partial revascularization plus medical treatment versus medical … · 2016. 12. 10. · partial...

The Egyptian Heart Journal (2013) 65, 57–64

Egyptian Society of Cardiology

The Egyptian Heart Journal

www.elsevier.com/locate/ehjwww.sciencedirect.com

ORIGINAL ARTICLE

Partial revascularization plus medical treatment versusmedical treatment alone in patients with multivesselcoronary artery disease not eligible for CABG

M. Sadaka *, M. Loutfy, M. Sobhy

Cardiovascular Department, Faculty of Medicine, Alexandria University, Egypt

Received 31 August 2012; accepted 8 October 2012Available online 9 November 2012

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KEYWORDS

Multivessel coronary artery

disease;

Coronary artery bypass

graft;

Optimal medical therapy;

Incomplete revascularization

Corresponding author. Tel.

-mail address: mohsadaka20

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10-2608 ª 2012 Egyptian Sotp://dx.doi.org/10.1016/j.ehj.2

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Abstract Aim: The purpose of this study was to compare the impact of incomplete revasculariza-

tion (IR) plus optimal medical therapy (OMT) to OMT alone on 1 year clinical outcomes in

patients with multivessel coronary artery disease (MVD) who were not eligible for coronary bypass

graft surgery (CABG).

Methods: This is a prospective randomized study conducted on 50 selected patients with chronic

stable angina with documented MVD and CABG was refused by the surgeon due to poor distal

vessel quality. Patients were randomized 1:1 into two groups, group (I): 25 patients were subjected

to OMT alone and group (II): 25 patients were subjected to IR plus OMT. All patients were sub-

jected to 1 year follow up.

Results: The baseline patients’ details were matched. At 1 year; death occurred slightly more in

group II (16% versus 12%; p= 1.000), ACS occurred more in the group I (32% versus 16%;

p= 0.321) while freedom from angina occurred more in group II (20% versus 4%; p= 0.189).

The OMT alone did not affect neither the level of angina class nor EF; while the IR plus OMT

markedly improved the decline in the level of angina class (p= 0.011), but it did not improve

EF significantly (p= 0.326).

Conclusion: In patients with MVD who were not eligible for CABG; IR plus OMT was not supe-

rior to OMT alone in improving the 1 year clinical outcomes except the improvement in the level of

angina class, which could be the adopted strategy to improve the quality of life in such patients.ª 2012 Egyptian Society of Cardiology. Production and hosting by Elsevier B.V. All rights reserved.

27498471.

oo.com (M. Sadaka).

tian Society of Cardiology.

g by Elsevier

ardiology. Production and hostin

02

1. Introduction

When treating patients with coronary artery disease (CAD),clinicians consider whether management should be medicaltherapy (MT) alone or in addition to coronary revasculariza-

tion. When revascularization is recommended, both coronaryartery bypass graft surgery (CABG) and percutaneous coro-nary intervention (PCI) are potential options. Typically, the

treatment recommendation is based on clinical presentation,

g by Elsevier B.V. All rights reserved.

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58 M. Sadaka et al.

severity and magnitude of ischemia, extent and distribution of

coronary anatomic disease, presence of other non-cardiacmedical conditions, and evidence of the effectiveness of eachstrategy.1 Unlike CABG surgery, where most patients are com-pletely revascularized and where complete revascularization

(CR) has been demonstrated to be associated with betterlong-term outcomes, the strategy for multivessel disease pa-tients undergoing PCI frequently involves incomplete revascu-

larization (IR). In IR, balloon angioplasty and stent placementare performed on only some of the patients’ diseased vessels.Reasons for not attempting all diseased vessels may include

the presence of one or more chronic total occlusions, the pres-ence of serious medical conditions such as severe left ventricu-lar dysfunction, severe renal impairment or the decision to

treat only the ‘‘culprit lesion’’ that is thought to be responsiblefor the patient’s symptoms.2 Although multiple studies havecompared the outcomes of patients who have been completelyand incompletely revascularized with PCI, few of these are re-

cent. Most of these studies were conducted before the intro-duction of coronary stenting, and many were conducted inthe context of randomized trials in which incompletely revas-

cularized patients were monitored more closely than theywould be under normal circumstances.3–7

