| pathology | Demonstrated benefit and harm | k | | | |
|---|
| coronary artery disease | versus no TMR No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Allen, 2000 | TMR+CABG vs CABG | | | | | Loubani, 2003 | TMR+CABG vs CABG | | | | | Zhao, 2006 | TMR+CABG vs CABG | | | |
| Trial | Treatments | Patients | Method |
|---|
| Allen, 2000 | coronary bypass of suitable vessels plus transmyocardial revascularization to areas not graftable (n=132) vs. coronary bypass alone with nongraftable areas left unrevascularized (n=131) | patients whose standard of care was coronary artery bypass grafting and who had one or more ischemic areas not amenable to bypass grafting | single blind Sample size: 132/131 Primary endpoint: FU duration: | | Loubani, 2003 | coronary artery bypass grafting plus transmyocardial laser revascularization with a holmium:YAG (yttrium-aluminum-garnet) laser to nongraftable areas (n=10) vs. coronary artery bypass grafting (n=10) | Patients who had elective coronary artery bypass with one or more nongraftable coronary arteries | open Parallel groups Sample size: 10/10 Primary endpoint: none defined FU duration: 36 months | | Zhao, 2006 | transmyocardial laser revascularization (holmium: YAG) combined with off-pump coronary artery bypass (n=40) vs. off-pump coronary artery bypass (n=40) | patients with diffusely diseased target vessels | open Parallel groups Sample size: 40/40 Primary endpoint: not defined FU duration: 3.4y |
|
| coronary artery disease | versus No demonstrated result for efficacy | 8 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| MASS II, 2007 | CABG vs medical treatment | | | 5y death 0.64 [0.35; 1.16] | | BARI 2D, 2009 | CABG or PCI vs medical treatment | | | MI 0.87 [0.69; 1.09] stroke 0.92 [0.57; 1.50] death, MI, stroke 0.95 [0.82; 1.10] 5y death 0.98 [0.79; 1.20] | | VA, 1984 | CABG vs medical treatment | 7yr death 0.76 [0.59; 0.99] | | 5y death 0.78 [0.58; 1.06] 10 year death 0.89 [0.74; 1.08] | | ECSS (European), 1988 | CABG vs medical treatment | cardiac death 0.57 [0.41; 0.80] 5y death 0.45 [0.30; 0.68] 7yr death 0.64 [0.46; 0.88] | | noncardiovascular death 1.54 [0.64; 3.67] 10 year death 0.79 [0.62; 1.00] | | CASS, 1983 | CABG vs medical treatment | | | 5y death 0.63 [0.36; 1.07] 7yr death 0.81 [0.56; 1.18] 10 year death 0.87 [0.65; 1.15] | | Texas, 1977 | CABG vs medical treatment | | | 5y death 0.82 [0.39; 1.73] 7yr death 0.89 [0.50; 1.60] 10 year death 0.99 [0.64; 1.52] | | Oregon, 1979 | CABG vs medical treatment | | | 5y death 0.48 [0.15; 1.49] 7yr death 0.61 [0.26; 1.45] 10 year death 0.96 [0.51; 1.80] | | New zealand 1, 1981 | CABG vs medical treatment | | | 5y death 1.00 [0.41; 2.46] 7yr death 0.91 [0.42; 1.95] 10 year death 1.06 [0.61; 1.86] |
| Trial | Treatments | Patients | Method |
|---|
| MASS II, 2007 | coronary artery bypass graft (CABG) (n=203) vs. medical therapy (n=203) | multivessel
coronary artery disease with stable angina and preserved ventricular function. | open Parallel groups Sample size: 203/203 Primary endpoint: death, MI, or unstable angina requiring revasc FU duration: 5 years | | BARI 2D, 2009 | prompt revascularization with intensive medical therapy (n=1176) vs. intensive
medical therapy alone (n=1192) factorial design with 2nd comparison: insulin-sensitization or insulin-provision
