Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis.

Use of a covered stent after percutaneous transluminal angioplasty (PTA) was compared to PTA alone for treatment of upper extremity hemodialysis patients with arteriovenous fistula (AVF) stenoses. Patients with AVF stenosis of 50% or more and evidence of AVF dysfunction underwent treatment with PTA followed by randomization of 142 patients to include a covered stent or 138 patients with PTA alone. Primary outcomes were 30-day safety, powered for noninferiority, and six-month target lesion primary patency (TLPP), powered to test whether TLPP after covered-stent placement was superior to PTA alone. Twelve-month TLPP and six-month access circuit primary patency (ACPP) were also hypothesis tested while additional clinical outcomes were observed through two years. Safety was significantly non-inferior while six- and 12-month TLPP were each superior for the covered stent group compared to PTA alone (six months: 78.7% versus 55.8%; 12 months: 47.9% versus 21.2%, respectively). ACPP was not statistically different between groups at six-months. Observed differences at 24 months favored the covered-stent group: 28.4% better TLPP, fewer target-lesion reinterventions (1.6 ± 1.6 versus 2.8 ± 2.0), and a longer mean time between target-lesion reinterventions (380.4 ± 249.5 versus 217.6 ± 158.4 days). Thus, our multicenter, prospective, randomized study of a covered stent used to treat AVF stenosis demonstrated noninferior safety with better TLPP and fewer target-lesion reinterventions than PTA alone through 24 months.

Long-term serial functional evaluation after implantation of the Fantom sirolimus-eluting bioresorbable coronary scaffold.

BACKGROUND: Quantitative flow ratio (QFR) has been validated as an accurate surrogate of standard wire-based fractional flow reserve. The clinical and angiographic outcomes of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) have been previously studied and reported. We investigate the functional performance of the Fantom BRS. METHODS: The FANTOM II trial prospectively enrolled 240 patients with stable coronary artery disease or unstable angina, of which 235 patients received the Fantom BRS and were included in the present analysis. We performed an independent serial QFR analysis of the target vessel at baseline, post-percutaneous coronary intervention (PCI), and at 6- or 9-month and 24-month follow-up, using a QFR threshold ≤0.80 to define functional ischemia. RESULTS: QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 30 at 24-month follow-up. At baseline, 119 patients (66.9%) had a QFR ≤0.80, whereas 12 (6.5%) post-PCI, 13 (7.3%) at 6- or 9-month follow-up, and 3 (10.0%) at 24-month follow-up had a QFR ≤0.80. QFR improved from baseline to post-PCI, and decreased from post-PCI up to 24-month follow-up. During follow-up period, 28 patients (11.9%) had target vessel revascularization, of which 21 had analyzable QFR and 16 patients (76.1%) had QFR ≤0.80 at the time of revascularization. CONCLUSIONS: Off-line serial QFR assessment demonstrated that around 30% patients did not have functionally significant lesions at baseline and the time with target vessel revascularization. PCI with the Fantom BRS improved functional ischemia with a slight decrease in QFR values over 24 months.

Prognostic utility of myocardial blush grade after PCI in patients with NSTE-ACS: Analysis from the ACUITY trial.

