Incidence, predictors and longer-term impact of troponin elevation following hybrid chronic total occlusion percutaneous coronary intervention.

OBJECTIVES: We examined the incidence of periprocedural cardiac enzyme rise (PCER) [troponin T (TnT) or high-sensivity (hs)TnT >5× the upper limit of normal (ULN)] and periprocedural myocardial infarction (PMI), predictors of PCER and impact of PCER on the longer-term major adverse cardiac events (MACE) following hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: PCER and PMI after CTO PCI, risk factors for PCER and its impact on longer-term MACE are not fully understood. METHODS: Among 469 CTO PCI cases performed between 01/2010 and 12/2015, next-day TnT or hsTnT was measured in 455 (97%). We examined the incidence of PCER and PMI (with clinical context or TnT ≥70× ULN). In 269 successful cases who had TnT measured, longer-term MACE (death, MI or target-vessel revascularisation/re-occlusion) were assessed. RESULTS: Overall, 420 CTOs (92.3%) were treated successfully. PCER was documented in 34%, while PMI in 2.9%. By multivariable analyses, higher J-CTO score (OR = 1.3 per point; P = 0.002), lower creatinine clearance (OR = 1.01 per each cc/min decrease; P < 0.0001) and recent MI (OR = 2.4; P = 0.007) were independent pre-PCI risk factors for PCER. Among procedural variables, retrograde approach (OR = 1.9; P = 0.014) and procedure duration (OR = 1.2 per 30 min; P = 0.007) were associated with PCER. At a median follow-up of 396 days following successful CTO PCI, PCER was not associated with higher MACE (9.3% vs. 8.1%; P = 0.60), and was not a predictor of MACE in multivariable analysis. CONCLUSIONS: PCER following hybrid CTO PCI is detected in 1/3 of patients. However, true PMI occurs in 2.9%. PCER does not predict adverse long-term outcomes.

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.

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.

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.

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 >or= 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.

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 approximately 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. CONCLUSIONS: 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.

Predictors of aorto-saphenous vein bypass narrowing late after coronary artery bypass grafting.

The objective of this study was to evaluate the clinical and angiographic factors associated with significant saphenous vein graft (SVG) atherosclerosis progression at mid-term follow-up in a series of unselected coronary patients who had previously received a coronary artery bypass graft (CABG). A total of 123 SVGs from 86 patients who underwent cardiac catheterization twice, 15 +/- 12 months apart, were included in the study. None of the SVGs presented any > or =50% diameter stenosis (DS) lesion or underwent any intervention at baseline. All SVGs were divided into 3 segments and each SVG segment was scored from 0 to 3 depending on the presence of lesions, with percent DS ranging from 0% to 19% (score 0), 20% to 29% (score 1), 30% to 39% (score 2), and > or =40% (score 3). The SVG atherosclerotic burden score (ABS) was calculated by adding the score obtained for each of the 3 SVG segments. Significant progression was defined as > or =10% increase in lesion percent DS or > or =0.6 mm decrease in minimal lumen diameter between baseline and follow-up studies. Mean age of the study population was 66 +/- 9 years, and most of the patients were receiving statin therapy with mean low-density lipoprotein cholesterol of 85 +/- 26 mg/dl. Significant angiographic progression occurred in > or =1 SVG in 41 patients (48%). On multivariate analysis, the variables associated with SVG atherosclerosis progression were SVG ABS (odds ratio [OR], 1.52 for each increase of 1 point in SVG ABS; 95% confidence interval [CI] 1.1 to 2.29) and high-density lipoprotein (HDL) cholesterol (OR 1.38 for each decrease of 5 mg/dl in HDL cholesterol levels, 95% CI 1.09 to 1.85). Twenty-two patients (26%) had a cardiac event at follow-up related to SVG disease progression. The percent DS of the SVG segment at baseline was associated with SVG disease progression leading to a cardiac event (OR 3.67 for each increase of 5% in percent DS, 95% CI 2.11 to 6.38). In conclusion, simple clinical and angiographic variables such as HDL cholesterol, ABS, and lesion severity remain independent predictors of significant SVG atherosclerosis progression in mild to moderately diseased SVGs despite mean low-density lipoprotein levels <90 mg/dl.

