Conventional Percutaneous Coronary Intervention Research Articles

Impact of thrombus aspiration use and direct stenting on final myocardial blush score in patients presenting with ST-elevation myocardial infarction

Many studies have reported that low final thrombolysis in myocardial infarction (TIMI) flow and/or myocardial blush grade (MBG) are independent predictors of mortality in patients with ST-elevation myocardial infarction (STEMI). In addition, distal coronary embolization is a major pitfall of conventional percutaneous coronary intervention (PCI) in such a context. This study aimed to assess the impact of thrombus aspiration (TA) use before primary PCI on final myocardial reperfusion in patients presenting with STEMI. From January to December 2006, 100 patients presenting with STEMI in our catheterization laboratory were considered for the present study. During this time period, 50 patients underwent TA before primary PCI for treatment of STEMI and were then matched 1:1 to 50 controls who underwent conventional primary PCI for treatment of STEMI without TA. Patients of the control group were chosen after matching on age+/-3 years, sex, history of diabetes, and distribution of the infarct related coronary artery during the same period. Baseline clinical characteristics, initial TIMI flow and initial MBG of both groups were similar. There was a trend for a better final TIMI flow in the group with TA and the final MBG was significantly improved in the group with TA compared to the group without TA: final MBG of two or three in 70% versus 30% of the cases (P=.001). In addition, direct stenting was significantly more often used in the TA group (92% versus 64%, P=.001). There were four patients with evident distal embolizations in the group without TA and none in the group with TA. TA use before primary PCI for STEMI treatment resulted in improved final myocardial reperfusion. Of importance, TA use may have led to a better choice of the stent size and more frequent direct stenting. This benefit may directly improve patient outcomes.

Primary percutaneous coronary intervention by magnetic navigation compared with conventional wire technique

Aims Comparison of magnetic guidewire navigation in percutaneous coronary intervention (MPCI) vs. conventional percutaneous coronary intervention (CPCI) for the treatment of acute myocardial infarction. Methods and results We compared 65 sequential patients (mean age 61 ± 15 years) undergoing primary MPCI with those of 405 patients undergoing CPCI (mean age 61 ± 13 years). The major endpoint was contrast media use. Technical success and procedural outcomes were evaluated. Clinical demographics and angiographic characteristics of the two groups were similar, except for fewer patients with previous coronary artery bypass grafting (CABG) and hypertension in the CPCI group and fewer patients with diabetes in the MPCI group. The technical success rate was high in both the MPCI and CPCI groups (95.4 vs. 98%). There was significantly less contrast media usage in the MPCI compared with the CPCI group, median reduction of contrast media of 30 mL with an OR = 0.41 (0.21-0.81). Fluoroscopy times were significantly reduced for MPCI compared with CPCI, median reduction of 7.2 min with an OR = 0.42 (0.20-0.79). Conclusion This comparison indicates the feasibility and non-inferiority of magnetic navigation in performing primary PCI and suggests the possibility of reductions in contrast media use and fluoroscopy time compared with CPCI.

Evaluation of antiplatelet effects of a modified protocol by platelet aggregation in patients undergoing “one-stop” hybrid coronary revascularization

“One-stop” hybrid coronary revascularization has emerged to be a reliable and attractive alternative for selected patients with multivessel coronary artery disease. However, the optimal antiplatelet regimen of the one-stop hybrid procedure still remains controversial. We modified the antiplatelet protocol in order to reduce the risk of perioperative bleeding and maximally inhibit platelet activity. This study sought to investigate whether the inhibition of platelet activity by this modified antiplatelet protocol is comparable with the conventional protocol widely used and recommended in percutaneous coronary interventions (PCI). Twenty three patients undergoing one-stop hybrid procedure and 20 patients undergoing conventional PCI were enrolled in this prospective study. The modified antiplatelet protocol included perioperative use of aspirin; clopidogrel was administered immediately before PCI with a 300 mg loading dose, followed by a maintenance dose of 75 mg/day for 12 months. Blood samples were obtained before the operation and 2 hours, day 1 and day 3 after operation. Platelet aggregation was induced with: 1) arachidonic acid (AA) (final concentration 0.5 mmol/L) to assess the efficacy of aspirin; 2) adenosine diphosphate (ADP) (final concentration 10 μmol/L) to assess the specific efficacy of clopidogrel. Platelet counts were statistically lower in the hybrid group than in the PCI control group (p = 0.0018) on day 1 after operation. AA-induced platelet aggregation increased significantly in comparison with the preoperative baseline values (p = 0.0079) and the PCI control group (p = 0.0023) on day 1 after operation. ADP-induced platelet aggregation gradually decreased in the hybrid group, and achieved similar platelet inhibition with the PCI group on 2 hours and day 1 after operation. No major adverse clinical events such as death, perioperative myocardial infarction, stent thrombosis or reoperation for bleeding occurred in both groups within 30 days after procedure. These results demonstrate that our modified antiplatelet therapy can sufficiently inhibit platelet activity similarly as the conventional protocol for PCI early after operation. Thus, this modified protocol, with continuous use of aspirin and intraoperative administration of loading dose clopidogrel, might be a safe and effective antiplatelet strategy for the one-stop hybrid coronary revascularization.