OBJECTIVE: We evaluated the ability of post-procedural myocardial blush grade (MBG) to stratify outcomes of patients undergoing percutaneous coronary intervention (PCI) for non-ST segment elevation acute coronary syndromes (NSTE-ACS). BACKGROUND: MBG strongly correlates with survival after reperfusion therapy in patients with ST-segment elevation myocardial infarction (STEMI). METHODS: Of 13,819 NSTE-ACS patients randomized in the ACUITY trial, 3,115 patients underwent PCI and had MBG analyzed by an independent angiographic core laboratory. We examined net adverse clinical events (NACE; composite ischemia or bleeding), composite ischemia (death, MI or ischemia-driven revascularization) and non-CABG major bleeding according to final MBG. RESULTS: At 30 days, patients with MBG-0/1 had higher rates of NACE (25.1% vs. 13.9%, P = 0.002) and composite ischemia (19.1% vs. 9.4%, P = 0.002) than patients with MBG-2/3. At 1-year follow-up, MBG-0/1 patients had significantly higher rates of composite ischemia compared to other patients (27.8% vs. 19.8%, P = 0.02). By multivariable analysis, MBG-0/1 was an independent predictor of 30-day ischemia-driven revascularization (OR 5.74 [2.63, 12.54], P < 0.0001) in the total population and among patients with normal post-PCI epicardial TIMI-3 flow (OR 6.39 [2.06, 19.78], P = 0.001). However, 1-year outcomes were similar between patients with and without normal myocardial perfusion. CONCLUSIONS: In conclusion, MBG is a predictor of 30-day revascularization in the overall population and in patients with normal epicardial flow but fails to stratify 1-year outcomes. Thus, unlike in STEMI patients, the prognostic value of MBG in NSTE-ACS patients appears to be limited to the short-term. © 2015 Wiley Periodicals, Inc.

A prospective natural-history study of coronary atherosclerosis.

BACKGROUND: Atherosclerotic plaques that lead to acute coronary syndromes often occur at sites of angiographically mild coronary-artery stenosis. Lesion-related risk factors for such events are poorly understood. METHODS: In a prospective study, 697 patients with acute coronary syndromes underwent three-vessel coronary angiography and gray-scale and radiofrequency intravascular ultrasonographic imaging after percutaneous coronary intervention. Subsequent major adverse cardiovascular events (death from cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization due to unstable or progressive angina) were adjudicated to be related to either originally treated (culprit) lesions or untreated (nonculprit) lesions. The median follow-up period was 3.4 years. RESULTS: The 3-year cumulative rate of major adverse cardiovascular events was 20.4%. Events were adjudicated to be related to culprit lesions in 12.9% of patients and to nonculprit lesions in 11.6%. Most nonculprit lesions responsible for follow-up events were angiographically mild at baseline (mean [±SD] diameter stenosis, 32.3±20.6%). However, on multivariate analysis, nonculprit lesions associated with recurrent events were more likely than those not associated with recurrent events to be characterized by a plaque burden of 70% or greater (hazard ratio, 5.03; 95% confidence interval [CI], 2.51 to 10.11; P<0.001) or a minimal luminal area of 4.0 mm(2) or less (hazard ratio, 3.21; 95% CI, 1.61 to 6.42; P=0.001) or to be classified on the basis of radiofrequency intravascular ultrasonography as thin-cap fibroatheromas (hazard ratio, 3.35; 95% CI, 1.77 to 6.36; P<0.001). CONCLUSIONS: In patients who presented with an acute coronary syndrome and underwent percutaneous coronary intervention, major adverse cardiovascular events occurring during follow-up were equally attributable to recurrence at the site of culprit lesions and to nonculprit lesions. Although nonculprit lesions that were responsible for unanticipated events were frequently angiographically mild, most were thin-cap fibroatheromas or were characterized by a large plaque burden, a small luminal area, or some combination of these characteristics, as determined by gray-scale and radiofrequency intravascular ultrasonography. (Funded by Abbott Vascular and Volcano; ClinicalTrials.gov number, NCT00180466.).

Impact of the presence and extent of incomplete angiographic revascularization after percutaneous coronary intervention in acute coronary syndromes: the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial.

