Complete revascularization reduces cardiovascular death in patients with ST-segment elevation myocardial infarction and multivessel disease: systematic review and meta-analysis of randomized clinical trials.

AIMS: The aim of this work was to investigate the prognostic impact of revascularization of non-culprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease by performing a meta-analysis of available randomized clinical trials (RCTs). METHODS AND RESULTS: Data from six RCTs comparing complete vs. culprit-only revascularization in STEMI patients with multivessel disease were analysed with random effect generic inverse variance method meta-analysis. The endpoints were expressed as hazard ratio (HR) with 95% confidence interval (CI). The primary outcome was cardiovascular death. Main secondary outcomes of interest were all-cause death, myocardial infarction (MI), and repeated coronary revascularization. Overall, 6528 patients were included (3139 complete group, 3389 culprit-only group). After a follow-up ranging between 1 and 3 years (median 2 years), cardiovascular death was significantly reduced in the group receiving complete revascularization (HR 0.62, 95% CI 0.39-0.97, I2 = 29%). The number needed to treat to prevent one cardiovascular death was 70 (95% CI 36-150). The secondary endpoints MI and revascularization were also significantly reduced (HR 0.68, 95% CI 0.55-0.84, I2 = 0% and HR 0.29, 95% CI 0.22-0.38, I2 = 36%, respectively). Needed to treats were 45 (95% CI 37-55) for MI and 8 (95% CI 5-13) for revascularization. All-cause death (HR 0.81, 95% CI 0.56-1.16, I2 = 27%) was not affected by the revascularization strategy. CONCLUSION: In a selected study population of STEMI patients with multivessel disease, a complete revascularization strategy is associated with a reduction in cardiovascular death. This reduction is concomitant with that of MI and the need of repeated revascularization.

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield.

BACKGROUND: Occupational radiation exposure is a growing problem due to the increasing number and complexity of interventional procedures performed. Radial artery access has reduced the number of complications at the price of longer procedure duration. Radpad® scatter protection is a sterile, disposable bismuth-barium radiation shield drape that should be able to decrease the dose of operator radiation during diagnostic and interventional procedures. Such radiation shield has never been tested in a randomized study in humans. METHODS: Sixty consecutive patients undergoing coronary angiography by radial approach were randomized 1:1 to Radpad use versus no radiation shield protection. The sterile shield was placed around the area of right radial artery sheath insertion and extended medially to the patient trunk. All diagnostic procedures were performed by the same operator to reduce variability in radiation absorption. Radiation exposure was measured blindly using thermoluminescence dosimeters positioned at the operator's chest, left eye, left wrist, and thyroid. RESULTS: Despite similar fluoroscopy time (3.52 ± 2.71 min vs. 3.46 ± 2.77 min, P = 0.898) and total examination dose (50.5 ± 30.7 vs. 45.8 ± 18.0 Gycm(2), P = 0.231), the mean total radiation exposure to the operator was significantly lower when Radpad was utilized (282.8 ± 32.55 µSv vs. 367.8 ± 105.4 µSv, P < 0.0001) corresponding to a 23% total reduction. Moreover, mean radiation exposure was lower with Radpad utilization at all body locations ranging from 13 to 34% reduction. CONCLUSIONS: This first-in-men randomized trial demonstrates that Radpad significantly reduces occupational radiation exposure during coronary angiography performed through right radial artery access.

Retrograde popliteal access as bail-out strategy for challenging occlusions of the superficial femoral artery: a multicenter registry.

BACKGROUND: The concomitant use of femoral and popliteal accesses has been recommended for challenging superficial femoral artery (SFA) occlusions, but no comprehensive comparison of this approach to a strategy of femoral access only is available. We thus aimed to appraise the risk-benefit balance of retrograde popliteal access as bail-out strategy for SFA occlusions. METHODS: Consecutive patients with symptomatic SFA occlusion and undergoing percutaneous revascularization were enrolled. We distinguished patients in whom retrograde popliteal access was required as bail-out strategy versus those not requiring such access. The primary end-point was procedural success. RESULTS: A total of 130 patients (152 limbs) were included, with 23 patients (25 limbs) requiring retrograde popliteal access. Occlusion length was 20.6 ± 8.8 cm in those requiring popliteal access versus 18.5 ± 8.5 cm in those without popliteal access, with TASC C/D lesions in 23 (92%) versus 106 (83%). Procedural success was achieved in 92 out of 107 patients (86.0%) treated with a standard approach and 22 out of 23 patients (95.7%) treated with retrograde popliteal access (total 114 out of 130 [87.7%]) and 112 out of 127 limbs (88.2%) and 24 out of 25 limbs (96.0%), respectively (total 136 out of 152 [89.5%]). No significant increase in early or long-term adverse events was associated with retrograde popliteal access. CONCLUSIONS: Whenever standard access sites do not enable successful recanalization of SFA occlusions, retrograde popliteal access can be safely and effectively envisioned as bail-out strategy.

