Transradial experience with bioresorbable vascular scaffolds: A case-matched study with metallic drug-eluting stents.

BACKGROUND: Whether polymeric bioresorbable vascular scaffolds (BVS) implantation with transradial approach is feasible and safe is unknown. We compared the feasibility and safety of the transradial approach for BVS delivery with metallic drug-eluting stents (DES). METHODS: We identified 118 consecutive patients who underwent BVS implantation and we compared 30-days and 1-year results with 118 matched patients with DES. Patients were matched for age, sex, risk factors and clinical indication. RESULTS: Rates of transradial approach were 98% in the BVS group vs 95% in the DES group (P = 0.16) with 5Fr used in 38% and 32% (P = 0.34), respectively. The number of stents was similar in both groups, 2.6 ±â€¯1.5 vs 2.4 ±â€¯1.3 (P = 0.23). Although maximal pressure for stent deployment was identical in both groups (16 ±â€¯3 atm), more lesions were pre-dilated (83% vs 52%, P < 0.001) and post-dilated (71% vs 33%, P < 0.001) in the BVS group. Contrast volume (217 ±â€¯97 vs 175 ±â€¯108 ml, P < 0.001), fluoroscopy time (16 [10-23] vs 13 [8-21] min, P = 0.04) and procedure duration (65 ±â€¯31 vs 56 ±â€¯47 min, P = 0.045) were significantly higher in the BVS group. Major adverse cardiac events, including death, myocardial infarction and target vessel revascularization remained similar in both groups, 1.7% vs 0.8% (P = 0.56) at 30 days and 10% vs 8.5% (P = 0.66) at 1 year. At 1 year, stent thrombosis occurred in 2 (1.7%) patients in the BVS group and 1 (0.8%) patient in the DES group (P = 0.56). CONCLUSION: The use of transradial approach for BVS compared to DES implantation was feasible and safe in all-comers, although BVS implantation included more technical challenges. Outcomes up to 1-year remained comparable in both groups.

Stent luxation: Possible complication of subadventitial stenting in coronary chronic total occlusion revascularization.

The entry to the subadventitial space is not a mode of failure, but the road to success in many chronic total occlusion (CTO) percutaneous coronary intervention (PCI) cases. Long-term clinical outcomes of subadventitial stenting are favorable and similar to intraluminal stenting. However, the subadventitial space histology and physiology remains different to the coronary true intraluminal space. We report a complication specific to stenting of the subadventitial space, where overlapping stents dislocated from one another, which resulted in late non-occlusive stent thrombosis. We describe, for the first time in the literature, this complication, possible reasons behind, and the ways to avoid this potentially major mischief. © 2016 Wiley Periodicals, Inc.

Effectiveness of low rate fluoroscopy at reducing operator and patient radiation dose during transradial coronary angiography and interventions.

OBJECTIVES: This study sought to determine the efficacy of low rate fluoroscopy at 7.5 frames/s (FPS) versus conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography (DCA) and percutaneous coronary intervention (PCI) via the transradial approach (TRA). BACKGROUND: TRA for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has the potential to reduce radiation exposure. METHODS: Patients undergoing TRA diagnostic angiography ± ad-hoc PCI were randomized to fluoroscopy at 7.5 FPS versus 15 FPS prior to the procedure. Both 7.5 and 15 FPS fluoroscopy protocols were configured with a fixed dose per pulse of 40 nGy. Primary endpoints were operator radiation dose (measured with dosimeter attached to the left side of the thyroid shield in µSievert [µSv]), patient radiation dose (expressed as dose-area product in Gy·cm(2)), and fluoroscopy time. RESULTS: From October 1, 2012 to August 30, 2013, from a total of 363 patients, 184 underwent DCA and 179 underwent PCI. Overall, fluoroscopy at 7.5 FPS compared with 15 FPS was associated with a significant reduction in operator dose (30% relative reduction [RR], p < 0.0001); and in patient's dose-area product (19% RR; p = 0.022). When stratified by procedure type, 7.5 FPS compared with 15 FPS was associated with significant reduction in operator dose during both DCA (40% RR; p < 0.0001) and PCI (28% RR; p = 0.0011). Fluoroscopy at 7.5 FPS, compared with 15 FPS, was also associated with substantial reduction in patients' dose-area product during DCA (26% RR; p = 0.0018) and during PCI (19% RR; p = 0.13). Fluoroscopy time was similar in 7.5 FPS and 15 FPS groups for DCA (3.4 ± 2.0 min vs. 4.0 ± 4.7 min; p = 0.42) and PCI (11.9 ± 8.4 min vs. 13.3 ± 9.7 min; p = 0.57), respectively. CONCLUSIONS: Fluoroscopy at 7.5 FPS, compared with 15 FPS, is a simple and effective method in reducing operator and patient radiation dose during TRA DCA and PCI.