Distal protection beneficial?

The pathogenesis of acute coronary syndromes (ACS) includes the rupture or erosion of a coronary atherosclerotic plaque with variable degrees of superimposed platelet aggregation inducing a thrombus [1]. ST-elevation myocardial infarction (STEMI) is often caused by a total coronary occlusion of the atherothrombotic plaque, whereas in non-ST-elevation myocardial infarction (NSTEMI) the thrombus is mainly nonocclusive or transient occlusive causing less myocardial damage [2]. Conventional percutaneous coronary intervention (PCI) focuses on compressing the atherothrombotic plaque with the aim to normalize flow in the coronary artery and therefore restore perfusion of the ischemic myocardium [3]. However, embolization of atherothrombotic material may occur spontaneously after plaque rupture or due to mechanical crushing of the culprit lesion during PCI [4]. This results in obstruction of distal vessels or the microcirculation in the down-stream bed of the ischemia-related artery. Although normal epicardial flow may be achieved, this will lead to diminished myocardial perfusion, which is associated with larger infarct size, diminished left ventricular ejection fraction and increased mortality [5]. Microvascular obstruction is frequently implicated as the underlying cause through the mechanism of embolization [6–8]. Distal protection devices (DPDs) can be used for transient distal balloon occlusion during PCI, and allow recovery of any liberated plaque by aspiration before restoration of the antegrade flow [9]. Whether myocardial function can be improved with DPDs compared with conventional PCI in patients with acute myocardial infarction (AMI) has still to be proven. Over the years, echocardiography [10–13] and CMR [14–37] have found a fixed niche in the setting of AMI. In particular CMR allows the visualization of infarct site and size whereby the identification of microvascular obstruction has become unique to CMR [38–40]. For echocardiography, there are limited data describing changes in cardiac function in DPDs studies, and no data describing changes in regional myocardial function. Tissue Doppler imaging (TDI) is a useful echocardiographic tool that permits quantitative and objective assessment of both global and regional function [41–43]. In the current issue of the International Journal of Cardiovascular Imaging, Duan et al. [44] assessed the effects of DPDs on global and regional LV systolic and diastolic function were assessed by TDI in 69 patients with anterior AMI, who were randomly assigned to either PCI with DPDs (DPD group, n = 46) or conventional PCI (control group, n = 50). At 3- and 6-month follow-up, the DPD group showed a higher LV ejection fraction than the control group. Moreover, peak systolic and early diastolic mitral annular velocities obtained by TDI were significantly higher in the DPD group than in the control group. Lastly, the systolic and diastolic regional myocardial velocities were significantly improved in the DPD group compared to the control group. The authors concluded that patients with DPDs showed significant improvement of LV function. Especially patients with anterior AMI may benefit from DPDs during PCI. In recent years various distal protection devices and thrombectomy devices have been developed to protect the microcirculation against embolization of atherothrombotic material and to improve myocardial reperfusion and LV function after PCI [45]. As the use of distal protection devices is still under debate, several trials in patients with STEMI have recently focused on thrombus aspiration [46–49]. These trials have clearly shown that thrombus aspiration improves myocardial reperfusion compared to conventional PCI. The largest study to date, the TAPAS-trial, showed that manual thrombus aspiration using the Export Aspiration Catheter (EAC) in patients with STEMI improves myocardial perfusion and one-year clinical outcome compared to conventional PCI [47]. As a consequence, thrombus aspiration has been included in the new European guidelines for patients with STEMI as a therapy to improve myocardial perfusion [50]. To conclude, the study of Duan et al. [44] lends support to the notion that distal protection may be beneficial in patients with STEMI.

