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Table of Contents
Year : 2020  |  Volume : 10  |  Issue : 4  |  Page : 174-180

Twelve months outcome of drug-eluting stenting versus off-pump bypass surgery for proximal left anterior descending coronary artery lesion in ischemic cardiomyopathy

1 Department of Cardiology, Zagazig University, Zagazig, Egypt
2 Department of Cardiothoracic Surgery, Cairo University, Cairo, Egypt
3 Department of Anesthesiology, Cairo University, Cairo, Egypt

Date of Submission10-Jul-2020
Date of Decision14-Jul-2020
Date of Acceptance21-Sep-2020
Date of Web Publication21-Jan-2021

Correspondence Address:
Dr. Yasser Gaber Metwally
Department of Cardiology, Zagazig University, Zagazig
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/JICC.JICC_51_20

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Background: The precise benefit/risk ratio of either procedure in patients with ischemic cardiomyopathy remains less clear. Objectives: This study is aimed to assess the 12 months outcome of drug-eluting stent (DES) versus off-pump CABG (OPCAB) for proximal left anterior descending lesions in ischemic cardiomyopathy. Patients and Methods: A total of 70 patients diagnosed with ischemic cardiomyopathy with ejection fraction <35% referred for revascularization were assigned to either stenting or surgery. The primary endpoint was (in stent restenosis [ISR]/graft occlusion) rates; the secondary endpoint was MACE at 12 months of follow-up. Results: Out of 70 patients enrolled; 71.4% were assigned to DES, while 28.6% were assigned to OPCAB; the mean the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery score for stent group was 17.5 ± 0.96, while the mean Euro-score II for the surgery group was 3 ± 0.86. The ISR/graft occlusion rates; angina; and target vessel revascularization were significantly higher among the stenting group (30% vs. 5%; P = 0.028); (4% vs. 25%; P = 0.017) and (22% vs. 0%, P = 0.028), respectively, while late transient ischemic attack/stroke and length of hospital stay were significantly higher among the surgery group (2% vs. 20%; P = 0.021) and (2 ± 0.5 days vs. 7.2 ± 0.5, P < 0.001), respectively; similar survival rates among the two groups. The relative risk of ISR/graft occlusion is six times more among the stent group compared to the surgery group (P = 0.028). Conclusion: Similar survival rates at 12 months of follow-up among the two groups; stent carries more risk of ISR; repeat revascularization while surgery carries more risk of late stroke.

Keywords: Cardiomyopathy, ischemic, off-pump bypass, stenting

How to cite this article:
Metwally YG, Mahmoud AF, Taha WS. Twelve months outcome of drug-eluting stenting versus off-pump bypass surgery for proximal left anterior descending coronary artery lesion in ischemic cardiomyopathy. J Indian coll cardiol 2020;10:174-80

How to cite this URL:
Metwally YG, Mahmoud AF, Taha WS. Twelve months outcome of drug-eluting stenting versus off-pump bypass surgery for proximal left anterior descending coronary artery lesion in ischemic cardiomyopathy. J Indian coll cardiol [serial online] 2020 [cited 2022 Dec 7];10:174-80. Available from: https://www.joicc.org/text.asp?2020/10/4/174/307617

  Introduction Top

Since 1968, when Dr. George Green[1] from the Saint Luke's Hospital in New York City had performed the first left internal thorathic artery to left anterior descending (LAD) anastomosis that has become the absolute gold standard of the coronary artery bypass graft (CABG) surgery. Since that date, the CABG surgery as it is known today was born.[2]

Nine years thereafter, the cardiologists have proceeded toward interventional catheter-based therapy. Already in 1977 in Zürich, Andreas Gruntzig first performed the first percutaneous coronary intervention (PCI) as a trans luminal balloon angioplasty to dilate a stenosis in the LAD,[3] then it took <10 years before metallic stents could be successfully designed and inserted into the coronary arteries to prevent arterial recoil and restenosis with the first clinical data reported by Ulrich Sigwart in Switzerland.[4]

The first generation of drug-eluting stents (DES) made out of stainless steel and delivering sirolimus (rapamycin) or paclitaxel soon yielded to the second generation of stent materials (e.g., cobalt-chromium) with decreased strut thickness reducing mechanical risk factors of incomplete stent apposition but delivering similar drugs (paclitaxel or sirolimus-derived zotarolimus and everolimus).[5]