therapy | patients with type 2 diabetes and heart disease | open Parallel groups Sample size: 1176/1192 Primary endpoint: death FU duration: 5.3 y | | VA, 1984 | coronary-artery bypass grafting (n=332) vs. medical treatment (n=354) | patients with stable angina | open Parallel groups Sample size: 332/354 Primary endpoint: FU duration: 7 y | | ECSS (European), 1988 | early coronary bypass surgery (n=394) vs. medical therapy (n=373) | men with midl or moderate angina pectoris of at least 3 months duration and an obstruction of 50% or more in at least 2 major coronary arteries in the absence of marked LV dysfunction | open Parallel groups Sample size: 394/373 Primary endpoint: FU duration: 12 y | | CASS, 1983 | surgical (n=390) vs. nonsurgical (n=390) | patients with stable ischemic heart disease | open Parallel groups Sample size: 390/390 Primary endpoint: FU duration: 5y | | Texas, 1977 | (n=56) vs. (n=60) | | Sample size: 56/60 Primary endpoint: FU duration: | | Oregon, 1979 | surgical treatment (n=51) vs. medical treatment (n=49) | patients with stable, disabling angina | Sample size: 51/49 Primary endpoint: FU duration: | | New zealand 1, 1981 | surgical (n=50) vs. nonsurgical (n=50) | men 60 years of age or younger who had recovered from a recurrent myocardial infarction | Sample size: 50/50 Primary endpoint: FU duration: 4.5 y |
|
| coronary artery disease | versus surgery No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| STICH (ventricular reconstruction), 2009 | CABG+surgical ventricular reconstruction vs CABG | | | Death from any cause 0.97 [0.80; 1.19] stroke 0.74 [0.44; 1.25] Acute myocardial infarction 0.91 [0.50; 1.64] Hospitalization for cardiac causes 0.96 [0.83; 1.12] Death, hospitalization for cardiac causes 0.99 [0.89; 1.10] |
| Trial | Treatments | Patients | Method |
|---|
| STICH (ventricular reconstruction), 2009 | CABG with surgical ventricular reconstruction (n=501) vs. CABG (n=499) | patients with anterior-apical regional left ventricular dysfunction | open Parallel groups Sample size: 501/499 Primary endpoint: death from any cause and hospitalization for cardiac causes FU duration: 48 months |
|
| stable angina | versus no TMR No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Allen, 2000 | TMR+CABG vs CABG | | | | | Loubani, 2003 | TMR+CABG vs CABG | | | | | Zhao, 2006 | TMR+CABG vs CABG | | | |
| Trial | Treatments | Patients | Method |
|---|
| Allen, 2000 | coronary bypass of suitable vessels plus transmyocardial revascularization to areas not graftable (n=132) vs. coronary bypass alone with nongraftable areas left unrevascularized (n=131) | patients whose standard of care was coronary artery bypass grafting and who had one or more ischemic areas not amenable to bypass grafting | single blind Sample size: 132/131 Primary endpoint: FU duration: | | Loubani, 2003 | coronary artery bypass grafting plus transmyocardial laser revascularization with a holmium:YAG (yttrium-aluminum-garnet) laser to nongraftable areas (n=10) vs. coronary artery bypass grafting (n=10) | Patients who had elective coronary artery bypass with one or more nongraftable coronary arteries | open Parallel groups Sample size: 10/10 Primary endpoint: none defined FU duration: 36 months | | Zhao, 2006 | transmyocardial laser revascularization (holmium: YAG) combined with off-pump coronary artery bypass (n=40) vs. off-pump coronary artery bypass (n=40) | patients with diffusely diseased target vessels | open Parallel groups Sample size: 40/40 Primary endpoint: not defined FU duration: 3.4y |
|