Randomized clinical trial on short-time compression with Kaolin-filled pad: a new strategy to avoid early bleeding and subacute radial artery occlusion after percutaneous coronary intervention.

BACKGROUND: Despite the increasing use of transradial techniques for cardiac percutaneous procedures, none of the strategies commonly utilized for hemostasis has been able to reduce the occurrence of radial artery occlusion (RAO). The aim of this study was to evaluate the occurrence of 24-hour RAO and the rate of bleeding of a novel hemostatic device for radial closure after percutaneous interventions, in adjunct to short-time compression. METHODS: Once the radial access was obtained, patients were randomized to 3 different strategies of radial closure: a short compression with the QuikClot® Interventional™ pad (Z-Medica Corporation, Wallingford, CT, USA) (15 minutes, group 1), a short compression (15 minutes, group 2), and a conventional prolonged compression (2 hours, group 3) both without QuikClot® utilization. RESULTS: Fifty patients in group 1, 20 in group 2, and 50 in group 3 were enrolled. The three groups were homogenous for baseline and procedural characteristics. None of patients in group 1 developed RAO, 1 (5%) occurred in group 2, and 5 (10%) in group 3 (P = 0.05). Active bleeding after compression removal occurred in 10 patients (20%) in group 1, 18 (90%) in group 2, and 1 (2%) in group 3 (P < 0.001). Among patients in group 1, at univariate analysis, the predictors of acute bleeding resulted in chronic therapy with clopidogrel (Odds Ratio 28.78, 95% Confidence Intervals 4.79-172.82, P < 0.001) and high levels of activated clotting time (ACT) at the time of sheath removal (OR 1.02, 95% CI 1.00-1.03, P = 0.009). At ROC analysis, the cutoff value of ACT for the risk of bleeding with a sensitivity of 80% and specificity of 75% was 287 seconds. CONCLUSIONS: Early sheet removal and short-time compression with QuikClot® Interventional™ can reduce the rate of RAO after diagnostic or interventional procedures especially in patients not on double antiplatelet therapy.

Acute myocardial infarction with occlusion of all three main epicardial coronary arteries: when Mother Nature takes care more than physicians.

Double-arterial coronary stent thrombosis in acute myocardial infarction (AMI) is an infrequent but severe complication, especially when the third main coronary artery is chronically occluded. The conus artery (CA) can serve as a major source of collateral when the left anterior descendent coronary artery (LAD) becomes obstructed. We report a case of a 48-year-old man presenting with AMI due to a very late double-arterial stent thrombosis (ST) following drug-eluting stent implantation and a chronic occlusion of LAD collateralized by a large anomalous CA, which provided for the entire vascularization of the coronary tree.

Echocardiographic diastolic dysfunction and magnetic resonance infarct size in healed myocardial infarction treated with primary angioplasty.

BACKGROUND: After acute myocardial infarction (MI) the severity of diastolic dysfunction by echocardiography represents an independent prognostic marker. However, the mechanisms whereby diastolic dysfunction portends an increased risk after MI are not fully understood. We investigated the relationship between echocardiographic diastolic dysfunction severity and infarct size quantitatively measured by contrast-enhanced magnetic resonance (ce-MR). METHODS: Cross-sectional prospective study. We quantified "healed" infarct size by ce-MR measuring the percentage of delayed enhancement with respect to left ventricular mass and diastolic function by Doppler echocardiography. Both exams were scheduled at least 1 month after a first acute ST segment elevation MI (STEMI) successfully treated with primary angioplasty and stenting. To increase the specificity, individual echocardiographic parameters were integrated to grade global diastolic function in 4 grades: normal diastolic function, impaired relaxation with normal, or near-normal filling pressures; impaired relaxation with moderate elevation of filling pressures, and impaired relaxation with marked elevation of filling pressures, "restrictive filling." RESULTS: We prospectively enrolled 52 patients (mean age 62 +/- 13 years, 77% men). ce-MR and echocardiography were performed 48 +/- 15 days after the MI. There was a significant but modest correlation between diastolic function grade and infarct size (r = 0.423, P = 0.002), which was independent of global and regional systolic function and persisted after further adjustment for age, sex, body surface area, left ventricular mass, end-diastolic volumes, and sphericity index (all P < 0.05). Among single echocardiographic variables, infarct size correlated best with tissue Doppler velocities Em (r =-0.307, P = 0.03), Am (r =-0.39, P = 0.005), and flow propagation velocity (r =-0.34, P = 0.015). CONCLUSIONS: In healed STEMI successfully treated with primary angioplasty and stenting, diastolic function grade was independently albeit weakly correlated with infarct size. Therefore, the increased risk of diastolic dysfunction after MI is not fully explained by infarct size.

