Key result
The R stent was successfully deployed in 100% of patients with coronary bifurcation lesions, with no major adverse events at 30 days.
Observational (n=28)
The R stent demonstrated procedural feasibility and safety for treating complex coronary bifurcation lesions, with 100% deployment success and no major adverse events at 30 days.
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Supports R stent feasibility in bifurcation lesions; leaves open need for randomized trials before practice change.
BACKGROUND: Percutaneous Coronary Intervention (PCI) of coronary bifurcation lesion is technically quite demanding. It has been associated with a lower procedural success, higher rates of complication and restenosis. Side-branch occlusion and plaque shifting or 'snow plow' effect are not uncommon. Stenting of the main vessel may cause 'stent jail' of the side-branch. Modern stent design may allow passage of a balloon or stent into the side-branch through the struts of the stent placed in the main vessel. A newly developed 316 stainless steel tubular stent, the Rtrade mark stent is uniquely designed to provide flexibility, radial strength on deployment and conformability. Its large cell size facilitates PCI of bifurcation lesion. AIM: To assess the feasibility of R(trade mark) stent in the treatment of symptomatic patients with bifurcation coronary lesions. The main objective was to assess the ease of deployment, side-branch access and overall success of the R(trade mark) stent in this group of patients without any major adverse events. METHODS: Between December 1998 and September 2000 the R(trade mark) stent was used as a main stent in 28 consecutive patients with coronary bifurcation lesions, 46% of which had unstable angina. The mean age was 59 +/- 10 and 89% were male. Adjunctive medical therapy included clopidrogel, aspirin and intraprocedure heparin. Abciximab (ReoPro) was given to 9 patients. RESULTS: Successful stent deployment was achieved in all patients. Thirty-four R Stents and 16 other stents were used. Two patients had post-procedure rise in cardiac enzymes. There were no major adverse events at 30 days. LAD/D1 with LAD/diagonal was the target lesion in the majority of patients. Stenting of the side-branch was done in 18 and balloon dilatation in 9 patients. At 3-23 months (mean 11.8) follow-up, repeat angiography was done in 18 patients with restenosis in 4, two of them had repeat PCI and one had coronary artery bypass graft (CABG). CONCLUSION: Coronary bifurcation lesions are not uncommon. Current advances in stent technology offer a safe and effective revascularisation strategy for such complex lesions. The R(trade mark) stent appears to be a suitable device that provides good wall coverage, radial strength, conformability and easy side-branch access.
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Khan et al. (2001) conducted an observational in Coronary bifurcation lesions (n=28). R stent was evaluated on Ease of deployment, side-branch access and overall success without major adverse events. The R stent was successfully deployed in 100% of patients with coronary bifurcation lesions, with no major adverse events at 30 days.
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