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Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease
EVOLVING
TECHNOLOGIES
coronary angioplasty (ELCA). Design: Retrospectiveanalysis of comprehensivedata collected at time of initial procedure and during planned follow-up intervals. Setting:There were 35 participating institutions throughout the United States. Patients: The study population was comprised of 3,069 patientswho had successfulELCA and completed follow-up at 6 months, representing91% of eligible cases.Forty percent had prior balloon angioplasty and 34% had prior bypasssurgery. Measurements:Patient symptomatology was assessedby Canadian Cardiovascular Society functional (CCSF) class.Interim adverseclinical events [death, Q wave myocardial infarction (QMI), repeat intervention, bypass surgery, and a compositeend-point] were tracked. Twentysix pre-ELCA clinical, angiographic and procedural variableswere evaluated to assesstheir ability to predict outcome. Results:At 6 months, there was 2.8% mortality, 2.5% incidence of QMI, and 28.7% required either repeat intervention or bypasssurgery. Overall, 69.2% of patientshad no adverse event. In this cohort, the pre-ELCA CCSF class gradewas2.7 -+ 1.2, but at 6 months, it was0.7 ? 1.1 (p < 0.001). The multivariate predictors of the composite end point were gender, stenosislocation, and rest and unstable angina. Conclusions:There is an excellent 6 month out-
ing a low dependent
Effect of lntracoronary Saline Infusion on Dissection During Excimer Laser Coronary Angioplasty: A Randomized Trial LI. Deckelbaum, M.K. Natarajan, ].A. Bittl, K. Rohlfs, J. Scott, R. Chisholm, K.A. Bowman, B.H. Strauss. Section of Cardiology, West Haven VA Medical Center, Yale University School of Medicine, West Haven, CT, J Am Coll Cardiol I995;26:1264-9.
Objectives:We sought to evaluate whether intracoronary saline infusion during excimer laser coronary angioplasty decreasesthe incidence of significant laser-induced coronary artery dissections.Background:Despiteprocedural successrates >90%, coronary artery dissectionsoccur in 17% to 27% of excimer laser coronary angioplasty procedures. Excimer laser irradiation of blood results in vapor bubble formation and acoustomechanicaltrauma to the vesselwall. Salineinfusion into a coronary artery may minimize blood irradiation and consequentarterial wall damage.Methods:In this prospective, randomized, controlled study, consecutive patients undergoing excimer laser coronary angioplasty were randomly assignedto conventional laserirradiation in a blood medium or to laserirradiation with blood displacement by intracoronary salineinfusion. In the patients randomized to intracoronary salineinfusion, prewarmed normal saline was injected through the coronary artery guide catheter at a rate of 1 to 2 ml/s using a power injector. The incidence and severity of dissectionafter excimer laserablation were evaluated in a core laboratory by angiographers with no knowledge of treatment assignment.The severity of coronary artery dissectionwas rated on an ordinal scaleof 1 to 5. Dissections of grade 2 or higher were considered significant. Results:The mean (+ SE) dissectiongrade after laser angioplasty in patients treated with intracoronary saline infusionwas 0.43 2 0.13 comparedwith 0.91 t 0.26 in patients undergoing laser angioplasty in a blood medium. The incidence of significant dissection was 7% in salinetreated patients compared with 24% in conventionally treated patients (p < 0.05). No significant complications were associatedwith saline infusion. Conclusions: Intra-
come after successful ELCA in this selected population with complex coronary artery disease. The majority of patients without interim events enjoy significant alleviation of symptoms. The predictors of adverse events are clinical rather than angiographic.
Predictors of Restenosis After Excimer Laser Coronary Angioplasty Z.M.B. Ghazzal, E. Burton, W.S. Weintraub, F. Litvack, D.A. Rothbaum, L Klein, S.B. King Ill. Emory University Hospital, Atlanta, GA. Am J Cardiol 1995;75:1012-4.