Huge coronary perforation during percutaneous intervention sealed by injection of polyvinyl alcohol microspheres.

During percutaneous coronary intervention, coronary perforation is one of the most feared life-threatening complications, as it may cause cardiac tamponade or acute myocardial infarction. The incidence of this serious complication in recent years has increased from 0.2 to 0.6%, most likely due to the increase of complex procedures. However, the management of coronary perforation has not been established yet. We report the first case of coronary perforation successfully managed with intracoronary injection of hydrogel microspheres.

Long term prognostic value of subclinical carotid and femoral arterial wall lesions in patients with ST-elevation-myocardial infarction having percutaneous coronary intervention.

The presence of clinical peripheral arterial disease (PAD) is associated with an increased risk for adverse cardiovascular outcomes in patients with coronary artery disease. However, there are few data regarding the impact of the presence and degree of the subclinical PAD on outcomes in patients with coronary artery disease. The aim of this study was to assess prospectively the grade of subclinical PAD in the setting of patients who underwent primary percutaneous coronary intervention for the prediction of intermediate- and long-term clinical outcomes. A total of 971 consecutive patients without histories of clinical PAD who under went primary percutaneous coronary intervention for ST-segment elevation myocardial infarction were included in a prospective follow-up. Subclinical PAD severity was blindly assessed on the basis of an ultrasound arterial morphologic classification defined with the assessment of wall carotid and femoral artery bifurcations. This classification included 4 increasing classes of subclinical carotid and femoral arterial wall lesions, and the total group was divided accordingly. Death and major cardiovascular and cerebrovascular events were evaluated. During a median follow-up period of 40 months, a total of 109 patients (11.2%) died, 9 (2.8%) in class I, 12 (3.1%) in class II, 37 (23.7%) in class III, and 51 (49.0%) in class IV (p <0.001). On multivariate analysis, mortality in class IV was sevenfold higher (hazard ratio [HR] 7.34, 95% confidence interval [CI] 3.3 to 16.33, p <0.001) compared to class I and was also increased in class III (HR 5.38, 95% CI 2.42 to 11.92, p <0.001). Similar results were obtained for major adverse cardiovascular and cerebrovascular events in class IV (HR 7.50, 95% confidence interval 5.36 to 10.50, p <0.0001), class III (HR 6.44, 95% CI 4.45 to 9.32, p <0.001), and class II (HR 1.73, 95% CI 1.23 to 2.43, p = 0.002). In conclusion, ultrasound arterial morphologic classification may be applied in patients with ST-segment elevation myocardial infarctions who undergo primary percutaneous coronary intervention and can stratify patients for poor clinical outcomes during long-term follow-up.

Long-term outcome of percutaneous exclusion of huge saphenous vein graft aneurysms using peripheral covered-stents as alternative to surgical repair.

Giant vein graft aneurysms occur infrequently after coronary artery bypass graft surgery and are most often detected incidentally during coronary angiography for suspected angina or as a mediastinal mass on chest radiographs. Hereby, we describe the percutaneous treatment of a huge right coronary artery saphenous vein bypass graft aneurysm by using peripheral stent-graft. Twelve months after the procedure, the aneurysm was completely sealed at computed tomographic angiography with a good distal run-off in the bypass graft. Different strategies adopted and the feasibility as well as the long-term outcomes of this technique are described thoroughly.

First results of the DEB-AMI (drug eluting balloon in acute ST-segment elevation myocardial infarction) trial: a multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in primary percutaneous coronary intervention with 6-month angiographic, intravascular, functional, and clinical outcomes.