Five-year follow-up of the plaque sealing with paclitaxel-eluting stents vs medical therapy for the treatment of intermediate nonobstructive saphenous vein graft lesions (VELETI) trial.

BACKGROUND: Very few data exist on the long-term follow-up of patients with intermediate nonobstructive saphenous vein graft (SVG) lesions. The purpose of this study was to evaluate the 5-year clinical outcomes of the patients enrolled in the Moderate Vein Graft Lesion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) and the factors associated with SVG disease progression and outcomes. METHODS: Patients with ≥ 1 intermediate SVG lesion (30%-60% diameter stenosis) were randomized to either stenting the SVG lesion with a paclitaxel-eluting stent (PES group, n = 30) or to medical treatment alone (MT group, n = 27). All patients were followed yearly up to 5 years. RESULTS: Major adverse cardiac events (MACEs) (cardiac death, myocardial infarction [MI], revascularization) related to the target SVG lesion tended to be lower in the PES group (17% vs 33%; P = 0.146) due to a lower lesion revascularization rate (13% vs 33%; P = 0.072), with no difference in cardiac death or MI between groups. MACEs related to the target SVG and global MACEs were similar between groups (P > 0.20 for both). A higher cholesterol level at baseline was the only independent predictive factor of MACEs related to the target SVG (P = 0.016). CONCLUSIONS: Over a 5-year period, one third of intermediate lesions in old SVGs progressed, leading to a cardiac event. Stenting these lesions with PESs tended to improve clinical outcomes by reducing lesion progression but not SVG failure. Higher cholesterol levels were associated with SVG disease progression and clinical events. This pilot study provides the basis for a larger trial to determine the efficacy of intermediate SVG lesion plaque sealing.

Risk score, causes, and clinical impact of failure of transradial approach for percutaneous coronary interventions.

OBJECTIVES: To study the causes of and to develop a risk score for failure of transradial approach (TRA) for percutaneous coronary intervention (PCI). BACKGROUND: TRA-PCI failure has been reported in 5% to 10% of cases. METHODS: TRA-PCI failure was categorized as primary (clinical reasons) or crossover failure. Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. RESULTS: From January to June 2010, TRA-PCI was attempted in 1,609 (97.3%) consecutive patients, whereas 45 (2.7%) had primary TRA-PCI failure. Crossover TRA-PCI failure occurred in 30 (1.8%) patients. Causes of primary TRA-PCI failure included chronic radial artery occlusion (11%), previous coronary artery bypass graft (27%), and cardiogenic shock (20%). Causes for crossover TRA-PCI failure included: inadequate puncture in 17 patients (57%); radial artery spasm in 5 (17%); radial loop in 4 (13%); subclavian tortuosity in 2 (7%); and inadequate guide catheter support in 2 (7%) patients. Female sex (odds ratio [OR]: 3.2; 95% confidence interval [CI]: 1.95 to 5.26, p < 0.0001), previous coronary artery bypass graft (OR: 6.1; 95% CI: 3.63 to 10.05, p < 0.0001), and cardiogenic shock (OR: 11.2; 95% CI: 2.78 to 41.2, p = 0.0011) were independent predictors of TRA-PCI failure. Risk score values from 0 to 7 predicted a TRA-PCI failure rate from 2% to 80%. CONCLUSIONS: In a high-volume radial center, 2.7% of patients undergoing PCI are excluded from initial TRA on clinical grounds, whereas crossover to femoral approach is required in only 1.8% of the cases. A new simple clinical risk score is developed to predict TRA-PCI failure.

Successive transradial access for coronary procedures: experience of Quebec Heart-Lung Institute.