However, So far, American guideline-driven recommendations in the context of heart failure ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS) 2017 Appropriate Use Criteria for Coronary Revascularization in Patients with Stable Ischemic Heart Disease Revascularization to improve survival compared with medical therapy in the anatomic setting of left ventricular dysfunction, recommend CABG for patients with ejection fraction (EF) <35% without significant left main coronary artery disease (CAD) as a class IIb with insuffient data for PCI.[6]

This had stimulated us to further investigate those with ischemic cardiomyopathy with EF % <35% referred for revascularization by either procedure. Hence, we aimed to assess the 12 months outcome of DES versus off-pump CABG (OPCAB) for proximal LAD Lesions in ischemic cardiomyopathy.

  Patients and Methods Top

Study population

This study was carried out in the Departments of Cardiothoracic Surgery and Cardiology, Faculty of Medicine, Cairo University as well as Zagazig University. The study was conducted from January 2018 to May 2020.

The study included 70 Consecutive patients with ischemic cardiomyopathy (EF% <35%) with proximal significant lesion (>50%) at LAD artery planned for revascularization were enrolled in this study.

Patients were eligible if documented viable myocardium (either by dobutamine stress or by thallium) study are available. Additional surgical procedures during the same operation (e.g. valve surgery, aneurysmectomy, carotid surgery, etc.), left main disease; cardiogenic shock, poorly controlled atrial fibrillation, sustained ventricular tachyarrhythmia, If death occurred in the operating room, end-stage renal disease or with a contraindication to antiplatelet therapy were exclusion criteria. The choice of revascularization modality (PCI versus CABG) was left to the physician's as well as to the patients' discretion rather than randomization.

The patients were assigned into two groups according to the revascularization modality done either PCI (DES group; n = 50) or (surgical group; n = 20).

The study complied with the Consolidated Standards of Reporting Trials 2010 statement[7] and the declaration of Helsinki and was approved by the independent medical ethics committee twente and the institutional review board of the participating centers. All patients gave written informed consent.

Invasive coronary angiography (ICA, QCA) as a reference standard.[8] The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) score was calculated where the cut-off value of ≤22; between 23 and 32 and ≥33 were used to identify low-, intermediate-, and high-risk, respectively, for PCI.[9] Furthermore, Euro score II was calculated where the cut-off value of 6% was used to identify high risk for surgery.[10]

For the PCI arm, the coronary intervention was done using a second-generation drug-eluting stent (either EES or PES); the detailed description of the devices are provided else-where: (http://www.abbotvascular.com/docs/coronaryintervention/xience/epg.xience.pdf) and (www.boston scientific.com, www.stent.com), respectively.

The interventional techniques were done according to the standard guidelines.[11] For the surgery arm; CABG surgery was done. They were initially planned for OPCAB, however, the decision of conversion from off-pump to on-pump (ONCAB) intraoperatively was left to the surgeon's discretion. Either technique was carried out according to the internationally established standards using LIMA to LAD. The off-pump surgery was performed by the use of the “Octopus” tissue stabilizer described in detail anywhere.[12]

Further medical management was provided according to the guidelines and the physician's judgment.[13] However, the use of aspirin was continued indefinitely while the dual antiplatelet use was mandatory for the stent arm up to 12 months.

Clinical endpoints were defined as proposed by the Academic Research Consortium (ARC), including the addendum on myocardial infarction (MI).[13],[14],[15]

Death was regarded as cardiac unless an un-equivocal noncardiac cause could be established. MI was defined by creatinine kinase concentration of more than double the upper limits of normal with raised cardiac biomarkers.[16]

A target vessel-related MI is defined as an MI related to the vascular territory of the previously treated target. Further MI classification could be based on laboratory, ECG, angiographic or clinical data.[13],[16]

Revascularization procedures were considered as clinically indicated (i.e. there was sufficient objective evidence of clinically significant lesion, if the angiographic diameter stenosis of the then treated lesion was 50% or more in the presence of ischemic signs or symptoms, or if the diameter stenosis was 70% or more irrespective of ischemic signs or symptoms.[16]

Stent thrombosis was proposed by the ARC.[17] A final residual percent diameter stenosis of <30% with TIMI flow III (using the assigned device only) was defined as procedural success. In-stent restenosis was defined as in-stent luminal diameter narrowing of at least 50%.

12 months clinical follow-up data were obtained through outpatient department visits or if not available; by the telephone follow-up using medical questionnaire form.


