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Prospective, Randomized, Multicenter Comparison of Laser-Facilitated Balloon Angioplasty Versus Stand-Alone Balloon Angioplasty in Patients With Obstructive Coronary Artery Disease - LAVA
Description:
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.
Hypothesis:
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.
Study Design
Study Design:
Patients Enrolled: 215
Patient Populations:
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.
Exclusions:
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.
Primary Endpoints:
Six-month composite incidence of freedom from death, MI, or need for CABG or repeat PTCA
Secondary Endpoints:
Procedural and clinical success, and quantitative angiographic analysis data
Drug/Procedures Used:
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.
Concomitant Medications:
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.
Principal Findings:
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).
Interpretation:
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.
References:
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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