BACKGROUND: Transradial approach (TRA) for cardiac catheterizations and interventions improves clinical outcomes compared with transfemoral access, and its use is increasing worldwide. However, there are limited data on successive use of same artery for repeat procedures. METHODS: Between May 2010 and May 2011, all consecutive patients undergoing a repeat TRA procedure (≥2) were retrospectively identified. Success rates and reasons for failure to use ipsilateral radial artery for repeat access were identified. RESULTS: A total of 519 patients underwent 1,420 procedures. In 480 patients (92%), right radial artery was used as initial access, and left radial artery, in 39 patients. All patients underwent ≥2 procedures; 218 patients, ≥3; 87 patients, ≥4; 39 patients, ≥5; 19 patients, ≥6; 11 patients, ≥7; and 5 patients, ≥8 procedures. Two patients had, respectively, 9 and 10 procedures. The success rate for second attempt was 93%, 81% for third, and declining to 60% for ≥8. Linear regression analysis estimated a 5% failure rate for each repeat attempt (R(2) = 0.87, P = .007). The main reason for failure was related to clinical radial artery occlusion (RAO) including absent or faint pulse, poor oximetry, and failed puncture. All patients with clinical RAO were asymptomatic. By multivariate analysis, female gender (odds ratio [OR] 3.08, 95% CI 1.78-5.39, P < .0001), prior coronary artery bypass graft (OR 5.26, 95% CI 2.67-10.42, P < .0001), and repeat radial access (OR 2.14, 95% CI 1.70-2.76, P < .0001) were independent predictors of radial access failure. CONCLUSION: Successive TRA is both feasible and safe in most cases for up to 10 procedures. However, failure rate for TRA increases with successive procedures, primarily due to clinical RAO. Strategies to minimize the risks of chronic clinical RAO and allow repeat use of ipsilateral radial artery need to be further defined.

Deadly association of cardiogenic shock and chronic total occlusion in acute ST-elevation myocardial infarction.

BACKGROUND: The association between cardiogenic shock and 1 or >1 chronic total occlusion (CTO) in unselected patients presenting with ST-elevation myocardial infarction (MI) (STEMI) has not been characterized. METHODS: Patients with STEMI referred with or without cardiogenic shock were categorized into no CTO, 1 CTO, and >1 CTO. The primary end point was the 30-day mortality. RESULTS: Between 2006 and 2011, 2,020 consecutive patients were included. A total of 141 patients (7%) presented with cardiogenic shock on admission. The prevalence of 1 CTO and >1 CTO in a non-infarct-related artery was 23% and 5%, respectively, among patients with shock compared with 6% and 0.5% in patients without shock (P < .0001). Independent predictors of cardiogenic shock included left main-related MI (odds ratio [OR] 6.55, 95% CI 1.39-26.82, P = .019), CTO (OR 4.20, 95% CI 2.64-6.57, P < .001), creatinine clearance <60 mL/min (OR 3.41, 95% CI 2.32-4.99, P < .0001), and left anterior descending-related MI (OR 2.20, 95% CI 1.51-3.23, P < .0001). Thirty-day mortality was 100% in shock patients with >1 CTO, 65.6% with 1 CTO, and 40.2% in patients without CTO (P < .0001). After adjustment for left ventricular ejection fraction and renal function, CTO remained an independent predictor for 30-day mortality (hazard ratio [HR] 1.83; 95% CI 1.10-3.01, P = .02). CONCLUSION: In patients with STEMI, CTO was strongly associated with cardiogenic shock on admission. In this setting, mortality was substantially higher in patients with 1 CTO and exceedingly high in those with >1 CTO. The presence of CTO was an independent predictor of early mortality.

Effects of aspiration thrombectomy on necrosis size and ejection fraction after transradial percutaneous coronary intervention in acute ST-elevation myocardial infarction.

BACKGROUND: The use of routine aspiration thrombectomy in primary percutaneous coronary intervention (PCI) remains controversial. METHODS: Patients in the EArly Discharge after Transradial Stenting of CoronarY Arteries in Acute Myocardial Infarction (n = 105) study were treated with aspirin, clopidogrel, and abciximab within 6 hr of symptoms onset. Operators were allowed to use 6 Fr Export aspiration catheter at their discretion. In this observational analysis, we compared acute and late results in patients treated with and without thrombectomy using cardiac biomarkers, angiographic, cardiovascular magnetic resonance (CMR), and clinical parameters. RESULTS: Patients in the thrombectomy group (n = 44) had longer symptoms to balloon time (196 ± 86 min vs. 164 ± 62, P = 0.039) and higher incidence of preprocedural TIMI flow grade 0 or 1 (84% vs. 64%, P = 0.028). Following PCI, both groups had similar incidence of TIMI flow grade 3 (93 vs. 92%, P = 0.73) and myocardial blush grade 2 or 3 (80 vs. 77%, P = 0.86), respectively. Patients in thrombectomy group had significantly higher post-PCI maximum values of creatine kinase-MB (P = 0.0007) and troponin T (P = 0.0010). Accordingly, post-PCI myocardial necrosis by CMR was higher (P = 0.0030) in patients in the thrombectomy group. At 6-month follow-up, necrosis size remained higher (20.7% ± 13.3% vs. 13.5% ± 11.1%, P = 0.012) in the thrombectomy group. Ejection fraction at 6 months was 65% ± 9% in patients in thrombectomy group compared to 70% ± 11% in patients without (P = 0.070). Results were not affected by initial TIMI flow or symptoms to balloon time. Clinical events remained comparable in both groups at 12 months follow-up. CONCLUSION: In patients with ST-segment elevation myocardial infarction presenting within 6 hr of symptoms and undergoing primary angioplasty with maximal antiplatelet therapy, acute and late results did not suggest significant benefit for additional aspiration thrombectomy, irrespective of initial TIMI flow or total ischemic time.

