Can Manh Nguyen

A Randomized Study Comparing Same-Day Home Discharge and Abciximab Bolus Only to Overnight Hospitalization and Abciximab Bolus and Infusion After Transradial Coronary Stent Implantation

Background— Systematic use of coronary stents and optimized platelet aggregation inhibition has greatly improved the short-term results of percutaneous coronary interventions. Transradial percutaneous coronary interventions have been associated with a low risk of bleeding complications. It is unknown whether moderate- and high-risk patients can be discharged safely the same day after uncomplicated transradial percutaneous coronary interventions. Methods and Results— We randomized 1005 patients after a bolus of abciximab and uncomplicated transradial percutaneous coronary stent implantation either to same-day home discharge and no infusion of abciximab (group 1, n=504) or to overnight hospitalization and a standard 12-hour infusion of abciximab (group 2, n=501). The primary composite end point of the study was the 30-day incidence of any of the following events: death, myocardial infarction, urgent revascularization, major bleeding, repeat hospitalization, access site complications, and severe thrombocytopenia. The noninferiority of same-day home discharge and bolus of abciximab only compared with overnight hospitalization and abciximab bolus and infusion was evaluated. Two thirds of patients presented with unstable angina and ≈20% presented with high-risk acute coronary syndrome prior to the procedure. The incidence of the primary end point was 20.4% in group 1 and 18.2% in group 2 (P=0.017 for noninferiority) with a troponin T–based definition of myocardial infarction; the incidence of the primary end point was 11.1% in group 1 and 9.6% in group 2 (P=0.0004 for noninferiority) with a creatinine kinase myocardial band–based definition of myocardial infarction. No death occurred. Rate of major bleeding in both groups was extremely low at 0.8% and 0.2%, respectively. From 504 patients randomized in group 1, 88% were discharged home the same day. Conclusion— Our data suggest that same-day home discharge after uncomplicated transradial coronary stenting and bolus only of abciximab is not clinically inferior, in a wide spectrum of patients, to the standard overnight hospitalization and a bolus followed by a 12-hour infusion. This novel approach offers a safe strategy for same-day home discharge after uncomplicated coronary intervention.

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= 0.03 vs. traditional risk factors). Twenty-three patients developed poor outcomes (1 death, 2 myocardial infarctions, 5 malignant arrhythmias, 4 severe LV dysfunction <35%, 11 hospital stays for heart failure) over 2.6 +/- 0.9 years; LGE volume remained a strong independent predictor of poor outcomes, whereas LGE >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.

Validation of the J-Chronic Total Occlusion Score for Chronic Total Occlusion Percutaneous Coronary Intervention in an Independent Contemporary Cohort

Background—Chronic total occlusion (CTO) recanalization is a complex and technically challenging procedure. The J-CTO score has been proposed to stratify case complexity and procedural success rates. However, the score has never been tested outside the setting of the original study. Moreover, its predictive value when using a hybrid antegrade or retrograde approach is unknown. We investigated the performance of the J-CTO score for predicting procedure complexity and success in an independent contemporary cohort. Methods and Results—A total of 209 consecutive patients who underwent CTO recanalization by a high-volume operator were included. Clinical and angiographic data were prospectively collected. The J-CTO score was applied for each patient, and discrimination and calibration were evaluated in the whole cohort, and according to the approach (antegrade 47% and retrograde 53%). Clinical and angiographic differences were noted between the original and studied cohort. The mean J-CTO score was 2.18±1.26, and successful guidewire crossing within 30 minutes and final angiographic success were 44.5% and 90.4%, respectively. The J-CTO score demonstrated good discrimination (c statistic, >0.70) and calibration (Hosmer–Lemeshow P>0.1) in the whole cohort and for antegrade and retrograde approaches. However, the final success rate was not associated with the J-CTO score. Conclusions—In this independent cohort, the J-CTO score showed good discriminatory and calibration capacity for guidewire CTO crossing within 30 minutes but it does not for final success rate. The J-CTO score helps to predict complexity of CTO recanalization, and the simplicity of the score supports the widespread use as a clinical tool.

