ABSTRACT
BACKGROUND: Vascular (VBT) has clearly been shown in multiple clinical trials to decrease restenosis rates for in-stent restenosis (ISR). However, patients enrolled in these randomized clinical trials represent a select group, and the efficacy of VBT in patients with ISR who were excluded from these controlled trials due to more complex coronary anatomy requires further investigation. This study sought to define the angiographic and clinical profile and outcomes of these high-risk patients with ISR who were excluded from the randomized clinical trials and who received VBTusing Strontium-90 (Sr-90) using the Novoste Beta-Cath System through a Compassionate Use Protocol (CUP). METHODS: The study was designed as a single center, prospective, open label registry trial evaluating the use of VBT on complex instent restenotic lesions in patients who were excluded from the START and START 40 trials. In general, these patients included those with saphenous vein graft (SVG) lesions, long lesions (>35 mm), and patients with a history of more than three prior interventions. VBT using Sr-90 was delivered using the Novoste Beta-Cath System after successful angioplasty. The predetermined primary endpoint was freedom from target vessel revascularization (TVR) at 8 months, one and two years. The secondary endpoint was a composite of death, myocardial infarction (MI) and TVR at 8 months, one year, and two years. RESULTS: Between September 4, 1998 and December 6, 2000, 32 patients were treated with VBT under the UCP protocol. The mean duration of follow up was 15.3 +/- 8.3 months. There were 9 major cardiac events at eight months including one death, one acute myocardial infarction and 7 TVR. Excluding the one patient who died, 33 lesions were available for follow-up. The rate of TVR in this high-risk patient population was 21.1% (n = 7/33 lesions). The method of revascularization included one bypass surgery and 6 repeat percutaneous coronary interventions. CONCLUSIONS: This trial demonstrates that utilization of the Beta-Cath System using Sr-90 for the treatment of ISR in a patient population excluded from the randomized clinical trials due to unfavorable lesions characteristics is feasible appears to be associated TVR rates that compare favorably with the event rates of patients enrolled in other trials enrolling lower-risk groups.
Subject(s)
Angioplasty, Balloon, Coronary/adverse effects , Brachytherapy/methods , Coronary Restenosis/radiotherapy , Coronary Stenosis/therapy , Stents/adverse effects , Aged , Angioplasty, Balloon, Coronary/methods , Coronary Restenosis/diagnostic imaging , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/mortality , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Radiography , Radiology, Interventional , Risk Assessment , Severity of Illness Index , Single-Blind Method , Survival Rate , Treatment OutcomeABSTRACT
BACKGROUND: The cutting balloon (CB) is an emerging therapy for the treatment of instent restenosis (ISR), but its impact on the clinical outcomes of patients treated with intracoronary radiation therapy (IRT) with Sr-90 compared with conventional PTCA and IRT is not clearly defined. METHODS: We compared the baseline demographics, angiographic characteristics and clinical outcomes of 102 consecutive patients with ISR treated either with CB+IRT (n=45) or with conventional PTCA+IRT (n=57). The combined endpoint was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of death, myocardial infarction (MI) or target vessel revascularization (TVR) at 6 months. RESULTS: The CB+IRT group had a shorter mean lesion length (14.3+/-6.5 vs. 21.1+/-15.7, P=.009), and greater utilization of glycoprotein IIb/IIIa inhibitors during the procedure (48.9% vs. 26.3%, P=.02) compared to the PTCA+IRT group. There were no significant differences in the baseline demographics, angiographic and procedural results, or subsequent MACE at 6 months between the two groups. CONCLUSION: The strategy of CB+IRT using Sr-90 for ISR is associated with similar procedural and clinical outcomes compared to conventional PTCA+IRT. Further study is warranted to determine which patient subgroups would derive the most benefit from this approach.
Subject(s)
Beta Particles/therapeutic use , Graft Occlusion, Vascular/therapy , Stents , Strontium Radioisotopes/therapeutic use , Aged , Angioplasty, Balloon , Blood Vessel Prosthesis Implantation , Clinical Trials as Topic , Female , Follow-Up Studies , Graft Occlusion, Vascular/etiology , Humans , Male , Middle Aged , Myocardial Infarction/etiology , Myocardial Infarction/therapy , Platelet Glycoprotein GPIIb-IIIa Complex/therapeutic use , Prospective Studies , Random Allocation , Stents/adverse effects , Treatment OutcomeSubject(s)
Brachytherapy/methods , Coronary Restenosis/prevention & control , Coronary Restenosis/radiotherapy , Heart Transplantation , Stents/adverse effects , Angioplasty, Balloon, Coronary , Beta Particles/therapeutic use , Cardiac Catheterization/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Ischemia/therapy , Treatment OutcomeABSTRACT
We report a case of a 70-year-old male who was undergoing elective angioplasty of the left anterior descending coronary artery. During the procedure, a coronary guidewire became unraveled after positioning an undeployed stent; we describe its successful retrieval by removal of the undeployed stent. Although sidebranch protection and placement of a stent with the guidewire left in place is commonly performed without complication, it should be realized that this practice is not without hazard because of the unusual, but serious consequences that could ensue if the entrapped wire were to unravel.