Percutaneous mitral valve annuloplasty for functional mitral regurgitation: acute results of the first patient treated with the Viacor permanent device and future perspectives.

BACKGROUND: There is a need to develop less invasive techniques to manage moderate or severe functional mitral regurgitation in patients at high surgical risk. OBJECTIVE: We report the acute results of the first patient treated with the permanent Viacor percutaneous transvenous mitral annuloplasty (PTMA) device in North America, introduce the PTOLEMY-2 protocol, and briefly discuss the current status of transvenous mitral valve techniques. CASE REPORT: After several episodes of pulmonary edema, an 87-year-old woman was referred for hemodynamic evaluation. Angiography revealed normal coronary arteries and severe mitral regurgitation. Baseline echocardiography showed severe (4+) functional mitral regurgitation. The coronary sinus was cannulated with a 9.5-Fr introducer from a left subclavian approach. After distal positioning of a coronary wire, the 7-Fr PTMA Viacor catheter was advanced to the anterior interventricular vein. Two 130 g/cm rods were then inserted resulting in an acute and dramatic reduction in mitral regurgitation as assessed by continuous transoesophageal echocardiography and which was associated with a sudden rise in arterial blood pressure. The next day, transthoracic echocardiogram showed a significant reduction in effective regurgitant orifice area (EROA) from 41 to 10 mm(2). The patient was discharged home the day following the procedure without complication. In accordance with the PTOLEMY-2 protocol, she will undergo 3-D transthoracic echocardiograms, quality of life assessments, and 6-min walk tests at regular intervals for the next 5 years. CONCLUSION: PTMA is a promising technique for the treatment of severe mitral regurgitation in selected patients. Further ongoing research will determine the predictors of success and long-term safety and performance of this technique.

Incidence, range, and clinical effect of hemoglobin changes within 24 hours after transradial coronary stenting.

Anemia and major bleeding are independent predictors of outcomes after acute coronary syndromes and percutaneous coronary intervention (PCI). Although the transradial approach reduces the incidence of bleeding, the hemoglobin changes after transradial PCI have not been defined. We serially assessed the hemoglobin values before and after transradial PCI and evaluated the effect of hemoglobin changes on outcomes. In the EArly Discharge After Transradial Stenting of CoronarY Arteries (EASY) trial, 1,348 patients underwent transradial PCI. All patients received aspirin, clopidogrel, and a bolus of abciximab before PCI. The hemoglobin values were assessed immediately before and 4 to 6 hours and 12 to 24 hours after PCI. The major adverse cardiac events (death, myocardial infarction, and target vessel revascularization) were assessed < or =3 years after PCI. According to the World Health Organization classification, 206 patients (15%) had anemia before PCI and 410 (30%) developed anemia within 24 hours after PCI. A mean hemoglobin decrease of 0.6 +/- 1.0 g/dl occurred within 24 hours after PCI. At 30 days, the major adverse cardiac events were significantly increased when the hemoglobin decrease within 24 hours after PCI was >3 g/dl (p = 0.0002). Patients with anemia within 24 hours after PCI had significantly more major adverse cardiac events at 30 days, 6 months, 1 year, and 3 years than patients without anemia (log-rank p = 0.0044). After adjustment for differences in the baseline characteristics, anemia within 24 hours after PCI remained an independent predictor of major averse cardiac events at 3 years (hazard ratio 1.30, 95% confidence interval 1.01 to 1.67, p = 0.045). In conclusion, within 24 hours after transradial PCI with maximal antiplatelet therapy, only a mild hemoglobin decrease was observed. The choice of a hemoglobin decrease >3 g/dl after PCI as a cutoff value for current definitions of major bleeding in modern PCI trials appears reasonable. Measures to prevent anemia and blood loss during PCI remain to be further studied.