The implications of the 10-year findings from MASS-II

are that revascularization, particularly with CABG, improvesthe outcomes of patients with multivessel disease in compar-ison to MT alone. To this point in time, data from individ-ual clinical trials have not demonstrated any benefit from

revascularization by CABG or PCI over optimum medicaltherapy (OMT) alone in regard to decreasing the incidenceof death (total or cardiac) or fatal myocardial infarction

(MI).8,9 In fact, recommendations of appropriateness andguideline documents have emphasized the lack of clinicalbenefit and have advocated against the routine application

of revascularization procedures for patients with multivesseldisease and preserved left ventricular function, except forthe relief of symptoms unresponsive to aggressive medical

therapy. Till now, no consensus about revascularization volumein multivessel disease has been reached in the worldwidepractice.10

The recently completed Clinical Outcomes Utilizing Revas-

cularization and Aggressive Drug Evaluation (COURAGE)Trial forms much of the basis for such a position. In this large,multi-national investigation, an initial management strategy of

PCI combined with intensive OMT was compared to a strategyof deferred PCI and OMT. At 5 years, COURAGE investiga-tors found no difference in rates of death, MI, stroke, or hos-

pitalization for an acute coronary syndrome between the twotreatment groups. COURAGE patients differed, however,from MASS-II patients, the extent of CAD was substantially

greater in MASS-II patients than those in COURAGE, a pos-sible explanation for the differences in findings. Of note,COURAGE did observe a benefit for PCI over OMT for reliefof angina. A similar effect was seen for CABG in MASS-II.

Importantly, MASS-II also compared revascularization byCABG to that of PCI. As noted above, however, cardiovascu-lar therapies evolve and become more refined over time.11

Although OMT, CABG, and PCI have each improved, PCIhas arguably changed the most in terms of procedural tech-nique, intensive use of ancillary antiplatelet and anticoagulant

drugs, and stents with superior design features, including thin-

ner struts and antirestenotic drug delivery. The purpose of this

study was to compare the impact of IR plus OMT to OMTalone on 9 month clinical outcomes (death, acute coronarysyndrome (ACS) and angina class) in patients with multivesseldisease who were not eligible or refused CABG.

2. Methods

This is a prospective randomized study conducted on 50 se-lected patients with chronic stable angina and without past his-tory of revascularization; they have documented multivessel

coronary artery disease (MVD) by standard coronary angiog-raphy and CABG was the only option of revascularization butwas refused by surgeon due to the poor quality of the distal

vessels. All patients had a non-viable myocardium documentedby viability studies (either dobutamine stress echocardiogra-phy (DSE) or myocardial perfusion scintigraphy) were ex-

cluded from the study. Syntax score was calculated for allpatients. Patients were randomized 1:1 into two groups, group(I): 25 patients were subjected to optimum medical therapy(OMT) alone and group (II): 25 patients were subjected to

incomplete revascularization (IR) {PCI in one or two vesselsonly with drug eluting stents (DES)} plus OMT. All patientswere subjected to detailed history taking, clinical evaluation,

electrocardiogram (ECG), echocardiography, and laboratoryinvestigations. All patients will be subjected to 1 year followup (FU) as regards; death, hospitalization for decompensated

heart failure, acute coronary syndrome (ACS), angina class,ejection fraction (EF) and revascularization {target vesselrevascularization (TVR) and non target vessel revasculariza-tion (non-TVR)}

Informed written consent was signed by every patient en-rolled in the study after a detailed complete explanation ofthe study purpose and details.