Effects of distal protection on left ventricular function in acute anterior myocardial infarction: a Doppler echocardiographic study

Whether distal protection devices (DPDs) during percutaneous coronary intervention (PCI) can improve myocardial function in patients with acute myocardial infarction (AMI) is still under debate. Using tissue Doppler imaging (TDI), we evaluate the global and regional left ventricular systolic and diastolic functions in patients with anterior AMI using DPDs compared with conventional PCI. Ninety-six patients with anterior AMI were randomly assigned to either PCI with DPDs (DPD, n = 46) or traditional PCI (control, n = 50) groups. At the 3- and 6-month follow-ups, the DPD group had a higher left ventricular ejection fraction than the control group (51.6 +/- 3.6 vs. 49.3 +/- 5.3% and 53.0 +/- 3.7 vs. 50.8 +/- 5.2%, respectively; both P < 0.05). Moreover, peak systolic (S (a)) and early diastolic (E (a)) mitral annular velocities obtained by TDI were significantly higher in the DPD group than in the control group (S (a): 7.57 +/- 0.53 vs. 7.12 +/- 0.62 cm/s and 7.71 +/- 0.63 vs. 7.32 +/- 0.59 cm/s; E (a): 7.23 +/- 0.78 vs. 6.89 +/- 0.86 cm/s and 7.49 +/- 0.69 vs. 7.04 +/- 0.85 cm/s, respectively; all P < 0.05). However, systolic and diastolic regional myocardial velocities significantly improved in the DPD group from the 1-month follow-up compared with those in the control group (all P < 0.05). Patients who received treatment with DPDs experienced enhanced improvement of cardiac function. Thus, anterior AMI patients can benefit from DPDs during PCI.

Noninvasive Evaluation of Coronary Endothelial Function following Sirolimus-Eluting Stent Implantation by Using Positron Emission Tomography

Objective: Several invasive studies have reported delayed reendothelialization and endothelial dysfunction following sirolimus-eluting stent (SES) implantation. We evaluated the changes in coronary endothelial function following SES implantation by using a noninvasive method that involved positron emission tomography and cold pressor testing (CPT). Methods: The study was conducted on 14 lesions on which percutaneous coronary intervention (PCI) was successively performed. The lesions were classified into 2 groups depending on the PCI performed: the conventional PCI group, in which 7 conventional PCIs (plain old balloon angioplasty or bare-metal stents) were performed, and the SES group, in which 7 SESs were implanted. Coronary endothelial function was defined as the percent increase in the myocardial blood flow (MBF) during CPT. Results: The resting MBF in the segments distal to the PCI sites did not differ between the conventional PCI and SES groups; however, the MBF significantly decreased in the SES group during CPT. Conclusions: These data suggest that SES implantation induces coronary endothelial dysfunction in the segments distal to the PCI sites.

German stereotaxis-guided percutaneous coronary intervention study group: first multicenter real world experience

The Niobe Stereotaxis system consists of two 0.8 Tesla magnets and a navigation software allowing to move specially designed coronary wires. The aim of this observational multicenter study was to systematically evaluate the capability of the Stereotaxis Niobe Magnetic Navigation system to facilitate wire navigation during percutaneous coronary intervention (PCI), to determine the success rate of magnetically guided PCIs in a real-world setting, and to analyze procedure-related variables influencing the outcome data. One hundred and fifty seven patients underwent magnetically guided PCI in three German centers. Demographic variables of the patients, lesion quality determined by quantitative coronary angiography, success rate of the procedure as well as radiation time were analyzed. A subanalysis was performed for two periods (06/04-10/06 and 10/06-10/07) owing to a second generation of wires which was introduced at the beginning of the second period and procured-related learning curves of the operators. Mean age of the patients was 65 +/- 0.4 years (82% male, 18% female). 25% of the patients were diabetics. The lesions were characterized by high complexity (11% AHA type A, 25% type B1, 38% type B2, 25% type C). Mean percent lesion stenosis was 83.7 +/- 11.9%. The total fluoroscopy time was 13.2 +/- 0.3 min and the fluoroscopy time to cross lesion was 90.4 +/- 62.2 s. The overall success rate of the magnetically guided approach was 89%. All failures occurred within the first period were. In these cases, 80% of the failures could be successfully treated after switching to the conventional wires. On the other hand, between 10/06 and 10/07 three conventional PCI failures could be successfully treated using the Stereotaxis system. Magnetically guided PCI represents a promising tool for the treatment of dedicated lesions. There is a marked difference in the success rates of the method between the two different time periods which were analyzed, reflecting advances in the wire development and learning curves of the respective operators. Randomized controlled trials are required to determine the method's overall value and to identify subgroups that may particularly benefit.