One hundred twenty-five lesionssuccessfullytreated with excimer laser coronary angioplasty at 3 centers were analyzed in a central core laboratory using detailed quantitative angiographic analysis.Sixty-seven narrowings had restenosis(250% diameterstenosisat restudy). Correlatesof restenosiswere asfollows: baselinediameterstenosiswas 79% in the restenosisgroup versus 71% in the group without restenosis(p = 0.0002), baselineminimal diameterstenosiswas 0.55 mm in the restenosisgroup versus 0.72 mm in the group without restenosis(p = 0.006), final diameter stenosiswas40% in the restenosisgroup versus32% in the group without restenosis(p = 0.002), lesion length 27 mm was present in 43% of the restenosisgroup versus 21% in the group without restenosis(p = 0.009), and Thrombolysis in Myocardial Infarction trial flow 0 to 2 was 33% in the restenosisgroup versus15% in the group without restenosis (p = 0.025). The strongest multivariate correlate of restenosis was the baseline Whereas most predictors
coronary saline infusion should be incorporated excimer laser coronary angioplasty procedures.
CURRENT
JOURNAL
into all
Randomised Trial of Excimer laser Angioplasty Versus Balloon Angioplasty for Treatment of Obstructive Coronary Artery Disease Y.E.A. Appelman, J.J. Pick, S. Strikwerda, J.G.P. Tijssen, P.J. De Feyter, G.K. David, P.W. Sermys, J.R. Margolis, Il.]. Koelemay, E.W.J. Montauban van Swijndregt J.J. Koolen. University of Amsterdam, Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands. lancet 1996;347:79-84.
Background:Excimer laser coronary angioplasty is reported to give excellent procedural resultsfor treatment of complex
diameter stenosis (p = 0.003). were not controllable, achievKC
residual diameter stenosis that is operatorcan favorably influence the restenosis rate.
REVIEW
37
July/.4u~usl
1996
EVOLVING
TECHNOLOGIES
coronary lesions, but this method has not been compared with balloon angioplasty in a randomised trial. Methods: Patients (n = 308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 15 1 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical end-points were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic end-point was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography. Findings: Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty, There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4.6%, 10.6%, and 21.2%, respectively, of the patients in the laser angioplasty group compared with 5.7%, 10.8%, and 18.5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0.40 (0.69) mm in patients treated with laser angioplasty and 0.48 (0.66) mm in those treated with balloon angioplasty (p = 0.34). The restenosis rate (>50% diameter stenosis) was 51.6% in the laser angioplasty group versus 41.3% in the balloon angioplasty group (p = 0.13). Interpretation: Excimer laser angioplasty plasty provides no benefit plasty alone with respect clinical and angiographic obstructive coronary artery
completion of 6-month follow-up angiography with 53 successfully treated balloon angioplasty lesions according to vessellocation, preprocedural minimal lumen diameter and referencediameter. Immediate and long-term angiographic resultswere assessed by an automatedlumen contour detection algorithm. Results:Before intervention in the laserand balloon angioplasty groups, respectively, minimal lumen diameter was 0.73 -f 0.47 and 0.74 f- 0.46 mm, and referencediameter was 2.71 + 0.42 and 2.72 f 0.41 mm. Laserangioplasty was followed by adjunctive balloon dilation in 50 lesions.Mean balloon diameter at maximal inflation wassimilarin both treatment groupsresulting in similar minimal lumen diametersafter intervention of 1.77 ? 0.41 and 1.78 + 0.34 mm, respectively. At follow-up angiography, minimal lumen diameter after excimer laser-assisted balloon angioplasty was 1.17 + 0.63 mm, and that after balloon angioplastyalone was 1.46 -+ 0.67 mm (p = 0.02). The angiographic restenosisrates at follow-up using the 50% diameter stenosiscutoff criterion were 57% and 34%, respectively (p = 0.02). Conclusions: Quantitative angiographic analysis of a matched group of 106 successfully treated coronary lesions showed a similar immediate outcome but reduced long-term efficacy of excimer laserassisted balloon angioplasty compared with that after balloon angioplasty alone.
followed by balloon angioadditional to balloon angioto the initial and long-term outcome in the treatment of disease.
Usefulness of a Prototype Directional Catheter for Excimer Laser Coronary Angioplasty in Narrowings Unfavorable for Conventional Excimer or Balloon Angioplasty E. Rechavia, J. Federman, A. Shefer, G. Macko, N.L Eigler, F. Litvack. Cardiovascular Intervention Center, Cedars-Sinai Medical Center, Los Angeles, CA. Am j Cardiol 1995; 7611144-6.