Predicting late myocardial recovery and outcomes in the early hours of ST-segment elevation myocardial infarction traditional measures compared with microvascular obstruction, salvaged myocardium, and necrosis characteristics by cardiovascular magnetic resonance.

OBJECTIVES: The aim of this study was to determine whether a very early imaging strategy improves the prediction of late systolic dysfunction and poor outcomes in ST-segment elevation myocardial infarction (STEMI) compared with traditional predictors. BACKGROUND: Earlier prediction of poor outcomes after STEMI is desirable, because it will allow tailored therapy at the earliest possible time, when benefits might be greatest. METHODS: One hundred and three patients with acute STEMI were studied by contrast-enhanced cardiovascular magnetic resonance within 12 h of primary angioplasty and at 6 months and followed >2 years. The primary end point was left ventricular (LV) dysfunction, whereas poor outcomes were a key secondary end point. RESULTS: Traditional risk factors were only modest predictors of late LV dysfunction. Late gadolinium enhancement (LGE) volume maintained a stronger association to LV ejection fraction change than infarct transmurality, microvascular obstruction, or myocardial salvage during STEMI (p = 0.02). Multivariable logistic regression identified LGE volume during STEMI as the best predictor of late LV dysfunction (odds ratio: 1.36, p = 0.03). An LGE >or=23% of LV during STEMI accurately predicted late LV dysfunction (sensitivity 89%, specificity 74%). The LGE volume provided important incremental benefit for predicting late dysfunction (area under the curve = 0.92, p or=23% carried a hazard ratio of 6.1 for adverse events (p < 0.0001). CONCLUSIONS: During the hyperacute phase of STEMI, LGE volume provides the strongest association and incremental predictive value for late systolic dysfunction and discerns poor late outcomes.

Improving myocardial salvage in late presentation acute ST-elevation myocardial infarction with proximal embolic protection.

BACKGROUND: Late-presenting ST-elevation myocardial infarction (STEMI) patients possess larger, more organized coronary thrombus leading to greater ventricular remodeling and arrhythmia despite angioplasty and pharmacological therapies. We hypothesized that myocardial injury would be reduced in late STEMI by proximal embolic protection (PEP). METHODS: 31 patients with first STEMI 12-24 hr after pain onset and TIMI 0-1 flow were treated with or without PEP (cohort design matched for age, gender, and infarct-related artery). Contrast-enhanced magnetic resonance determined myocardial function, area at risk, necrosis, salvaged myocardium, and arrythmogenic peri-infarct region. Clinical follow-up was performed. RESULTS: Pain to balloon time was 18 hr (95% CI 15.5-21.2 h), and Q waves were present in 87%. Angioplasty was performed with PEP in 15 and without in 16. Left ventricular (LV) volumes and ejection fraction were similar (EF 46.9% vs. 49.0% without PEP, P = 0.9). Although myocardial necrosis was similar (32.5 vs. 37.3% of LV, P = 0.3), PEP improved microvascular obstruction (8.7 vs. 11.2% of LV, P = 0.02) salvaged myocardium (39.6% vs. 29.6% of area at risk, P = 0.001), and the peri-infarct region (20.9 vs. 29.6% of infarct, P < 0.0001). On multivariate analysis, the use of PEP was an independent predictor of decreased arrythmogenic peri-infarct region and greater myocardial salvage. CONCLUSION: In this pilot study, PEP improved myocardial salvage and the arrythmogenic peri-infarct region in late-presentation STEMI. Randomized trials are required to assess the clinical impact of improving salvaged myocardium and the peri-infarct region with PEP.

Comparison of plaque sealing with paclitaxel-eluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions: the moderate vein graft lesion stenting with the taxus stent and intravascular ultrasound (VELETI) pilot trial.