Comparison of magnetically navigated and conventional wire percutaneous coronary intervention of a single discrete stenosis

The objective of this study is to compare magnetic guidewire navigation in percutaneous coronary intervention (MPCI) to conventional percutaneous coronary intervention (CPCI) for the elective treatment of a single discrete stenosis. Magnetic navigation actively steers an angioplasty wire-tip and may improve PCI procedures, but it is not known whether the intricacy and increased preparation necessary for using the system negatively influences the performance of simple procedures in terms of time and contrast use. The procedures of 44 patients (mean age 65 +/- 10 year) undergoing elective single vessel MPCI of a single discrete stenosis were matched for age, gender, and lesion location with 44 concurrent patients (mean age 65 +/- 10 year) undergoing CPCI. The major endpoint was procedural time. Technical success was defined as an intraluminal wire position distal to the stenosis. Procedural outcome, contrast use, and costs were evaluated. Clinical demographics and angiographic characteristics of the two groups were similar, except for a higher incidence of previous MI and class III angina pectoris in the conventional group. The technical success rate was high and identical in both groups (97.7%). Procedural and fluoroscopy times were not significantly different for MPCI compared to CPCI (21.0 +/- 14.5 min vs. 24.7 +/- 14.0 min; 4.9 +/- 4.8 min vs. 7.3 +/- 10.3 min, P = NS). There was a significant reduction in median contrast use [60 ml/patient (41-100) vs. 100 ml/patient (64-130); P = 0.006]. Magnetic navigation does not increase procedural time, irradiation, equipment use, or cost compared to conventional PCI of a single discrete stenosis. It proved feasible, yielding high rates of procedural success with less contrast use.

Long-term results of immunosuppressive oral prednisone after coronary angioplasty in non-diabetic patients with elevated C-reactive protein levels

To present the long-term results of prednisone-treated patients enrolled in the IMPRESS studies. Such studies demonstrated the efficacy of a short course of immunosuppression with oral prednisone after percutaneous coronary intervention (PCI) with bare metal stent (BMS) implantation compared to BMS alone at one year. Eighty-four non-diabetic patients with elevated C-reactive protein after PCI treated with BMS and prednisone, were followed clinically for a minimum of five years. Event-free survival was defined as freedom from death, myocardial infarction, and need for target vessel revascularisation. Event-free survival rate at a mean of 6.5 +/- 1.4 years was significantly better in prednisone-treated patients of the IMPRESS and IMPRESS-2/MVD respectively compared to their original control arms: 87.8 versus 47.6%, relative risk: 7.9; 95%CI: 2.6-24.1, p<0.0001, log-rank=13.06, p=0.0003; and 93 versus 60.5%, relative risk: 8.7; 95%CI: 2.3-32.7, p=0.0004, log-rank=13,18, p=0.0003, respectively. The event-free survival was 54.1% in controls and 90.5% in the prednisone group; relative risk: 8.1; 95%CI: 3.5-18.7, p<0.0001, log-rank= 26.33, p<0.0001. The clinical benefits of oral treatment with prednisone after conventional PCI in non-diabetic patients with evidence of systemic inflammation after stenting are maintained at long-term follow-up, either in patients with single or multivessel coronary artery disease.

