Study | Type | Size | Endpoints | Results |
---|---|---|---|---|
MUST-EECP Arora et al., (33) 1999 | Randomized Prospective placebo controlled multicentre | 139 patients randomized CCS class I, II, or III | Exercise duration Daily average anginal
attacks Nitroglycerin usage Time to 1 mm ST segment depression |
Increase in time to 1 mm ST segment depression for
active CP group, p=0.01 (adjusted mean: active CP 37±11 s
vs. inactive CP –4+12s) Decrease in anginal episodes, p=NS (intent to treat) Decrease nitroglycerin use, p=NS (intent to treat) Increase in exercise duration, p=NS Active CP group reported more adverse events, p<0.001. |
MUST-EECP (34) Arora et al., 2002 | Randomized Prospective placebo controlled multicentre | 71/139 randomized patients completed questionaires
at baseline, end of therapy, and 12 months. Same study patients as Arora et al., (1999). |
Health Related Quality of Life (HQOL) at end of treatment and 12 months | At end of treatment and 12-month follow-up, patients who had active EECP reported greater improvement than those having inactive EECP in all 4 primary HQOL quality of life parameters (p<0.05). |
Schecter et al., (38) 2003 | Comparative | 40 patients (20 ECP and 20 age/gender matched controls who refused EECP) | Nitroglycerin tablets in the previous 24 hours. Change in CCS angina class. | EECP patients and nitroglycerine tablet
usage: Pre EECP 4.2 (2.7); Post EECP 0.4 (0.5); p<0.001. Control patients and nitroglycerine usage: Pre EECP 4.5 (2.3); Post EECP 4.4 (2.6); p=0.87. EECP patients and change in CCS angina class: Pre EECP 3.5 (0.5); Post EECP 1.9 (0.3); p<0.0001. Control patients and change in CCS angina class: Pre EECP 3.3 (0.6); Post EECP 3.5 (0.5); p=0.89. |
Barsness et al., (48) 2001 | IEPR Registry | 978 patients 69% of patients had CCS class III/IV [Candidates = patients suitable for revascularization. Noncandidates = patients not suitable for revascularization] | Anginal class Quality of life Adverse effects | Angina class improved post EECP Pre EECP: CCS I 5.5%; II 24.8%; III 48.1%; IV 21.6%. Post EECP: 36.0%; 32.4%; 9.8%; 2.8% Decrease in at least 1 anginal class: 81% overall Mean decrease in anginal episodes per week: 6.4±12.6 overall Decrease in use of nitroglycerin: 61.7% overall Overall, 11 patients (1.1%) withdrew due to a serious cardiac event. Clinical events were cited as the reason for discontinuing treatment in 43.8% of patients withdrawing. 15% of patients starting EECP treatment did not complete full course of treatment. |
Holubkov et al., (57) 2002 | Registry | 2 cohorts: 1. IEPR, n=323 (PCI candidates at time of index EECP) 2. NHLBI, n=448 (patients who underwent PCI) |
Mortality Patients’ self-reported level of exertional angina. | 85.8% of EECP patients completed full course of
treatment. 92.1% of PCI treated patients had a successful initial procedure. At 1 year, survival and rates of CABG were comparable, p=NS. IEPR patients reported more usage of Ca channel blockers [50.6% vs. 33.7%](p<0.001); angiotensin receptor blockers [5.6% vs. 1.9%](p<0.01); and long acting nitrates [53.0% vs. 30.3%](p<0.001). PCI registry patients reported using more short acting nitroglycerin [43.3% vs. 82.2%](p<0.001). Class III/IV or unstable symptoms were reported in 15.5% of EECP patients and 9.5% of PCI patients, p=0.02. 73.4% of PCI patients reported no angina after 1 year compared to IEPR patients (43.7%), p<0.001. |
Lawson et al., (49) | Registry EECP Consortium | Cohort of 2,289 consecutive patients from 84 centres had completed follow-up. CCS I-IV. | Adverse effects Anginal class | 91 adverse patient experiences were observed out of
the entire patient registry (n=2,991). Overall, the average CCS class improved after EECP [average CCS class 2.78 vs. 1.81 p<0.001]. Pre EECP CCS IV (compared to CCS I and II) improvement: OR 3.30 (2.49-4.39), p<0.0001. PreEECP CCS III (compared to CCS I and II) improvement: OR 4.38 (3.46-5.56), p<0.0001. Patients receiving >35 hrs of treatment did not benefit more over the standard 35 hour course OR 1.02 (0.77-1.36). |
