Table 1.
Characteristics of included trials
| Study | Gray et al 200330 |
|---|---|
| Design | RCT |
| Relevant outcomes, definitions Sample size, participant characteristics, setting, country |
Angina severity, Exercise duration, QoL, N = 73 (M-70/F-3), RFA patients, CCS class III–IV, MMT, unsuitable for revascularization single UK center, 21 of this sample were also analyzed in Oesterle et al, 2000 |
| Measurement occasions, outcome measures, reliability and validity | Change in exercise duration, CCS, McGill pain score and SAQ at 3, 6, 12 mths from baseline, (reliable and valid tools) change in LVEF from baseline to 3 mths as assessed on echocardiograph |
| Intervention | PMLR plus MMT compared to MMT |
| Notes | Coaxial Cardiogenesis™ PMLR laser system |
| Study | Leon et al 200528DIRECT Trial |
| Design | RCT |
| Relevant outcomes, definitions | Exercise tolerance, angina frequency, QoL, morbidity, mortality, myocardial perfusion |
| Sample size, participant characteristics, setting, country | N = 298, (m-229/f-69), RFA patients, CCS class III–IV, MMT, unsuitable for revascularization, 14 US Centers |
| Measurement occasions, outcome measures, reliability and validity | Change in exercise duration from baseline to 6 mths using modified Bruce protocol, MACE at 1, 6, 12 mths, procedural adverse events at 30 d, change in CCS class from baseline to 6 and 12 mths, SF-12, SAQ from baseline to 6 and 12 mths, change in radionuclide perfusion scores from baseline to 6 mths |
| Intervention | Three arm trial comparing low-dose laser vs high-dose laser vs medical management |
| Notes | Holmium:YAG laser with Biosense DMR ™ catheter |
| Study | McNab et al 200632SPiRiT Trial |
| Design | RCT |
| Relevant outcomes, definitions | Exercise tolerance, angina severity, QoL, adverse events, myocardial perfusion |
| Sample size, participant characteristics, setting, country | N = 69 (M-60/F-8), RFA patients, CCS class III–IV, MMT, unsuitable for revascularization, UK tertiary referral center |
| Measurement occasions, outcome measures, reliability and validity | Change in exercise treadmill time using modified Bruce protocol, CCS class, SF-36, SAQ, and Euroqol from baseline at 3 and 12 mths procedural and disease-related adverse events documented reliability and validity of tools |
| Intervention | PMLR compared to intermittent spinal cord stimulation |
| Notes | Axcis PTMR™ Holmium:YAG laser |
| Study | Oesterle et al 200012PACIFIC Trial |
| Design | RCT |
| Relevant outcomes, definitions | Exercise duration, angina severity, survival, death, MI, hospitalization |
| Sample size, participant characteristics, setting, country | N = 221 (M-190/F-31), RFA patients, CCS class III–IV, MMT, unsuitable for revascularization, 12 US and 1 UK centers |
| Measurement occasions, outcome measures, reliability and validity | Change in exercise duration, CCS and SAQ at 3, 6, 12 mths from baseline (reliable and valid tools) |
| Intervention | PMLR plus MMT compared to MMT |
| Notes | Axcis PTMR™ Holmium:YAG laser system, 24 patients received revascularization procedures during the one year follow-up, analysis was done by ITT and also excluding this group |
| Study | Salem et al 200413Belief Trial |
| Design | RCT |
| Relevant outcomes, definitions | Exercise tolerance, angina severity, QoL |
| Sample size, participant characteristics, setting, country | N = 82 (M-75/F-7), RFA patients, CCS class III–IV, MMT, unsuitable for revascularization, 2 Norwegian centers |
| Measurement occasions, outcome measures, reliability and validity | Change in CCS, SAQ, medication usage, from baseline to 6 and 12 mths, chronotropic assessment exercise protocol used to assess change in exercise time, oxygen uptake, and respiratory exchange ratio from baseline to 12 mths |
| Intervention | PMLR plus MMT vs MMT |
| Notes | Coaxial Cardiogenesis™ Holmium:YAG system, LVEF reported unchanged but no description of instrument used, blinding of all personnel, participants and outcome assessors for 12 mths |
| Study | Stone et al 200241 |
| Design | RCT |
| Relevant outcomes, definitions | Adverse events, 6 month cumulative MACE |
| Sample size, participant characteristics, setting, country | N = 141 (M-112/F-29), RFA patients, CCS class III–IV, MMT, unsuitable for revascularization, 17 US centers |
| Measurement occasions, outcome measures, reliability and validity | Change in exercise duration with Bruce protocol and CCS from baseline to 6 and 12 mths, difference in MACE between groups |
| Intervention | PMLR vs MMT |
| Notes | Enrolled after failed attempt at PCI, no description of randomization process, only procedure room staff aware of group allocation, Eclipse™ Holmium:YAG system |
| Study | Whitlow et al 200329 |
| Design | RCT |
| Relevant outcomes, definitions | Exercise duration, angina severity, QoL |
| Sample size, participant characteristics, setting, country | N = 330 (M-245/F-85) RFA patients, CCS class III–IV,MMT, unsuitable for revascularization |
| Measurement occasions, outcome measures, reliability and validity | Change in exercise tolerance (Naughton protocol) and from baseline to 12 mths, change in CCS, DASI from baseline to 6 and 12 mths |
| Intervention | PMLR plus MMT vs MMT |
| Notes | Eclipse™ Holmium:YAG laser system, no patient blinding |
Abbreviations: CCS, Canadian Cardiovascular Society; d, days; DASI, Duke Activity Status Index; LVEF, left ventricular ejection fraction; MACE, major adverse cardiovascular event; MI, myocardial infarction; MMT, maximum medical therapy; mths, months; PCI, percutaneous coronary intervention; PMLR, percutaneous myocardial laser revascularization; QoL, quality of life; RFA, refractory angina; SF-12, Medical Outcome Study: General Health Survey; SF-36, Medical Outcomes Study: 36 Item Short Form; SAQ, Seattle Angina Questionnaire; YAG, yttrium-aluminum-garnet.