Therapeutic Strategy for In-Stent Restenosis Based on the Restenosis Pattern After Drug-Eluting Stent Implantation

Background and ObjectivesThe aim of this study was to evaluate the outcomes of repeated percutaneous coronary intervention (PCI) based on the restenosis pattern in drug-eluting stent (DES) failure.Subjects and MethodsFrom April 2003 to March 2006, all 67 patients (67 lesions) at our 3 centers who had DES in-stent restenosis (ISR) were enrolled. The patients were divided into 3 groups: group I had focal edge restenosis, group II had focal body restenosis, and group III had non-focal restenosis. All patients were treated with conventional PCI including plain old balloon angioplasty (POBA), cutting balloon angioplasty (CBA), and repeated DES implantation (Re-DES). Angiographic and clinical one year follow-up results for the 3 groups were evaluated.ResultsSixteen patients were enrolled in group I, 36 in group II, and 15 in group III. Baseline clinical and angiographic characteristics and the proportion of patients in each group receiving each type of treatment strategy were not significantly different among the groups. Within each group, a comparison of angiographic and clinical outcomes for each therapeutic modality revealed that restenosis rates were not statistically different. Although rates of major adverse cardiac events (MACE) were not statistically different between groups I and II, in group III, MACE were 3-fold higher for the POBA (4/4, 100.0%) and CBA (4/4, 100.0%) subgroups than for Re-DES (1/3, 33.3%) (p=0.06), but the differences did not reach statistical significance.ConclusionThe present study suggests that treatment of DES ISR should be individualized according to restenosis pattern: any PCI strategy appears appropriate for focal ISR patterns, while Re-DES might be a better choice for non-focal ISR patterns.

Acute Simultaneous Proximal Occlusion of Two Major Coronary Arteries in Acute Myocardial Infarction: Successful Treatment with Percutaneous Coronary Intervention

Acute myocardial infarction (AMI) due to acute simultaneous proximal occlusion of two major coronary arteries (ASOMC) is a rare but life-threatening situation. Most patients die suddenly or go into cardiogenic shock (CS). In patients with AMI due to ASOMC identified by coronary angiography (CA), percutaneous coronary intervention (PCI) performed in both infarct-related arteries (IRAs) at the same time as diagnostic CA is the fastest option to complete revascularization. However, no prospective studies regarding the outcome of such procedures have been published so far. In this prospective single-center study, between October 2004 and March 2007, consecutive patients with acute coronary syndrome (ACS) reporting to our university hospital and regional referral center were evaluated for ASOMC by means of emergent CA. When diagnosed with ASOMC, PCI of the IRAs was performed. Clinical data were obtained at baseline, discharge, after 6 months, and after 1 year. Out of 417 patients with ACS, 379 patients (90.9%) suffered an AMI. In 5 patients CA revealed an ASOMC. PCI was performed in 4 patients. One patient with severe triple-vessel disease was referred for emergent coronary artery bypass graft (CABG) surgery after conventional PCI of one IRA. One patient died in-hospital due to early in-stent thrombosis after PCI. At 6-month follow-up and at 1-year follow-up, 4 patients were alive. In spite of the complex interventions, PCI patients had low in-hospital mortality and good clinical results at 1-year follow-up. Our observations are important in the clinical decision-making process of AMI due to ASOMC.

Vascular Brachytherapy for Patients with Drug‐Eluting Stent Restenosis

The rate of drug-eluting stent (DES) in-stent restenosis (ISR) exceeds 10% in complex subsets of patients and lesions. The optimal management of DES ISR remains undetermined. Vascular brachytherapy (VBT) is proven to be effective for the treatment of bare metal stent ISR but its outcome for DES ISR has not been established. Ninety-nine consecutive patients who presented with ISR following DES implantation in 122 lesions were subjected to conventional percutaneous coronary intervention with adjunct VBT using either beta radiation (Beta Rail in 74 patients [82.2%] and the Galileo system in 13 patients [14.4%]) or gamma radiation (Checkmate system in 3 patients [3.3%]). Patients were followed clinically for major adverse cardiac events (MACE) during 1-year follow-up. A high proportion of patients in this cohort presented with complex ISR; 31.1% had recurrences of ISR to the same site, 55% had diffuse or proliferate pattern of restenosis, and 23 lesions (18.9%) were located in a saphenous vein graft. Procedural success and uneventful in-hospital course were documented in all patients post VBT. At 12 months' follow-up, the target lesion revascularization (TLR) rate was 11% and the overall MACE rate was 26%. Patients with multiple episodes of ISR to the same site had a TLR of 16% and MACE rate of 35.5%. VBT for the treatment of DES ISR was found to be effective and safe and should be considered for the treatment of DES ISR, in particular in complex patients with multiple recurrences.