2.1. Statistical analysis

Data were analyzed using SPSS software package version18.0 (SPSS, Chicago, IL, USA). Quantitative data wereexpressed using Range, mean, standard deviation and

median while Qualitative data were expressed in frequencyand percent. Qualitative data were analyzed using theChi-square test also exact tests such as Fisher exact andMonte Carlo were applied to compare different groups,

while McNemar-Bowker was used to analyze the signifi-cance between the different stages. Not normally distrib-uted quantitative data were analyzed using the Mann

Whitney test for comparing two groups. P value was assumedto be significant at 0.05.

3. Results

3.1. Descriptive data (Tables 1 and 2)

The baseline patients’ demographic characteristics (Table 1),

echocardiographic and angiographic details (Table 2) did notdiffer substantially between the two studied groups. Also, ahigh syntax score (P33) was almost found in majority ofpatients in both groups (23 patients in the OMT group and

24 patients in the IR plus OMT group; p = 1.000).

Table 1 Baseline demographic data of both groups.

OMT group (n= 25) IR plus OMT group (n= 25) p Value

No. (%) No. (%)

Age, (years) 65.24 ± 10.38 65.72 ± 9.11 p= 0.863

Sex

Male 18 72.0 17 68.0 p= 0.758

Female 7 28.0 8 32.0

Smoking

Current smoker 8 32.0 2 8.0 p= 0.105

Ex-smoker 10 40.0 14 56.0

Diabetes mellitus 14 56.0 18 72.0 p= 0.239

Hypertension 17 68.0 16 64.0 p= 0.765

Dyslipidemia 19 76.0 17 68.0 p= 0.529

Previous ACS 20 80.0 17 68.0 p= 0.333

Previous Stoke 2 8.0 2 8.0 p= 1.000

Renal impairment 7 28.0 6 24.0 p= 1.000

Peripheral arterial disease 5 20.0 2 8.0 p= 0.417*COPD 7 28.0 3 12.0 p= 0.289**Anemia 5 20.0 7 28.0 p= 0.508

Angina class

I 2 8.0 2 8.0 p= 0.756

II 12 48.0 8 32.0

III 10 40.0 14 56.0

IV 1 4.0 1 4.0

* COPD is defined as chronic obstructive pulmonary disease documented by pulmonary function tests.** Anemia is defined as hemoglobin less than 10 grams.

Partial revascularization plus medical treatment versus medical treatment alone in patients 59

3.2. Treatment details (Table 3)

As regards the medications prescribed to the patients, they did

not differ substantially between the two groups except for theclopidogrel (plavix) which was prescribed more frequent in theIR plus OMT group than in the medical group (100% vs.76.0%, p= 0.022).

In the IR plus OMTgroup, as regards the PCI procedure, theselected vessel was based upon the ischemic burden judged bythe viability study also by the feasibility to angioplasty. PCI of

the LM was done in 4% of patients, LAD in 52%, D1 in 8%,LCX in 36% and RCA in 36% of patients. One vessel was at-tempted in 64% of patients and two vessels were attempted in

36% of patients. The procedural success rate was 96%.

3.3. One year follow up: (Table 4)

All patients were followed up for 1 year; death occurredslightly more in the IR plus OMT group (16% versus 12%;p = 1.000), hospitalization for decompensated CHF occurred

more in the OMT group (28% versus 12%; p= 0.289), ACSoccurred more in the OMT group (32% versus 16%;p = 0.321) while freedom from angina occurred more in the

IR plus OMT group (20% versus 4%; p = 0.189); howeverall these differences were not statistically significant. In theIR plus OMT group; TVR occurred in 16% of patients while

non-TVR in 32% of patients.

3.4. The effect of OMT alone versus IR plus OMT on EF andangina class

The OMT alone did not affect neither the level of angina classnor EF; while the IR plus OMT markedly improved the

decline in the level of angina class with statistically significantdifference (p= 0.011), but it did not improve EF significantly(p= 0.326), as demonstrated in (Table 5).

