Paclitaxel-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents: The TAXUS V ISR Randomized Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 295; no. 11; pp. 1253 - 1263
• Main Authors: Stone, Gregg W, Ellis, Stephen G, O’Shaughnessy, Charles D, Martin, Steven L, Satler, Lowell, McGarry, Thomas, Turco, Mark A, Kereiakes, Dean J, Kelley, Lynne, Popma, Jeffrey J, Russell, Mary E, TAXUS V ISR Investigators, for the
• Format: Journal Article
• Language: English
• Published: Chicago, IL American Medical Association 15.03.2006
• Subjects: Aged; Angioplasty; Angioplasty, Balloon, Coronary; Biological and medical sciences; Blood vessels; Brachytherapy; Coronary Angiography; Coronary Restenosis - therapy; Drug therapy; Female; General aspects; Humans; Male; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Patient safety; Prospective Studies; Stents; Antineoplastic agent; Endoprosthesis; Metal; Radiotherapy; Medicine; Restenosis; Treatment; Taxane derivatives; Blood vessel; Paclitaxel; Clinical trial; Circulatory system; Antimitotic; Curietherapy; Drug eluting stent; Comparative study
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.295.11.1253

CONTEXT Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy (VBT) affording the best results. The effectiveness of drug-eluting stents in this setting has not been established. OBJECTIVE To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in patients with restenotic lesions after prior stent implantation in native coronary arteries. DESIGN, SETTING, AND PATIENTS Prospective, multicenter, randomized trial conducted between June 6, 2003, and July 16, 2004, at 37 North American academic and community-based institutions in 396 patients with in-stent restenosis of a previously implanted bare-metal coronary stent (vessel diameter, 2.5-3.75 mm; lesion length, ≤46 mm). INTERVENTIONS Patients were randomly assigned to undergo angioplasty followed by VBT with a β source (n = 201) or paclitaxel-eluting stent implantation (n = 195). Clinical and angiographic follow-up at 9 months was scheduled in all patients. MAIN OUTCOME MEASURE Ischemia-driven target vessel revascularization at 9 months. RESULTS Diabetes mellitus was present in 139 patients (35.1%). Median reference vessel diameter was 2.65 mm and median lesion length was 15.3 mm. In the VBT group, new stents were implanted in 22 patients (10.9%) and in the paclitaxel-eluting stent group, multiple stents were required in 57 patients (29.2%), with median stent length of 24 mm. Follow-up at 9 months was complete in 194 patients in the VBT group and 191 patients in the paclitaxel-eluting stent group (96.5% and 97.9%, respectively). For VBT and paclitaxel-eluting stents, respectively, the number of events and 9-month rates for ischemic target lesion revascularization were 27 (13.9%) vs 12 (6.3%) (relative risk [RR], 0.45; 95% confidence interval [CI], 0.24-0.86; P = .01); for ischemic target vessel revascularization, 34 (17.5%) vs 20 (10.5%) (RR, 0.60; 95% CI, 0.36-1.00; P = .046); and for overall major adverse cardiac events, 39 (20.1%) vs 22 (11.5%) (RR, 0.57; 95% CI, 0.35-0.93; P = .02), with similar rates of cardiac death or myocardial infarction (10 [5.2%] vs 7 [3.7%]; RR, 0.71; 95% CI, 0.28-1.83; P = .48) and target vessel thrombosis (5 [2.6%] vs 3 [1.6%]; RR, 0.61; 95% CI, 0.15-2.50; P = .72). Angiographic restenosis at 9 months was 31.2% (53 of 170 patients) with VBT and 14.5% (25 of 172 patients) with paclitaxel-eluting stents (RR, 0.47; 95% CI, 0.30-0.71; P<.001). CONCLUSION Treatment of bare-metal in-stent restenotic lesions with paclitaxel-eluting stents rather than angioplasty followed by VBT reduces clinical and angiographic restenosis at 9 months and improves event-free survival. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00287573Published online March 12, 2006 (doi:10.1001/jama.295.11.1253).