We report clinical and angiographic results in 53 patients with 57 significant coronary or saphenousvein graft narrowings treated with directional excimer laserangioplasty. The target vesselswere the left main (l%), anterior descending (32%), circumflex (19%), right coronary artery (39%), and vein grafts (9%). Lesionswere morphologic classBl (18%), B2 (79%), or C (3%), with 40 de nova and 17 restenotic lesions.Adjunctive balloon angioplasty was used in 53 lesions (93%). Mean pre and postprocedural minimal lumen diameterswere 0.6 5 0.3 and 1.9 ? 0.7 mm (p < O.OOl), correspondingto a meandiameterstenosisof 72 + 20% and 27 t 16%. Procedural successrate was 91%. Cumulative risk of death, Q-wave myocardial infarction, or emergency bypassoperation was9% (5 patients). Of patients who had a successfullaserprocedure, 28 (60%) with 30 lesionsunderwent angiographic follow-up at 6 + 3 months after the procedure. Restenosisrates (>50% diameter restenosisor acute gain loss) were 37% and 23%, respectively. Four patientsunderwent bypass,3 angioplasty, and 1 patient died
Immediate and Late Outcome of Excimer Laser and Balloon Coronary Angioplasty: A Quantitative Angiographic Comparison Based on Matched Lesions 5. Strikwerda, E. Montauban Van Swijndreg, D.P. Foley, E. Boersma, V.A. Umanr, R Melkert, P.W. Serruys. Catheterization Laboratory, Thoraxcenter, University Hospital Dijkzigt, Rotterdam, The Netherlands. ] Am Coil Cardiol 1995;26:939-46.
Objectives: This study sought to compare acute lumen changesand late lumen narrowing during and after excimer laser-assisted balloon angioplasty,measuredby quantitative coronary angiography, with the immediate and long-term outcome of balloon angioplastyalone.Bachground:Although excimer lasercoronary angioplasty is used asan adjunct or alternative to balloon angioplasty, limited comparative data exist regarding the immediate and long-term efficacy of excimer laser-assistedballoon angioplasty versus balloon angioplasty alone. Methods: A seriesof 53 lesions in 47 consecutivepatients successfullytreated with excimer laserassistedballoon angioplastywere individually matched after ACC
CURRENT
JOURNAL
REVIEW
38
July/August
1996
TECHNOLOGIES
coronary angioplasty (ELCA). Design: Retrospectiveanalysis of comprehensivedata collected at time of initial procedure and during planned follow-up intervals. Setting:There were 35 participating institutions throughout the United States. Patients: The study population was comprised of 3,069 patientswho had successfulELCA and completed follow-up at 6 months, representing91% of eligible cases.Forty percent had prior balloon angioplasty and 34% had prior bypasssurgery. Measurements:Patient symptomatology was assessedby Canadian Cardiovascular Society functional (CCSF) class.Interim adverseclinical events [death, Q wave myocardial infarction (QMI), repeat intervention, bypass surgery, and a compositeend-point] were tracked. Twentysix pre-ELCA clinical, angiographic and procedural variableswere evaluated to assesstheir ability to predict outcome. Results:At 6 months, there was 2.8% mortality, 2.5% incidence of QMI, and 28.7% required either repeat intervention or bypasssurgery. Overall, 69.2% of patientshad no adverse event. In this cohort, the pre-ELCA CCSF class gradewas2.7 -+ 1.2, but at 6 months, it was0.7 ? 1.1 (p < 0.001). The multivariate predictors of the composite end point were gender, stenosislocation, and rest and unstable angina. Conclusions:There is an excellent 6 month out-
ing a low dependent
Effect of lntracoronary Saline Infusion on Dissection During Excimer Laser Coronary Angioplasty: A Randomized Trial LI. Deckelbaum, M.K. Natarajan, ].A. Bittl, K. Rohlfs, J. Scott, R. Chisholm, K.A. Bowman, B.H. Strauss. Section of Cardiology, West Haven VA Medical Center, Yale University School of Medicine, West Haven, CT, J Am Coll Cardiol I995;26:1264-9.
