Study | Type | Size | Endpoints | Results |
---|---|---|---|---|
Lawson et al., (25) 2001. | Registry (IEPR) | Angina patients: 548 patients = HF history 1409 patients = nonHF history |
Adverse effects Angina symptoms | Significantly fewer HF patients completed course of
EECP (p<0.001); exacerbation of HF was more frequent
during treatment (p<0.001); angina class in HF patients
decreased less (p<0.01); and HF patients reported more
musculoskeletal problems (p<0.05). At 6 months, HF patients maintained reduction in angina but were more likely to have a MACE, p<0.001. |
Soran et al., (45) 2002 | Prospective, uncontrolled case series | 32 HF patients NYHA class II and III LVEF <35% | Safety Exercise capacity Quality of life Patients followed up for 6 months. | 6 patients withdrew before treatment. 26 patients received EECP, including follow-up at 1 week.
46 adverse events in 23 patients: 14 events led to hospitalization in 8 patients 22 adverse events occurred during treatment period 12 adverse events occurred outside treatment session 24 adverse events occurred during 6 month follow-up At 1 week follow-up, overall mean exercise duration increased, p<0.001. AT 6 month follow-up, overall mean exercise duration increased, p<0.028. 24 patients had a posttreatment QOL assessment. Overall changes were significant for total score, and physical and emotional dimension, p<0.01. |
PEECH [Prospective Evaluation of Enhanced External Counterpulsation in Heart Failure] (68-70) |
Prospective Controlled RCT | 187 pats. with Class 11/111 NYHA stable CHF, and an ejection fraction </=35%, with ACE inhibitor or ARD for at least 1 month prior to enrollment, and and a beta-blocker for at least 3 months prior | Co-primary endpoints were % of pts. with at least a 60 second increase in exercise duration from baseline to 6-months, or the % of pts. with at least a 1.25 ml/min/kg increase in Peak VO2 from baseline; Exercise duration measured using a standardized ETT on a treadmill (modified Naughton protocol), or, peak VO2 at 6-months; Secondary endpoints inc. changes in exercise time and Peak VO2, NYHA class, quality of life, adverse events, and predefined clinical outcomes | ITT analysis indicates that 35% of the EECP group
versus 25% of the control group increased exercise time by at
least 60 seconds (p=0.016) at 6 months. No difference in Peak
VO2 at 6 months. Secondary endpoints: Exercise time sig.
Improved at 1 week, 3 and 6 months (24.7 second increase in EECP
group, versus decrease of 9.9 seconds in the controls, p=0.01).
NYHA class sig. improved in EECP group with 31.3% of patients
reporting improvement in NYHA class versus 14.3% in the controls
at 6-months (p<.01), Improvement in QoL NS at 6 months,
but sig. at 3 months and 1 week. Adverse events: 27 (30%) of EECP and 36 (26%) of control group required hospitalization during treatment (p value?). During follow-up, 21 subjects in EECP and 23 in control reported serious adverse events, 1 report in EECP group of DVT, and 1 case of worsening heart failure in the control group. |
Lawson et al., (43) 2005 | Registry | N=746 IEPR angina patients with a history of heart failure; divided into two groups, LVEF</=35%, [S] (n=355) of which 90.9% had CCS class III/IV angina, and LVEF>35%[D] (n=391), 92% with CCS class III/IV angina; some sig. differences between groups at baseline, incl. prior MI, gender, and some medications | Changes in angina functional class; changes in quality of life; changes in angina pattern and nitroglycerin use; medication changes; interim events (incl. cardiac hospitalizations and MACE | In both groups similar decreases in angina class,
(72.2% S versus 71.9% D) anginal episodes and nitroglycerin use.
Overall MACE rate over the course of therapy in S group was 3.1%
versus 2.3% in D group. 87% of patients were available for 1-year follow-up: Reduction of at least 1 CCS class seen in 76% of S and 78% of D, and 71% of each group reported either no angina or CCS class I/II. Adverse events: Death sig. more frequent in S group (14.1%) versus D group (9.2%), p=0.39, PCI more frequent in D group (7.3% versus 5.8%). |
Soran et al., (35) 2006 | Registry | N=363 (7% of 5000 IEPR patients) EF </= 35% | Angina class, QoL | 81% completed full course of therapy (no reasons
provided for drop-out rate although during therapy heart failure
exacerbation and events reported 5.4%). Immed post-EECP 77% improved more than 1 anginal class, 15.6% - 18% had no angina post-treatment (p<.001). At 2-years 265 patients completed follow-up and 55% had sustained improvement of anginal class. QoL indicated 58% improved immed. post-EECP and at 2-years, 63% improved (p<.001). At 2 years, 70% of patients had event-free survival; adverse event rates during, post-EECP, and at 2–years not provided though the authors state that observed events were within expectations. |
Vijayaraghavan et al.,(46) 2005 |
Cardiometrics ECP registry | 127 NYHA class III-V CHR patients with a comorbidity of CCS class III-IV angina; sig. differences in baseline characteristics | Comparative changes in mortality, LVEF, NYHA and CCS class, incidence of all-cause hospitalizations | 1 year follow-up data, no drop-outs. 127 patients divided into 3 groups based on EECP pressure applied which was based on LVEF and response to EECP; n=54 in Low D/S ratio (av. 7:1); 39 patients in Mid (av. 1.08:1); n=34 in High D/S (av. 1.32:1) which is the usual EECP treatment pressure. Mortality: 1 death in Low (1.5%), 3 in Mid (7.69%), 3 deaths in High (8.82%), the 1.85% annual mortality in the Low group was a 75.3% reduction from the 7.69% in the Mid (p<.001) and a 77.8% reduction from the 8.82% in the High DS ratio group (p<.0001). LVEF improved by 23%, 20.1%, 17.5%, and 20.4% in the Low (p=.05), Mid (p=NS), High (p=NS) and Total (p=NA) survivors. NYHA class: Low D/S improved by an av. of 36.6% (p=.0001); improved by 29.6% av. in Mid group (p<.005); high D/S improved by 29.6% (p<.01). Hospitalizations reduced by 87.5% in Low D/S (p<.0001); 83.2% in Mid (p<.0001); 46.2% in High (p<.01). |