BACKGROUND: The clinical significance of incomplete coronary revascularization (ICR) after percutaneous coronary intervention in patients with acute coronary syndromes is unknown. METHODS AND RESULTS: We performed quantitative angiography of the entire coronary tree in 2954 patients with acute coronary syndromes in the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. ICR was variably defined if any lesion with diameter stenosis (DS) cutoffs ranging from ≥30% to ≥70% with reference vessel diameter ≥2.0 mm remained after percutaneous coronary intervention. The primary outcome was 1-year composite rate of major adverse cardiac events (death, myocardial infarction, or ischemia-driven unplanned revascularization). With the use of DS cutoffs ≥30%, ≥40%, ≥50%, ≥60%, and ≥70%, the prevalence of ICR after percutaneous coronary intervention was 75%, 55%, 37%, 25%, and 17%, respectively. The 1-year major adverse cardiac event rate was increased among patients with ICR using all of the DS cutoffs. ICR (≥50% DS) was associated with higher 1-year rates of myocardial infarction (12.0% versus 8.2%; hazard ratio, 1.50; 95% confidence interval, 1.18-1.89; P=0.0007) and ischemia-driven unplanned revascularization (15.7% versus 10.2%; hazard ratio, 1.58; 95% confidence interval, 1.28-1.96; P<0.0001), with a trend toward increased mortality (3.1% versus 2.2%; hazard ratio, 1.43; 95% confidence interval, 0.90-2.27; P=0.13). By multivariable analysis, ICR (≥50% DS) was an independent predictor of 1-year major adverse cardiac events (hazard ratio, 1.36; 95% confidence interval, 1.12-1.64; P=0.002). The impact of ICR on major adverse cardiac events was similar regardless of chronic total occlusion presence, but it was more pronounced with a greater number of nonrevascularized lesions. CONCLUSIONS: Depending on the threshold of percent DS, ICR was present in 17% to 75% of patients with acute coronary syndromes after percutaneous coronary intervention. Regardless of the threshold, ICR was strongly associated with 1-year myocardial infarction, ischemia-driven unplanned revascularization, and major adverse cardiac events. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00093158.

Frequency and predictors of stent thrombosis after percutaneous coronary intervention in acute myocardial infarction.

BACKGROUND: Concerns persist regarding the risk of stent thrombosis in the setting of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. METHODS AND RESULTS: The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial included 3602 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention who were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) (n=1802) versus bivalirudin monotherapy (n=1800). Stents were implanted in 3202 patients, including 2261 who received drug-eluting stents and 861 who received only bare metal stents. Definite or probable stent thrombosis within 2 years occurred in 137 patients (4.4%), including 28 acute events (0.9%), 49 subacute events (1.6%), 32 late events (1.0%), and 33 very late events (1.1%). The 2-year cumulative rates of stent thrombosis were 4.4% with both drug-eluting stents and bare metal stents (P=0.98) and 4.3% versus 4.6% in patients randomized to bivalirudin monotherapy versus heparin plus a GPI, respectively (P=0.73). Acute stent thrombosis occurred more frequently in patients assigned to bivalirudin compared with heparin plus a GPI (1.4% versus 0.3%; P<0.001), whereas stent thrombosis after 24 hours occurred less frequently in patients with bivalirudin compared with heparin plus a GPI (2.8% versus 4.4%; P=0.02). Pre-randomization heparin and a 600-mg clopidogrel loading dose were independent predictors of reduced acute and subacute stent thrombosis, respectively. CONCLUSIONS: Stent thrombosis is not uncommon within the first 2 years after primary percutaneous coronary intervention in ST-segment elevation myocardial infarction, and occurs with similar frequency in patients receiving drug-eluting stents versus bare metal stents and bivalirudin alone versus heparin plus a GPI. Optimizing adjunct pharmacology including early antithrombin therapy preloading with a potent antiplatelet therapy may further reduce stent thrombosis in ST-segment elevation myocardial infarction.

Strut coverage and late malapposition with paclitaxel-eluting stents compared with bare metal stents in acute myocardial infarction: optical coherence tomography substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial.

