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Long-Term Clinical Safety and Efficacy of Paclitaxel-Eluting TAXUS Stent in Complex Lesions: Three-Year Results

This article presents the three-year results of a randomized trial comparing the TAXUS MR stent with bare metal controls in complex lesions. The study shows that the TAXUS MR stent provides a clinical benefit in treating patients with complex lesions, confirming its long-term safety and efficacy.

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Long-Term Clinical Safety and Efficacy of Paclitaxel-Eluting TAXUS Stent in Complex Lesions: Three-Year Results

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  1. TAXUS VIRandomized Trial of Moderate-Rate Release Polymer-Based Paclitaxel-Eluting TAXUS Stent for the Treatment of Longer Lesions Three Year Clinical Results Keith D. Dawkins MD FRCP FACC Southampton University Hospital, United Kingdom on behalf of TAXUS VI Investigators

  2. TAXUS VI: Background Double-blinded, randomized, superiority trial comparing TAXUS MR stent with bare metal controls in complex lesions. The commercially unavailable MR stent releases 3x the amount of Paclitaxel than the SR stent. • Lesion length (mean, mm) 20.6 ± 7.6 • Stented length (mean, mm) 33.4 ± 10.5 • Overlapping stents 27.8 % • Type C lesions (AHA/ACC) 55.6 % • Diabetics 20.0 % The most complex lesions and procedures of any DES trial

  3. Randomized Patients N=446 9-Mo Clinical FU 437/441 (99.0%) Control N=220 TAXUS MR N=217 24-Mo Clinical F/U 428/434 (98.6%) Control N=214 TAXUS MR N=214 36-Mo Clinical F/U 420/428 (98.1%) Control N=210 TAXUS MR N=210 Study flow

  4. Freedom from Target Lesion Revascularization to 3 Years 1 Year 2 Years 3 Years 100% 91.7 % 90.3 % 88.4 % 90% P=0.005 Freedom of TLR log rank 80% TAXUS MR Control 80.0 % 79.1 % 79.1 % 70% Days Since Index Procedure Number Needed to Treat to avoid 1 TLR = 10.75

  5. Three Year MACE Composition *Chi-Square test †Fisher’s Test

  6. Stent thrombosis at 3 Years

  7. Conclusions: • Numerous studies involving simpler lesions have shown a clinical benefit in treating patients with DES, but TAXUS VI remains the trial that has recruited patients with the most complex lesions • Follow-up rates are exceedingly high, adding confidence to the reliability of the data • The TAXUS TLR benefit extends to the more complex lesions, justifying real world clinical practice • These results confirm the long-term (three year) clinical safety and efficacy of the TAXUS MR stent

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