PMID- 17938126 OWN - NLM STAT- MEDLINE DCOM- 20080619 LR - 20181201 IS - 0195-668X (Print) IS - 0195-668X (Linking) VI - 28 IP - 21 DP - 2007 Nov TI - TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions. PG - 2578-82 AB - AIMS: Drug-eluting stents (DESs) have shown to be effective in reducing in-stent restenosis, although data relating to long-term experience in treating more complex lesion subsets are limited. In order to assess the long-term safety and clinical efficacy of the polymer-based moderate release (MR) paclitaxel-eluting TAXUS MR stent in treatment of complex lesion subsets, we evaluated the 2-year follow-up of TAXUS VI. METHOD AND RESULTS: TAXUS VI was a randomized multi-centre study enrolling 446 patients with complex lesions, including small vessels in 28% of patients and a mean lesion length of 20.6 mm. At 9-month follow-up, the use of the TAXUS MR stent was highly effective, resulting in a significant 53% reduction of the target vessel revascularization (TVR) rate (primary endpoint) from 19.4% in the control group to 9.1% in the TAXUS group (P = 0.0027). Clinical follow-up at 2 years post-stenting was available in 98.6% of the TAXUS group and 95.6% of the control group. The incidence of major adverse cardiac event at 1- and 2-year follow-up was 16.4% and 21.3% in the TAXUS group when compared with 22.5 and 25.1% in the control group, respectively. A significant difference in TVR was maintained at 2-year follow-up (TAXUS 13.9%; control 21.9%; P = 0.0335). The cumulative 1- and 2-year survival rates free from TVR were, respectively, 91.7 and 90.3% in the TAXUS group vs. 80.0 and 79.0% in the control group (log-rank P < 0.001). The number of patients required to be treated with a TAXUS stent to prevent one re-percutaneous coronary intervention at 2 years was 12.5. CONCLUSION: Treatment of complex coronary lesions with the polymer-based MR paclitaxel-eluting TAXUS MR stent is associated with a sustained clinical benefit and low rates of TVR up to 2 years after device implantation. FAU - Grube, Eberhard AU - Grube E AD - HELIOS Heart Center Siegburg, Siegburg, Germany. grubee@aol.com FAU - Dawkins, Keith D AU - Dawkins KD FAU - Guagliumi, Giulio AU - Guagliumi G FAU - Banning, Adrian P AU - Banning AP FAU - Zmudka, Krzysztof AU - Zmudka K FAU - Colombo, Antonio AU - Colombo A FAU - Thuesen, Leif AU - Thuesen L FAU - Hauptman, Karl AU - Hauptman K FAU - Marco, Jean AU - Marco J FAU - Wijns, William AU - Wijns W FAU - Popma, Jeffrey J AU - Popma JJ FAU - Buellesfeld, Lutz AU - Buellesfeld L FAU - Koglin, Joerg AU - Koglin J FAU - Russell, Mary E AU - Russell ME LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20071014 PL - England TA - Eur Heart J JT - European heart journal JID - 8006263 RN - 0 (Fibrinolytic Agents) RN - 0 (Platelet Aggregation Inhibitors) RN - 0 (Polymers) RN - A74586SNO7 (Clopidogrel) RN - OM90ZUW7M1 (Ticlopidine) RN - P88XT4IS4D (Paclitaxel) RN - R16CO5Y76E (Aspirin) SB - IM CIN - Eur Heart J. 2007 Nov;28(21):2559-60. PMID: 17938127 MH - Aspirin/administration & dosage MH - Clopidogrel MH - Coronary Artery Disease/mortality/*therapy MH - Coronary Restenosis/*prevention & control MH - Coronary Thrombosis/etiology MH - Drug-Eluting Stents/adverse effects/*standards MH - Epidemiologic Methods MH - Female MH - Fibrinolytic Agents/*administration & dosage MH - Humans MH - Male MH - Middle Aged MH - Myocardial Revascularization/methods MH - Paclitaxel/*administration & dosage MH - Platelet Aggregation Inhibitors/administration & dosage MH - Polymers/administration & dosage MH - Ticlopidine/administration & dosage/analogs & derivatives EDAT- 2007/10/17 09:00 MHDA- 2008/06/20 09:00 CRDT- 2007/10/17 09:00 PHST- 2007/10/17 09:00 [pubmed] PHST- 2008/06/20 09:00 [medline] PHST- 2007/10/17 09:00 [entrez] AID - ehm424 [pii] AID - 10.1093/eurheartj/ehm424 [doi] PST - ppublish SO - Eur Heart J. 2007 Nov;28(21):2578-82. doi: 10.1093/eurheartj/ehm424. Epub 2007 Oct 14.