Management of coronary artery disease in patients undergoing transcatheter aortic valve implantation. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions in collaboration with the ESC Working Group on Cardiovascular Surgery.

Significant coronary artery disease (CAD) is a frequent finding in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI), and the management of these two conditions becomes of particular importance with the extension of the procedure to younger and lower-risk patients. Yet, the preprocedural diagnostic evaluation and the indications for treatment of significant CAD in TAVI candidates remain a matter of debate. In this clinical consensus statement, a group of experts from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the European Society of Cardiology (ESC) Working Group on Cardiovascular Surgery aims to review the available evidence on the topic and proposes a rationale for the diagnostic evaluation and indications for percutaneous revascularisation of CAD in patients with severe aortic stenosis undergoing transcatheter treatment. Moreover, it also focuses on commissural alignment of transcatheter heart valves and coronary re-access after TAVI and redo-TAVI.

Safety and efficacy of the NovaCross microcatheter in facilitating crossing of chronic total occlusion coronary lesions: a multicenter, single-arm clinical trial.

BACKGROUND: The aim of this study was to evaluate the safety and efficacy of the novel NovaCross microcatheter system in patients with ischemic heart disease due to coronary chronic total occlusions (CTO). METHODS: A total of 191 subjects between the ages of 25-80 years were recruited in 10 investigational sites. Each subject underwent a percutaneous coronary intervention (PCI) of a CTO lesion using the NovaCross microcatheter, equipped with expandable nitinol scaffolds to enhance guidewire penetration and crossing of the CTO lesion. The primary safety endpoint was procedural major adverse cardiac events [composite of death, myocardial infarction (MI), or urgent target vessel revascularization]. The primary efficacy endpoint was to assess the ability of the NovaCross microcatheter to successfully facilitate the placement of a guidewire beyond a native coronary CTO in the true vessel lumen. After the PCI, subjects remained in hospital until a 12-lead ECG and blood tests for cardiac biomarkers were taken at 3-6 h and 8-16 h post-procedure. RESULTS: No deaths, urgent revascularization, or urgent coronary artery bypass surgery were reported. The reported MI rate according to the protocol definition was 12.3%, and technical success was achieved in 75.3% of the subjects regardless of CTO procedure technique. In 89.2% of the subjects, the NovaCross succeeded in penetrating the proximal CTO cap, and in 25.8% of the subjects, the extendable portion of the NovaCross crossed the full length of the CTO lesion. CONCLUSIONS: The NovaCross met both the primary safety endpoint and the primary efficacy endpoint. We, therefore, conclude that the device is well tolerated, effective, and could be easily adopted by interventional cardiologists.

Comparison of abciximab versus eptifibatide during percutaneous coronary intervention in ST-segment elevation myocardial infarction (from the HORIZONS-AMI trial).

There are limited safety and effectiveness data comparing glycoprotein IIb/IIIa inhibitors in the setting of primary percutaneous coronary intervention. In this substudy of the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, the clinical and bleeding outcomes of eptifibatide versus abciximab were evaluated in patients with ST-segment elevation myocardial infarction who underwent percutaneous coronary intervention. Three-year clinical outcomes of patients in the heparin plus glycoprotein IIb/IIIa inhibitor arm were compared according to treatment with abciximab (n = 907) versus eptifibatide (n = 803). Adjudicated end points included major adverse cardiovascular events (MACEs; mortality, reinfarction, ischemia-driven target vessel revascularization, or stroke), major bleeding, and net adverse clinical events (MACEs or major bleeding). Propensity score matching was used to identify 1,342 matched cases (671 each in the abciximab and eptifibatide groups). Multivariate analysis was performed in the entire cohort and the propensity-matched groups. At 3-year follow-up, eptifibatide and abciximab resulted in nonsignificantly different rates of MACEs (18.3% vs 19.6%, hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.74 to 1.16, p = 0.51), major bleeding (10.7% vs 11.9%, HR 0.90, 95% CI 0.67 to 1.19, p = 0.44), and net adverse clinical events (24.5% vs 25.5%, HR 0.96, 95% CI 0.79 to 1.17, p = 0.69). Similarly, at 3 years by multivariate analysis, there was no statistically significant difference between abciximab and eptifibatide for net adverse clinical events (HR 0.89, 95% CI 0.73 to 1.09, p = 0.27), MACEs (HR 0.96, 95% CI 0.77 to 1.20, p = 0.73), and major bleeding (HR 1.05, 95% CI 0.78 to 1.41, p = 0.75). The propensity-matched groups also had similar outcomes. In conclusion, abciximab and eptifibatide have comparable bleeding risks and clinical efficacy in primary percutaneous coronary intervention.