BACKGROUND: The safety of drug-eluting stents in ST-segment elevation myocardial infarction (STEMI) continues to be debated. Pathological studies have demonstrated an association between uncovered struts and subsequent stent thrombosis. Optical coherence tomography can detect stent strut coverage in vivo on a micron-scale level. We therefore used optical coherence tomography to examine strut coverage in patients with STEMI treated with paclitaxel-eluting stents (PES) and bare metal stents (BMS). METHODS AND RESULTS: In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients with STEMI were randomized 3:1 to PES or BMS implantation. In a formal substudy, optical coherence tomography at 13 months was performed in 118 consecutive randomized patients (89 PES, 29 BMS) in whom 188 stents were assessed (146 PES and 42 BMS). A total of 44 139 stent struts were analyzed by an independent core laboratory blinded to stent assignment. The primary prespecified end point, the percentage of uncovered stent struts per lesion at follow-up, was 1.1 ± 2.5% in BMS lesions versus 5.7 ± 7.0% in PES lesions (P < 0.0001). Malapposed struts were observed in 0.1 ± 0.2% of BMS lesions versus 0.9 ± 2.1% of PES lesions (P = 0.0003). Percentage net volume obstruction was 36.0 ± 15.4% with BMS and 19.2 ± 11.3% with PES (P < 0.0001). CONCLUSIONS: In patients with STEMI undergoing primary percutaneous coronary intervention, implantation of PES as compared with BMS significantly reduces neointimal hyperplasia but results in higher rates of uncovered and malapposed stent struts as assessed by optical coherence tomography at 13-month follow-up. Further studies are required to determine the clinical significance of these findings. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

Comparison of clinical and angiographic prognostic risk scores in patients with acute coronary syndromes: Analysis from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial.

BACKGROUND: Several prognostic risk scores have been developed for patients with coronary artery disease, but their comparative use in patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing percutaneous coronary intervention (PCI) has not been examined. We therefore investigated the accuracy of the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score, Clinical Synergy Between PCI With Taxus and Cardiac Surgery score (CSS), New Risk Stratification (NERS) score (NERS), Age, Creatinine, Ejection Fraction (ACEF) score, Global Registry for Acute Coronary Events (GRACE) score, and Thrombolysis in Myocardial Infarction (TIMI) score for risk assessment of 1-year mortality, cardiac mortality, myocardial infarction, target vessel revascularization, and stent thrombosis in patients with NSTEACS undergoing PCI. METHODS: The 6 scores were determined in 2,094 patients with NSTEACS treated with PCI enrolled in the angiographic substudy of the ACUITY trial. The prognostic accuracy of the 6 scores was assessed using the c statistic for discrimination and the Hosmer-Lemeshow test for calibration. The index of separation and net reclassification improvement (NRI) were also determined. RESULTS: Scores incorporating clinical and angiographic variables (CSS and NERS) showed the best tradeoff between discrimination and calibration for most end points, with the best discrimination for all end points and good calibration for most of them. The CSS had the best index of separation for most ischemic endpoints and displayed an NRI for cardiac death and myocardial infarction (MI) compared to the other scores, whereas NERS displayed an NRI for all-cause death and target vessel revascularization. The 3 scores-CSS, NERS, and SYNTAX-were the only scores to have both good discrimination and calibration for cardiac mortality. CONCLUSIONS: In patients with NSTEACS undergoing PCI, risk scores incorporating clinical and angiographic variables had the highest predictive accuracy for a broad spectrum of ischemic end points.

Does clinical presentation affect outcome among patients with acute coronary syndromes undergoing percutaneous coronary intervention? Insights from the Providing Regional Observations to Study Predictors of Events in the Coronary Tree study.

BACKGROUND: In some prior studies, patients with ST-elevation myocardial infarction (STEMI) as compared with patients with non-STEMI (NSTEMI) tended to have a higher early mortality but similar long-term outcomes. We compared the angiographic and intravascular ultrasound (IVUS) characteristics of patients with STEMI and NSTEMI in the PROSPECT study to evaluate the independent prognostic value of clinical presentation on long-term outcome. METHODS: After successful revascularization, patients had 3-vessel quantitative coronary angiography, gray scale, and radiofrequency intravascular ultrasound (IVUS) imaging. The primary end point was the occurrence of major adverse cardiac events (MACE) (cardiac death, myocardial infarction, or rehospitalization for unstable or progressive angina). RESULTS: There were 211 patients (31.6%) with STEMI and 457 (68.4%) with NSTEMI. Patients with STEMI and NSTEMI had similar angiographic and IVUS morphologic characteristics. At 3 years, MACE occurred in 22.1% and 19.6%, respectively (hazard ratio [HR] 1.16 [0.81, 1.68], P = .42). There was a higher overall mortality (HR 2.16 [0.94, 4.99], P = .06) and a significantly higher incidence of probable stent thrombosis (HR 4.34 [1.09, 17.36], P = .02) in the STEMI cohort. There were no significant differences between the 2 groups with respect to events related to culprit or to nonculprit lesions. ST-elevation myocardial infarction presentation was not an independent predictor of 3-year MACE (HR 1.14 [0.77, 1.67], P = .52). CONCLUSION: Patients with STEMI and NSTEMI did not differ with respect to residual nonculprit lesion angiographic or IVUS characteristics and had similar rates of MACE at 3 years, without late "catch-up" in NSTEMI. However, probable stent thrombosis and mortality were higher in the STEMI cohort.

