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n estimated 17.6 million patients in the United States (US) suffer from symptom-atic coronary artery disease (CAD) and de-spite optimal medical therapy and invasive procedures, such as percutaneous coronary intervention (PCI) and cardiac bypass surgery
(CABG), there are an estimated 300,000 to 900,000 patients in the US who suffer from disabling an-gina.[1,2] In Turkey, the prevalence of atherosclerotic heart disease is 3.8% in adults (4.1% in men, 3.5% in women).[3] Age-adjusted (45-74 years) overall car-diac mortality rate in Turkey is 7.4 and 4.1 per 1000 person-years in men and women, respectively.[4,5]
'DLO\ WDVNV VXFK DV FOLPELQJ D ÀLJKW RI VWDLUV walking a dog, or mowing the lawn become infeasible ZLWKRXWH[SHULHQFLQJFKHVWSDLQIRUWKHVHGLI¿FXOWWR treat patients.[6] Current non-pharmacologic options for patients with disabling angina are limited. En-hanced external counterpulsation (EECP) therapy of-fers a safe and effective treatment option for such pa-tients. Several placebo controlled randomized[6-9] and non-randomized clinical studies[8,10-15] have shown EHQH¿FLDOHIIHFWVRI((&3LQ&$'SDWLHQWVLQFOXGLQJ VLJQL¿FDQW UHGXFWLRQ LQ DQJLQD V\PSWRPV LPSURYH-ment in objective measures of myocardial ischemia, functional capacity, and improvement in left ventricu-lar function (both systolic and diastolic).[6]
EECP therapy is a noninvasive, outpatient treat-ment consisting of electrocardiography (ECG)-gated sequential leg compression, which produces hemody-namic effects similar to those of an intra-aortic bal-loon pump. However, EECP therapy also increases venous return different from an intra-aortic balloon pump.[16] Since 1999, it has gained wide acceptance in the management of severe angina in the US.
It has been approved by the Food and Drug Ad-ministration for the treatment of stable angina, unsta-ble angina, cardiogenic shock, acute myocardial in-farction and heart failure. Although primarily used in the United States the treatment is now also being used in Turkey. The purpose of this study is to compare WKHHI¿FDF\UHSHDW((&3DQGRQH\HDUPDMRUDGYHUVH
cardiovascular rates in patients treated with EECP for angina management in the Turkish (TR) population and within the US in a real world setting.
3$7,(176$1'0(7+2'6 Patient population and study design
The International EECP Patient Registry (IEPR) Phase I and II has been initiated and coordinated at the University of Pittsburgh and has enrolled consecutive patients who underwent EECP therapy for chronic an-gina from 90 centers between 1998 and 2004. Since all clinical outcome results on EECP have been com-ing from clinical trials, the aim of the registry was to assess the outcomes of the clinical trials in the real world setting without using inclusion and exclusion criteria. Another unique feature of this study was to enroll patients not only from university hospitals but also from private hospitals, educational hospitals, and treatment centers.
In this study, 2072 patients were treated and fol-lowed in the US and 82 were treated and folfol-lowed in TR. In Turkey, one center from Ankara was invited to join the study since there was only one site in Tur-key at the time of IEPR study initiation. The IEPR methods have been described previously.[2] Patients in the IEPR were required to give informed consent. The IEPR tracks the demographics, baseline charac-teristics, clinical events, and outcomes of consecutive patients who underwent EECP treatment for angina, with no exclusion due to demographics, clinical sta-tus, or outcome. At 1 year, patients were interviewed by telephone or at a clinic visit, and data concerning interim clinical events, hospitalizations, and current symptomatology were recorded. Major adverse car-GLDFHYHQWV 0$&( ZHUHVSHFL¿HGDVWKHFRPSRVLWH of death, myocardial infarction, percutaneous coro-nary intervention, and corocoro-nary artery bypass graft-ing. Patient data were included only from sites with 85% complete follow-up.