OBJECTIVES: The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI). BACKGROUND: Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis. METHODS: In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed. RESULTS: Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C. CONCLUSIONS: In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765).

Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study.

OBJECTIVES: The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. BACKGROUND: In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. METHODS: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. RESULTS: The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). CONCLUSIONS: Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614).

Stent-triggered 'electric shock' during leg bending 2 years after emergency iliac artery percutaneous revascularization.

We report a case of a 41-year-old woman who underwent surgical removal of an uterine leiomyoma, complicated by accidental injury of the left external iliac artery, treated by suturing. A few days after the intervention the patient was treated with emergency percutaneous stent implantation for acute thrombotic occlusion of the external iliac artery. Two years later, the patient began to complain of pain in the left leg, as an 'electric shock' sensation in the leg during squatting and leg adduction on the trunk. An angiographic control showed a critical in-stent restenosis at the level of a misplaced stent. Thus the patient was submitted to surgical exploration and stent removal.

Modified mother-child technique for selective cannulation of complex take-off left coronary artery.

An 85-year-old male patient, with long-standing hypertension, was admitted to our hospital for a late inferior myocardial infarction. An elective coronary angiogram was performed, but due to severe iliac artery tortuosity, thoracic aortic dilatation, high left coronary artery take-off, and separated origin of the left descending coronary artery and circumflex, selective cannulation with different catheter shapes was not possible. Thus, we decided to utilize a modified mother-child technique by cutting the first 10 cm from the hub of a conventional 7 F Judkins left 4 guiding catheter and inserting it into a 7 F valved sheath. Then, we introduced a conventional 6 F Amplatz Left 2 diagnostic catheter inside it. In this way, we were able to easily reach both separate ostia and to perform complete left coronary angiography. The technique we described herewith could represent a valid solution to allow utilization of standard coronary catheters with different shapes commercially available in cases of complex coronary artery origin.

Rationale and study design of the OISTER trial: optical coherence tomography evaluation of stent struts re-endothelialization in patients with non-ST-elevation acute coronary syndromes--a comparison of the intrEpide tRapidil eluting stent vs. taxus drug-eluting stent implantation.

BACKGROUND: Drug-eluting stents (DES) have been designed to prevent restenosis, but long-term clinical outcome may be offset by an increased risk of stent thrombosis, which is associated with suboptimal stent implantation or delayed re-endothelialization. DES implantation has also been associated with local persistent endothelial dysfunction. Conversely, Trapidil is a potent anti-inflammatory, vasodilatator and antiproliferative drug and several studies have shown anti-restenotic effects, suggesting substantial clinical benefits through the use of Trapidil-eluting DES. STUDY DESIGN: This is a longitudinal, single-blind, double-arm, randomized multicenter study. Forty patients with non-ST-elevation acute coronary syndromes who present at the index procedure with multivessel coronary disease in the major epicardial coronary arteries will be enrolled. Patients should present a culprit lesion with stenosis 70% or more associated with another stenosis 70% or more in another coronary artery. Patients will be randomized in a 1: 1 fashion to receive either an Intrepide trapidil-eluting stent or a Taxus paclitaxel-eluting stent on the culprit lesion. After 90 days, the nonculprit lesion will be treated with the stent of the opposite randomization arm and optical coherence tomography (OCT) analysis of the index stented segment will be performed. Follow-up angiography, combined with vasomotor analysis of endothelial function by rapid atrial pacing, will be done at 12 months after the index procedure on both stents. To further characterize the status of the endothelium, serum measurement of vascular endothelial growth factor gradient between the aorta and 15 mm distal to the implanted stent will be performed at 12 months. The primary endpoint of the study is to compare stent struts re-endothelialization at 90 days by OCT. The secondary endpoint is to compare angiographic outcome and coronary endothelial function 12 months after the index procedure and to compare clinical outcome at 1 and 2 years between trapidil-eluting DES versus paclitaxel-eluting DES. CONCLUSION: We hypothesize that the utilization of trapidil-eluting DES in the setting of acute coronary syndromes will be characterized by a greater early re-endothelialization associated with an antiproliferative effect offering a similar efficacy with a better safety profile compared with first-generation DES.

A randomised trial of target-vessel versus multi-vessel revascularisation in ST-elevation myocardial infarction: major adverse cardiac events during long-term follow-up.