Effect of bivalirudin compared with unfractionated heparin plus abciximab on infarct size and myocardial recovery after primary percutaneous coronary intervention: the horizons-AMI CMRI substudy.

BACKGROUND: Myocardial infarct size is a strong independent predictor of mortality in patients with ST-elevation myocardial infarction (STEMI). In the Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor reduced cardiac mortality in STEMI patients, which was attributed to reduced major bleeding. Whether a possible reduction in infarct size with bivalirudin may have contributed to the enhanced survival with this agent is unknown. METHODS: Cardiac magnetic resonance imaging was performed within 7 days and after 6 months in 51 randomized patients from a single center in HORIZONS-AMI trial (N = 28 bivalirudin, N = 23 heparin plus abciximab). Infarct size, microvascular obstruction (MVO), left ventricular ejection fraction (LVEF), and LV end-diastolic and end-systolic volume indices were evaluated. RESULTS: Infarct size was not significantly different after treatment with bivalirudin compared with heparin plus abciximab either within 7 days (median 9.3% [interquartile range 4.9%, 26.6%] vs. 20.0% [5.9%, 28.2%], P = 0.28) or at 6 months 6.7% [3.8%, 20.0%] vs. 8.2% [1.8%, 16.5%], P = 0.73). MVO was present in 28.6% versus 34.8% of patients respectively (P = 0.63). LVEF and LV volume indices also did not significantly differ between the two groups at either time period, nor were differences in myocardial recovery evident. CONCLUSIONS: In conclusion, in the HORIZONS-AMI Cardiac magnetic resonance imaging (CMRI) substudy, cardiac magnetic resonance imaging within 7 days and at 6 months after primary percutaneous coronary intervention (PCI) did not demonstrate significant differences in infarct size, MVO, LVEF, or LV volume indices in patients treated with bivalirudin compared with unfractionated heparin plus abciximab.

Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial.

PURPOSE: To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty. METHODS: Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment. RESULTS: The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented. CONCLUSION: In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial.