BACKGROUND: The presence of moderate saphenous vein graft (SVG) lesions is a major predictor of cardiac events late after coronary artery bypass grafting. We determined the effects of sealing moderate nonsignificant SVG lesions with paclitaxel-eluting stents (PES) on the prevention of SVG atherosclerosis progression. METHODS AND RESULTS: Patients with at least 1 moderate SVG lesion (30% to 60% diameter stenosis) were randomized either to stenting the moderate SVG lesion with a PES (n=30, PES group) or to medical treatment alone (n=27, medical treatment group). Patients had an angiographic and intravascular ultrasound evaluation of the SVG at baseline and at 12-month follow-up. The primary end points were (1) the ultrasound SVG minimal lumen area at follow-up and (2) the changes in ultrasound atheroma volume in an angiographically nondiseased SVG segment. Mean time from coronary artery bypass grafting was 12+/-6 years, and mean low-density lipoprotein cholesterol level was 73+/-31 mg/dL. A total of 70 moderate SVG lesions (39+/-7% diameter stenosis) were evaluated. Significant disease progression occurred in the medical treatment group at the level of the moderate SVG lesion (decrease in minimal lumen area from 6.3+/-3.0 to 5.6+/-3.1 mm(2); P<0.001), leading to a severe flow-limiting lesion or SVG occlusion in 22% of the patients compared with none in the PES group (P=0.014). In the PES group, mean minimal lumen area increased (P<0.001) from 6.1+/-2.2 to 8.6+/-2.9 mm(2) at follow-up (P=0.001 compared with the medical treatment group at 12 months). There were no cases of restenosis or stent thrombosis. No significant atherosclerosis progression occurred at the nonstented SVG segments. At 12-month follow-up, the cumulative incidence of major adverse cardiac events related to the target SVG was 19% in the medical treatment group versus 3% in the PES group (P=0.091). CONCLUSIONS: Stenting moderate nonsignificant lesions in old SVGs with PES was associated with a lower rate of SVG disease progression and a trend toward a lower incidence of major adverse cardiac events at 1-year follow-up compared with medical treatment alone, despite very low low-density lipoprotein cholesterol values. This pilot study supports further investigation into the role of plaque sealing in SVGs. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT002289835.

Long term efficacy of abciximab bolus-only compared to abciximab bolus and infusion after transradial coronary stenting.

BACKGROUND: No data are available on the long term efficacy of abciximab bolus-only with aspirin and clopidogrel pretreatment and systematic coronary stenting. Our objective was to evaluate the 3-year clinical outcomes in the EASY trial. METHODS: After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day home discharge and no infusion (bolus-only group, n = 504) or to overnight hospitalization and 12 hours abciximab infusion (bolus + infusion group, n = 501). In contrast, 343 patients were not randomized after stenting for safety reasons and received abciximab bolus and infusion (not-randomized group). The rate of major adverse cardiovascular events (MACE), including death, myocardial infarction (MI) and target vessel revascularization (TVR) after percutaneous coronary intervention (PCI) was evaluated. RESULTS: Up to 3 years, the incidence of MACE remained similar in the two randomized groups, 14% in bolus-only vs. 17% in bolus + infusion (P = 0.38). Similar efficacy was observed in subgroups analysis including higher-risk patients such as those with diabetes, unstable angina or non-ST elevation MI. Conversely, the incidence of MACE remained significantly higher in patients not-randomized post-PCI at all time intervals (P < 0.0001). The difference in outcomes between randomized and not-randomized patients was mostly accounted by the higher rates of MI, TVR as survival rate remained similar. CONCLUSION: In patients pretreated with aspirin and clopidogrel and undergoing uncomplicated coronary artery stenting, abciximab bolus-only was associated with similar outcomes compared with bolus followed by infusion, up to 3 years after PCI. Conversely, patients with suboptimal results or clinical complications during PCI remained at higher risk of late revascularization or MI.

Comparison of outcomes in patients > or =70 years versus <70 years after transradial coronary stenting with maximal antiplatelet therapy for acute coronary syndrome.

Elderly patients are at a higher risk for complications after percutaneous coronary intervention (PCI) when performed through the femoral approach. The impact of age on complications in patients treated using the transradial approach is not known. The bleeding and ischemic outcomes at 30 days, 6 months, 1 year, and 3 years after transradial PCI and maximal antiplatelet therapy were compared in 1,348 patients aged <70 or > or =70 years with acute coronary syndromes. All patients received aspirin and clopidogrel before catheterization, followed by abciximab at the time of PCI. Patients aged > or =70 years (n = 259 [19%]) had more hypertension, dyslipidemia, family histories, and previous coronary artery bypass grafting. Older patients had lower baseline hemoglobin, platelet, and creatinine clearance values, and they also more often had 2- or 3-vessel syndrome (p = 0.001), as well as longer procedure durations (p = 0.024). At 30 days, the rates of major adverse cardiac events and major bleeding were similar in older and younger patients. Only the incidence of gastrointestinal bleeding (p = 0.021) and mild to moderate access-site hematoma were higher in older patients (p = 0.036). The rates of major adverse cardiac events were also similar in the 2 age groups at 6 months (6% vs 9%, p = 0.08), 1 year (10% vs 13%, p = 0.22), and 3 years (19% vs 20%, p = 0.73), but mortality was significantly higher at 3 years in patients aged > or =70 years (p = 0.0031). In conclusion, age per se is not a predictor of major adverse cardiac events or major bleeding after transradial PCI with maximal antiplatelet therapy. However, older patients remain more prone to gastrointestinal bleeding and local hematoma compared to younger patients, and preventive measures need to be further investigated.