Objectives:We sought to evaluate whether intracoronary saline infusion during excimer laser coronary angioplasty decreasesthe incidence of significant laser-induced coronary artery dissections.Background:Despiteprocedural successrates >90%, coronary artery dissectionsoccur in 17% to 27% of excimer laser coronary angioplasty procedures. Excimer laser irradiation of blood results in vapor bubble formation and acoustomechanicaltrauma to the vesselwall. Salineinfusion into a coronary artery may minimize blood irradiation and consequentarterial wall damage.Methods:In this prospective, randomized, controlled study, consecutive patients undergoing excimer laser coronary angioplasty were randomly assignedto conventional laserirradiation in a blood medium or to laserirradiation with blood displacement by intracoronary salineinfusion. In the patients randomized to intracoronary salineinfusion, prewarmed normal saline was injected through the coronary artery guide catheter at a rate of 1 to 2 ml/s using a power injector. The incidence and severity of dissectionafter excimer laserablation were evaluated in a core laboratory by angiographers with no knowledge of treatment assignment.The severity of coronary artery dissectionwas rated on an ordinal scaleof 1 to 5. Dissections of grade 2 or higher were considered significant. Results:The mean (+ SE) dissectiongrade after laser angioplasty in patients treated with intracoronary saline infusionwas 0.43 2 0.13 comparedwith 0.91 t 0.26 in patients undergoing laser angioplasty in a blood medium. The incidence of significant dissection was 7% in salinetreated patients compared with 24% in conventionally treated patients (p < 0.05). No significant complications were associatedwith saline infusion. Conclusions: Intra-
come after successful ELCA in this selected population with complex coronary artery disease. The majority of patients without interim events enjoy significant alleviation of symptoms. The predictors of adverse events are clinical rather than angiographic.
Predictors of Restenosis After Excimer Laser Coronary Angioplasty Z.M.B. Ghazzal, E. Burton, W.S. Weintraub, F. Litvack, D.A. Rothbaum, L Klein, S.B. King Ill. Emory University Hospital, Atlanta, GA. Am J Cardiol 1995;75:1012-4.
One hundred twenty-five lesionssuccessfullytreated with excimer laser coronary angioplasty at 3 centers were analyzed in a central core laboratory using detailed quantitative angiographic analysis.Sixty-seven narrowings had restenosis(250% diameterstenosisat restudy). Correlatesof restenosiswere asfollows: baselinediameterstenosiswas 79% in the restenosisgroup versus 71% in the group without restenosis(p = 0.0002), baselineminimal diameterstenosiswas 0.55 mm in the restenosisgroup versus 0.72 mm in the group without restenosis(p = 0.006), final diameter stenosiswas40% in the restenosisgroup versus32% in the group without restenosis(p = 0.002), lesion length 27 mm was present in 43% of the restenosisgroup versus 21% in the group without restenosis(p = 0.009), and Thrombolysis in Myocardial Infarction trial flow 0 to 2 was 33% in the restenosisgroup versus15% in the group without restenosis (p = 0.025). The strongest multivariate correlate of restenosis was the baseline Whereas most predictors
coronary saline infusion should be incorporated excimer laser coronary angioplasty procedures.
CURRENT
JOURNAL
into all
Randomised Trial of Excimer laser Angioplasty Versus Balloon Angioplasty for Treatment of Obstructive Coronary Artery Disease Y.E.A. Appelman, J.J. Pick, S. Strikwerda, J.G.P. Tijssen, P.J. De Feyter, G.K. David, P.W. Sermys, J.R. Margolis, Il.]. Koelemay, E.W.J. Montauban van Swijndregt J.J. Koolen. University of Amsterdam, Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands. lancet 1996;347:79-84.
Background:Excimer laser coronary angioplasty is reported to give excellent procedural resultsfor treatment of complex
diameter stenosis (p = 0.003). were not controllable, achievKC
residual diameter stenosis that is operatorcan favorably influence the restenosis rate.