CONTEXT: Thrombus embolization during percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) is common and results in suboptimal myocardial perfusion and increased infarct size. Two strategies proposed to reduce distal embolization and improve outcomes after primary PCI are bolus intracoronary abciximab and manual aspiration thrombectomy. OBJECTIVE: To determine whether bolus intracoronary abciximab, manual aspiration thrombectomy, or both reduce infarct size in high-risk patients with STEMI. DESIGN, SETTING, AND PATIENTS: Between November 28, 2009, and December 2, 2011, 452 patients presenting at 37 sites in 6 countries within 4 hours of STEMI due to proximal or mid left anterior descending artery occlusion undergoing primary PCI with bivalirudin anticoagulation were randomized in an open-label, 2 x 2 factorial design to bolus intracoronary abciximab delivered locally at the infarct lesion site vs no abciximab and to manual aspiration thrombectomy vs no thrombectomy. INTERVENTIONS: A 0.25-mg/kg bolus of abciximab was administered at the site of the infarct lesion via a local drug delivery catheter. Manual aspiration thrombectomy was performed with a 6 F aspiration catheter. MAIN OUTCOME MEASURES: Primary end point: infarct size (percentage of total left ventricular mass) at 30 days assessed by cardiac magnetic resonance imaging (cMRI) in the abciximab vs no abciximab groups (pooled across the aspiration randomization); major secondary end point: 30-day infarct size in the aspiration vs no aspiration groups (pooled across the abciximab randomization). RESULTS: Evaluable cMRI results at 30 days were present in 181 and 172 patients randomized to intracoronary abciximab vs no abciximab, respectively, and in 174 and 179 patients randomized to manual aspiration vs no aspiration, respectively. Patients randomized to intracoronary abciximab compared with no abciximab had a significant reduction in 30-day infarct size (median, 15.1%; interquartile range [IQR], 6.8%-22.7%; n = 181, vs 17.9% [IQR, 10.3%-25.4%]; n = 172; P = .03). Patients randomized to intracoronary abciximab also had a significant reduction in absolute infarct mass (median, 18.7 g [IQR, 7.4-31.3 g]; n = 184, vs 24.0 g [IQR, 12.1-34.2 g]; n = 175; P = .03) but not abnormal wall motion score (median, 7.0 [IQR, 2.0-10.0]; n = 188, vs 8.0 [IQR, 3.0-10.0]; n = 184; P = .08). Patients randomized to aspiration thrombectomy vs no aspiration had no significant difference in infarct size at 30 days (median, 17.0% [IQR, 9.0%-22.8%]; n = 174, vs 17.3% [IQR, 7.1%-25.5%]; n = 179; P = .51), absolute infarct mass (median, 20.3 g [IQR, 9.7-31.7 g]; n = 178, vs 21.0 g [IQR, 9.1-34.1 g]; n = 181; P = .36), or abnormal wall motion score (median, 7.5 [IQR, 2.0-10.0]; n = 186, vs 7.5 [IQR, 2.0-10.0]; n = 186; P = .89). CONCLUSION: In patients with large anterior STEMI presenting early after symptom onset and undergoing primary PCI with bivalirudin anticoagulation, infarct size at 30 days was significantly reduced by bolus intracoronary abciximab delivered to the infarct lesion site but not by manual aspiration thrombectomy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00976521.

Angiographic Lesion Discordance in Women Presenting With Ischemic Heart Disease: Comparison of Visual Assessment, Quantitative Coronary Angiography, and Quantitative Flow Ratio.

BACKGROUND: Although visual assessment of stenosis severity is routinely used to guide coronary revascularization, there are concerns about its accuracy, especially in women, who present a higher variability in coronary anatomy and ischemic heart disease (IHD). The aim of this study was to assess whether quantitative coronary angiography (QCA) and quantitative flow ratio (QFR) could provide better discrimination of coronary stenosis severity and functional significance than visual assessment alone in women with IHD. METHODS: Coronary angiography was performed in a cohort of women with ischemic symptoms and non-invasive stress perfusion imaging. Visual assessment was done by blinded operators in clinical practice, while QCA and QFR were analyzed in an independent core laboratory. RESULTS: Ninety-nine consecutive patients with 101 lesions were included in the registry, and QFR was successfully measured in 81 lesions (80.2%). Visual assessment provided higher readings of angiographic severity than QCA in 50.5% (n = 51) of lesions. Mean absolute difference between QCA and visual assessment was significantly higher in lesions with >70% diameter stenosis (DS) (25.3 ± 7.3%), compared with both the 40%-55% (9.3 ± 6.8%; P<.001) and the <40% groups (7.0 ± 6.0%; P<.001). QFR was >0.80 in 33.3% of lesions with visually defined >70% DS, while all lesions with QCA-defined >70% DS had QFR ≤0.80. CONCLUSIONS: Interventional cardiologists' visual assessment results in a higher degree of coronary stenosis than QCA. Among women with ischemic symptoms and non-invasive stress perfusion imaging, additional lesion assessment by QCA and QFR may improve operators' ability to determine which patients and lesions will benefit from coronary revascularization.

Changes in reference vessel diameter in ST-segment elevation myocardial infarction after primary percutaneous coronary intervention: implications for appropriate stent sizing.