EECP therapy is composed of an air compressor unit, a computer module, 3 sets of pneumatic cuffs, and a treatment table (Vasomedical, Inc, Westbury, NY, US). Cuffs are wrapped around the patient’s calves, thighs, and upper thighs (including buttocks) and a computer-controlled pneumatic system acts to LQÀDWHDQGGHÀDWHWKHFXIIV,QÀDWLRQDQGGHÀDWLRQDUH triggered by events in the cardiac cycle through
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$EEUHYLDWLRQVCABG Cardiac bypass surgery CAD Coronary artery disease ECG Electrocardiography EECP Enhanced external counterpulsation IEPR The International EECP Patient Registry
MACE Major adverse cardiac events
MUST-EECP Multicenter Study of Enhanced Counter Pulsation PCI Percutaneous coronary intervention
processor-interpreted electrocardio graphic signals. Cuffs resembling oversized blood pressure cuffs–on the calves and lower and upper thighs, including the EXWWRFNV±LQÀDWHUDSLGO\DQGVHTXHQWLDOO\YLDFRPSXWHU interpreted ECG signals, starting from the calves and proceeding upward to the buttocks during diastole. This creates a strong retrograde counterpulsation in the arterial system. This sequential compression re-sults in augmented diastolic pressure which increases coronary perfusion and provides enhanced afterload reduction and increased venous return with a
follow-LQJLQFUHDVHLQFDUGLDFRXWSXW5DSLGGHÀDWLRQRIWKH cuffs at the onset of systole enhances systolic unload-ing and reduces the workload of the heart by decreas-ing peripheral vascular resistance. This is achieved because the vascular beds in the lower extremities are UHODWLYHO\HPSW\ZKHQWKHFXIIVDUHGHÀDWHGVLJQL¿-cantly lowering the resistance to blood ejected by the heart and reducing the amount of work the heart must do to pump oxygenated blood to the rest of the body. Systolic and diastolic pressure waves are monitored WKURXJKRXW WUHDWPHQW E\ QRQLQYDVLYH ¿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
mography. A typical treatment course consists of 35 one hour sessions over a 5-7 week period and is usu-ally well tolerated with a low risk of adverse events.
Statistical analysis
Baseline characteristics are presented for categorical variables as the proportion of patients who reported and as mean ± standard deviation (SD) for continu-RXVYDULDEOHV6WDWLVWLFDOVLJQL¿FDQFHZDVWHVWHGXVLQJ Chi-squared or Fisher tests for categorical analyses and Wilcoxon tests for continuous variables. Kaplan-Meier survival analysis was used to estimate rates of adverse events at 1 year following start of EECP. Sta-tistical differences were determined using the log rank test. Two-tailed p values less than 0.05 were consid-HUHGVWDWLVWLFDOO\VLJQL¿FDQW
5(68/76
In this study, 2072 were treated and followed in the US and 82 in TR. TR patients were younger (p<0.001) with a similar proportion of men (75.6% vs. 73.5%) and were less obese than US patients (p<0.001). Dura-tion of coronary artery disease was less in TR patients (p<0.01) and previous revascularization was 57% for TR patients vs. 89% for US patients (p<0.001). Heart failure was reported in 46% of TR patients and 34% of US patients. TR patients were less likely to have had PCI (p<0.001). CABG rates were 49% for TR patients vs. 71% for US patients (p<0.001). Sixty eight percent of patients from TR and 88% from US were no longer candidates for further revasculariza-tion (p<0.001). TR patients had less hypertension and hyperlipidemia than US patients (p<0.001). TR SDWLHQWVKDGOHVVFKURQLFUHQDOLQVXI¿FLHQF\ S and peripheral vascular disease as well (p<0.001). Pa-tients from TR had less Class III and IV stable angina (p<0.001) with a similar rate of unstable angina but higher rates of heart failure. Forty four percent pa-tients from TR and 75% from the US had multives-sel disease (p<0.001). Medication use (beta blockers, CA Channel blockers and lipid lowering drugs) was higher in the US patients (Table 1).
After a mean treatment course of 33 hours for the US group and 36 hours for the TR group (p<0.01), 91% of TR patients vs. 77% of US patients had at least one Canadian Cardiovascular Society (CCS) class angina reduction (p<0.01). MACE during the treatment course (2.5% vs. 2.7%) and discontinuation
of nitroglycerin usage after the treatment was similar in both groups (Table 2). At 1 year follow up, 83% of TR patients and 76% of US patients had maintained the improvement in angina class (p=NS); (Table 2). Survival rate was 100% in TR and 96% in US. MACE free survival rate was 95% in patients from TR vs. 83% in the US (p=0.011). Repeat EECP rates at 1 year follow up were lower in TR patients (2.3% vs. 8.9%, p<0.075).
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Several randomized placebo control[7-9,17-20] and non-randomized trials[11-13,16,21-23]KDYHGHPRQVWUDWHGD¿UP positive clinical response among patients with CAD WUHDWHG ZLWK ((&3 %HQH¿WV DVVRFLDWHG ZLWK ((&3 therapy include reduction in angina and nitrate use, increased exercise tolerance, favorable psychosocial effects, and enhanced quality of life as well as pro-longation of the time to exercise-induced ST-segment depression and an accompanying resolution of myo-cardial perfusion defects. Numerous clinical trials have shown EECP therapy to be safe and effective for patients with CAD, with a clinical response rate aver-aging 70% to 80%, which is maintained up to 5 years. [1,16,21,22,24,25]
Although placebo-controlled randomized and non-UDQGRPL]HGVWXGLHVKDYHVKRZQEHQH¿FLDOHIIHFWVRI EECP therapy, investigators saw the need to assess the effectiveness of EECP in real-world settings, lead-ing them to develop the IEPR under the management of the University of Pittsburgh. The main aim of the registry was to assess the outcomes of the clinical tri-als in a real world setting without applying any inclu-sion and excluinclu-sion criteria while maintaining indica-tions and contraindicaindica-tions only.[26]
7KH SUHVHQW UHVXOWV VKRZ DQG UHÀHFW WKH XWLOL]D-tion patterns and cardiovascular outcomes in the real world setting in two distinct patient populations who have undergone EECP therapy. Patients treated with EECP in TR and the US showed very different base-OLQH GHPRJUDSKLF DQG FOLQLFDO SUR¿OHV +RZHYHU there was only one center in Turkey at the time of IEPR study initiation; therefore, this one center was invited to take part in this study. Hence, the results from Turkey cannot be generalized to the entire Turk-ish population.