Abstract 2664: Clinical Outcome and Left Ventricular Contractile Function After Distal Protection in Primary Percutaneous Coronary Intervention The Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction (DEDICATION) Trial

Objective Embolization of material from an infarct-related lesion during percutaneous coronary intervention (PCI) may result in an increased infarct size. We evaluated the effect of distal protection during PCI for ST-segment elevation myocardial infarction (STEMI) on clinical outcome and myocardial function. Methods and results Patients with STEMI were randomly referred within 12 hours for PCI with (n = 312) or without distal protection (n = 314). Left ventricular (LV) contractile function was assessed with echocardiography 8 month after PCI. Global LV myocardial wall motion index (WMI) was calculated as the average wall motion score of all myocardial segments. Major adverse cardiac and cerebral events (MACCE) 8 months after PCI was 7.1 % after distal protection and 5.7 % after conventional treatment (p = 0.17). WMI improved by 4.1% at 8 months in patients treated with distal protection compared to patients receiving conventional PCI (p&lt;0.01). In myocardium subtended by culprit coronary vessels treated with distal protection regional LV function was 9 –11% higher than myocardial regions treated conventionally (p&lt;0.02). Conclusion Routine use of distal protection during primary PCI is associated with a significant improvement in LV contractile function, with no detectable impact on intermediate term clinical outcome.

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

A randomized comparison of the magnetic navigation system (MNS) to conventional guidewire techniques in percutaneous coronary interventions. The MNS precisely directs a magnetized guidewire in vivo through two permanent external magnets. 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. The crossing success for magnetic and the conventional wires were 93.3 and 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. 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.

Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study

Percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction can be complicated by spontaneous or angioplasty-induced embolisation of atherothrombotic material. Distal blockage induces microvascular obstruction and can result in less than optimum reperfusion of viable myocardium. The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) found that thrombus aspiration resulted in improved myocardial reperfusion compared with conventional PCI, but whether this benefit improves clinical outcome is unknown. We aimed to investigate whether the early efficacy of thrombus aspiration seen in TAPAS translated into clinical benefit after 1 year. Patients with ST-elevation myocardial infarction enrolled at the University Medical Centre Groningen were randomly assigned in a 1:1 ratio to either thrombus aspiration or conventional treatment, before undergoing initial coronary angiography. Exclusion criteria were rescue PCI after thrombolysis and known existence of a concomitant disease with life expectancy less than 6 months. Of the 1071 patients enrolled between January, 2005, and December, 2006, vital status at or beyond 1 year after randomisation was available for 1060 (99%). The primary endpoint was cardiac death or non-fatal reinfarction after 1 year, and analysis was by intention to treat. The TAPAS trial is registered with Current Controlled Trials number ISRCTN16716833. Cardiac death at 1 year was 3.6% (19 of 535 patients) in the thrombus aspiration group and 6.7% (36 of 536) in the conventional PCI group (hazard ratio [HR] 1.93; 95% CI 1.11-3.37; p=0.020). 1-year cardiac death or non-fatal reinfarction occurred in 5.6% (30 of 535) of patients in the thrombus aspiration group and 9.9% (53 of 536) of patients in the conventional PCI group (HR 1.81; 95% CI 1.16-2.84; p=0.009). Compared with conventional PCI, thrombus aspiration before stenting of the infarcted artery seems to improve the 1-year clinical outcome after PCI for ST-elevation myocardial infarction.

Comparison of Efficacy and Safety of Lower-Dose to Higher-Dose Oral Prednisone After Percutaneous Coronary Interventions (the IMPRESS-LD Study)