Retrograde recanalization of chronic total occlusions from the transradial approach; Early canadian experience†

Background: Retrograde approach for chronic total occlusions (CTO) improves recanalization success rates. Eight French (Fr) catheters and the femoral approach are advocated. Objectives: Evaluate whether transradial operators can achieve similar success rates using smaller catheters. Methods: This is a single‐operator series of 42 consecutive cases performed between January and December 2010, including 13 while demonstrating CTO recanalization. Patients were referred because of complexity of the CTO or after failed attempt. Results: Most frequent indications for recanalization were CCS 3–4 angina (52%) and CCS 1–2 in 21%. Eighteen (43%) patients underwent previous failed attempts. CTO was in the right coronary in 74%, left anterior descending in 24%, and a left main in 1. Most lesions (88%) were ≥20 mm long and 52% were calcified. We used septal collateral channels (CC) in 33 (79%), epicardial CC in 8 (20%), and a saphenous vein graft in one case. Radial access was used in all patients and was bilateral in 37 (88%). Five cases required one radial and one femoral access. Six French guides were used in 91% for the retrograde side and 71% for the antegrade side. Otherwise, 7 Fr guides were used. The Corsair® was used in 38 (90%). Procedural success was achieved in 37 (88%), mostly using reverse controlled antegrade–retrograde tracking (60%) or retrograde crossing (29%). The average <24‐h Hb drop was 0.75 ± 0.84 g/dl. No in‐hospital major cardiac events occurred. Conclusion: Transradial retrograde CTO recanalization is feasible, safe, and still associated with high success rates despite the use of smaller guide catheters.

Comparison of medical treatment and coronary revascularization in patients with moderate coronary lesions and borderline fractional flow reserve measurements

Objectives: (1) To evaluate the clinical outcomes of patients with moderate coronary lesions and borderline fractional flow reserve (FFR) measurements (between 0.75 and 0.80), comparing those who underwent coronary revascularization (CR) to those who had medical treatment (MT), and (2) to determine the predictive factors of major adverse cardiac events (MACE) at follow‐up. Methods: A total of 107 consecutive patients (mean age 62 ± 10 years) with at least one moderate coronary lesion (mean percent diameter stenosis 47 ± 12%) evaluated by coronary pressure wire with FFR measurement between 0.75 and 0.80 (mean 0.77 ± 0.02) were included in the study. MACE [CR, myocardial infarction (MI), cardiac death) and the presence of angina were evaluated at follow‐up. Results: Sixty‐three patients (59%) underwent CR and 44 patients (41%) had MT, with no clinical differences between groups. At a mean follow‐up of 13 ± 7 months, MACE related to the coronary lesion evaluated by FFR were higher in the MT group compared with CR group (23% vs. 5%, P = 0.005). Most MACE consisted of CRs, with no differences between groups in MI and cardiac death rate at follow‐up. Both MT and FFR measurements in an artery supplying a territory with previous MI were independent predictive factors of MACE at follow‐up, respectively (hazard ratio 5.2, 95% CI 1.4–18.9, P = 0.01; hazard ratio 4.1, 95% CI 1.1–15.3, P = 0.03). The presence of angina at follow‐up was more frequent in the MT group compared with the CR group (41% vs. 9%, P = 0.002). Conclusions: In patients with moderate coronary lesions and borderline FFR measurements deferral of revascularization was associated with a higher rate of MACE (CR) and a higher prevalence of angina at follow‐up, especially in those with previous MI in the territory evaluated by FFR. Further prospective randomized studies should confirm whether or not an FFR cut‐off point of 0.80 instead of 0.75 would be more appropriate for deferring CR in these cases.

