EXCELLA™ First-in-Man (FIM) study: safety and efficacy of novolimus-eluting stent
in de novo coronary lesions.
Alexandre Abizaid et al
A total of 15 patients were included with 67% being female patients. Diabetes was detected in 47% of the cohort. Angiographic and procedural success was achieved in all patients. At 4-month angiographic follow-up there was in-stent late lumen loss (0.15±0.29 mm) by QCA and % volume obstruction (2.6±2.6) by IVUS. The angiographic in-stent late lumen loss results at eight months were 0.31±0.25mm and % volume obstruction by IVUS was 6.0±4.4%. Late ISA were not observed among these patients and no MACE was evidenced through nine month clinical follow-up. In this first-in-man study, implantation of the novolimus-eluting stent was proven to be feasible, safe and elicited minimum neointimal proliferation.
Novel drug eluting stent system for customised treatment of coronary lesions: CUSTOM I
feasibility trial 24 month results
Eberhard Grube et al
The Custom NX® 36 drug eluting stent (DES) system is designed to treat coronary lesions via in situ stent length customisation. The objective of the non-randomised prospective multicentre CUSTOM I trial was to demonstrate the safety of in situ stent length customisation in 30 consecutive patients. Procedural success was 93%. There were a total of three MACEs reported from enrolment through two year follow-up. In-hospital MACE rate was 2/30, with events in two patients presenting post-procedural non-Q-wave myocardial infarctions without further sequelae. At five months, one patient who had crossed over to PTCA required CABG surgery. One non-cardiac death was reported between one and two year follow-up. There was no in-stent restenosis. This first evaluation of the new customisable Biolimus A9-eluting Custom NX stent suggests safety and efficacy through twenty four month follow-up.
European experience with the retrograde approach for the recanalisation of coronary artery
chronic total occlusions. A report on behalf of the EuroCTO club
Georgios Sianos et al
Recanalisation rates of coronary chronic total occlusions (CTO) remain suboptimal. The retrograde technique was recently introduced to improve success rates. From February 2005 until December 2007, 175 patients were treated with this technique in seven European Centres by highly experienced operators; in 84 (48%) as primary strategy, in 41 (23.5%) immediately after antegrade failure and in 50 (28.5%) as a repeat procedure after previous antegrade failure. The mean occlusion duration was 50.8 months (determined in 32% of patients). The target vessel was: LAD 21%, LCX 6.3%, RCA 71.4%. Epicardial collaterals were accessed in 20.6% and septal in 79.4% of the patients. Overall success rate was 83.4%. The retrograde approach was used with high degree of success and safety and can thus be regarded as a valid contributor to the armamentarium of the modern day interventional cardiologist.
Diabetic patients treated for unprotected left main coronary artery disease with drug eluting stents: a 3-year clinical outcome study. The Diabetes and Drug Eluting stent for LeFT main registry (D-DELFT)
Emanuele Meliga et al
We investigated the very long-term efficacy of percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for unprotected left main coronary artery (ULMCA) disease in a population of 100 consecutive diabetic patients (DM) analysed in seven tertiary care centres. A control group of 193 consecutive non-diabetic patients (nonDM) with ULMCA disease was selected. After three years, major adverse cardiovascular events (MACE) free survival was 63.4% in the DM and 77.6% in the nonDM (p<0.001). No significant differences were found in terms of freedom from cardiac death (CD) and myocardial infarction (MI), target lesion and target vessel revascularisation (TLR and TVR). Insulin-dependent diabetes mellitus was found to be an independent predictor of CD, TLR, TVR and MACE. The decision to perform PCI in this subset of patients should be taken cautiously and on a case by case basis.
The role of thrombectomy and distal protection devices during percutaneous
coronary interventions
Mamas A. Mamas et al
PCI in lesions containing thrombus are associated with an increased risk of complications occurring through dislodgement of thrombotic material resulting and distal embolisation leading to slow flow – or even no – reflow. Devices which remove thrombus from coronary arteries (thrombectomy devices), or protect from distal embolisation of thrombus (distal protection devices), are increasingly used in PCI. We have performed a systematic review of the literature to investigate the role of these devices in PCI in the setting of AMI. Use of thrombectomy devices in randomised and multi-centre trials in patients undergoing PCI during STEMI is associated with a significant benefit in a number of markers of myocardial perfusion including MBG (myocardial blush grade), ST segment resolution and improvement of distal embolisation, although no significant benefits in mortality have been observed.
Chronic total coronary occlusions and the Occluded Artery Trial. A critical appraisal.
Gerald S. Werner et al
One of the highlights of the recent AHA 2006 was the long-awaited presentation of the Occluded Artery Trial (OAT), a commendable effort of a large group of investigators headed by Dr. Judith Hochman to address the open artery hypothesis in a large-scale randomised trial. The open artery hypothesis was a widely accepted concept despite the absence of confirmation from randomised controlled trials. The question now arises whether the new data presented by the OAT trial indeed replace and forfeit the open artery concept. The present comment and discussion of the OAT trial will address these issues on the basis of a critical analysis of the published data, and discuss strength but also pitfalls and shortcomings of these data. We will also try to better define the patient population for whom the conclusions drawn by the authors and commentators are applicable.
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