Randomized evaluation of intralesion versus intracoronary abciximab and aspiration thrombectomy in patients with ST-elevation myocardial infarction: The COCTAIL II trial.

BACKGROUND: Thrombus burden and distal embolization are predictive of no-reflow during primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI). We sought to compare the efficacy of pharmacological and catheter-based strategies for thrombus in patients with STEMI and high atherothrombotic burden. METHODS: Between January 2012 and December 2013, 128 STEMI patients undergoing primary PCI at 5 centers were randomly assigned in a 2 × 2 factorial design to intracoronary (IC) abciximab bolus (via the guide catheter) versus intralesion (IL) abciximab bolus, each with versus without aspiration thrombectomy (AT). Study end points were residual intrastent atherothrombotic burden, defined as the number of cross-sections with residual tissue area >10% as assessed by optical coherence tomography, and indices of angiographic and myocardial reperfusion. RESULTS: Residual intrastent atherothrombotic burden did not significantly differ with IL versus IC abciximab (median [interquartile range] 6.0 [1-15] vs 6.0 [2-11], P = .806) and with AT versus no aspiration (6.0 [1-13] vs 6.0 [2-12], P = .775). Intralesion abciximab administration was associated with improved angiographic myocardial reperfusion in terms of thrombolysis in myocardial infarction (TIMI) flow (3 [3-3] vs 3 [2-3], P = .040), corrected TIMI frame count (12 ± 5 vs 17 ± 16, P = .021), and myocardial blush grade (3 [2-3] vs 3 [2-3], P = .035). In particular, IL abciximab was associated with higher occurrence of final TIMI 3 flow (90% vs 73.8%, P = .032) and myocardial blush grade 3 (71.6% vs 52.4%, P = .039). Conversely, AT had no significant effect on indices of angiographic or myocardial reperfusion. CONCLUSIONS: In patients with STEMI and high thrombotic burden, neither IL versus IC abciximab nor AT versus no aspiration reduced postprocedure intrastent atherothrombotic burden in patients with STEMI undergoing primary PCI. However, IL abciximab improved indices of angiographic and myocardial reperfusion compared to IC abciximab, benefits not apparent with AT.

Randomized trial of standard versus ClearWay-infused abciximab and thrombectomy in myocardial infarction: rationale and design of the COCTAIL II study.

BACKGROUND: Patients with ST-elevation myocardial infarction (STEMI) are at substantial risk of suboptimal procedural results and late adverse events. Angiography and optical coherence tomography (OCT) studies have identified residual coronary thrombus and microcirculatory injury as potential culprits for these adverse outcomes. We hypothesized that coronary thrombectomy and local infusion of glycoprotein IIb/IIIa inhibitors by means of a dedicated infusion device can synergistically improve results of percutaneous coronary intervention (PCI) for STEMI, as appraised by OCT. METHODS: A total of 128 patients with STEMI will be randomized, to one of the following: abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A), thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration (groups C or T+C) will result in a significant reduction of intrastent thrombus formations when compared with intravenous or intracoronary abciximab with or without thrombectomy (groups A or T+A). The primary endpoint will be the number of cross-sections with thrombus area more than 10% immediately after stent implantation as assessed with OCT. Additional angiographic, ECG and clinical endpoints will be collected and adjudicated. CONCLUSION: This trial will provide important mechanistic insights on the most appropriate invasive treatment strategy for patients with STEMI and significant thrombus burden, by exploiting its factorial design and reliance on sensitive OCT endpoints.

Reproducibility of coronary optical coherence tomography for lumen and length measurements in humans (The CLI-VAR [Centro per la Lotta contro l'Infarto-VARiability] study).

Frequency-domain optical coherence tomography (FD-OCT) is becoming a useful diagnostic tool for coronary imaging for quantitative coronary analysis. Second-generation FD-OCT produces detailed coronary lumen images. However, the reproducibility of coronary measurements using FD-OCT in humans has not been thoroughly explored. Our goal was to determine the intraobserver, interobserver, and interpullback reproducibility of the in vivo FD-OCT measurements of the lumen area and/or lesion length. Twenty-five patients undergoing coronary angioplasty were included. In all subjects, FD-OCT pullbacks (20 mm/s) were acquired twice from the same coronary segment different from the target lesion, at an interval of 5 minutes, with no other intervention. A total of 9,396 cross-sectional lumen area frames and the relative coronary lesion length of each pullback were analyzed off-line with dedicated software by 2 independent expert readers (A and B). We compared the lumen area and length measurements as follows: pullback 1, read by reader A twice at an interval of 7 days (intraobserver analysis); pullback 1, independently read by readers A and B (interobserver comparison); and pullback 1 versus pullback 2, read by reader A (interpullback comparison). The per-segment and per-frame analyses showed very high and significant correlation coefficients for the interobserver, intraobserver, and interpullback comparisons for the lumen area and lesion length (R ≥0.95 and p <0.001 in all cases). Accordingly, the Bland-Altman estimates of bias showed nonsignificant differences in the interobserver, intraobserver, and interpullback comparisons at all levels, with average biases never >0.150 mm(2) for the lumen area or 0.200 mm for the lesion length. In conclusion, coronary imaging using FD-OCT showed excellent reproducibility, with low intraobserver, interobserver, and interpullback variability for both lumen area and lesion length measurements in humans. Thus, FD-OCT can be proposed for precise analysis in the catheterization laboratory to guide decision making and in clinical trials focusing on imaging end points.

Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study.

AIMS: Angiographic guidance for percutaneous coronary intervention (PCI) has substantial limitations. The superior spatial resolution of optical coherence tomography (OCT) could translate into meaningful clinical benefits. We aimed to compare angiographic guidance alone versus angiographic plus OCT guidance for PCI. METHODS AND RESULTS: Patients undergoing PCI with angiographic plus OCT guidance (OCT group) were compared with matched patients undergoing PCI with angiographic only guidance (Angio group) within 30 days. The primary endpoint was the one-year rate of cardiac death or myocardial infarction (MI). A total of 670 patients were included, 335 in the OCT group and 335 in the Angio group. OCT disclosed adverse features requiring further interventions in 34.7%. Unadjusted analyses showed that the OCT group had a significantly lower one-year risk of cardiac death (1.2% vs. 4.5%, p=0.010), cardiac death or MI (6.6% vs. 13.0%, p=0.006), and the composite of cardiac death, MI, or repeat revascularisation (9.6% vs. 14.8%, p=0.044). Angiographic plus OCT guidance was associated with a significantly lower risk of cardiac death or MI even at extensive multivariable analysis adjusting for baseline and procedural differences between the groups (OR=0.49 [0.25-0.96], p=0.037) and at propensity-score adjusted analyses. CONCLUSIONS: This observational study, the first ever formally to appraise OCT guidance for PCI decision-making, suggests that the use of OCT can improve clinical outcomes of patients undergoing PCI.