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European Heart Journal Advance Access originally published online on February 19, 2008
European Heart Journal 2008 29(5):673-679; doi:10.1093/eurheartj/ehn026
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org

Impact of previous percutaneous transluminal coronary angioplasty and/or stenting revascularization on outcomes after surgical revascularization: insights from the imagine study

Sidney Chocron1,*, Richard Baillot2, Jean Lucien Rouleau3, Wayne J. Warnica4, Pierre Block5, David Johnstone6, Martin G. Myers7, Cristina Dana Calciu8, Anna Nozza3, Pierre Martineau8, Wiek H. van Gilst for the IMAGINE Investigators9

1 Department of Cardiac Surgery, Hopital Jean Minjoz, University of Franche-Comté, 25030 Besançon Cedex, France
2 Hôpital Laval, Laval University, Québec, Canada
3 Montreal Heart Institute, University of Montréal, Montréal, Canada
4 Foothills Hospital, University of Calgary, Calgary, Canada
5 AZ-VUB, Brussels, Belgium
6 Queen Elizabeth II Hospital, Dalhousie University, Halifax, Canada
7 Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada
8 Pfizer Canada Medical Division, Montréal, Canada
9 University of Groningen, Groningen, The Netherlands

Received 29 September 2007; revised 15 December 2007; accepted 10 January 2008; online publish-ahead-of-print 19 February 2008.

* Corresponding author. Tel: +33 3 81 66 86 64, Fax: +33 3 81 66 86 61, Email: sidney.chocron{at}univ-fcomte.fr. URL: http://www.chirurgie-cardiaque-besancon.org/

See page 573 for the editorial comment on this article (doi:10.1093/eurheartj/ehm645)


   Abstract
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Aim: To determine the impact of previous coronary artery revascularization by percutaneous transluminal coronary angioplasty and/or stenting (PCI) on outcome after subsequent coronary artery bypass grafting (CABG).

Methods and results: The ischaemia management with Accupril post-bypass Graft via Inhibition of the coNverting Enzyme (IMAGINE) trial, conducted between November 1999 and September 2004, tested whether early initiation of an angiotensin-converting enzyme inhibitor post-CABG, in stable patients with LVEF ≥40%, would reduce cardiovascular events. Of the 2489 patients included in the IMAGINE trial, undergoing their first operation, 430 had a history of PCI prior to surgery (PCI group), and 2059 were referred to surgery without previous PCI (non-PCI group). There was a significant increase in the primary IMAGINE endpoint in the PCI group, HR = 1.53 [1.17–1.98], P = 0.0016. Coronary revascularization, HR = 1.80 [1.13–2.87], P = 0.014, unstable angina requiring hospitalization, HR = 2.43 [1.52–3.89], P = 0.0002, were the two individual components that significantly increased in the PCI group, even when adjusted for baseline characteristics (age, sex, history of myocardial infarction or stroke, diabetes, treatment group, or off-pump surgery).

Conclusion: Patients with left ventricular ejection fraction ≥40% having a history of PCI prior to surgery had a worse outcome post-CABG than those with no prior PCI. Further studies are needed to investigate whether these results apply for drug eluting stents.

Key Words: Angioplasty • Transluminal • Percutaneous coronary • Coronary artery bypass


   Rationale
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The widespread use of percutaneous coronary interventions (percutaneous transluminal coronary angioplasty and/or stenting) (PCI) has resulted in a greater number of patients being referred for coronary artery bypass grafting (CABG) after prior PCI. Depending on the studies on bare metal stents, from 6 to 13% of patients undergo CABG within 1 year after PCI, and from 13 to 26% within 10 years.1–3 When a patient is eligible for both procedures, PCI is often preferred to surgery.4 The initial choice of PCI is reinforced by the perception that patients can safely be referred to surgery after PCI. However, little is known about the outcomes in patients who develop recurrent symptoms after initial PCI necessitating subsequent revascularization by CABG.

The objective of this study was to assess the association between prior PCI and patients' outcome after subsequent revascularization by CABG. In order to do this, we used the contemporary IMAGINE (Ischemia Management with Accupril post bypass Graft via Inhibition of the coNverting Enzyme) trial database of 2553 patients with preserved left ventricular function undergoing CABG. IMAGINE patients with redo CABG were excluded from this study.


   Methods
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IMAGINE study
The design of the IMAGINE study, previously described,5 as well as the results of the main study,6 is summarized here. The IMAGINE study is a double-blind, placebo-controlled, parallel group, randomized, multi-centre international study conducted in patients who have undergone CABG between November 1999 and September 2004.

Patients were screened for eligibility within 4 weeks of surgery or following surgery, and randomized within 7 days post-CABG, except for France where randomization occurred within 10 days post-CABG.