The primary endpoint was (in stent restenosis [ISR]/graft occlusion) rates; the secondary endpoint was MACE at 12 months follow-up.

Statistical analysis

The continuous variables were expressed in mean ± standard deviation , while discrete variables were expressed in percentage. The differences in continuous variables were checked for statistical significance by t-test as appropriate, the differences in the discrete variables were checked for statistical significance by Chi-square test. The association between ISR/graft occlusion versus revascularization modalities was done using Fisher's exact test.

P < 0.05 was considered significant. The statistical analysis was performed using SPSS.11 for Windows (SPSS Inc., Chicago, IL, USA).

  Results Top

The baseline, demographic and clinical characteristics of our study population are shown in [Table 1]. No statistically significant differences in the frequency of the age, gender, HTN, dyslipidemia, smoking, previous stroke, diabetes mellitus, previous MI, significant MR, the mean body mass index, waist circumference or the mean EF% between the two groups.
Table 1: The baseline, demographic and clinical characteristics of the study groups

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Angiographic and procedural variables are shown in [Table 2]. No statistically significant differences in the: number of more than one vessel disease, reference vessel diameter, %DS before revascularization procedures, lesion length, % of complex lesion (Class B2/C), SYNTAX score. On the other hand there was a significantly higher Euro score II, shorter mean time to revascularization among the DES group.
Table 2: Angiographic and procedural variables of the study groups

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Clinical outcomes at 12 months of follow-up are shown in [Table 3]. No statistically significant difference in the frequency of deaths (e.g., Similar survival rates among the two groups); target vessel-related MI, procedure success rate between the two groups. On the other hand; there were significantly higher rate of: ISR/graft occlusion (30% vs. 5%; P = 0.028); frequency of angina after revascularization (4% vs. 25%, P = 0.017) and target vessel revascularization (TVR) (22% vs. 0%, P = 0.028) among the stenting group, (as shown in [Figure 1]) while significantly higher rates of late transient ischemic attack (TIA) stroke (2% vs. 20%, P = 0.021) (as shown in [Figure 2]), and length of hospital stay (2 ± 0.5 days vs. 7.2 ± 0.5, P < 0.001) among the surgery group.
Figure 1: Frequancy of TVR at 12 month follow up among the study groups. *P < 0.05 significant when comparing G1 to G2

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Figure 2: Frequancy of TIA/stroke after revascularization at 12 month follow up. *P < 0.05 significant when comparing G1 to G2

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Table 3: Postprocedural outcome of the study groups

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The association between the ISR/graft occlusion and the revascularization modalities are shown in [Table 3] showed that; the relative risk (RR) of ISR/graft occlusion is six times more among the stent group compared to the surgery group (RR = 6; 95% confidence interval is 0.85–42.5), (P = 0.028).

  Discussion Top

The intension to treat approach for OPCAB in most cases with isolated CAD and low EF% is still an exceptional concept.[18] The majority of publications about revascularization in patients with low EF% deal with ONCAB as the gold standard[19],[20],[21],[22],[23],[24] with 5-year survival rates of about 71% (while only 50% with the medical treatment.

The relative efficacy of PCI versus surgical revascularization in HF as well as the exact role of OPCAB in patients with low EF%, had been already discussed.[19],[20],[21],[22],[23],[24],[25]

Pusca and Puskas[25] compared PCI and surgical revascularization in patients with heart failure and favored an operation (no further differentiation in OPCAB or ONCAP), with exception of specific situation as status after several cardiac operations or sever co-morbidities preventing major surgery.

The results of our study demonstrated lower TVR rates among the surgery group. The lower TVR rates could be explained in turn by lower graft occlusion rates among the surgery group. High graft patency rates of IMA to LAD are well known, especially on long-term follow-up basis[26] although that our study follow-up time was too short to demonstrate.