Lawson et al., (50) | Case series | Single centre cohort of 33 consecutive angina patients followed for mean of 5 years. | Major adverse cardiovascular events (MACE) | In early post treatment: Radionuclide stress tests demonstrated a significant (p<0.01) improvement in perfusion defects in 26/33 (79%) of patients = responders. In the remaining 7 patients, stress tests were unchanged = nonresopnders. Over 5 years: 13/33 patients underwent additional EECP treatment.. 4 patients died, 9 patients experienced interim adverse events. 21/33 patients remained alive post therapy without cardiovascular morbidity or repeat revascularization. |
Bonetti et al., (61) 2003 | Case series | Single centre cohort of 23 patients. | Change in CCS functional class. DASI |
17/23 (74%) improved 1+ CCS class and improved DASI score (maintained at 1 month followup). |
Tartaglia et al., (62) 2003 | Caser series | Single centre cohort of 25 patients. | Exercise duration (seconds) Significant change on ECG during ETT Change in CCS functional class. |
Exercise duration: PreEECP 357 seconds; Post EECP 449 seconds; P<0.001. Of 16 patients with ST-segment depression preEECP, 10 (63%) had significant delay and 3 (19%) had no ST-segment depression post EECP. Reduction of 1+ angina class 24/25 (96%). |
Werner et al., (63) 2003 | Case series | Single centre cohort of 48 patients. | Symptom limited bicycle test (Watts) Symptom limited bicycle test (minutes) Angina count/week Nitroglycerin use/week |
Symptom limited bicycle test: PreEECP 117.3 watts; PostEECP 137.8 watts; p<0.005. Symptom limited bicycle test: PreEECP 7.4 min; PostEECP 9.0 min; p<0.05. Angina count/week: PreEECP 6.4; PostEECP 3.3; p<0.05. Nitroglycerin use/week: PreEECP 5.5; PostEECP 2.7; p=Not significant. |
Bagger et al., (64) 2004 | Case series | Single centre cohort of 26 patients | CCS angina class (group mean) Exercise duration |
CCS angina class: PreEECP 3.1; PostEECP 2.2; p<0.05. Exercise duration: Improved by 21% in the 78% who were able to perform the exercise test. |
Michaels et al.,(42) 2004 | Case series | Registry study. 1,097 patients from sites with >85% followup. |
2 year followup Multiple clinical
endpoints. Change in CCS class. Quality of life improvement (Likert scale). |
Death 8.5% MI 8.9% Unstable angina 21.8% HF exacerbation 11.7% Cardiac hospitalization 39.3% Noncardiac hospitalization 40.9% Revascularization procedure 15% Repeat EECP 16.1% Event free 40.8% Change in CCS class: Among those event free, sustained reduction in CCS class at 2 years. Quality of Life: Improvement in 47% at 2 years. |
Lawson et al. (65) 2005 | Registry | N=2007 EECP patients completing at least 30 h of EECP, with 1 year follow-up and info on acute angina reduction | Determine predictors of 1-year angina status in patients who demonstrated initial clinical improvement (responders [R] vs. those who did not show benefit non-responders [NR] after EECP; anginal class, weekly anginal episodes, frequency of nitroglycerin use; quality of life | Angina reduced by at least 1 CCS class in 83%
immediately post-EECP (1665), 17% no initial reduction
(342). In R, weekly angina decreased from 10.4 to 1.7 (p<.001). NR sig. decrease from 11.5 to 5.8 (p<.05). Nitroglycerin use decreased in R from 9.3 – 1.6 (p<.001), but not significantly in the NR (10.5 – 8.0). QoL reported in 63% or R vs. 37% of NR. The only significant independent predictor of lack of initial response to EECP was baseline anginal class (I, II, III, versus IV with odds ratios 5.0, 4.8, 1.4 and CI 2.4 – 10.4, 3.2 – 7.0 and 1.0 – 2.0, respectively. At 1 year, 15% of NR vs. 8% of R had PCI or CABG (p<.0001). |
Michaels et al. (66) 2005 | Registry | N=1192 patients who completed a 1st course of EECP, and were enrolled in IEPR sites that provided >/=85% follow-up at 2 years; 90% had CCS class III or IV at baseline. | CCS class, angina episodes, nitroglycerin use | After initial course, 86% reported a decrease by at
least 1 CCS class and nitroglycerin use discontinued by 57% of
patients. Within 2 years post-EECP, 194 patients (18%) underwent a repeat EECP course of which 78% (152) had available data on 2nd course. Among repeaters, 70% demonstrated sig. decrease in angina, although distribution of CCS class not sig. different. At 2-year follow-up anginal symptoms remained sig. worse in patients who had repeat EECP (6 episodes per week in repeaters vs. 3 per week in non (p<.01), more nitroglycerin use in repeaters (63% vs. 45%, p<.001). |