Usefulness of coronary fractional flow reserve measurements in guiding clinical decisions in intermediate or equivocal left main coronary stenoses.

The objectives of this study were to evaluate the usefulness of fractional flow reserve (FFR) measurements to guide the clinical decision in patients with intermediate left main coronary artery (LMCA) stenosis and to determine the predictors of major adverse cardiac events (MACE) -- cardiac death, myocardial infarction, coronary revascularization -- in such cases; 142 consecutive patients with intermediate LMCA stenosis (mean percent diameter stenosis 42 +/- 13%) were included. All patients underwent FFR measurement after intracoronary administration of adenosine at a dose > or =30 microg. The clinical decisions were based on FFR as follows: coronary revascularization was recommended if FFR was <0.75, medical treatment if FFR was >0.80, and individualized decision based on additional clinical data if FFR was between 0.75 and 0.80. Mean FFR was 0.81 +/- 0.09 after the administration of 176 +/- 99 microg of adenosine. Based on FFR results, 60 patients (42%) underwent coronary revascularization, and 82 patients (58%) received medical treatment. At 14 +/- 11 months follow-up, the incidence of MACE related to the LMCA stenosis was 13% in the medical treatment group and 7% in the revascularization group (p = 0.27). The incidence of cardiac death or myocardial infarction was 6% in the medical treatment group and 7% in the revascularization group (p = 0.70). In the medical treatment group, with MACE had received a lower dose of intracoronary adenosine (86 +/- 57 vs 167 +/- 102 microg; odds ratio 1.39 for each decrease of 30 microg of intracoronary adenosine, 95% confidence interval 1.02 to 1.89) and more frequently had diabetes (55% vs 21%; odds ratio 4.40, 95% confidence interval 1.17 to 16.42). In conclusion, FFR measurement is helpful in guiding the decision whether to revascularize patients with intermediate LMCA stenosis. However, patients with diabetes remain at higher risk, and higher doses than previously recommended of intracoronary adenosine might have to be used in the evaluation of LMCA stenosis.

Nonrandomized comparison of coronary artery bypass surgery and percutaneous coronary intervention for the treatment of unprotected left main coronary artery disease in octogenarians.

BACKGROUND: The objective of the present study was to compare the midterm follow-up results of percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG) for the treatment of unprotected left main coronary artery disease in octogenarians. METHODS AND RESULTS: A total of 249 consecutive patients > or =80 years of age diagnosed with left main coronary artery disease underwent coronary revascularization in our center between January 2002 and January 2008; 145 patients underwent CABG, and 104 patients had PCI. Major adverse cardiac and cerebrovascular events (MACCE [cardiac death, myocardial infarction, cerebrovascular event, revascularization]) were evaluated at a mean follow-up of 23 +/- 16 months. Patients who underwent PCI were older; had higher creatinine levels, lower ejection fraction, and higher EuroSCORE; and presented more frequently with an acute coronary syndrome. Drug-eluting stents were used in 48% of PCI patients. A propensity score analysis was performed to adjust for baseline differences between the 2 groups. Survival free of cardiac death or myocardial infarction (PCI, 65.4%; CABG, 69.7%) and MACCE-free survival (PCI, 56.7%; CABG, 64.8%) at follow-up were similar between the groups (adjusted hazard ratio for survival free of cardiac death or myocardial infarction, 1.28; 95% CI, 0.64 to 2.56; P=0.47; adjusted hazard ratio for MACCE-free survival, 1.11; 95% CI, 0.59 to 2.0; P=0.73). The EuroSCORE value was an independent predictor of MACCE regardless of the type of revascularization (hazard ratio, 1.17 for each EuroSCORE increase of 1 point; 95% CI, 1.09 to 1.25; P<0.0001). CONCLUSIONS: In this single-center, nonrandomized study, there were no significant differences in cardiac death or myocardial infarction and MACCE between CABG and PCI for the treatment of left main coronary artery disease in octogenarians after a mean follow-up of 2 years. Baseline EuroSCORE was the most important predictor of MACCE regardless of the type of revascularization. Randomized studies comparing both revascularization strategies in this high-risk coronary population are warranted.

