April 1, 1995
View Full PaperA Multicenter, Randomized Trial of Coronary Angioplasty Versus Directional Atherectomy for Patients With Saphenous Vein Bypass Graft Lesions
Key Result
Directional coronary atherectomy for de novo vein graft lesions yielded similar 6-month restenosis rates compared to angioplasty (45.6% vs 50.5%, P=0.491), despite better initial luminal gain.
Study Design
Type
RCT (n=305)
Multicenter
Yes
Structured PICO
Does directional coronary atherectomy improve angiographic outcomes and reduce restenosis compared to angioplasty in patients with de novo saphenous vein bypass graft lesions?
P
Population
305 patients with de novo saphenous vein bypass graft stenoses randomized to atherectomy or angioplasty, with 6-month follow-up.
I
Intervention
Directional coronary atherectomy
C
Comparator
Percutaneous transluminal coronary angioplasty (balloon dilatation)
O
Outcome
Initial angiographic success and 6-month restenosis rates assessed by quantitative coronary angiographysurrogate
Directional atherectomy for de novo vein graft lesions improves initial angiographic success compared to angioplasty but increases distal embolization without reducing 6-month restenosis rates.
Main Result
Absolute Event Rate: 45.6% vs 50.5%
p-value: p=0.491
Abstract
BACKGROUND: Directional coronary atherectomy and percutaneous transluminal coronary angioplasty have both been used in symptomatic patients with coronary saphenous vein bypass graft stenoses. The relative merits of plaque excision and removal versus balloon dilatation remain uncertain. We compared outcomes after directional coronary atherectomy or angioplasty in patients with de novo bypass graft stenoses. METHODS AND RESULTS: Fifty-four North American and European sites randomized 305 patients with de novo vein graft lesions to atherectomy (n = 149) or angioplasty (n = 156). Quantitative coronary angiography at a core laboratory assessed initial and 6-month results. Initial angiographic success was greater with atherectomy (89.2% versus 79.0%), as was initial luminal gain (1.45 versus 1.12 mm, P < .001). Distal embolization was increased with atherectomy (P = .012), and a trend was shown toward more non-Q-wave myocardial infarction (P = .09). Although the 6-month net minimum luminal diameter gain was 0.68 mm for atherectomy and 0.50 mm for angioplasty, the restenosis rates were similar, 45.6% for atherectomy and 50.5% for angioplasty (P = .491). At 6 months, there was a trend toward decreased repeated target-vessel interventions for atherectomy (P = .092); in addition, 13.2% of patients treated with atherectomy versus 22.4% of the angioplasty patients (P = .041) required repeated percutaneous intervention of the initial target lesion. CONCLUSIONS: Atherectomy of de novo vein graft lesions was associated with improved initial angiographic success and luminal diameter but also with increased distal embolization. There was no difference in 6-month restenosis rates, although primary atherectomy patients tended to require fewer target-vessel revascularization procedures.