This study assessed clinical and angiographic efficacies of oral treatment with prednisone at low-dose (LD) versus the previous high-dose (HD) immunosuppressive dosage used after percutaneous coronary interventions (PCIs) with bare metal stents in patients with multivessel coronary artery disease. Forty-three patients with multivessel disease successfully treated with multiple PCIs were matched to the previous HD IMPRESS-2/MVD study population. The 43 patients were treated for 103 coronary stenoses and received 30-day oral prednisone treatment (LD group 1 mg/kg for 5 days, 0.5 mg/kg for 10 days, 0.25 mg/kg for 15 days) and were compared retrospectively with the 43 patients in the HD IMPRESS-2/MVD study with 116 treated coronary lesions (HD group 1 mg/kg for 10 days, 0.5 mg/kg for 20 days, 0.25 mg/kg for 15 days). The primary clinical end point was 12-month event-free survival rate (defined as freedom from death, myocardial infarction, and need for target vessel revascularization). The secondary end point was angiographic restenosis at 8 months assessed by quantitative coronary angiography. Event-free survival rates were 74% and 93% in the LD and HD groups, respectively (relative risk 4.6, 95% confidence interval 1.18 to 17.8, p = 0.019). Restenosis was observed in 4 lesions (4%) in the HD group and in 20 lesions (22%) in the LD group (p <0.001). Mean late lumen loss was 0.61 +/- 0.35 mm, and the loss index was 31.3 +/- 21.6% in the HD group compared with 0.87 +/- 0.61 mm and 52.03 +/- 25.1% in the LD group (p = 0.03 and 0.02, respectively). In conclusion, antirestenotic efficacy of oral treatment with prednisone after conventional PCI is dose sensitive. A 50% dose decrease in oral prednisone, as tested in this study, is less effective than the previously tested HD IMPRESS therapeutic scheme.

Selective Intracoronary Administration of Nitroprusside Before Balloon Dilatation Prevents Slow Reflow During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

Previous studies have shown that intracoronary nitroprusside injection is safe and effective after slow reflow complicates percutaneous coronary intervention (PCI). We sought to determine the safety and efficacy of selective intracoronary administration of nitroprusside through the drug delivery catheter before balloon dilatation to prevent no or slow reflow during PCI for acute myocardial infarction (AMI). We studied 120 consecutive patients with AMI treated by PCI. In 60 patients (nitroprusside group), nitroprusside (120 mug) was selectively administered through the drug delivery catheter into the distal coronary artery to reach the target lesion before balloon dilatation. Clinical and angiographic data, as well as in-hospital outcomes, of the nitroprusside group were retrospectively compared with 60 patients who had conventional PCI without nitroprusside (control group). There were no significant differences in the baseline clinical and angiographic characteristics between the 2 groups. Compared to the control group, the nitroprusside group had 1) less slow reflow during the procedure (12% versus 35%, P = 0.0025), 2) a shorter fluoroscopic time (14.4 +/- 7.9 versus 18.7 +/- 9.1 minutes, P = 0.0093), 3) a shorter procedure time (57.6 +/- 20.6 versus 78.1 +/- 26.4, P < minutes, P < 0.0001), 4) a better final TIMI flow grade (III:II:I:0 = 59:1:0:0 versus 53:6:1:0, P = 0.0284), 5) a better blush grade (III:II:I:0 = 49:10:1:0 versus 33:15:8:4, P = 0.0006), and 6) a better corrected TIMI coronary flame count (30.8 +/- 13.7 versus 46.5 +/- 44.7, P = 0.0102). There were no particular complications with nitroprusside use. The selective intracoronary administration of nitroprusside prior to PCI is safe and well tolerated, prevents no or slow reflows, and improves reperfusion of the infarcted myocardium.

Intravascular Brachytherapy Versus Drug-Eluting Stents for the Treatment of Patients With Drug-Eluting Stent Restenosis

Drug-eluting stents (DESs), although promising technology, still are associated with restenosis; therefore, we evaluated the safety and efficacy of intravascular radiation therapy for the treatment of DES in-stent restenosis (ISR). Treatment of DES ISR has not been established, although intravascular radiation therapy is an effective treatment for patients with ISR of bare metal stents. Other modalities are conventional percutaneous coronary intervention (PCI), including restenting with DES. Radiation for Eluting Stents in Coronary FailUrE (RESCUE) is an international, Internet-based registry of 61 patients who presented with ISR of a DES and were assigned to intravascular radiation therapy with commercially available systems after PCI. Outcomes of these patients were compared with those of a consecutive series of 50 patients who presented with ISR of a DES and were assigned to repeat DES (r-DES) treatment. Baseline clinical and angiographic characteristics were similar between groups, except for more Cypher stents as the initial DES that restenosed in the r-DES group than in the intravascular radiation therapy group (88.5% vs 69%, p = 0.01). At 8 months there were fewer overall major adverse cardiac events in the intravascular radiation therapy group compared with the r-DES group (9.8% vs 24%, p = 0.044). The need for target vessel and target lesion revascularizations was similar in the 2 groups at 8 months. There has been no report of subacute thrombosis in either group. In conclusion, intravascular radiation therapy as adjunct therapy to PCI for patients presenting with ISR of a DES is safe and should be considered an alternative therapeutic option for this difficult subset of patients.