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.

Outpatient percutaneous coronary intervention: Ready for prime time?

Outpatient practice after percutaneous coronary intervention (PCI) is gaining momentum due to constantly optimizing results. Furthermore, the availability of limited beds to handle the large volume of coronary interventions also promotes outpatient practice. The present report relates the current experience with same-day discharge and defines persisting challenges in promoting accelerated in-hospital turnover. Since the mid-1990s, there have been several reports on same-day discharge following uncomplicated procedures. Overall, the success of outpatient PCI practice is based on a few technological and pharmacological advances. First, the systematic use of stents and potent antiplatelet agents have revolutionized the acute success rates of PCI by virtually eliminating the risks of acute vessel closure within the first 24 h following a successful procedure. Second, the miniaturization of catheter sizes has also simplified access site management, accelerated ambulation time and limited the risks of puncture site bleeding. In this regard, the transradial approach initially described in Canada and later popularized in Europe has transformed the acute care of patients after PCI. Today, however, the practice of transradial PCI still varies largely from country to country. From the literature review, it appears that after a short period of observation (4 h to 6 h), the majority of eligible patients who have undergone uncomplicated coronary stenting can be discharged on the same day. Whereas implementation of same-day discharge to referring centres is simple, home discharge requires the development of structured outpatient programs with dedicated resources to assist the patient and family with short-term logistics, to provide reassurance, to serve as a 'safety net' and, lastly, to promote medication compliance and cardiovascular risk factor management. Further studies are required to better define the cost-minimization effects of outpatient PCI practice, as well as patient perception of fast-track PCI. It is proposed that outpatient PCI will likely continue to expand over the next decade.

Safety and effectiveness of the surfing technique to cross septal collateral channels during retrograde chronic total occlusion percutaneous coronary intervention.

AIMS: Septal surfing and distal tip injections are two techniques used for septal crossing in retrograde chronic total occlusion (CTO) percutaneous coronary interventions (PCI). The aim of this study was to examine for the first time the safety and feasibility of the septal surfing technique. METHODS AND RESULTS: Among 470 consecutive CTO PCIs performed in the Quebec hybrid CTO PCI program between January 2010 and December 2015, 240 (51%) involved a retrograde attempt. In the septal crossing subgroup, we evaluated whether the Werner collateral channel (CC) classification, CTO location, tortuosity, and number of large septal CCs influenced retrograde crossing success, time, and perforation. Septal channels were used in the majority (n=152, 63%) of cases. Patients in the septal subgroup were younger, had less bypass surgery, were more likely to have RCA CTO and had previous failure. Septal channels were successfully crossed with the wire using the surfing technique in 81%, irrespective of the CC size. Septal crossing success and time were not influenced by Werner CC class but by septal CC tortuosity. One quarter of cases had septal perforations; all were minor and asymptomatic. CONCLUSIONS: Septal surfing is a safe and highly successful technique for crossing septal CCs when a retrograde approach is mandated for CTO PCI. The Werner class does not affect retrograde CC crossing success or time.

Effectiveness and Safety of the Transradial 8Fr Sheathless Approach for Revascularization of Chronic Total Occlusions.

The experience with the transradial approach in percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) in the United States is limited. We looked at the safety and feasibility of a home-made sheathless transradial technique (STT) with regular 8Fr catheters in CTO PCI. In March 2013, we developed an 8Fr STT for CTO PCI. We compared 119 patients who had the STT versus 122 treated with a standard transradial or transfemoral approach. The primary outcomes of interest were major vascular or bleeding site access complications. In a subgroup of patients with bilateral transradial approach, we assessed and compared radial patency 3 to 6 months after the procedure. Technical success rate of the CTO PCI was 93% in both groups. There were no major vascular or bleeding complications in the STT group. Radial hematomas were frequent but grade III occurred in 4 patients (3%) treated with the STT, not different to the incidence in the other group. The STT did not result in any increase in procedure time, contrast use, or radiation dose. Radial Doppler follow-up in 28 patients revealed 2 occlusions (7.1%) on the 8Fr shealthless side and one on the 6Fr side. In conclusion, our STT with regular 8Fr guides for CTO PCI is feasible, safe, and associated with low complication rate. We show that the hybrid CTO PCI nowadays can be performed through transradial access in the majority, with limited use of transfemoral approach.