Patients in our study had chronic multivessel coro-nary artery disease. EECP therapy is often used for
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patients with refractory angina pectoris; however, patients who deny undergoing invasive revascular-ization may undergo EECP therapy. In the US, the majority of patients who were suffering from angina
refractory to medical therapy or conventional revas-cularization techniques underwent EECP therapy. In TR only 57% of patients had prior PCI or CABG and 32% were candidates for invasive revascularization at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
the time of EECP therapy. However, these patients de-nied undergoing further invasive procedures.
Medication use (beta blockers, CA Channel block-HUV DQG OLSLG ORZHULQJ GUXJV ZHUH DOVR VLJQL¿FDQW-ly higher in US patients. The major reasons for this GLIIHUHQFH ZHUH KLJKHU VLGH HIIHFW SUR¿OHV VHHQ LQ polydrug therapy and low compliance rates seen in TR patients.
$QRWKHULQWHUHVWLQJ¿QGLQJZDVWKDWWKHGLDVWROLF DXJPHQWDWLRQ UDWLR ZDV VLJQL¿FDQWO\ KLJKHU LQ 75 ZKHQFRPSDUHGWRWKH86DWEDVHOLQH7KH¿QJHUSOH-thysmogram tracing is used to set, monitor and adjust the timing of EECP therapy and to quantify the hemo-dynamic effects of counterpulsation. During EECP, FXIILQÀDWLRQDQGGHÀDWLRQFKDQJHWKHDUWHULDOZDYH-form so that the diastolic peak is elevated, indicating diastolic augmentation, while the end diastolic pres-sure and the systolic peak are lowered, demonstrating systolic unloading. The measurement of augmentation is based upon the ratio of the diastolic (D) to systolic (S) wave, or the D/S ratio. The D/S ratio may be mea-sured in terms of area or peak. The peak measurement (P) is more common as it is easily done by estimation. 7KHJRDORI((&3LV3ZKLFKLVFDOOHGRSWLPDO therapeutic diastolic augmentation. One reason to ex-plain this difference was that US patients had a more extensive disease with higher rates of risk factors. At the end of the EECP course, however, both groups achieved optimal therapeutic diastolic augmentation which can explain why both cohorts achieved similar substantial reduction in angina with high event free survival rates at 1 year follow up. Similar results have been demonstrated in other studies.[1,21,27,28]
The effects of EECP therapy on exercise-induced myocardial ischemia and angina were evaluated in MUST-EECP (Multicenter Study of Enhanced Coun- WHU3XOVDWLRQ WKH¿UVWPXOWLFHQWHUSURVSHFWLYHUDQ-domized, double blinded, sham controlled trial in pa-tients with refractory angina. This trial was conducted at seven centers with 55 patients in the active EECP group and 65 in the sham group completing the study. [7] Average pre-treatment and post-treatment exercise duration, time to 1-mm ST-segment depression, daily number of angina attacks and glyceryl trinitrate were collected. Patients in the active EECP therapy group VKRZHG D VWDWLVWLFDOO\ VLJQL¿FDQW LQFUHDVH LQ WLPH WR exercise-induced ST-segment depression when
com-pared with sham and baseline, and reported a statisti-FDOO\VLJQL¿FDQWGHFUHDVHLQWKHIUHTXHQF\RIDQJLQD episodes when compared with sham and baseline. Ex-HUFLVHGXUDWLRQLQFUHDVHGVLJQL¿FDQWO\LQERWKJURXSV however, the increase was greater in the active EECP group. Follow-up was done at 1 year to assess the TXDOLW\RIOLIH7KHUHZDVDVLJQL¿FDQWGLIIHUHQFHEH-tween the groups favoring the active EECP arm in re-gards to quality of life.[7] Our study results in regards WRDQJLQDUHGXFWLRQDQGORZHYHQWUDWHVFRQ¿UPHGWKH results of randomized clinical trial outcomes in the real world settings.
Mechanism of action studies suggests that EECP shows its effectiveness through collateral develop-ment, endothelial function and neurohormonal im-provement.[8,15,22,29-31]
The best treatment options for patients with disabling angina have not been fully described. EECP therapy is a valuable, safe, outpatient procedure pro-YLGLQJ DFXWH DQG ORQJWHUP EHQH¿WV LQ DQJLQD UHOLHI in patients with symptomatic CAD with or without congestive heart failure.
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