified according to the AHA/ACC criteria. Three tertiles of vessel/lesion complexity [low (<5), medium (6–10) and high (>10)] were defined using 3D reconstructions and angiographic information. Results: The crossing success for magnetic and the conventional wires were 93.3and 95.6%, respectively. Crossing and fluoroscopy times were longer with the magnetic wires (72.9 ± 50.3 sec vs. 58.1 ± 47.2 sec, P < 0.001 and 66.2 ± 44.1 sec vs. 55.2 ± 44.4 sec, P = 0.03, respectively). In vessels with low and medium complexity the magnetic wires had significantly longer times (P < 0.001) but for those with high scores (>10) a trend towards shorter times was observed. The MNS resulted in a small but significant reduction in contrast usage (2.3 ± 3.5 ml vs. 4.5 ± 4.4 ml, P < 0.001). Moreover by superimposing a virtual roadmap of the vessel on the live fluoroscopy image 48% of the lesions were crossed without requiring contrast agents with the MNS. Conclusion: The MNS has comparable crossing success to conventional PCI. It is relatively slower but there is a trend to support a potential advantage in more complex vessels. By simultaneously employing a virtual roadmap there is a small but significant reduction in contrast usage.

A randomised controlled study comparing conventional and magnetic guidewires in a two-dimensional branching tortuous phantom simulating angulated coronary vessels.

To directly compare the magnetic navigation system (MNS) guidewires with conventional guidewires in branching tortuous phantoms with operators of varying MNS and percutaneous coronary intervention experience.