One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study

BACKGROUND Long-term clinical follow-up has shown a significant benefit after percutaneous coronary intervention (PCI) for abciximab bolus followed by 12-hour infusion over placebo or bolus-only. With contemporary techniques and clopidogrel pretreatment, it is unknown whether the 12-hour infusion is still associated with a clinical benefit. The purpose of this study is to compare 6- and 12-month clinical outcomes in patients treated after PCI with abciximab bolus-only and abciximab bolus followed by 12-hour infusion. METHODS After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day discharge and no infusion of abciximab (bolus-only group, n = 504) or to overnight hospitalization and 12 hours (0.125 microg/[kg min]) of abciximab infusion (bolus + infusion group, n = 501). The rate of major adverse cardiovascular events (MACE) was evaluated at 30 days, 6 months, and 12 months. RESULTS At 30 days, the rate of MACE including death, myocardial infarction, and target vessel revascularization was similar in the 2 groups: 1.4% in the bolus-only group versus 1.8% in the bolus + infusion group (P = .63). At 6 months, the MACE rate was 5.6% in the 2 randomized groups. At 12 months, the MACE rate was also similar in both groups: 8.7% in the bolus-only group and 9.2% in the bolus + infusion group (hazard ratio 0.97, 95% CI 0.79-1.20, P = .80). Similar efficacy was also observed in several subgroups including higher-risk patients such as those with elevated troponin T before PCI. CONCLUSIONS In patients pretreated with clopidogrel and undergoing uncomplicated coronary artery stenting, there is no difference in the 6- and 12-month outcomes between patients treated with abciximab bolus-only versus those treated with bolus + infusion, a finding consistent with the initial 30-day outcomes.

Early and late outcomes in patients excluded from same‐day home discharge after transradial stenting and maximal antiplatelet therapy

Background: To develop a safe practice of same‐day discharge after percutaneous coronary intervention (PCI), it is important to identify early the patients who need to remain hospitalized and potentially require more careful follow‐up. In the EASY trial, a large number of patients with acute coronary syndromes were enrolled prior to PCI to be randomized between same‐day discharge or overnight hospitalization. Based on a few angiographic criteria, suboptimal results, or clinical complications, some patients were excluded from randomization after PCI. Objectives: We report the early and late outcomes of those patients, and evaluate the use of simple criteria precluding same‐day discharge. Results: The rate of major adverse cardiac events including death, myocardial infarction, and target vessel revascularization in patients excluded from randomization (n = 343) was significantly higher at 30 days (10.2% vs. 1.6%), 6 months (17.5% vs. 5.6%), and 12 months (24.5% vs. 9%) compared with randomized patients (n = 1,005; P < 0.0001). At 12 months, only transient vessel closure (HR 1.78, 95% CI 1.10–2.65, P = 0.023) and a residual dissection ≥ grade B post‐PCI (HR 1.53, 95% CI 1.11–2.05, P = 0.011) were independent predictive factors of adverse outcomes. Conclusion: Criteria associated with angiographic suboptimal results or clinical complications are useful to identify patients ineligible for same‐day discharge after PCI, regardless of the clinical presentation. Patients excluded from same‐day discharge after PCI for safety concerns have worse early and late outcomes. Transient vessel closure and persisting moderate dissection after PCI remain independent predictors of late adverse outcomes after PCI with maximal antiplatelet therapy.

Recanalization of Chronic Total Occlusions in Patients With Previous Coronary Bypass Surgery and Consideration of Retrograde Access via Saphenous Vein Grafts

Background—The prevalence of native coronary chronic total occlusions (CTOs) after coronary artery bypass grafts (CABGs) is higher than in non-CABG population. We examined outcomes of CTO percutaneous coronary intervention (PCI) post-CABG versus without CABG. Then, we looked at feasibility and outcomes of retrograde CTO PCI via patent or occluded saphenous vein graft. Methods and Results—We compared patient and procedural characteristics of 470 CTO cases treated from January 2010 to December 2015 depending on history of CABG. We assessed major adverse cardiac events, including cardiac death, myocardial infarction, ischemia-driven target-vessel revascularization, or reocclusion 1 year after successful CTO PCI in patients treated before February 2015. Post-CABG patients (175 cases) had a higher J-CTO score (2.5 versus 2.1; P=0.002). In-hospital complications were similar, although the incidence of contrast-induced nephropathy was higher in post-CABG patients (4.6% versus 1%; P=0.01). With multivariable analysis, post-CABG status was associated with higher incidence of 1-year major adverse cardiac event (hazards ratio=2.2; P=0.02). As a second level analysis, we looked at the feasibility and safety of CTO PCI via saphenous vein grafts (19% of post-CABG cases) versus collateral channels (36%) versus with an antegrade-only approach (45%), and assessed short-term outcomes and complications. High success was achieved in the saphenous vein graft group. In-hospital events were similar in the 3 groups. Conclusions—Post-CABG CTO PCI is associated with similar high success and low complications compared with CTO PCI in patients who never had CABG. However, it is associated with higher recurrent events at 1 year. To achieve high success rate, use of saphenous vein grafts as retrograde conduits seems to be safe and effective.