| stable angina | versus No demonstrated result for efficacy | 8 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| MASS II, 2007 | CABG vs medical treatment | | | 5y death 0.64 [0.35; 1.16] | | BARI 2D, 2009 | CABG or PCI vs medical treatment | | | MI 0.87 [0.69; 1.09] stroke 0.92 [0.57; 1.50] death, MI, stroke 0.95 [0.82; 1.10] 5y death 0.98 [0.79; 1.20] | | VA, 1984 | CABG vs medical treatment | 7yr death 0.76 [0.59; 0.99] | | 5y death 0.78 [0.58; 1.06] 10 year death 0.89 [0.74; 1.08] | | ECSS (European), 1988 | CABG vs medical treatment | cardiac death 0.57 [0.41; 0.80] 5y death 0.45 [0.30; 0.68] 7yr death 0.64 [0.46; 0.88] | | noncardiovascular death 1.54 [0.64; 3.67] 10 year death 0.79 [0.62; 1.00] | | CASS, 1983 | CABG vs medical treatment | | | 5y death 0.63 [0.36; 1.07] 7yr death 0.81 [0.56; 1.18] 10 year death 0.87 [0.65; 1.15] | | Texas, 1977 | CABG vs medical treatment | | | 5y death 0.82 [0.39; 1.73] 7yr death 0.89 [0.50; 1.60] 10 year death 0.99 [0.64; 1.52] | | Oregon, 1979 | CABG vs medical treatment | | | 5y death 0.48 [0.15; 1.49] 7yr death 0.61 [0.26; 1.45] 10 year death 0.96 [0.51; 1.80] | | New zealand 1, 1981 | CABG vs medical treatment | | | 5y death 1.00 [0.41; 2.46] 7yr death 0.91 [0.42; 1.95] 10 year death 1.06 [0.61; 1.86] |
| Trial | Treatments | Patients | Method |
|---|
| MASS II, 2007 | coronary artery bypass graft (CABG) (n=203) vs. medical therapy (n=203) | multivessel
coronary artery disease with stable angina and preserved ventricular function. | open Parallel groups Sample size: 203/203 Primary endpoint: death, MI, or unstable angina requiring revasc FU duration: 5 years | | BARI 2D, 2009 | prompt revascularization with intensive medical therapy (n=1176) vs. intensive
medical therapy alone (n=1192) factorial design with 2nd comparison: insulin-sensitization or insulin-provision
therapy | patients with type 2 diabetes and heart disease | open Parallel groups Sample size: 1176/1192 Primary endpoint: death FU duration: 5.3 y | | VA, 1984 | coronary-artery bypass grafting (n=332) vs. medical treatment (n=354) | patients with stable angina | open Parallel groups Sample size: 332/354 Primary endpoint: FU duration: 7 y | | ECSS (European), 1988 | early coronary bypass surgery (n=394) vs. medical therapy (n=373) | men with midl or moderate angina pectoris of at least 3 months duration and an obstruction of 50% or more in at least 2 major coronary arteries in the absence of marked LV dysfunction | open Parallel groups Sample size: 394/373 Primary endpoint: FU duration: 12 y | | CASS, 1983 | surgical (n=390) vs. nonsurgical (n=390) | patients with stable ischemic heart disease | open Parallel groups Sample size: 390/390 Primary endpoint: FU duration: 5y | | Texas, 1977 | (n=56) vs. (n=60) | | Sample size: 56/60 Primary endpoint: FU duration: | | Oregon, 1979 | surgical treatment (n=51) vs. medical treatment (n=49) | patients with stable, disabling angina | Sample size: 51/49 Primary endpoint: FU duration: | | New zealand 1, 1981 | surgical (n=50) vs. nonsurgical (n=50) | men 60 years of age or younger who had recovered from a recurrent myocardial infarction | Sample size: 50/50 Primary endpoint: FU duration: 4.5 y |
|
| stable angina | versus surgery No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| STICH (ventricular reconstruction), 2009 | CABG+surgical ventricular reconstruction vs CABG | | | Death from any cause 0.97 [0.80; 1.19] stroke 0.74 [0.44; 1.25] Acute myocardial infarction 0.91 [0.50; 1.64] Hospitalization for cardiac causes 0.96 [0.83; 1.12] Death, hospitalization for cardiac causes 0.99 [0.89; 1.10] |
| Trial | Treatments | Patients | Method |
|---|
| STICH (ventricular reconstruction), 2009 | CABG with surgical ventricular reconstruction (n=501) vs. CABG (n=499) | patients with anterior-apical regional left ventricular dysfunction | open Parallel groups Sample size: 501/499 Primary endpoint: death from any cause and hospitalization for cardiac causes FU duration: 48 months |
|
