Prospective, Randomized, Multicenter Comparison of Laser-Facilitated Balloon Angioplasty Versus Stand-Alone Balloon Angioplasty in Patients With Obstructive Coronary Artery Disease - LAVA
The Laser Angioplasty Versus Angioplasty (LAVA) was a multicenter, randomized trial designed to examine the acute and late outcomes of laser-facilitated percutaneous transluminal coronary angioplasty (PTCA) versus standard PTCA.
Plaque debulking with lasing before PTCA may result in improved lumen dimensions and decreased rates of periprocedural ischemic complications, thus improving short- and long-term outcomes after percutaneous intervention.
Patients Enrolled: 215
Entry criteria were nonrestrictive and included patients ≥18 years old, with no upper age limit, with primary or restenotic lesions in a native coronary artery or saphenous vein bypass graft. Patients with stable or unstable angina were randomized.
Patients presenting with an acute MI within 24 hours of the procedure were excluded. Patients were also excluded for specific laser contraindications, including an index lesion that was on a bend >60°, if the reference segment was <2.0 mm in diameter or if excessive proximal tortuosity or heavy calcification was present. The presence of a chronic total occlusion was not an exclusion criterion itself; however, randomization occurred only after the lesion was successfully crossed with a guide wire, and thus nonrecanalizable total occlusions were excluded.
Six-month composite incidence of freedom from death, MI, or need for CABG or repeat PTCA
Procedural and clinical success, and quantitative angiographic analysis data
After left ventriculography and coronary arteriography, if suitable coronary anatomy was present for study entry, patients were randomized to laser (n=117) or standard PTCA (n=98) after the index lesion was successfully wired. Clinical follow-up was scheduled for one, three, and six months after the procedure.
Patients were pretreated with ≥324 mg of aspirin daily for ≥24 hours and calcium channel blocking agents. Intravenous heparin was administered to maintain an activated clotting time >350 seconds. Intracoronary nitroglycerin (≥100g) was given before intervention.
There were no major differences in baseline demographic characteristics by treatment group except for a higher rate of previous myocardial infarction (MI) in the laser-treated group. With the exception of a higher rate of thrombus in the laser group, baseline angiographic characteristics were similar. Final post-PTCA residual stenosis did not differ between the two groups, nor did dissection (16.8% for laser vs. 15.9% for PTCA, p=0.85) or procedural success (96.6% vs. 96.9%, p=0.88).
Procedural complications were significantly more frequent in patients undergoing laser treatment than stand-alone PTCA and the only correlate predictive of procedural complications was randomization to laser treatment (odds ratio 7.5, p=0.002). Postprocedural MI was more common in laser-treated patients than the PTCA only group (4.3% vs. 0%, p=0.04). There was no difference in cumulative survival at six months (96.4% and 96.7% for the laser and PTCA groups, respectively, p=0.90) and cumulative survival free from MI, coronary artery bypass graft (CABG), and repeat PTCA (71.1% vs. 76.5% for the laser and PTCA groups, respectively, p=0.55). Similarly, there was no difference in cumulative survival at 12 months (96.4% and 96.7% for the laser and PTCA groups, respectively, p=0.90) and cumulative survival free from MI, CABG, and repeat PTCA (64.9% vs. 66.5% for the laser and PTCA groups, respectively, p=0.55).
Among patients with acute coronary syndrome, no acute or late benefits of holmium laser-facilitated PTCA versus stand-alone PTCA were found. Procedural complications were significantly increased by lasing before PTCA, and as a result, the rate of periprocedural MI was increased. The present trial does not support the use of laser angioplasty as an everyday tool.
Stone GW, de Marchena E, Dageforde D, et al. Prospective, randomized, multicenter comparison of laser-facilitated balloon angioplasty versus stand-alone balloon angioplasty in patients with obstructive coronary artery disease. The Laser Angioplasty Versus Angioplasty (LAVA) Trial Investigators. J Am Coll Cardiol 1997;30:1714-21.
Keywords: Odds Ratio, Myocardial Infarction, Follow-Up Studies, Heparin, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Calcium, Angioplasty, Laser, Thrombosis, Saphenous Vein, Coronary Artery Bypass, Lasers, Solid-State, Nitroglycerin
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