REVIEW
37
July/.4u~usl
1996
EVOLVING
TECHNOLOGIES
coronary lesions, but this method has not been compared with balloon angioplasty in a randomised trial. Methods: Patients (n = 308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 15 1 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical end-points were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic end-point was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography. Findings: Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty, There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4.6%, 10.6%, and 21.2%, respectively, of the patients in the laser angioplasty group compared with 5.7%, 10.8%, and 18.5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0.40 (0.69) mm in patients treated with laser angioplasty and 0.48 (0.66) mm in those treated with balloon angioplasty (p = 0.34). The restenosis rate (>50% diameter stenosis) was 51.6% in the laser angioplasty group versus 41.3% in the balloon angioplasty group (p = 0.13). Interpretation: Excimer laser angioplasty plasty provides no benefit plasty alone with respect clinical and angiographic obstructive coronary artery
completion of 6-month follow-up angiography with 53 successfully treated balloon angioplasty lesions according to vessellocation, preprocedural minimal lumen diameter and referencediameter. Immediate and long-term angiographic resultswere assessed by an automatedlumen contour detection algorithm. Results:Before intervention in the laserand balloon angioplasty groups, respectively, minimal lumen diameter was 0.73 -f 0.47 and 0.74 f- 0.46 mm, and referencediameter was 2.71 + 0.42 and 2.72 f 0.41 mm. Laserangioplasty was followed by adjunctive balloon dilation in 50 lesions.Mean balloon diameter at maximal inflation wassimilarin both treatment groupsresulting in similar minimal lumen diametersafter intervention of 1.77 ? 0.41 and 1.78 + 0.34 mm, respectively. At follow-up angiography, minimal lumen diameter after excimer laser-assisted balloon angioplasty was 1.17 + 0.63 mm, and that after balloon angioplastyalone was 1.46 -+ 0.67 mm (p = 0.02). The angiographic restenosisrates at follow-up using the 50% diameter stenosiscutoff criterion were 57% and 34%, respectively (p = 0.02). Conclusions: Quantitative angiographic analysis of a matched group of 106 successfully treated coronary lesions showed a similar immediate outcome but reduced long-term efficacy of excimer laserassisted balloon angioplasty compared with that after balloon angioplasty alone.
followed by balloon angioadditional to balloon angioto the initial and long-term outcome in the treatment of disease.
Usefulness of a Prototype Directional Catheter for Excimer Laser Coronary Angioplasty in Narrowings Unfavorable for Conventional Excimer or Balloon Angioplasty E. Rechavia, J. Federman, A. Shefer, G. Macko, N.L Eigler, F. Litvack. Cardiovascular Intervention Center, Cedars-Sinai Medical Center, Los Angeles, CA. Am j Cardiol 1995; 7611144-6.
We report clinical and angiographic results in 53 patients with 57 significant coronary or saphenousvein graft narrowings treated with directional excimer laserangioplasty. The target vesselswere the left main (l%), anterior descending (32%), circumflex (19%), right coronary artery (39%), and vein grafts (9%). Lesionswere morphologic classBl (18%), B2 (79%), or C (3%), with 40 de nova and 17 restenotic lesions.Adjunctive balloon angioplasty was used in 53 lesions (93%). Mean pre and postprocedural minimal lumen diameterswere 0.6 5 0.3 and 1.9 ? 0.7 mm (p < O.OOl), correspondingto a meandiameterstenosisof 72 + 20% and 27 t 16%. Procedural successrate was 91%. Cumulative risk of death, Q-wave myocardial infarction, or emergency bypassoperation was9% (5 patients). Of patients who had a successfullaserprocedure, 28 (60%) with 30 lesionsunderwent angiographic follow-up at 6 + 3 months after the procedure. Restenosisrates (>50% diameter restenosisor acute gain loss) were 37% and 23%, respectively. Four patientsunderwent bypass,3 angioplasty, and 1 patient died
Immediate and Late Outcome of Excimer Laser and Balloon Coronary Angioplasty: A Quantitative Angiographic Comparison Based on Matched Lesions 5. Strikwerda, E. Montauban Van Swijndreg, D.P. Foley, E. Boersma, V.A. Umanr, R Melkert, P.W. Serruys. Catheterization Laboratory, Thoraxcenter, University Hospital Dijkzigt, Rotterdam, The Netherlands. ] Am Coil Cardiol 1995;26:939-46.
Objectives: This study sought to compare acute lumen changesand late lumen narrowing during and after excimer laser-assisted balloon angioplasty,measuredby quantitative coronary angiography, with the immediate and long-term outcome of balloon angioplastyalone.Bachground:Although excimer lasercoronary angioplasty is used asan adjunct or alternative to balloon angioplasty, limited comparative data exist regarding the immediate and long-term efficacy of excimer laser-assistedballoon angioplasty versus balloon angioplasty alone. Methods: A seriesof 53 lesions in 47 consecutivepatients successfullytreated with excimer laserassistedballoon angioplastywere individually matched after ACC
CURRENT
JOURNAL
REVIEW
38
July/August
1996