A case example of male patient 67 years old with diffuse

distal LAD disease, subtotal occlusion of diffuse OM1 and dif-fuse mid to distal RCA disease with class III angina,EF = 50%. The patient was refused by the surgeon due to

poor distal vessel quality. The patient was then subjected toPCI RCA with 2 DES and a good final result was obtainedwith improvement in his angina class to class I during 1 year

of FU as demonstrated in (Fig. 1).Another case example of female patient 74 years old with

angina class IV with ostial LM 30%, diffuse disease of theLAD, diffuse disease of LCX and critical proximal RCA le-

sion, EF = 30%. The patient was refused by the surgeondue to very poor vessel quality and poor EF. The patientwas then subjected to PCI of proximal RCA with 1 DES

and a good final result was obtained but with a partialimprovement in the level of angina class to class II, the patientdied at home at 8 months of FU as demonstrated in (Fig. 2).

4. Discussion

In MVD patients, when CABG the only option of revascular-ization was refused by the surgeon due to the poor quality ofthe distal vessels, the option of complete revascularization by

PCI sometimes is not applicable to all patients for many rea-sons including unsuitable anatomy for PCI, poor LV function,renal impairment and in some patients for financial issues.Many studies had investigated the option of incomplete revas-

cularization but with conflicting results and till this momentboth American and European guidelines of PCI are not clearin this particular group of patients.

Table 2 Echocardiographic and angiographic details of both groups.


No. (%) No. (%)

Echocardiography

Ejection fraction p= 0.534

Range 30.0 � 62.0 25.0 � 79.0Mean 46.36 ± 9.69 48.48 ± 13.86

Median 48.0 48.0

Mitral regurgitation 13 52.0 9 36.0 p= 0.254

Angiography

LM 8 32.0 5 20.0 p= 0.333

LAD 25 100.0 25 100.0 –

D1 18 72.0 14 56.0 p= 0.239

LCX 19 76.0 23 92.0 p= 0.247

RCA 20 80.0 22 88.0 p= 0.702

Syntax score

Range 28.0 � 57.0 29.0 � 52.0Mean 40.96 ± 7.06 40.36 ± 5.92 p= 0.746

Median 40.0 39.0

High syntax score (P33) 23 92.0 24 96.0 p= 1.000

Table 3 Treatment details of both groups.


No. % No. %

Medical treatment

BBS 17 68.0 19 76.0 p= 0.754

Ivabradine 7 28.0 5 20.0 p= 0.508

ACE-I or ARBS 22 88.0 16 64.0 p= 0.095

ASA 25 100.0 25 100.0 –

Clopidogrel 19 76.0 25 100.0 p= 0.022*

CCBs 3 12.0 3 12.0 p= 1.000

Statins 25 100.0 23 92.0 p= 0.490

Nitrates 24 96.0 21 84.0 p= 0.349

Digoxin 10 40.0 6 24.0 p= 0.225

Diuretics 12 48.0 15 60.0 p= 0.571

Nicorandil 3 12.0 0 0.0 p= 0.235

Trimedazidine 16 64.0 21 84.0 p= 0.196

PCI

LM – 1 4.0 –

LAD 13 52.0

D1 2 8.0

LCX 9 36.0

RCA 9 36.0

No. of vessels attempted

One – 16 64.0 –

Two 9 36.0

* Statistically significant at p 6 0.05.

60 M. Sadaka et al.

The mean age of our studied patients in both groups was65 years while male gender was more predominant aroundtwo third of the cases. Kim et al.12 studied a total of 1914 con-

secutively enrolled patients with MVD undergoing drug-elut-ing stent implantation (1400 patients) or CABG (514patients). The outcomes of patients undergoing CR were com-pared with those undergoing IR. Hannan et al.2 studied 11,294

stent patients with MVD undergoing either IR or CR in 39

hospitals. The mean age and male gender predominance inboth studies were comparable to our patients.

