Advice
Appendix
Contents
Data tables
Table 1: Overview of the COCTAIL trial (Prati et al. 2010, 2011)
Table 2: Summary of results from the COCTAIL trial (Prati et al. 2010, 2011)
Table 3: Overview of the Crystal AMI trial (Dave, 2010)
Table 1 Overview of the COCTAIL trial (Prati et al. 2010, 2011)
|
Study component |
Description |
|
Objectives/hypotheses |
To investigate whether local abciximab delivery to the site of an intracoronary thrombus is more effective than intracoronary bolus infusion in patients with acute coronary syndromes undergoing percutaneous coronary intervention and downstream clopidogrel administration. |
|
Study design |
Randomised controlled trial |
|
Intervention |
Abciximab (0.25 mg/kg) given through a ClearWay RX catheter Comparator: Abciximab (0.25 mg/kg) given through a guiding catheter |
|
Setting |
Coronary care units in Rome and Catania in Italy and Warsaw, Poland. The date of the trial recruitment was not given but it is believed to be between 2001 (when the protocol was published) and 2010. |
|
Inclusion/exclusion criteria |
Inclusion criteria: Patients with unstable angina, NSTEMI or STEMI undergoing primary PCI, with a significant lesion in the culprit artery indicative of local thrombus (thrombus score ≥50 according to OCT. Exclusion criteria: Myocardial ischaemia precipitated by a condition other than atherosclerotic disease, use of a fibrinolytic agent within 14 days before randomisation, use of abciximab or any other glycoprotein IIb/IIIa inhibitor within 30 days before randomisation, suspected active internal bleeding or history of haemorrhagic diathesis, major surgery, biopsy of a parenchymal organ, eye surgery or serious trauma, gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks before randomisation, history of CVA or TIA within the previous 2 years or any CVA with a residual neurological deficit, administration of oral anticoagulants within 7 days before randomisation unless prothrombin time 1.2 or less times control (or international normalised ratio ≤1.4) or ongoing treatment with oral anticoagulant, known current platelet count <100,000 cells/µl, intracranial neoplasm, arteriovenous malformation, aneurysm or aneurysm repair, known allergy to abciximab or other murine proteins, known positive pregnancy test for women of childbearing age. |
|
Primary outcomes |
The primary outcome was change in thrombus burden defined by the thrombus score. This was assessed on the semi-quantitative assessment of thrombus (number of involved quadrants in the cross-sectional OCT images) and the longitudinal extension of the thrombus. Myocardial blush grade, TIMI frame count, arterial profile and clinical events at 30 days and 1 year were also measured. |
|
Statistical methods |
Categorical variables presented as counts and percentages and compared with chi-square or Fisher's exact tests. Continuous variables presented as mean±SD and compared with Student's t test. |
|
Patients included |
50 patients were included. ClearWay RX group: n=25, 72% men, mean age 62.7±9.2 years; 12% unstable angina, 48% NSTEMI, 40% STEMI. Control group: n=25, 68% men, mean age 64.4±10.3 years; 8% unstable angina, 56% NSTEMI, 36% STEMI. No difference in proportions with hypertension, diabetes mellitus, hyperlipidaemia, smoking, family history, prior MI, prior CABG, target vessel. |
|
Results |
See table 2 |
|
Author's conclusions |
Local intracoronary delivery of abciximab through a ClearWay RX catheter significantly reduces thrombus burden, with the potential to improve coronary microcirculation and reduce major event rates. |
|
Abbreviations: CABG, coronary artery bypass graft; CVA, cerebrovascular accident; MI. myocardial infarction; µl, microlitre; n, number of patients; NSTEMI, non-ST-elevated myocardial infarction; OCT, optical coherence tomography; SD, standard deviation; STEMI, ST-elevated myocardial infarction; TIA, transient ischaemic attack; TIMI, thrombolysis in myocardial infarction. |
|
Table 2 Summary of results from the Coctail trial (Prati et al. 2010, 2011)
|
ClearWay |
Control |
Analysis |
|
|
Randomised |
n=25 |
n=25 |
|
|
Efficacy |
n=20 |
n=21 |
|
|
Primary outcome: thrombus score (mean±SD) |
68.8±44.8 |
85.4±52.7 |
p=0.393 |
|
Selected secondary outcomes: |
|||
|
Diameter stenosis (%, mean±SD) |
5.94±3.27 |
11.21±9.07 |
p=0.022 |
|
TIMI frame count (mean±SD) |
15.3±10.2 |
21.1±9.9 |
p=0.049 |
|
Mean myocardial blush grade (%, mean±SD) |
2.78±0.43 |
2.59±0.62 |
p=0.303 |
|
Clinical events at 30 days |
0% |
0% |
Not applicable |
|
Safety – procedure-related MI |
10% |
43% |
p=0.018 |
|
MACE at 1 year |
5.9% |
27.2% |
p=0.046 |
|
Target lesion revascularisation at 1 year |
5.9% |
21.6% |
p=0.126 |
|
Abbreviations: MACE, major adverse coronary events; MI, myocardial infarction; n, number of patients; SD, standard deviation; TIMI, thrombolysis in myocardial infarction. |
|||
Table 3 Overview of the Crystal AMI trial (Dave, 2010)
|
Study component |
Description |
|
|
Objectives/hypotheses |
To investigate whether delivery of intracoronary abciximab with ClearWay RX leads to better ST resolution, higher MBG, improved TIMI flow and smaller infarct size than intravenous abciximab during STEMI percutaneous coronary intervention. |
|
|
Study design |
Single-centre, prospective randomised controlled trial. Pilot proof-of-concept trial, not powered to show statistical differences. 30 day follow‑up. |
|
|
Intervention |
Intracoronary abciximab given through a ClearWay RX catheter. Comparator: intravenous abciximab. |
|
|
Setting |
No information given. |
|
|
Inclusion/exclusion criteria |
Inclusion criteria: Patients with STEMI, having PCI within 6 hours of symptom onset, and given heparin and 600 mg clopidogrel. No exclusion criteria were reported. |
|
|
Outcomes |
Primary: myocardial blush grade. Secondary: TIMI flow, ST resolution, LV function at discharge. |
|
|
Patients included |
50 patients were included, 48 were randomised. ClearWay RX group: n=25, 23 men, mean age 62±25 years. Control group: n=23, 18 men, mean age 65±23 years. |
|
|
Results |
||
|
Intracoronary abciximab through ClearWay RX |
Intravenous abciximab |
|
|
Primary outcome: Myocardial blush grade |
Grade >2: 23/25 (92%) Grade 3: 18/25 (72%) |
Grade >2: 20/23 (87%a) Grade 3: 12/23 (52%) |
|
Selected secondary outcomes: |
||
|
TIMI flow |
TIMI 0 flow: 1/25 TIMI 3 flow: 24/25 (96%) |
TIMI 2 flow: 4/23 (96%) TIMI 3 flow: 19/25 (82%) |
|
ST resolution |
80% (21/25) |
70% (18/23) |
|
LV function at discharge |
Not reported |
Not reported |
|
Readmissions |
n=0 |
n=2 |
|
Safety – deaths |
n=0 |
n=1 |
|
Author's conclusions |
Intracoronary abciximab is safely and effectively delivered via ClearWay RX and produced higher MBG scores and a trend towards higher ST-segment resolution. |
|
|
Abbreviations: MBG, myocardial blush grade; PCI, percutaneous coronary intervention; STEMI, ST-elevated myocardial infarction. a Incorrectly reported as 86%. |
||