Repeat intracoronary β-brachytherapy using a rhenium-188-filled balloon catheter for recurrent restenosis in patients who failed intracoronary radiation therapy

Conventional percutaneous coronary intervention (PCI) in restenotic lesions after brachytherapy failure is associated with a high recurrence rate of restenoses and revascularizations. Intracoronary brachytherapy using a liquid rhenium-188-filled balloon in de novo or restenotic lesions safely and effectively reduced restenosis rates. We report clinical and angiographic data regarding the safety and efficacy of rhenium-188 brachytherapy in restenoses after brachytherapy failure. Fourteen patients with restenosis after brachytherapy failure received rhenium-188 beta-brachytherapy. Follow-up was performed angiographically after 6 months and clinically after 12 months. Primary clinical endpoint was the incidence of major adverse cardiac events (MACE) defined as any death, myocardial infarction or repeat revascularization in the target vessel within 12 months. Secondary angiographic endpoints were the binary restenosis rate and late loss in the total segment including edge effects at 6 months. The prescribed dose of 22.5 Gy (n=12) or 30 Gy (n=2) was successfully delivered in all patients. In two lesions, a bare-metal stent was implanted. The mean length of the irradiated segment was 40.0+/-15.7 mm. The mean diameter of the irradiation balloon was 2.96+/-0.37 mm. Angiographic follow-up was done in 13 of 14 patients. There was no edge stenosis or coronary aneurysm. Within the total segment, late loss was 0.39+/-0.64 mm and late loss index was 0.18+/-0.40 with a binary restenosis rate of 23%. Twelve months' clinical follow-up was available in all patients, which showed a MACE rate of 7% due to one target lesion revascularization (TLR). Intracoronary beta-brachytherapy with a liquid rhenium-188-filled balloon in restenoses after intracoronary radiation therapy failure including 12 months combined antiplatelet therapy is safe with respect to vessel thrombosis, late coronary occlusion or aneurysm formation. With limited use of stenting, angiographic and clinical follow-up for repeat brachytherapy were favorable and it is associated with low restenosis and target vessel revascularization rate.

X-Sizer for Thrombectomy in Acute Myocardial Infarction Improves ST-Segment Resolution: Results of the X-Sizer in AMI for Negligible Embolization and Optimal ST Resolution (X AMINE ST) Trial

We sought to compare, in a prospective randomized multicenter study, the effect of adjunctive thrombectomy using X-Sizer (eV3, White Bear Lake, Minnesota) before percutaneous coronary intervention (PCI) versus conventional PCI in patients with acute myocardial infarction (AMI) for <12 h and Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1. The primary end point was the magnitude of ST-segment resolution after PCI. Despite a high rate of TIMI flow grade 3 achieved by PCI in patients with AMI, myocardial reperfusion remains relatively low. Distal embolization of thrombotic materials may play a major role in this setting. We conducted a prospective, randomized, multicenter study in patients with AMI <12 h and initial TIMI flow grade 0 to 1 who were treated with primary PCI. The magnitude of ST-segment resolution 1 h after PCI was the primary end point. A total of 201 patients were included. Treatment groups were comparable by age (61 +/- 13 years), diabetes (22%), previous MI (8%), anterior MI (52%), onset-to-angiogram (258 +/- 173 min), and glycoprotein IIb/IIIa inhibitor use (59%). The magnitude of ST-segment resolution was greater in the X-Sizer group compared with the conventional group (7.5 vs. 4.9 mm, respectively; p = 0.033) as ST-segment resolution >50% (68% vs. 53%; p = 0.037). The occurrence of distal embolization was reduced (2% vs. 10%; p = 0.033) and TIMI flow grade 3 was obtained in 96% vs. 89%, respectively (p = 0.105). Myocardial blush grade 3 was similar (30% vs. 31%; p = NS). Six-month clinical outcome was comparable (death, 6% vs. 4% and major adverse cardiac and cerebral events, 13% vs. 13%, respectively). By multivariate analysis, independent predictors of ST-segment resolution >50% were: younger age, non-anterior MI, use of the X-Sizer, and a short time interval from symptom onset. Reducing thrombus burden with X-Sizer before stenting leads to better myocardial reperfusion, as illustrated by a reduced risk of distal embolization and better ST-segment resolution.