|Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials.|
|PMID: 20129555 Owner: NLM Status: MEDLINE|
|OBJECTIVES: We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS).
BACKGROUND: Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown.
METHODS: From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis > or =50%) was determined.
RESULTS: The post-intervention IVUS MSA was similar in PES and BMS (6.6 +/- 2.5 mm(2) vs. 6.7 +/- 2.3 mm(2), p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm(2) for PES and 6.4 mm(2) for BMS.
CONCLUSIONS: Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748).
|Hiroshi Doi; Akiko Maehara; Gary S Mintz; Alan Yu; Hong Wang; Lazar Mandinov; Jeffrey J Popma; Stephen G Ellis; Eberhard Grube; Keith D Dawkins; Neil J Weissman; Mark A Turco; John A Ormiston; Gregg W Stone|
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|Type: Comparative Study; Journal Article; Multicenter Study|
|Title: JACC. Cardiovascular interventions Volume: 2 ISSN: 1876-7605 ISO Abbreviation: JACC Cardiovasc Interv Publication Date: 2009 Dec|
|Created Date: 2010-02-04 Completed Date: 2010-04-22 Revised Date: 2014-09-05|
Medline Journal Info:
|Nlm Unique ID: 101467004 Medline TA: JACC Cardiovasc Interv Country: United States|
|Languages: eng Pagination: 1269-75 Citation Subset: IM|
|Data Bank Information|
Bank Name/Acc. No.:
|ClinicalTrials.gov/NCT00301522; NCT00371423; NCT00371475; NCT00371748|
|APA/MLA Format Download EndNote Download BibTex|
Angioplasty, Balloon, Coronary / adverse effects, instrumentation*
Cardiovascular Agents / administration & dosage*
Clinical Trials as Topic
Coronary Artery Disease / physiopathology, therapy*, ultrasonography
Coronary Restenosis / etiology, physiopathology, ultrasonography*
Paclitaxel / administration & dosage*
Predictive Value of Tests
Thrombosis / etiology, physiopathology, ultrasonography
|0/Cardiovascular Agents; 0/Metals; 33069-62-4/Paclitaxel|
JACC Cardiovasc Interv. 2009 Dec;2(12):1276-8
JACC Cardiovasc Interv. 2010 Mar;3(3):364 [PMID: 20299000 ]
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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