Changes in CYP2C19 enzyme activity evaluated by the [13C]-pantoprazole breath test after co-administration of clopidogrel and proton pump inhibitors following percutaneous coronary intervention and correlation to platelet reactivity

Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is used for the prevention of cardiovascular events following percutaneous coronary intervention (PCI). These agents increase the risk of gastrointestinal bleeding. To prevent these events, proton pump inhibitors (PPI) are routinely prescribed. It has been reported that with the exception of pantoprazole and dexlanzoprazole, PPIs can impede conversion of clopidogrel by cytochrome P450 2C19 (CYP2C19) to its active metabolite, a critical step required for clopidogrel efficacy. Changes in CYP2C19 enzyme activity (phenotype) and its correlation with platelet reactivity following PPI therapy has not yet been fully described. In this study we attempted to determine if the [ (13)C]-pantoprazole breath test (Ptz-BT) can evaluate changes in CYP2C19 enzyme activity (phenoconversion) following the administration of PPI in coronary artery disease (CAD) patients treated with DAPT after PCI. Thirty (30) days after successful PCI with stent placement, 59 patients enrolled in the Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects (SPICE) trial (ClinicalTrials.gov Identifier: NCT00930670) were recruited to participate in this sub study. Patients were randomized to one of 4 antacid therapies (omeprazole, esomeprazole. pantoprazole or ranitidine). Subjects were administered the Ptz-BT and platelet function was evaluated by vasodilator-stimulated phosphoprotein (VASP) phosphorylation and light transmittance aggregometry before and 30 d after treatment with antacid therapy. Patients randomized to esomeprazole and omeprazole had greater high on-treatment platelet reactivity and lowering of CYP2C19 enzyme activity at Day 60 after 30 d of PPI therapy. Patients randomized to ranitidine and pantoprazole did not show any changes in platelet activity or CYP 2C19 enzyme activity. In patients treated with esomeprazole and omeprazole, changes in CYP2C19 enzyme activity (phenoconversion) correlated well with changes in platelet reactivity. Co-administration of omeprazole or esomeprazole in patients treated with clopidogrel results in lower CYP2C19 enzyme activity and increased platelet reactivity as measured by VASP phosphorylation test while patients given pantoprazole or ranitidine did not show any significant changes in CYP2C19 enzyme activity and platelet reactivity.

Safety of the cardiac triple therapy: The experience of the Quebec Heart Institute

BACKGROUND Contemporary treatment of acute coronary syndrome is based on the combination of acetylsalicylic acid (ASA) and clopidogrel. However, an increasing proportion of patients with cardiovascular disease also have an indication for anticoagulant therapy with warfarin. The combination of ASA, clopidogrel and warfarin, also called the cardiac triple therapy (CTT), is emerging in clinical practice, although little is known about its safety. OBJECTIVES To determine the risk of major and minor bleeding associated with the CTT compared with two other regimens using the combination of either ASA and clopidogrel or ASA and warfarin in patients with cardiovascular disease. METHODS A retrospective study was performed of all susceptible patients who may have received the CTT on discharge from the Quebec Heart Institute (Sainte-Foy, Quebec) between 2002 and 2005. The charts of patients treated with the CTT, ASA and clopidogrel, or ASA and warfarin were reviewed and patients were interviewed to document any bleeding episodes. RESULTS A total of 183 patients were studied. Overall bleeding in the CTT group was 3% compared with 5% in the group receiving ASA and clopidogrel and 16% in the group receiving ASA and warfarin (P=0.03). Patients who experienced bleeding were older, had more hypertension and had been exposed to their drug regimens for a longer duration. There was no significant difference in major bleeding episodes. CONCLUSIONS The CCT appears to be relatively safe compared with other regimens. Higher bleeding rates within the ASA-warfarin group emphasize the need to carefully educate and follow patients on combination therapy.