BACKGROUND: Few reports described outcomes of complete compared with infarct-related artery (IRA)-only revascularisation in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD). Moreover, no studies have compared the simultaneous treatment of non-IRA with the IRA treatment followed by an elective procedure for the other lesions (staged revascularisation). METHODS: The outcomes of 263 [corrected] consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty were studied. Before the first angioplasty patients were randomly assigned to three different strategies: culprit vessel angioplasty-only (COR group); staged revascularisation (SR group) and simultaneous treatment of non-IRA (CR group). RESULTS: During a mean follow-up of 2.5 years, 42 (50.0%) patients in the COR group experienced at least one major adverse cardiac event (MACE), 13 (20.0%) in the SR group and 15 (23.1%) in the CR group, p<0.001. Inhospital death, repeat revascularisation and re-hospitalisation occurred more frequently in the COR group (all p<0.05), whereas there was no significant difference in re-infarction among the three groups. Survival free of MACE was significantly reduced in the COR group but was similar in the CR and SR groups. CONCLUSIONS: Culprit vessel-only angioplasty was associated with the highest rate of long-term MACE compared with multivessel treatment. Patients scheduled for staged revascularisation experienced a similar rate of MACE to patients undergoing complete simultaneous treatment of non-IRA.

Mehran contrast-induced nephropathy risk score predicts short- and long-term clinical outcomes in patients with ST-elevation-myocardial infarction.

BACKGROUND: The Mehran Risk Score (MRS) has been demonstrated to be clinically useful for prediction of contrast-induced nephropathy (CIN) after nonurgent percutaneous coronary intervention. We aim to validate the MRS in the setting of Primary percutaneous coronary intervention for prediction of both CIN and short- and long-term clinical outcomes. METHODS AND RESULTS: We assigned 891 consecutive patients with ST-elevation-myocardial infarction undergoing primary percutaneous coronary intervention to 4 groups of risk of CIN (RC) according to MRS (low, medium, high, and very high risk). We evaluated CIN, death, and major cardiovascular and cerebrovascular events after 25 months' mean follow-up. At multivariable analysis, mortality in very high-risk group was more than 10-fold higher (hazard ratio [HR], 10.11; 95% confidence interval [CI], 4.83 to 21.1; P<0.001) when compared with the low-risk group and was also increased in the high-risk group (HR, 6.31; 95% CI, 3.28 to 12.14; P<0.001) and medium-risk group (HR, 3.18; 95% CI, 1.83 to 5.51; P<0.001). Similarly, an increasing effect was seen across MRS strata for major cardiovascular and cerebrovascular events both in the very high-risk group (HR, 3.79; 95% CI, 2.27 to 6.6.32; P<0.001), high-risk group (HR, 1.90; 95% CI, 1.31 to 2.75; P=0.001), and medium-risk group (HR, 1.42; 95% CI, 1.10 to 1.85; P=0.007). In addition, the HR for rehospitalization increased with the increasing RC groups (HR, 3.32; 95%CI, 1.96 to 5.63; P<0.001; HR, 3.11; 95% CI, 1.35 to 7.20; P=0.008; HR, 7.73; 95% CI, 2.97 to 20.10; P<0.001, respectively). The odds ratio for CIN was 2.84 (95% CI, 1.16 to 6.92; P=0.021) in the very high RC group, 1.33 (95% CI, 0.68 to 2.61; P=0.398) in the high RC group, and 1.10 (95% CI, 0.67 to 1.79; P=0.699) in the medium RC group, as compared with the lower one. CONCLUSIONS: The MRS may be applied in the primary angioplasty setting population and is able to predict CIN and to stratify patients for poor clinical outcomes both in the short- and long-term follow-up.

A multicenter randomized study to evaluate intracoronary abciximab with the ClearWay catheter to improve outcomes with Lysis (IC ClearLy): trial study design and rationale.

