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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Randomized Comparison of Sirolimus and Paclitaxel Drug-Eluting Stents for Long Lesions in the Left Anterior Descending Artery

An Intravascular Ultrasound Study

Cardiology Unit, Cardiothoracic Department, University of Pisa, Pisa, Italy.

Manuscript received July 5, 2006; revised manuscript received September 22, 2006, accepted September 27, 2006.

^_* Reprint requests and correspondence: Dr. Anna S. Petronio, Dipartimento Cardiotoracico, Ospedale Cisanello, Via Paradisa, 2, 56124 Pisa, Italy. (Email: a.petronio{at}ao-pisa.toscana.it).

OBJECTIVES: The goal of this work was to verify whether the superiority of the sirolimus-eluting stent (SES) in inhibiting neointimal hyperplasia could be demonstrated in complex coronary lesions.

BACKGROUND: Both the SES (Cypher, Cordis, Miami Lakes, Florida) and the paclitaxel-eluting stent (PES) (Taxus, Boston Scientific, Natick, Massachusetts) have shown a marked reduction in neointimal hyperplasia compared with bare-metal stents. Intravascular ultrasound (IVUS) is the best method to assess arterial response to stent deployment, but few IVUS data are available comparing complex lesions treated with SES or PES.

METHODS: We prospectively randomized patients with complex lesions to SES or PES implantation. Intravascular ultrasound and quantitative angiography were performed post-procedure and at 9 months. Mean neointimal hyperplasia area (NIHA), percent of NIHA (NIHA%), mean peristent plaque area (PSPA), and percent of PSPA (PSPA%) were calculated. The primary end point was NIHA% at follow-up. Secondary end points included change in PSPA% and angiographic late luminal loss at follow-up.

RESULTS: Of the 100 patients enrolled, 42 receiving the SES and 43 receiving the PES had adequate IVUS assessment. Vessel, plaque, and lumen areas were comparable at follow-up, but NIHA% was significantly lower with SES than PES (7.4 ± 4.2% vs. 15.4 ± 8.1%; p < 0.001). A significant reduction in PSPA% was observed with SES (–4 ± 10% vs. 0 ± 8%; p = 0.01). Late loss was significantly lower with SES (0.16 ± 0.19 mm vs. 0.32 ± 0.33 mm; p = 0.003).

CONCLUSIONS: The SES shows a significantly higher inhibition of neointimal hyperplasia compared with PES in complex lesions. However, both stents have excellent IVUS and angiographic results at 9 months. A significant reduction in peri-stent plaque is observed only with SES.

Abbreviations and Acronyms   IVUS = intravascular ultrasound   LL = late luminal loss   MLA = minimal lumen area   MLD = minimal luminal diameter   NIHA = mean neointimal hyperplasia area   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent   PSPA = mean peristent plaque area   RVD = reference vessel diameter   SES = sirolimus-eluting stent

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