Five-year outcomes of ST-elevation myocardial infarction versus non-ST-elevation acute coronary syndrome treated with biodegradable polymer-coated sirolimus-eluting stents: Insights from the CREATE trial.

BACKGROUND: Long-term outcome of drug-eluting stents (DES) for ST-elevation myocardial infarction (STEMI) versus non-ST-elevation acute coronary syndrome (NSTE-ACS) remains unclear. This study sought to compare the long-term outcomes of biodegradable polymer-coated DES in patients with STEMI versus NSTE-ACS. METHODS: We explored a post hoc analysis of the 5-year outcome of the CREATE trial in the subgroup of patients with STEMI (n=318) versus NSTE-ACS (n=1223) who were implanted with biodegradable polymer-coated DES. The primary outcome was the rate of major adverse cardiac events (MACE) at 5 years. Clopidogrel and aspirin for 6 months followed by chronic aspirin therapy were recommended. RESULTS: STEMI patients showed a trend of increase in MACE (8.7% vs. 6.8%, log rank p=0.289) compared to NSTE-ACS patients at 5 years, and a greater risk of cardiac death (5.4% vs. 2.1%, log rank p=0.003), mainly driven by the higher cardiac death rate within the first month after stent placement (log rank p=0.003) and the last year of follow-up (log rank p=0.001). No significant difference in stent thrombosis was found between them (3.1% vs. 2.5%, log rank p=0.653). Prolonged clopidogrel therapy (>6 months) showed no effect on risk of MACE or stent thrombosis between the two groups (both p for interaction >0.1). CONCLUSIONS: STEMI patients have a higher risk of cardiac mortality compared with NSTE-ACS patients after biodegradable polymer-coated DES placement, primarily attribute to more cardiac deaths that happened within the first month after the event and the last year of follow-up.

Correlation between dual-axis rotational coronary angiography and intravascular ultrasound in a coronary lesion assessment.

The purpose of this study was to evaluate the accuracy of dual-axis rotational coronary angiography (DARCA) for coronary lesion assessment by directly comparing with intravascular ultrasound (IVUS). From October 2014 to December 2015, 40 patients (58 lesions) who had undergone both DARCA and IVUS were included in the image analysis. The minimum lumen diameter (MLD), lesion length, reference vessel diameter (RVD) and percent diameter stenosis at the same lesion, were identified and assessed. Significant correlation with IVUS was found for DARCA in either lesion length (r = 0.90, P < 0.001) or RVD (r = 0.81, P < 0.001) comparison. DARCA had fair correlation with IVUS for both MLD (r = 0.65, P < 0.001) and diameter stenosis (r = 0.48, P < 0.001). From the Bland-Altman plots, there was a good agreement between DARCA and IVUS regarding MLD (mean difference: -0.23 mm, 95 % limits of agreement: -0.96 to 0.50 mm) and RVD (mean difference: -0.15 mm, 95 % limits of agreement: -0.85 to 0.55 mm), while lesser agreement was found on lesion length (mean difference: -3.39 mm, 95 % limits of agreement: -12.63 to 5.85 mm) and diameter stenosis (mean difference: 4.82 %, 95 % limits of agreement: -17.05 to 26.68 %). There is an adequate correlation and agreement between DARCA and IVUS in coronary lesion assessment.

Design and Rationale of the APELOT Trial: A Randomized, Open-Label, Multicenter, Phase IV Study to Evaluate the Antiplatelet Effect of Different Loading Dose of Ticagrelor in Patients With Non-ST Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

Ticagrelor is a direct acting on the P2Y12 receptor blocker, which provides faster and greater platelet inhibition than clopidogrel. However, several studies suggested that in ST-segment elevation myocardial infarction patients undergoing percutaneous coronary intervention (PCI), ticagrelor exhibits initial delay in the onset of antiplatelet action. Unlike ST-segment elevation myocardial infarction, in non-ST-segment elevation acute coronary syndrome (NSTE-ACS), management pathways are highly variable, and some patients may require surgery. Effect of higher loading dose (LD) of ticagrelor in patients with NSTE-ACS in providing faster and stronger inhibition of platelet aggregation is unknown and needs to be explored further.The AntiPlatelet Effect of different Loading dOse of Ticagrelor trial is an interventional, randomized, open-label, multicenter, phase IV trial designed to evaluate whether a high LD (360 mg) of ticagrelor compared with the conventional LD (180 mg) will result in a higher inhibition of platelet aggregation without increasing bleeding events in NSTE-ACS participants undergoing PCI.A total of 250 NSTE-ACS participants will be randomized to receive a ticagrelor LD (360 or 180 mg), followed by a maintenance dose of 90 mg twice a day (bid) starting 12 hours after the LD. The primary endpoint is platelet reactivity index measured by vasodilator-stimulated phosphoprotein phosphorylation 2 hours after the LD, and the secondary endpoints include occurrence of periprocedural myocardial infarction and bleeding events.The AntiPlatelet Effect of different Loading dOse of Ticagrelor trial will provide important information on the risks and benefits of a high LD (360 mg) of ticagrelor in achieving a faster and stronger platelet inhibition compared with the conventional LD (180 mg) in NSTE-ACS patients undergoing PCI.

Randomized study on the safety and efficacy of dual-axis rotational versus standard coronary angiography in.