BACKGROUND: Percutaneous coronary intervention (PCI) is a highly effective therapy for acute ST-elevation myocardial infarction. Adjunctive therapy with platelet glycoprotein (GP) IIb/IIIa inhibitor can result in increased vessel patency and improved outcomes in ST-elevation myocardial infarction patients undergoing PCI. The investigation of novel dosing and delivery strategies of this therapy may help to further improve outcomes. METHODS: IC-Clearly is a randomized, open-label, multicenter trial, with the purpose of evaluating the effectiveness of an intracoronary bolus dose of abciximab delivered using the ClearWay RX catheter vs. an intravenous bolus of abciximab for ST-elevation myocardial infarction with angiographically visible thrombus (thrombus grade >or=2). A total of 150 patients will be randomized 1: 1 to treatment of the culprit artery with intracoronary abciximab (75 patients) or intravenous abciximab (75 patients) in addition to a maintenance infusion regimen of abciximab administered intravenously for 12 h after PCI. The number of patients included in this study is based on the estimation of sample size needed to identify a statistically significant difference in the primary endpoints between the two groups. The primary endpoint chosen to evaluate this hypothesis is infarct size assessed by cardiac magnetic resonance. Clinical outcomes will be assessed for each patient through hospital discharge and at 30-day follow-up. CONCLUSION: The purpose of this study is to evaluate whether an intracoronary bolus of abciximab delivered with the ClearWay RX catheter prior to the 12 h post-PCI intravenous infusion regimen of abciximab will result in significant additional clot resolution in vivo and improved myocardial perfusion when compared with an intravenous bolus of abciximab on top of the 12 h post-PCI intravenous infusion regimen of abciximab as per standard practice. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed by cardiac magnetic resonance.

Maximum persisting single lead ST elevation after primary angioplasty: a good predictor of left ventricular dilatation assessed by magnetic resonance imaging.

AIMS: To determine the frequency and predictors of left ventricular dilatation assessed by magnetic resonance imaging among patients with a first acute myocardial infarction treated with successful primary angioplasty and stent. METHODS AND RESULTS: Cine magnetic resonance imaging and late enhancement imaging were prospectively performed in 42 patients 1 month and more than 1 year after successful early reperfusion of a first acute ST elevation myocardial infarction (age 61 +/- 13 years, 76% men, 55% anterior myocardial infarction, and mean symptom-to-balloon time 199 +/- 130 min). Both at the 1-month and at the 15-month magnetic resonance imaging examinations, 57% of patients had left ventricular dilatation (end-systolic volume indexed > 36 ml/m2, values above the upper 95th percentile based on magnetic resonance imaging reference values for left ventricular size in normal participants). The most accurate predictor of left ventricular dilatation was maximum persisting single lead ST elevation 60 min after reperfusion (area under the curve 0.81, P = 0.001). Maximum single lead ST elevation was significantly and independently associated with larger end-systolic volume indexed (beta = 0.35, P = 0.040) after adjusting for muscle and brain isoenzyme of creatine kinase and echocardiographic wall motion score index. CONCLUSION: More than half of patients with a first acute myocardial infarction have left ventricular dilatation despite successful primary coronary angioplasty. Maximum persisting single lead ST elevation 60 min after mechanical reperfusion represents a simple tool for predicting left ventricular dilatation.

Vascular surgery patients: perioperative and long-term risk according to the ACC/AHA guidelines, the additive role of post-operative troponin elevation.

AIMS: The objectives of this study are to evaluate the prognostic role of pre-operative stratification in patients undergoing elective major vascular surgery, the timing of adverse outcomes, and the predictive role of troponin (cTn). METHODS AND RESULTS: Consecutive vascular surgery candidates (n=391) were prospectively stratified and treated according to the ACC/AHA guidelines. The patients were categorized into three groups: (1) with coronary revascularization in the past 5 years, (2) with intermediate clinical risk predictors, and (3) with minor or no clinical risk predictors. cTnI was measured post-operatively. By 18 months, 18.7% of subjects had experienced death or acute myocardial infarction (MI) (by the ACC/ESC criteria). The hazard ratio (HR) was 5.21 (95% CI=2.60-10.43; P<0.0001) in group 1 and 2.58 (95% CI=1.27-4.38; P=0.004) in group 2 when compared with group 3. Most events occurred within 30 days. Elevations of cTnI were associated with adverse outcomes even after multivariable adjustment at long-term (adjusted overall HR=4.73, 95% CI=2.92-7.65; P<0.0001) and at 30 days (adjusted HR=5.52, 95% CI=3.23-9.42; P<0.0001). CONCLUSION: After pre-operative stratification, patients undergoing elective major vascular surgery remain at high risk of MI and death. Events occur mainly early after surgery. cTnI elevations are frequent and independently associated with increased risk. These findings suggest the need for a major re-evaluation of our approach to these patients.