Impact of bivalirudin therapy in high-risk patients with acute myocardial infarction: 1-year results from the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial.

OBJECTIVES: This study sought to assess the relationship between 1-year mortality and baseline patient risk in the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial. BACKGROUND: The HORIZONS-AMI trial showed that bivalirudin compared with unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI) decreased major bleeding and 30-day and 1-year mortality in patients undergoing primary percutaneous intervention for acute myocardial infarction. METHODS: Patients in the HORIZONS-AMI trial were classified as low, intermediate, and high risk according to the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) risk score based on 7 clinical variables. RESULTS: Among 2,530 CADILLAC-score evaluable HORIZONS-AMI trial patients, 1,522 (60%) were classified as low risk, 531 (21%) as intermediate risk, and 477 (19%) as high risk. The mortality rates in the bivalirudin and UFH plus GPI arms, respectively, were 0.4% and 1.2% (p = 0.09) in the low-risk group, 4.2% and 4.1% (p = 0.99) in the intermediate-risk group, and 8.4% and 15.9% (p = 0.01) in the high-risk group. Among high-risk patients, there was also a decreased rate of recurrent myocardial infarction in patients randomized to bivalirudin as compared to UFH plus GPI (3.6% vs. 7.9%, p = 0.04). CONCLUSIONS: In high-risk patients undergoing primary percutaneous coronary intervention for acute myocardial infarction, bivalirudin compared with UFH plus GPI reduces 1-year mortality and recurrent myocardial infarction. (HORIZONS-AMI trial; NCT00433966).

Coronary plaque dimensions and composition by intravascular ultrasound radio frequency lesion segment analysis in stable and unstable angina patients.

AIMS: We hypothesized that the plaque composition and plaque type classification differs between acute coronary syndrome (ACS) and stable angina (SA) patients. METHODS AND RESULTS: We analyzed culprit lesion (CL) and nonculprit lesion (NCL) of ACS patients compared with target lesion (TL) and nontarget lesion (NTL) of SA patients by intravascular ultrasound radio frequency analysis in 874 lesion segments of 424 patients (ACS: 193 patients/SA: 231 patients). Comparing all lesion segments in ACS and SA patients did not show significant differences in absolute or relative plaque composition. However, necrotic core area was larger in CL versus TL (0.9+/-0.7 vs. 0.7+/-0.5 mm, P=0.005) and all plaque components were significantly higher in CL compared with NCL and TL compared with NTL, respectively. A higher amount of thin cap fibroatheroma lesions (15.2 vs. 5.1%, P<0.0001) was detected in ACS compared with SA patients. Fibrocalcific lesions were lower in ACS patients (3 vs. 10.5%, P<0.0001). CONCLUSION: The differentiation in CL/NCL of ACS and TL/NTL of SA patients revealed significant differences in plaque composition and plaque types when examined by intravascular ultrasound radiofrequency analysis. However, considerable overlap between plaque characteristics exists for ACS and SA patients.

Design and rationale for the Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: a multicenter, prospective, randomized, single-blind trial comparing early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of nonselected autologous bone marrow cells to patients after acute myocardial infarction.

BACKGROUND: Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling. METHODS: The Myocardial Stem Cell Administration After Acute Myocardial Infarction Study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery. The primary end points are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated single photon emission computed tomography [SPECT] scintigraphy) 3 months after BM-SCs therapy. The secondary end points relate to evaluation of (1) the safety and feasibility of the application modes, (2) the changes in left ventricular wall motion score index (transthoracic echocardiography), (3) myocardial voltage and segmental wall motion (NOGA mapping), (4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and (5) the clinical symptoms (Canadian Cardiovascular Society [CCS] anina score and New York Heart Association [NYHA] functional class) at follow-up. Three hundred sixty patients are randomly assigned into 1 of 4 groups: group A, early treatment (21-42 days after AMI) with intracoronary injection; group B, early treatment with combined application; group C, late treatment (3 months after AMI) with intracoronary delivery; and group D, late treatment with combined administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients. CONCLUSIONS: The Myocardial Stem Cell Administration After Acute Myocardial Infarction Trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.