BACKGROUND: Dual-axis rotational coronary angiography (DARCA) was developed as an innovative adaptation of rotational angiography (RA), but it requires a longer coronary injection compared to standard coronary angiography (SA). As the body of the average Chinese patient is smaller than that of most western patients, with the same contrast injection time, the risk of complications from the contrast agent is increased in this population. The purpose of this study was to assess the clinical safety and efficacy of DARCA in the diagnosis of coronary artery disease (CAD) in the Chinese population by directly comparing it to SA. METHODS: Two hundred Chinese patients were randomized to either the SA group (n = 100) or DARCA group (n = 100). Contrast utilization, radiation exposure and procedure time were recorded for each modalities. Blood pressure (BP), heart rate (HR) pre and post injection symptoms and any arrhythmias were recorded. RESULTS: Compared to the SA group, there was a 42% reduction in contrast utilization, 55% reduction in radiation exposure and a 31% shorter procedure time in the DARCA group. In both groups, there were slight declines in the systolic BP values in the left coronary artery (LCA) post injection (P < 0.01). Moreover, post injection HRs for the LCA were also reduced in the DARCA group (P < 0.01). But all of these changes were small, transient and without clinical importance. Only one patient (1%) in the DARCA group had an attack of ventricular tachycardia immediately post injection and it resolved by itself during LCA angiography. No arrhythmias occurred in the SA group. CONCLUSION: DARCA is a safe, efficient, and clinically comparable alternative to SA in the diagnosis of coronary artery disease in the Chinese population with less contrast utilized, which is less radiation exposure and a shorter procedure time than SA.

Long-term effects of biodegradable versus durable polymer-coated sirolimus-eluting stents on coronary arterial wall morphology assessed by virtual histology intravascular ultrasound.

BACKGROUND: The durable presence of polymer coating on drug-eluting stent (DES) surface may be one of the principal reasons for stent thrombosis. The long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent (BSES) in vivo remained unclear. METHODS: Forty-one patients were enrolled in this study and virtual histology intravascular ultrasound (VH-IVUS) was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES (DSES) during long-term follow-up (median: 8 months). The incidence of necrotic core abutting to the lumen was evaluated at follow-up. RESULTS: With similar in-stent late luminal loss (0.15 mm (0.06-0.30 mm) vs. 0.19 mm (0.03-0.30 mm), P = 0.772), the overall incidence of necrotic core abutting to the lumen was significantly less in BSES group than in DSES group (44% vs. 63%, P < 0.05) (proximal 18%, stented site 14% and distal 12% in BSES group, proximal 19%, stented site 28% and distal 16% in DSES group). The DSES-treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts (73% vs. 36%, P < 0.01). In addition, more multiple necrotic core abutting to the lumen was observed in DSES group (overall: 63% vs. 36%, P < 0.05). Furthermore, when the stented segments with necrotic core abutting to the lumen had been taken into account only, DSES-treated lesions tended to contain more multiple necrotic core abutting to the lumen through the stent struts than BSES-treated lesions (74% vs. 33%), although there was no statistically significant difference between them (P = 0.06). CONCLUSIONS: By VH-IVUS analysis at follow-up, a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs. The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on DES surface biodegraded as time went by.

Coronary plaque characterization of nonculprit or nontarget lesions assessed by analysis of in vivo intracoronary ultrasound radio-frequency data.

BACKGROUND: Unheralded sudden death and acute myocardial infarction are common manifestations of coronary atherosclerosis. Such events are related to thrombotic occlusion at the site of non-flow limiting atherosclerotic plaques in epicardial coronary arteries. This study aimed to assess plaque characterization of nonculprit lesions in patients with acute coronary syndrome (ACS) compared with those with stable angina pectoris (SAP) determined by analysis of intravascular ultrasound (IVUS) radiofrequency (RF) data. METHODS: In 81 patients, nonculprit vessels with < 50% diameter stenosis and nontarget segment of culprit vessels with < 50% diameter stenosis were studied with IVUS. Tissue maps were reconstructed from RF data using IVUS-Virtual Histology software. RESULTS: Mean lipid core percentage was significantly higher in patients with ACS than in those with SAP ((25.78 +/- 6.30)% vs (9.11 +/- 4.90)%, P < 0.001). In addition, patients with SAP showed more fibrotic vessels ((59.66 +/- 16.87)% vs (49.07 +/- 10.20)%, P < 0.001). There was no significant difference in either mean calcium ((4.37 +/- 2.40)% vs (5.12 +/- 3.00)%, P = 0.225) or fibrolipid ((24.94 +/- 9.40)% vs (25.82 +/- 13.60)%, P = 0.731) percentages in nonculprit vessels, but the mean calcium percentage was significantly higher in nontarget lesions of culprit vessels ((5.51 +/- 3.29)% vs (3.57 +/- 2.10)%, P = 0.003). In addition, there was a positive correlation between lipid core and remodeling index (RI) (r = 0.847, P < 0.001) and a negative correlation between fibrous tissue and RI (r = -0.946, P < 0.001). CONCLUSIONS: In this study, in both nonculprit vessels and nontarget lesion of culprit vessels, plaque characterization of nonculprit lesions determined by spectral analysis of IVUS RF data was significantly different in patients with ACS. The percentage of lipid core was significantly higher in patients with ACS than in those with SAP. Conversely, SAP patients showed more fibrotic content. In vivo plaque composition and morphological changes were related to remodeling of the coronary artery tree.