Our results also surprisingly demonstrated incident angina among the surgery group. This could be explained by the surgical procedure modality chosen at our study protocol for the surgery arm. OPCAB is documented to be associated with less effective revascularization of the posterior and lateral wall than the anterior wall (LAD territory).[27]

A major concern and argument against OPCAB,[28],[29],[30] although may be considered safer than ONCAB in patients with an enlarged heart and associated with low EF.[31]

Our results demonstrated also higher rates of late TIA/stroke among the surgery group. The interpretation of a higher incidence of stroke despite the use of OPCAB variety of CABG needs certain precautions: first the onset of stroke was after the hospital discharge in 20% of case, for example, not immediately noted postoperatively. Second, most cases of surgery arm (20%) were not maintained the dual antiplatelet therapy (DAPT) during the 12 months follow up, thus; it seems that; the pathophysiology of stroke among the surgery arm of our study, not directly related to the surgical procedure itself. CABG is a known risk factor for stroke because of large atherosclerotic emboli detached by surgical manipulation of the aorta in cases of moderate-to-severe proximal aortic atherosclerosis,[32] for example, in patients with a high atherosclerotic burden. Observational trials have suggested that, by avoiding the deleterious effects of cardiac bypass, OPCAB may extensively reduce the mortality and morbidity rates when compared to the conventional CABG[33] and in particular in high-risk patients.[34]

Standard OPCAB, however, still requires application of a side biting clamp to complete the proximal anastomosis, thus increasing the risk of disclosing fragile material from the aortic intimal wall. It has been demonstrated that in cases of the diffusely diseased aorta, the off-pump procedures performed the so-called “no-touch” or with the use of proximal anastomotic devices allow the avoidance of any type of clamping and may reduce the risk of postoperative neurologic events and cognitive functional impairment.[35]

However, so far, data available were inconclusive to provide a definite conclusion regarding the above-mentioned two techniques because of the small sample size.[35]

Serruys et al.[36] had found that; compared to PCI, patients of the CABG arm were less likely to receive secondary preventive treatment such as DAPT and statin. This may explain why 50% of the strokes in the CABG arm had occurred after 30 days of the operation in his study.

Previous randomized clinical trials have demonstrated the value of PCI versus CABG in patients with low EF% (<35%).[37]

The AWESOME trial[37] was the only completed randomized trial conducted on 94 patients with EF <35%, ended after 3 years, showed a survival of 69% for PCI and 72% after CABG surgery (the overall use of stent in the PCI arm was only 54%). In the large Canadian study (APPROACH study), the 1-year survival rate for CABG including low EF patient using territorial registry; was 91.4% for the surgery arm for patients with EF <30%.[38]

OPCAB versus on-OPCAB has been investigated by Gorki et al.[39] who conducted a study on 346 patients with EF <30% with isolated OPCAB, were compared with a propensity-matched historical group operated On pump (ONCAB); the 30-day survival rate was significantly better among the OPCAB arm while the in-hospital MACE all were nonsignificant (stroke, MI, renal failure, and sepsis) except the length of hospital stay that was significantly shorter among the OPCAB arm.

The findings of this study demonstrated similar survival rates with the shorter hospital stay. The ROOBy trial[40] showed less patency and less effective revascularization with a significantly higher adverse event rates with the OPCAB arm with no significant difference in the neuro-psychological outcome between the two groups. Charlesworth et al.[41] suggested NNECDSG stroke risk scores to identify those who are at high risk for postoperative stroke.

The finding of less patency and less effective revascularization noted at the ROOBy trial; come consistent with the incident angina found among the surgery group of this study. On the other hand, there were no major differences between the outcome of both techniques that were found in the SMART trial.[33]

Eefting et al.[42] reported that stenting was more cost-effective than off-pump surgery while maintaining comparable cardiac outcomes in terms of (death, stroke, MI, repeat revascularization, and quality of life) at 1-year follow-up.

Study limitations

First, our sample size is relatively small to detect small differences in binary event rates; larger scaled prospective multicentred randomized trials are needed. Second, despite the study was not randomized could have introduced a sampling bias. However, there was no major difference that appeared in the demographic or other variables that could seriously affect our main results, still, we suggest that further prospective multicenter (RCT) to confirm our results. Third, longer term follow-up >1 year not studied.

  Conclusion Top

Similar survival rates at 12 months of follow-up among the two groups; stent carries more risk of ISR; repeat revascularization while surgery carries more risk of stroke.


Recruiting the NNECDSG stroke risk scores to identify those who are at high risk for postoperative stroke; so may be considered either: candidates for neuroprotection during surgery (using off-pump surgery, aorta no-touch strategy, intraoperative epi aortic ultrasound examination of the ascending aorta); or who could be regarded as candidates for percutaneous coronary revascularization and possibly routine postoperative DAPT and statin therapy.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

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  [Figure 1], [Figure 2]

  [Table 1], [Table 2], [Table 3]


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