Clinical and Procedural Evaluation of the Nile Croco® Dedicated Stent for Bifurcation – Six-month Clinical Follow-up Results of the Nile Croco Registry

Clinical and Procedural Evaluation of the Nile Croco® Dedicated Stent for Bifurcation – Six-month Clinical Follow-up Results of the Nile Croco Registry

Angel Joan, Brenot Philippe , Candell Jaume, del Blanco Bruno Garcia, Ferreira Ignacio, Ffalu Ricardo, Garcia-Dorado David, Marti Gerard, Otaegui Imanol, Royer Thierry
Interventional Cardiology - Volume 3 - Issue I
Published: November 2008
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A true bifurcated lesion in coronary atherosclerotic disease is present in approximately 15% of patients referred for percutaneous coronary intervention (PCI).1 The percutaneous approach to this especially complex scenario has been faced in many different ways depending on the techniques available at any particular time.2–4 In the last few years, the introduction of drug-eluting stents (DES) has remarkably improved the outcome in bifurcation lesions compared with using baremetal stents (BMS), resulting in fewer adverse events and lower main branch (MB) restenosis rates.5–7 However, the most suitable approach to the side branch (SB) remains uncertain. Although the initial ‘provisional’ stenting technique (i.e. stenting of the SB after MB stenting only in cases of suboptimal or inadequate result) is probably the prevailing approach, the four stent techniques that allow the stenting of both branches (i.e. crush, V, T, culottes) are appealing. However, even if the strategy of stenting both branches when the SB stenosis is suitable for stenting is promising, data in the literature indicate that clinical outcomes are better if routine usage of the two-stent strategy is avoided.8

The introduction of dedicated stents may be supposed to be an attractive strategy for approaching the different types of bifurcation lesion. These stents are specifically designed to provide good deliverability, secured access to the SB and complete coverage of the lesion site without double/triple layers of stent struts. They also incorporate the benefits of drug elution and ensure drug availability to all diseased surfaces. The objective of the observational multicentre Nile Croco Registry was to assess the angiographic and six-month clinical results of a cohort of patients with bifurcation lesions who underwent PCI with dedicated stents.

Methods

Patients and Lesions
From May 2005 to December 2007, 103 consecutive patients were enrolled in the Nile Croco International registry at two French sites and on Spanish sites (Centre Cardiologique d’Evecquemont, Centre Cardiologique du Nord and University Hospital Vall d’Hebron). The main inclusion criteria were:

  • stable, unstable angina or silent ischaemia;
  • presumed new bifurcation lesion in a main vessel with a reference diameter ≥2.5mm (visually assessed); and
  • an SB diameter ≥2.0mm.


Patients with two- or three-vessel disease were included if the other vessel lesions could presumably be successfully treated by PCI or were not tributary for either PCI or coronary bypass graft (CABG). In addition, patients with other lesions in the same vessel were included if these were proximal to the bifurcation lesion.

The major exclusion criteria were:

  • presence of non-cardiac severe pathology or life expectancy of less than six months;
  • bifurcation lesion type 0,0,1 according to the Medina Classification9 (type 4b according to Massy class);
  • presence of thrombus in the target lesion;
  • severely tortuous coronary vessel;
  • calcifications proximal to the target lesion; and
  • left main coronary lesion or left anterior descending artery (LAD) lesion involving the ostia.


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