Changes in CYP2C19 enzyme activity evaluated by the [(13)C]-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.

The transulnar approach for coronary intervention: a safe alternative to transradial approach in selected patients.

The study reports our single center experience in transulnar coronary interventions in 122 consecutive cases. Success rate was 85.2%. Vascular complications were low (5.7%) and minor (6 hematomas and 1 pseudoaneurysm treated by compression). Transulnar catheterization is feasible and safe. It represents a useful alternative to the transradial approach in selected cases.

Dissection and re-entry techniques and longer-term outcomes following successful percutaneous coronary intervention of chronic total occlusion.

New techniques involving dissection of the subintimal space and re-entry into the true lumen increase success rates in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). However, their long-term safety and efficacy were unknown. This study included a series of consecutive patients who underwent CTO PCI. All patients who did not present events were contacted 12 to 18 months after their PCI. The combined incidence of cardiac death, myocardial infarction, ischemia-driven target-vessel revascularization (TVR), or reocclusion was assessed as our primary outcome. From January 2010 to January 2013, of 212 CTOs treated in our CTO program, 192 (91%) were successfully opened (in 179 patients). Follow-up data were available for 187 CTOs (97.4%), with 82 (44%) that were opened with dissection re-entry and 105 (56%) with conventional wire escalation techniques. At a median follow-up of 398 days, the primary outcome occurred in 18 of 179 CTOs treated (10.7%), driven by TVR. No patient died from cardiac causes. Eleven CTOs (15.2%) treated with dissection re-entry versus 7 CTOs (7.3%) treated with wire escalation presented with the primary outcome (p = 0.17). With multivariate adjustment, dissection re-entry techniques had no significant impact on outcomes. However, treatment of an in-stent occlusion was independently associated with TVR (hazards ratio >6.0, p <0.001). In conclusion, dissection re-entry techniques have minimal impact on long-term outcomes after CTO PCI, which are favorable in most patients. However, treatment of an in-stent occlusion and use of sirolimus-eluting stent were predictors of subsequent adverse 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.

Telephone contact to improve adherence to dual antiplatelet therapy after drug-eluting stent implantation.

BACKGROUND: Many patients delay or interrupt dual antiplatelet therapy (DAT) after drug-eluting stent (DES) implantation, which increases the risk of stent thrombosis and death. OBJECTIVE: To test the hypothesis that simple telephone contact made by nurses would improve adherence to and persistence of DAT. DESIGN: Randomised controlled trial. PATIENTS AND INTERVENTION: A total of 300 patients (mean±SD 64±10 years, 73% male) were recruited immediately after DES implantation performed between June 2009 and June 2010. The last patient recruited reached the 1-year follow-up time point in June 2011. Patients were randomised to one of two groups: intervention, with four telephone follow-ups, versus a control group. In the intervention group, phone calls were made within 7 days of the DES implantation and at 1, 6 and 9 months to support drug adherence. Control patients were followed as per usual clinical practice. Pharmacy data were collected to assess drug prescription filling and refill. SETTING: Tertiary care university cardiovascular centre and community. MAIN OUTCOME MEASURES: The primary end point was the proportion of days covered with aspirin and clopidogrel over the year after discharge as assessed by pharmacy refill data. Secondary outcome measures included persistence of aspirin and clopidogrel treatment, defined as no gaps longer than 14 days during follow-up. RESULTS: Most patients (73%) underwent DES implantation in the context of an acute coronary syndrome. All patients had drug insurance cover, either from the public plan (59%) or through private plans (41%). Complete pharmacy follow-up data were available for 96% of the cohort. At 12 months, median scores (25th-75th centile) for adherence to aspirin and clopidogrel were 99.2% (97.5-100%) and 99.3% (97.5-100%), respectively, in the intervention group compared with 90.2% (84.2-95.4%) and 91.5% (85.1-96.0%), respectively, in the control group (p<0.0001 for aspirin and clopidogrel). Patients in the intervention group were significantly more persistent in the aspirin and clopidogrel treatment than those in the control group. For clopidogrel, 87.2% of patients in the intervention group were still persistent at 12 months compared with only 43.1% in the control group (p<0.0001). CONCLUSIONS: A simple approach of four telephone calls to patients after DES implantation significantly improved 1-year drug adherence to near-perfect scores. Persistence of DAT was also significantly improved by the intervention.

