CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Meta-Analysis of randomized trials of percutaneous transluminal coronary angioplasty versus atherectomy, cutting balloon atherotomy, or laser angioplasty
John A. Bittl, MD, FACC*,*,
Derek P. Chew, MBBS, MPH ,
Eric J. Topol, MD, FACC ,
David F. Kong, MD, FACC and
Robert M. Califf, MD, FACC
* Ocala Heart Institute, Munroe Regional Medical Center, Ocala, Florida, USA
Flinders Medical Center, Adelaide, Australia
Cleveland Clinic Foundation, Cleveland, Ohio, USA
Duke Clinical Research Institute, Durham, North Carolina, USA
Manuscript received September 30, 2003;
accepted October 9, 2003.
* Reprint requests and correspondence: Dr. John A. Bittl, Ocala Heart Institute, 1511 SW 1st Avenue, Ocala, Florida 34474, USA.
jabittl{at}aol.com
OBJECTIVES: We conducted a systematic overview (meta-analysis) of randomized trials of balloon angioplasty versus coronary atherectomy, laser angioplasty, or cutting balloon atherotomy to evaluate the effects of plaque modification during percutaneous coronary intervention.
BACKGROUND: Several mechanical approaches have been developed that ablate or section atheromatous plaque during percutaneous coronary interventions to optimize acute results, minimize intimal injury, and reduce complications and restenosis.
METHODS: Sixteen trials (9,222 patients) constitute the randomized controlled experience with atherectomy, laser, or atherotomy versus balloon angioplasty with or without coronary stenting. Each trial tested the hypothesis that ablative therapy would result in better clinical or angiographic results than balloon dilation alone.
RESULTS: Short-term death rates (<31 days) were not improved by the use of ablative procedures (0.3% vs. 0.4%, odds ratio [OR] 0.94 [95% confidence interval 0.46 to 1.92]), but periprocedural myocardial infarctions (4.4% vs. 2.5%, OR 1.83 [95% CI 1.43 to 2.34]) and major adverse cardiac events (5.1% vs. 3.3%, OR 1.54 [95% CI 1.25 to 1.89]) were increased. Angiographic restenosis rates (6,958 patients) were not improved with the ablative devices (38.9% vs. 37.4%, OR 1.06 [95% CI 0.97 to 1.17]). No reduction in revascularization rates (25.2% vs. 24.5%, OR 1.04 [95% CI 0.94 to 1.14]) or cumulative adverse cardiac events rates up to one year after treatment were seen with ablative devices (27.8% vs. 26.1%, OR 1.09 [95% CI 0.99 to 1.20]).
CONCLUSIONS: The combined experience from randomized trials suggests that ablative devices failed to achieve predefined clinical and angiographic outcomes. This meta-analysis does not support the hypothesis that routine ablation or sectioning of atheromatous tissue is beneficial during percutaneous coronary interventions.
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Abbreviations and Acronyms
| | CBA | = coronary balloon atherotomy | | CI | = confidence interval | | DCA | = directional coronary atherectomy | | ELA | = excimer laser coronary angioplasty | | LA | = (excimer or holmium) laser angioplasty | | MACE | = major adverse cardiac events | | MI | = myocardial infarction | | OR | = odds ratio | | PTRA | = percutaneous transluminal rotational atherectomy |
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