BACKGROUND: Stents may be undersized during primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI), leading to higher rates of stent thrombosis. We sought to compare the reference vessel diameter (RVD) of the infarct-related artery before, immediately after, and at late follow-up after PCI for STEMI. We further investigated whether vessels treated with paclitaxel-eluting (PES) or bare-metal stents (BMS) behave differently with respect to RVD at follow-up. METHODS: From the HORIZONS-AMI trial, we identified 2,974 patients (3,589 lesions) with complete quantitative angiographic data for stent implantation (2,233 treated with PES and 741 treated with BMS). RESULTS: Considering all lesions, the median RVD was 2.87 mm (25th-75th percentile 2.54-3.22 mm) at baseline, 2.92 mm (2.58-3.28 mm) immediately post-PCI, and 2.88 mm (2.55-3.22 mm) after 13 months (1,197 patients; P = .001 pre vs post, P = .06 post vs follow-up, and P = .21 pre vs follow-up). There were no significant differences between the RVD for PES versus BMS at any period. The maximal stent or balloon size was 3.00 mm (3.00-3.50 mm) for both groups. There were no differences in RVD at baseline or post-PCI between patients with and without stent thrombosis. CONCLUSIONS: Reference vessel diameter does not change substantially from baseline to follow-up, irrespective of stent type. Stent diameter was appropriate for vessel size. The RVD of patients with and without stent thrombosis was similar at baseline and post-PCI. Thus, the high rates of stent thrombosis after primary PCI for STEMI cannot be attributed to stent undersizing.

Relationship between angiographic dynamic and densitometric assessment of myocardial reperfusion and survival in patients with acute myocardial infarction treated with primary percutaneous coronary intervention: the harmonizing outcomes with revascularization and stents in AMI (HORIZONS-AMI) trial.

OBJECTIVES: We evaluated 2 different methods of assessing tissue myocardial perfusion (TMP) and its impact on long-term mortality in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Although primary percutaneous coronary intervention restores brisk epicardial flow in approximately 90% of patients with STEMI, normal TMP is less commonly achieved. Tissue myocardial perfusion has been shown to correlate mostly with early clinical outcomes. METHODS: We analyzed the outcomes of 3,267 patients in the HORIZONS-AMI study according to final TMP, assessed by angiographic dynamic (Dyn) and densitometric (Den) methods. Multivariable analysis was performed to identify the independent influence of TMP grade 2/3 on late survival. RESULTS: Dyn TMP 2/3 was achieved in 2,600 patients (79.6%), whereas Den TMP 2/3 was achieved in 2,483 (76.0%). Mortality was significantly lower in those with Dyn TMP 2/3 compared with TMP 0/1 at 30 days (1.1% vs 6.9%, P < .0001) and at 3 years (5.1% vs 11.2%, P < .0001). Similar results were obtained with Den TMP. Dyn TMP 2/3 was an independent predictor of mortality at both time points (HR 0.21, 95% CI 0.12-0.37, P < .0001 and HR 0.53, 95% CI 0.38-0.73, P < .0001, respectively), as was Den TMP. Survival was comparable in patients with TMP 2 and TMP 3. CONCLUSIONS: Angiographic TMP can be assessed reliably using either Dyn or Den methods and is a powerful, independent predictor of early and late mortality after primary percutaneous coronary intervention in STEMI.

Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction.

BACKGROUND: Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies. DESIGN: INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid-left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding. SUMMARY: INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin.

The Firehawk Stent: A Review of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent.

Despite recent advances in drug-eluting stent (DES) technology, late adverse events remain concerns after percutaneous coronary intervention. The persistence of polymer material on DES has been suggested as a trigger for chronic inflammation. The Firehawk, a novel DES, has a unique design with recessed abluminal grooves, to which sirolimus and biodegradable polymer are applied. The Firehawk stent is designed to minimize polymer volume and antiproliferative drug concentration to reduce inflammation and hypersensitivity reactions. Several recent trials have reported the clinical outcomes of this device. This article provides a review of the current clinical evidence concerning the Firehawk stent.

Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial.

OBJECTIVES: We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial. BACKGROUND: The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown. METHODS: A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed. RESULTS: A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents. CONCLUSIONS: Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women.

Outcomes of patients with coronary artery perforation complicating percutaneous coronary intervention and correlations with the type of adjunctive antithrombotic therapy: pooled analysis from REPLACE-2, ACUITY, and HORIZONS-AMI trials.

BACKGROUND: The lack of a specific counteragent to bivalirudin may complicate the management of patients with coronary artery (CA) perforation during percutaneous coronary intervention (PCI). AIM: Assess outcomes of patients with CA perforation from three PCI trials comparing intravenous bivalirudin with provisional glycoprotein (GP) IIb/IIIa inhibition versus unfractionated heparin (UFH) plus GP IIb/IIIa. METHODS: A pooled analysis of patients treated with PCI in three randomized trials including REPLACE-2, ACUITY, and HORIZONS-AMI. RESULTS: Among a total of 12,921 patients, CA perforation occurred in 35 patients (0.27%). By multivariable analysis, baseline creatinine clearance was the only independent predictor of CA perforation (per 10 mL/min decrease, odds ratio [95% confidence interval]= 1.28 [1.11, 1.47], P = 0.0007). At 30 days, patients with versus without CA perforation had significantly (all P values < or =0.001) higher rates of 30-day mortality (11.4% vs. 1.0%), myocardial infarction (MI) [Q wave: 22.9% vs. 5.7%; non-Q wave: 17.1% vs. 4.9%], target vessel revascularization (TVR) [20.1% vs. 1.8%], and composite end-point of death/MI/TVR (31.4% vs. 7.8%). Patients assigned to bivalirudin versus UFH plus a GP IIb/IIIa inhibitor had nonsignificantly lower rates of death (0% vs. 18.8%, P = 0.08), similar rates of MI (26.7% vs. 25.0%, P = 0.92), significantly lower rates of TVR (6.7% vs. 37.5%, P = 0.04), and similar rates of the composite end-point of death/MI/TVR (35.5% vs. 26.7%, P = 0.54). CONCLUSION: In three PCI trials, treatment of patients experiencing CA perforation with adjunctive antithrombotic therapy of bivalirudin monotherapy was not associated with worse outcomes compared to treatment with UFH plus GP IIb/IIIa inhibitors.

Comparison between ticlopidine and clopidogrel in patients undergoing primary stenting in acute myocardial infarction: results from the CADILLAC trial.

OBJECTIVE: The aim of this article is to examine whether clopidogrel and ticlopidine treatments produce similar clinical outcomes for patients receiving primary stenting for acute myocardial infarction (AMI). BACKGROUND: Prior studies have yielded conflicting results on the relative safety and efficacy of clopidogrel and ticlopidine after stent implantation, warranting an evaluation in primary stenting for AMI. METHODS: In the multicenter, prospective CADILLAC trial, patients undergoing primary infarct stenting were treated at operator discretion with either ticlopidine (931 patients) or clopidogrel (163 patients) and then followed for 1 year. Baseline clinical and angiographic characteristics were comparable except for baseline TIMI 0/1 flow (72.5% clopidogrel vs. 63.9% ticlopidine, P = 0.04). RESULTS: Patients receiving clopidogrel had more recurrent ischemia in hospital (6.1 vs. 2.8%, P = 0.02) and at 30 days (10.5 vs. 5.8%, P = 0.02), more moderate and severe bleeding at 30 days (7.4 vs. 2.7%, P = 0.002), and similar rates of stent thrombosis out to 1 year (P = 0.11). By multivariable analysis, clopidogrel use was an independent predictor for recurrent ischemia in hospital (P = 0.0002), and at 30 days (P = 0.012); and of moderate and severe bleeding in hospital (P = 0.002), and at 30 days (P = 0.001). CONCLUSIONS: Despite thienopyridines similarities, their efficacy may be different within the first 30 days of primary stenting for AMI. A prospective, randomized trial is required to confirm these findings.