Effects of intracoronary compared to intravenous abciximab administration in patients undergoing transradial percutaneous coronary intervention: A sub-analysis of the EASY trial.

BACKGROUND: In the EASY trial, we have shown the clinical equivalence between abciximab bolus-only and abciximab bolus followed by 12-h infusion in a wide spectrum of patients after percutaneous coronary intervention (PCI). Some reports have suggested better outcomes following intracoronary (IC) abciximab administration compared to intravenous (IV) delivery. We sought to compare cardiac biomarkers release and early and late clinical outcomes after IC or IV abciximab bolus delivery. METHODS: From 1005 patients randomized in the EASY trial and undergoing transradial coronary stent implantation, 208 received IC abciximab bolus and 797 received IV abciximab bolus. Route of administration was left to operators' discretion. Creatine Kinase-MB, and Troponin-T (Tn-T) were obtained immediately prior to angiography, 4-6 h after PCI and the next day. MACE (death, MI, TVR) rate was evaluated at 30 days, 6 months and 12 months. RESULTS: There were more patients with acute coronary syndrome (75% vs 64%, P=0.004) and previous MI (53% vs 42%, P=0.005) in the IC group and more patients with >or=3 dilated sites in the IV group (2% IC vs 7% IV, P=0.03). After PCI, the extent of Tn-T and CK-MB release remained comparable in both groups. The MACE rate was 2% in both groups at 30 days, 9% in IC bolus vs 5% in IV bolus (P=0.04) at 6 months and 10% in IC bolus vs 9% in IV bolus (P=0.50) at 12 months. By multivariate analysis, IC abciximab bolus was not associated with better outcomes at 12 months compared to IV bolus (HR 1.07, 95% CI 0.82-1.35, P=0.62). CONCLUSION: Compared to IV abciximab administration, IC abciximab was not associated with less cardiac biomarkers release or better clinical outcomes after uncomplicated transradial PCI. Further studies are required in clinical scenarios including patients with higher thrombotic burden and/or occluded vessels as in primary and rescue PCI.

Clinical outcomes after multilesion percutaneous coronary intervention: comparison between exclusive and selective use of drug-eluting stents.

OBJECTIVES: This study compared acute and late outcomes following a strategy of selective drug-eluting stent (DES) use guided by a set of 4 criteria defining higher risk of in-stent restenosis compared to an exclusive DES strategy in 362 patients with multilesion (n = 900) percutaneous coronary interventions. RESULTS: At a mean follow up of 412 +/- 110 days, major adverse cardiac events (death, myocardial infarction, revascularization) were 16.8% in the exclusive DES group compared to 18.4% in the selective DES group (p = 0.78). By univariate analysis, revascularization rates (9.9% in the exclusive DES group versus 10.5% in the selective DES group; p = 1.0) and target lesion revascularization (TLR) rates (5.5% versus 6.2%; p = 0.77) were similar in the 2 groups. By multivariate analysis adjusted by propensity score to account for differences in baseline characteristics, the strategy of exclusive DES use was not associated with lower risks of revascularization (hazard ratio [HR]: 0.91, 95% confidence interval [CI] 0.64-1.29) or TLR (HR: 0.81, 95% CI 0.59-1.08) compared with selective DES use. Using the Academic Research Consortium criteria, stent thrombosis occurred in 6/161 (3.7%) cases in the exclusive DES group and in 1/201 (0.5%) case in the selective DES group (p = 0.03). CONCLUSIONS: In patients with multiple coronary lesions, a selective DES strategy for lesions at higher risk of restenosis and bare-metal stents for other lesions was safe and effective when compared to the exclusive use of DES. A large, prospective, randomized trial is required to validate a criteria-based selective DES strategy compared to systematic DES use.