Lawson et al. (44) 2004 | Registry | Patients divided into 3 groups: those without left main coronary artery disease (LMD; n=2,377), those with LMD and prior CABG (LMD-CABG) (n=431); and those with LMD and no prior CABG (LMD-NCABG (n=53) | CCS class Weekly angina episodes Weekly nitroglycerin use MACE | Post EECP improvements in CCS by at least one class
in all three groups (NS between-group differences), No LMD
(74%), LMD-CABG (75%), LMD-NCABG (65%). No between-group differences in mean decrease in weekly angina episodes (7.1 vs. 8.0 vs. 7.6) or frequency of weekly nitroglycerin use (6.6 vs. 8.1 vs. 8.9). At 6 month follow-up, CCS class further improved, and there was a further reduction in mean weekly angina episodes (4.7 vs. 4.6 vs. 5.3) and nitroglycerin use (6.5 vs. 6.8 vs. 8.2). MACE 8 months after EECP treatment was 11.2% in non-LMD, 15.6% in LMD with CABG, and 24.3% in LMD without CABG. Late mortality in LMD non-CABG was 13.2% (CI 3.3-23.1) versus 4.8% (CI 2.7 – 7.1) in LMD with CABG, and 2.8% (CI 2.1 – 3.5) without LMD. |
Fitzgerald et al., (40) 2003 | Registry | IEPR; N=4454 patients with prior CABG or PCI (CCS Class III/IV for 83.9%) compared with a group of patients (Pumpers, 77.2% Class II/III) who were candidates for either/both procedures but chose EECP as their initial revascularization treatment | Angina class; nitroglycerin use, angina episodes | Post-EECP a reduction by at least 1 CCS class was
seen in 74.8% of Pumper vs. 72.7% non-pumper,
p=NS. Decrease in angina episodes per week: 7.6% NP vs. 5.2 in pumpers, p<.001. Nitroglycerin use: 17.4% non-pumpers vs. 15.2% (5.9 times per week) pumpers, as compared to baseline of 71.4% (9.8 times per week) non-pumpers, 46.9 % (7.1 times per week) pumpers. |
Lawson et al., (67) 2003 | Registry | N=4592 patients with no prev. EECP treatment on enrollment in the IEPR registry; 82.3% in CCS class III or IV at baseline. | CCS functional class; angina frequency, nitroglycerin use, changes in medications, quality of life, interim MACE; Determination of patient characteristics which influence EECP success | 83.1% completed prescribed EECP course. MACE over the course of therapy included death (.3%), MI (.9%), CABG (.2%), PCI (.8%), exacerbation of HF in 1.9%, unstable angina in 2.8%. CCS improvement of >/= 1 class in 73% of patients, >/=2 classes in 38.2%, >/=3 classes in 17.3% did not change in 26.0% and worsened in 1.1%. Mean angina episodes per week at baseline were 10.1 and decreased to 2.5 per week post EECP. Baseline nitroglycerin use was 9.5 times per week pre EECP, 2.5 times post-EECP. Overall success rate in patients with diabetes, prior CABG, and HF was 70% (success defined as 1 CCS class decrease). |
Linnemeier et al.; (39) 2003 | Registry | N=249 IEPR patients >/=80 years (elderly); Elderly more likely to be female, have a history of CHF (41% vs. 29%, p<.001), and less likely to have had prior revascularization (74% vs. 86%, p<.001); about 87% of elderly CCS Class III/IV pre-EECP, somewhat more severe than in younger (Class not reported). | MACE; cardiac hospitalization; angina frequency, nitroglycerin use; CCS class, Quality of Life, | Sig. fewer >/=80 years (elderly) completed treatment (76% versus 84%, p=.05); Treatment non-completion not stopped due to clinical event any more than in younger (11% versus 9%), rather, patient discontinued in 11% of elderly vs. 7% of non-elderly). At 6-month follow-up low rates of MACE in both groups NS except for death (8 in younger versus 6 in elderly (p=.05) and cardiac hospitalization, 12 in younger vs. 6 in elderly (p=.05). Very little change in medication use recorded, and NS between group differences. Sig, improvement post-EECP in patient-assessed QoL, health, and satisfaction (all p<.001). |
Linnemeier et al., (41) 2003 | Case series | N=1532 IEPR patients of which 665 (43%) reported a diagnosis of diabetes; patients with DM sig. more likely to have a history of heart failure | CCS class, MACE, angina episodes per week, nitroglycerin use, quality of life | In post-EECP period, MI (1.7% vs. .2%,
p<.01) and HF (3.3% vs. 1.3%, p<.01) occurred sig.
more often in the DM group. Post-EECP angina decreased by at least 1 CCS class in DM (69%) and ND (72%) of patients, diff.=NS. At 1 year, follow-up available for 86% of DM and 89.9% of ND; At 1-year, sig, increase in death (3.9% ND vs 7.5 % DM, p<.01), MACE (16.3% ND vs. 22.6% DM, p<.01, and CHF (6.1% ND vs. 12.8% DM, p<.001). |