In our study the one year follow up revealed; death oc-

curred slightly more in the IR plus OMT group (16% versus12%; p = 1.000), hospitalization for decompensated CHF oc-curred more in the OMT group (28% versus 12%; p = 0.289),ACS occurred more in the OMT group (32% versus 16%;

p= 0.321) while freedom from angina occurred more in the

Table 4 One year follow up of both groups.


No. % No. %

Death 3 12.0 4 16.0 p= 1.000

Hospitalization for decompensated CHF 7 28.0 3 12.0 p= 0.289

ACS 8 32.0 4 16.0 p= 0.321

Angina free 1 4.0 5 20.0 p= 0.189

Angina class

I 10 40.0 12 48.0 p= 0.461

II 11 44.0 7 28.0

III 3 12.0 1 4.0

IV 0 0.0 0 0.0

Ejection fraction

Range 30.0 � 60.0 20.0 � 75.0 p= 0.343Mean 44.44 ± 10.17 47.76 ± 14.02

Median 47.0 50.0

Revascularization

TVR – 4 16.0 –

Non TVR 8 32.0


IR plus OMT group (20% versus 4%; p = 0.189); however allthese differences were not statistically significant. The OMTalone did not affect neither the level of angina class nor EF;while the IR plus OMT markedly improved the decline in

the level of angina class with a statistically significant differ-ence (p= 0.011), but it did not improve EF significantly(p= 0.326).

Nikolsky et al.13 examined 658 consecutive diabetic patients,MVD was present in 352 patients (94 CR patients and 258 IR

Table 5 Angina class and EF at baseline and 1 year follow up in t

Baseline

No. %

OMT

Angina class

0 0 0.

I 2 8.

II 12 48.

III 10 40.

IV 1 4.

EF

Range 30.0 – 62.0

Mean ± SD 46.36 ± 9.69

Median 48.0

IR plus OMT

Angina class

0 0 0.

I 2 8.

II 8 32.

III 14 56.

IV 1 4.

EF

Range 25.0 � 79.0Mean ± SD 48.48 ± 13.86

Median 48.0

* Statistically significant at p 6 0.05.

patients) who underwent PCI and they found that CR patientshad a significantly higher survival rate at 5 years (94.5% vs.83.0%, p = 0.001). Also, the rate ofMI-free survival was signif-icantly higher for CR patients (92.9% vs. 79.9%, respectively).

In a single center observational study,Kalarus et al.14 found thatamong PCI patients with acuteMI, remote mortality (18.5% vs.7.2%, p= 0.001) and major adverse cardiac event (53.1% vs.

24.3%, p = 0.001) rates were both higher for IR patients thanfor CR patients. Hannan et al.2 found that incomplete

he two studied groups.

1 year FU p Value

No. %

0 10 40.0 p= 0.249

0 11 44.0

0 3 12.0

0 0 0.0

0 0 0.0

30.0 – 60.0 p= 0.058

44.44 ± 10.17

47.0

0 12 48.0 p= 0.011*

0 7 28.0

0 1 4.0

0 0 0.0

0 0 0.0

20.0 � 75.0 p= 0.32647.76 ± 14.02

50.0

Figure 1 Case example of male patient 67 years old with IR plus OMT.

62 M. Sadaka et al.

revascularization was associated with significantly higher18-month mortality (adjusted HR: 1.23, 95% CI: 1.04 to 1.45)and higher 18-month MI/mortality (adjusted HR: 1.27, 95%

CI: 1.09 to 1.47). Kim et al.12 observed a borderline significantassociation between multivessel IR and clinical prognosis.WhenMVDwas not revascularized, the risk of 5-year MACCE

was significantly elevated in either PCI or CABG patients. Aprevious radionuclide study showed that revascularization formore than moderate ischemia (P 10% of total myocardium)with the use of a myocardial perfusion scan improved the

survival.15 Similarly, Shaw et al.16 in the Clinical OutcomesUtilizing Revascularization and Aggressive Drug Evaluation

(COURAGE) trial, which compared OMT with prompt PCIfor stable patients, patients with ischemia reduction aftertreatment, based on pretreatment and post treatment myocar-

dial perfusion scans, revealed that those patients tended to havelower risks of death and MI. Thus, the association between CRand clinical outcomes in previous studies may be indirectly

related to the extensive reduction of ischemia and not directlyrelated to anatomic revascularization.17,18 Also, Tamburino etal.19 studied 508 patients: 212 (41.7%) and 296 (58.3%) hadCR and IR, respectively. The median follow-up was 27 months.

