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CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY

The impact of lesion length and reference vessel diameter on angiographic restenosis and target vessel revascularization in treating in-stent restenosis with radiation

^* Cardiovascular Research Institute, Washington Hospital Center, Washington, D.C., USA

Manuscript received May 24, 2001; revised manuscript received January 7, 2002, accepted January 18, 2002.

^* Reprint requests and correspondence: Dr. Ron Waksman, 110 Irving Street, NW, Suite 4B-1, Washington, DC 20010, USA
ron.waksman{at}medstar.net

OBJECTIVES: The study assessed the influence of lesion length and reference vessel diameter (RVD) on recurrent restenosis after gamma intracoronary radiation therapy (ICRT) for in-stent restenosis (IRS).

BACKGROUND: Intracoronary radiation therapy reduces angiographic and clinical restenosis in patients with ISR. The impact of ICRT on challenging subgroups, such as long lesions and small vessels, has not been established.

METHODS: Six-month quantitative coronary angiography and clinical follow-up were conducted to evaluate the influence of lesion length and RVD in patients with ISR treated with ICRT who were enrolled in gamma radiation trials. Angiographic binary restenosis (>50% diameter stenosis) and clinical events were assessed in 311 patients treated with gamma ICRT and 105 patients who received placebo.

RESULTS: Baseline demographic, angiographic and procedural details were similar in the two treatment groups. The ICRT group had reduced binary restenosis in vessels of all sizes (30% vs. 66%, p < 0.001), with the most benefit seen in small vessels. A trend toward reduced restenosis with ICRT was found across all lesion lengths. At six months, major adverse cardiac events (MACE) were reduced in the ICRT group compared to placebo (34% vs. 71%, p < 0.0001), driven by reduced target vessel revascularization (27% vs. 71%, p < 0.0001). The independent predictors of angiographic restenosis include ICRT (OR [odds ratio] 0.16; CI [confidence interval] 0.10 to 0.28, p < 0.001), lesion length (OR 1.03; CI 1.01 to 1.05, p = 0.004) and RVD (OR 0.40; CI 0.23 to 0.67, p < 0.001).

CONCLUSIONS: Intracoronary radiation therapy, compared to placebo, results in a significant reduction of angiographic restenosis across all vessel sizes, with a trend toward reduction of angiographic restenosis across all lesion lengths; this effect is seen predominantly in small vessels and diffuse lesions.

Abbreviations and Acronyms   CI   confidence interval   ICRT   intracoronary radiation therapy   ISR   in-stent restenosis   IVUS   intravascular ultrasound   LTO   late total occlusion   LVEF   left ventricular ejection fraction   MACE   major adverse cardiac events   MI   myocardial infarction   MLD   minimal luminal diameter   OR   odds ratio   PTCA   percutaneous transluminal coronary angioplasty   QCA   quantitative coronary angiography   RVD   reference vessel diameter   SCRIPPS   Scripps Coronary Radiation to Inhibit Proliferation Post Stenting   TLR   target lesion revascularization   TVR   target vessel revascularization   WRIST   Washington Radiation for In-Stent restenosis Trial

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