ECG-guided immediate intervention at the time of primary PCI to reduce door-to-balloon time in ST-elevation myocardial infarction patients.

BACKGROUND: In ST-segment elevation acute myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI), all efforts must be made to improve door-to-balloon (DTB) times. This study was designed to assess the impact of electrocardiographic-guided immediate intervention (EGII) without performing a complete coronary evaluation on DTB times and clinical outcomes of STEMI patients treated with primary PCI. METHODS: Consecutive STEMI patients undergoing primary PCI at Laval Hospital between May 2006 and August 2007 were considered for inclusion. Patients with thrombolysis in myocardial infarction (TIMI) 2-3 flow in the culprit vessel on initial angiography and patients with previous coronary bypass surgery were excluded from the analysis. The primary evaluation was DTB time. Clinical outcomes consisted of cardiac death, reinfarction, revascularization or stroke. RESULTS: Two hundred seventy-nine (279) patients were included in the present analysis. Eighty-seven (87) patients underwent EGII (Group 1) and 192 underwent PCI after a complete angiographic diagnostic evaluation (Group 2). Median catheterization laboratory DTB was 21 minutes in Group 1 and 25.5 minutes in Group 2 (p < 0.0001). The median DTB time was 80 minutes for patients in Group 1, compared to 90 minutes for patients in Group 2 (p = 0.01). More patients in Group 1 received timely reperfusion (DTB < 90 min) than patients in Group 2 (63% vs. 49%; p = 0.04). There was a trend towards reduced mortality in Group 1 compared to Group 2 (p = 0.11, unadjusted). CONCLUSION: A strategy of EGII reduces DTB times with a possible impact on clinical outcomes in STEMI patients undergoing primary PCI.

Impact of fractional flow reserve measurement on the clinical management of patients with coronary artery disease evaluated with noninvasive stress tests prior to cardiac catheterization.

PURPOSE: Fractional flow reserve (FFR) is often performed to assess the severity of coronary artery stenoses. However, the usefulness of measuring FFR when a noninvasive test has been obtained prior to coronary angiography has not been studied. METHODS AND MATERIALS: We retrospectively reviewed 122 patients who underwent noninvasive stress test with cardiac imaging (SPECT or stress echocardiography) prior to FFR assessment of a coronary lesion. The usefulness of FFR measurement was determined. FFR was judged useful if decision to revascularize the patient reflected the result of FFR rather than the result of the stress test. RESULTS: A total of 136 lesions were evaluated. Of these, 66 were associated with a positive noninvasive test and 70 had no ischemia present in the territory of the evaluated vessel. When FFR was negative (> or =0.75) and the test positive (57 lesions), revascularization was deferred in 55. When FFR was positive (<0.75) and the functional test negative (8 lesions), revascularization was performed in 8. FFR measurement changed the clinical decision to revascularize the patient in 55 (83%) of the 66 lesions with ischemia documented on noninvasive tests compared to 8 (11%) of the 70 lesions without ischemia (P<.0001). CONCLUSION: FFR can be helpful in patients with coronary artery disease even when noninvasive testing is performed prior to coronary angiography. In this study, FFR measurement had the greatest impact in the evaluation of lesions with documented ischemia on noninvasive tests. In these patients, appropriate use of FFR based on the operator's judgment can prevent unnecessary revascularizations of intermediate lesions.

Glycoprotein IIb/IIIa receptor antagonists: a comparative review of their use in percutaneous coronary intervention.

Antiplatelet therapy is critical during percutaneous coronary intervention (PCI) as it reduces the incidence of abrupt closure and distal thrombi embolization, which are significant acute peri-procedural complications likely responsible for the clinical adverse outcomes with PCI, namely death, myocardial infarction or urgent target vessel revascularization. Glycoprotein (GP) IIb/IIIa receptor antagonists, potent antiplatelet agents, have been specifically tested during PCI. There are currently three commercially available GP IIb/IIIa receptor antagonists and results from more than ten randomized clinical PCI trials have established their clinical efficacy and tolerability during coronary intervention. There remain questions regarding variability in efficacy among individual clinical trials and among population subsets, potential clinical differences among the available agents, and their optimal use. This article will critically review the body of evidence for clinical efficacy and tolerability of each individual tested compound, highlight potential differences among agents, and raise important issues involving their use in clinical practice.