Anouar Belkacemi

First Results of the DEB-AMI (Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction) Trial A Multicenter Randomized Comparison of Drug-Eluting Balloon Plus Bare-Metal Stent Versus Bare-Metal Stent Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention With 6-Month Angiographic, Intravascular, Functional, and Clinical Outcomes

OBJECTIVES The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI). BACKGROUND Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis. METHODS In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed. RESULTS Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C. CONCLUSIONS In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765).

A multicenter randomized comparison of drug‐eluting balloon plus bare‐metal stent versus bare‐metal stent versus drug‐eluting stent in bifurcation lesions treated with a single‐stenting technique: Six‐month angiographic and 12‐month clinical results of the drug‐eluting balloon in bifurcations trial

Percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug‐eluting stents (DES). Paclitaxel drug‐eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T‐stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T‐stenting technique with a DEB plus bare‐metal stent (BMS) versus BMS versus paclitaxel DES.

Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study.

Coronary bifurcation lesions, which account for 15-20% of all lesions treated percutaneously, remain hampered by procedural difficulties, post-procedural complications and suboptimal long-term results, even with the introduction of the drug-eluting stent (DES). Side branch (SB) restenosis rates remain a drawback even in the provisional T-stenting technique with final kissing balloons. The introduction of drug-eluting balloons (DEB) creates a new hope for this technique by maintaining the relatively easy provisional T-technique but promising better long term outcomes for the SB treated with DEB. The DEB delivers locally a high concentration of an anti-restenotic drug, paclitaxel, thereby potentially reducing restenosis rates as compared to a regular balloon. However little is still known on the optimal use and long-term outcomes of DEB in bifurcations. First results of the DEBIUT study will help to understand future directions in development of this new and promising device.

Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: the nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial.

To evaluate a paclitaxel drug‐eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and paclitaxel eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST‐Segment Elevation Myocardial Infarction (DEB‐AMI) trial.

Diagnostic accuracy of optical coherence tomography parameters in predicting in-stent hemodynamic severe coronary lesions: Validation against fractional flow reserve

BACKGROUND By means of optical coherence tomography (OCT), coronary dimensions can be assessed accurately. However, whether OCT can identify hemodynamic significant coronary lesions as determined by fractional flow reserve (FFR) in patients with an in-stent lesion is not known. Therefore, we tried to assess the predictive value of OCT parameters in this setting as compared to FFR. METHODS AND RESULTS In patients who underwent a percutaneous coronary intervention for an in-stent restenotic lesion, pre-, post-procedural and 6-month follow-up OCT and FFR acquisitions were performed. In case of an FFR ≤ 0.80, a lesion was classified as hemodynamically severe. Diagnostic efficiency of several OCT parameters were assessed with receiver operating characteristic curves. In 27 patients, 66 coupled OCT and FFR segments were analyzed and compared. The diagnostic efficiencies of OCT-based minimal luminal diameter (MLD) and minimal luminal area (MLA) are good, with an area under the curve (AUC) of 0.83 (95% confidence interval: 0.74-0.93) and 0.83 (0.73-0.93), and a best cutoff value of 1.77 mm (sensitivity 74% and specificity 78%) and 2.54 mm(2) (sensitivity 71% and specificity 84%), respectively. The diagnostic efficiency of OCT-based maximum neointimal area is moderate [AUC 0.73 (0.61-0.85)], and regarding maximum neointimal area stenosis, it is poor [0.39 (0.25-0.53)]. The corresponding best cutoff values are 5.01 mm(2) (sensitivity 66% and specificity 72%) and 49% (sensitivity 40% and specificity 66%), respectively. CONCLUSIONS With OCT, a good diagnostic efficiency can be achieved in identifying coronary severity in in-stent lesions in a per-group analysis. This hallmark provides an extra dimension, next to morphological information, when acquiring OCT images in scientific studies. However, OCT seems limited in a per-patient clinical decision making process due to reasonable but limited sensitivity and specificity in predicting coronary severity.

Drug-eluting balloons and bifurcations, a new future?

J161 Current perspective In recent years, the drug-eluting balloon (DEB) technology has emerged as a potential alternative to drug-eluting stents (DES) to prevent restenosis. The DEB technology has demonstrated safety and efficacy in the porcine model of restenosis and in randomised clinical trials for patients with in-stent restenosis. Nevertheless, the technology carries challenges in release kinetics, ability to overcome elastic recoil, and concerns whether it can be coupled successfully to bare metal stents. The active substance on a DEB should be lipophilic enough to have a high absorption rate through the vessel wall, compensating for the short time of contact between the inflated balloon and the vessel wall itself, and to maintain sustained effect once released. The drug of choice at this moment seems to be paclitaxel. Paclitaxel was identified as the primary drug for DEB with the ability to retain in the vessel wall for nearly a week. Paclitaxel is a broad-spectrum antimitotic agent that inhibits cell division in the G2/M phase, stabilising the polymerised microtubules, and thus inhibiting cell replication of the smooth muscle cells and by that reducing neointimal hyperplasia. Cells have been shown to contain effective doses of paclitaxel in vivo experiments for at least six days, even when plasma levels of paclitaxel were below the detection limit. Currently there are several commercially available DEB in Europe (all CE approved) which all use paclitaxel as an active drug. However the coating and release methods are quite different. It has been demonstrated that the coating method, next to the active substance paclitaxel, highly determines the efficacy of a DEB.

Automated 3D analysis of multislice computed tomography to define the line of perpendicularity of the aortic annulus and of the implanted valve: Benefit on planning transcatheter aortic valve replacement

We aimed to determine whether preprocedural analysis of multislice computed tomography (MDCT) scan could accurately predict the “line of perpendicularity” (LP) of the aortic annulus and corresponding C‐arm angulations required for prosthesis delivery.

Aortic dissection, a complication during successful angioplasty of chronic total occlusion of the right coronary artery, was treated conservatively.

Aortic dissection is an uncommon but potentially lethal complication that can occur during the engagement of a guiding catheter. We report a case of a 59-year-old woman with acute aortic dissection due to percutaneous coronary intervention. This resulted in a retrograde extension of the dissection into the proximal part of the ascending aorta. With haemodynamic stability, we decided to treat the aortic dissection medically. As a result, a complete resolution of the aortic dissection was documented by coronary angiography and the follow-up computed tomography scan.

Optical coherence tomography assessment of early stent strut coverage in patients treated with a thin-strut bare cobalt-chromium stent coated with silicon carbide.

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Angiographic fate of side branch dissections in bifurcation lesions treated with a provisional single stenting strategy: a post-hoc analysis of the international multicenter randomized DEBIUT study.

The provisional single stenting strategy is currently the preferred treatment strategy in bifurcation lesions. However, in case of nonflow limiting side branch (SB) dissections, it is not clear whether outcomes may be inferior to coronaries without a SB dissection, whether it can be safe to leave a SB dissection untreated, and whether bail‐out SB stenting provides benefits over conservative treatment.