Abstract
Restenosis remains a major limitation of coronary angioplasty in spite of major advances in techniques and technology. Recent studies have demonstrated that ionizing radiation may limit the degree of this problem. Gamma radiation has been shown to be effective in reducing in stent restenosis in humans, and beta radiation following encouraging results in animals has been shown to be feasible in humans. The objective of this study was to assess the feasibility of a 5 F non-centered catheter to deliver beta radiation emitting seeds to the lesion site post angioplasty and its effect on restenosis.
Following successful angioplasty, patients were randomized to treatment with 12, 14 or 16 Gy at the angioplasty site. This was delivered with a 5 F non-centered catheter. Twelve beta radiation emitting seeds (90Sr/Y) were delivered to an area 3 cm in length to cover the angioplasty site. Angiographic follow-up was performed at 6 months. Baseline and follow-up angiograms were performed by blinded investigators at a core laboratory.
This interim report comprises the first 35 patients to complete 6-month angiographic follow-up. There were no major radiation incidents. Four patients had evidence of angiographic restenosis. The MLD (mm) and percent stenosis were 0.77±0.27/72.5±8.6 pre angioplasty, 2.08±0.4/25.7±9.8 post angioplasty and radiation and 2.05±0.59/25.7±19.8 at follow-up respectively.
Conclusion: Beta radiation can be feasibly and safely delivered post coronary angioplasty with a very encouraging reduction of restenosis.
Zusammenfassung
Trotz größerer Fortschritte bleibt die Restenose die entscheidende Limitation der PTCA. Kürzlich durchgeführte Studien haben gezeigt, daß ionisierende Strahlen das Ausmaß dieses Problems begrenzen können. Gammastrahlung ist zur Reduktion der Instentrestenose auch bei Patienten effektiv, für Betastrahlen gibt es sowohl in Tieruntersuchungen als auch bei Patienten ermutigende Ergebnisse. Das Ziel dieser Studie war festzustellen, ob die Verwendung eines nicht zentrierten 5 F-Katheters zur Verabreichung von betastrahlenden Zylindern einen Effekt auf die Restenose nach PTCA aufweist.
Im Anschluß an eine erfolgreiche PTCA wurden die Patienten zur Behandlung mit 12, 14 oder 16 Gy randomisiert. Zwölf betastrahlende Zylinder («seeds») mit90Sr/Y wurden über eine Länge von 3 cm appliziert, um die PTCA-Stelle abzudecken. Die Kontrollangiographie erfolgte nach sechs Monaten. Die Auswertung der Ausgangs-und Kontrollangiogramme wurde entsprechend eines doppelblinden Protokolls durchgeführt.
Dieser Zwischenbericht umfaßt die ersten 35 Patienten, bei denen die Sechs-Monats-Kontrollangiographie durchgeführt wurde. Es gab keine größeren Strahlenunfälle. Bei vier Patienten kam es zu einer angiographisch definierten Restenose. Der minimale Lumendurchmesser (MLD) betrug 0,77±0,27 mm und die Durchmesserstenose 72,5±8,6% (vor PTCA), 2,08±0,4 mm und 25,7±9,8% nach PTCA und Bestrahlung sowie 2,05±0,59 mm und 25,7±19,8% bei Kontrollangiographie.
Schlußfolgerung
Eine Betabestrahlung kann einfach und sicher nach PTCA durchgeführt werden, die Ergebnisse zur Verhinderung der Restenose sind ermutigend.
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Meerkin, D., Bonan, R., Crocker, I.R. et al. Efficacy of beta radiation in prevention of post-angioplasty restenosis. Herz 23, 356–361 (1998). https://doi.org/10.1007/BF03043600
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DOI: https://doi.org/10.1007/BF03043600