CR was associated with better outcomes for components of thecomposite endpoint: 0.37 (0.15–0.92, p = 0.03) for cardiac

Figure 2 Case example of female patient 74 years old with IR plus OMT.


death, 0.34 (0.16–0.75 p= 0.008) for the composite of cardiacdeath or MI and 0.45 (0.29–0.69, p= 0.0003) for any repeatrevascularization.

In contrary some other studies advocated the IR strategydemonstrating favorable outcomes. Mariani et al.20 studied208 consecutive patients (171 men) with MVD. Mean age of

the group was 63.8 ± 10.3 years (range, 31–91). Completeand incomplete revascularization was achieved in 49 and 159patients, at 1-year follow-up, 11.3% and 11.5% of patients

with complete and incomplete revascularization, respectively,had MACE. These results indicate that the strategy of incom-plete revascularization in unstable angina patients with MVD

does not expose them to a higher risk of death or other major

ischemic events in comparison to those undergoing completerevascularization. Same data reported by Bourassa et al.21

intended incomplete angioplasty revascularization in non-

diabetic patients with MVD who are candidates for both angi-oplasty and CABG does not compromise long-term survival;however, a subsequent need for CABG may be increased with

this strategy while the risk of long-term MI is also increased.Rossi et al.22 studied 165 octogenarians, 73 elderly patients(44%) underwent CR and 92 (56%) IR. Major in-hospital car-

diac events were similar in the two subgroups. At 1-year fol-low-up 65% of patients in the CR and 68% in the IR group(p= ns) referred improvement in angina status and quality

of life. They concluded that, current PCI coronary techniques

64 M. Sadaka et al.

are safe and effective in octogenarians. PCI limited to the cul-

prit lesion may suffice in most patients, with favorable clinicaloutcome at 1 year.

By comparing our results to the previous studies; despitethe majority of data defers the strategy of IR and recom-

mended total revascularization, it remains that patient withMVD was refused by the surgeon as a common problem everyday in catheter laboratory. We found that the policy of IR plus

OMT in patients is superior to OMT alone in relieving anginabut has no impact on long term survival or freedom from MI.The outcomes of our study are more or less different from

many reported previous studies; this could be explained bythe small number of patients recruited for the study, differentpatients’ subsets and the relative short duration of follow up.

May be further studies, testing the IR guided by myocardialperfusion scintigraphy for detecting the ischemic burden, couldhave an impact on long term MACE plus angina relief in thoseparticular group of patients.

5. Conclusion

In patients with MVD who were not eligible for CABG; IRplus OMT was not superior to OMT alone in improving the1year clinical outcomes except the improvement in the level

of angina class, which could be the adopted strategy to improvethe quality of life in such patients but with close follow up.

6. Study limitations

There are a few caveats to the study. First, it is single center

study. Second, the small number of the patients included inthis study. Third, the undermined ischemic burden before thestrategy of incomplete revascularization. Fourth, the relativeshort duration of follow-up.

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Partial revascularization plus medical treatment versus medical treatment alone in patients with multivessel coronary artery disease not eligible for CABG1 Introduction2 Methods2.1 Statistical analysis

3 Results3.1 Descriptive data (Tables 1 and 2)3.2 Treatment details (Table 3)3.3 One year follow up: (Table 4)3.4 The effect of OMT alone versus IR plus OMT on EF and angina class

4 Discussion5 Conclusion6 Study limitationsReferences

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