Endpoints
The primary endpoint was the time to first occurrence of any of the composite of cardiovascular death or resuscitated cardiac arrest, non-fatal myocardial infarction (MI), coronary revascularization, unstable angina requiring hospitalization, documented angina not requiring hospitalization, stroke, or congestive heart failure requiring hospitalization.

Patient characteristics
Of the 2553 patients who underwent randomization, 1280 were assigned to receive quinapril, and 1273 matching placebo. Baseline characteristics were similar in both treatment groups. The mean age was of 61 years; 13% were women, 10% had diabetes, 3% had previous CABG, and 18% had previous PCI. Left ventricular ejection fraction (LVEF) was 60%.

Follow-up and compliance
Median follow-up was of 2.95 years. A total of 330 patients experienced a primary endpoint. Among the patients who did not present a primary endpoint, 201 had a 12 month follow-up or less, 547 had more than 12 months but ≤24 months, 451 had more than 24 months but ≤36 months, and 1024 had more than 36 months. One patient on quinapril and four patients in placebo were lost to follow-up.

Primary endpoint
The incidence of the primary endpoint was 12.2% in the placebo group and 13.7% in the quinapril group (hazard ratio 1.15; 95% confidence intervals, 0.92–1.42; P = 0.212). Adjustment for baseline characteristics (age, sex, history of MI, stroke, diabetes, or previous CABG) did not alter the results. When individual components of the primary endpoint were considered separately, no differences in the primary endpoint according to treatment group were found.

The current study
We classified patients into two groups: those who had a history of percutaneous transluminal coronary angioplasty and/or stenting before surgery (PCI group) and those who were referred to surgery without any percutaneous transluminal coronary angioplasty and/or stenting in their history (non-PCI group).

Completeness of coronary revascularization
Myocardial revascularization completeness was evaluated by the two most common definitions. The first being all vessels >1 mm with a stenosis >70% having been bypassed (Definition 1), and the second is the presence of at least one graft on a coronary territory supplied by a vessel with ≥70% stenosis (Definition 2).

Endpoints
We used the same endpoints as the IMAGINE trial. The primary endpoint was the time to first occurrence of any of the composite events. Time-to-event data continued to be captured for individual component endpoints even after the first primary endpoint had been experienced. For individual endpoints, we calculated the time to the first occurrence regardless of whether it was the first event occurring in the patient.

Statistical analysis
Differences between the PCI group and the non-PCI group were estimated as a hazard ratio, including the associated adjusted two-sided 95% confidence interval from a Cox proportional hazards regression model that includes the effects of treatment group, LVEF, number of distal anastomosis, if all vessels >1 mm with a stenosis >70% were bypassed, the presence of at least one graft on a coronary territory supplied by a vessel with ≥70% stenosis, number of diseased vessels, if LM stenosis was >50%, hypertension, gender, previous MI, previous stroke, age, diabetes, and beating heart (off pump) surgery. Assumption of proportional hazard was assessed using log–negative-log plot and the interaction ‘group x time'. Additionally, the effects of these covariates were assessed in a univariate COX model. The Efron method was used for handling event ties.

Categorical variables are described as percentages, and either the {chi}2 test or Fisher exact test was used depending on the size of each cell. Continuous variables are expressed as the mean value ± SD if normally distributed or the median value (interquartile range) if the distribution was skewed. The differences were tested by t-test or Wilcoxon rank sum test when appropriate.

The hazard ratio and 95% confidence intervals were used to compare the delay between PCI and randomization, ≤6 to >6 months.

In an additional effort to control for systematic differences between the PCI and non-PCI groups, we applied the propensity score stratification technique.7 A stepwise logistic regression model was used to estimate propensity scores based on baseline and operative variables mentioned above. For continuous variables, we compared the groups after adjusting for their propensity quintile using a two-way analysis of variance model that included the main effects for propensity score quintile and group and the two-way interaction of quintile and group. For two-level categorical variables, we determined the significance level of the Breslow-Day test of the homogeneity of the quintile-specific odds ratio (OR) and the Mantel–Haenszel test of the significance of the common OR. For categorical variables with more than two levels of responses, logistic regression was used to assess comparability. The model included propensity score quintile and group as independent variables as well as the two-way interaction of quintile and group. Hazard ratios from a Cox proportional hazards regression model were then calculated by incorporating the group and the propensity score quintile into the model.


   Results
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Patient characteristics
Of the 2553 patients included in the IMAGINE trial, 455 (17.8%) had a history of PCI prior to surgery (PCI group) and 2098 (82.2%) were referred to surgery without previous PCI (non-PCI group). After the exclusion of patients with previous CABG, 430 (17.3%) and 2059 (82.7%) patients are in the PCI and non-PCI groups, respectively. Baseline characteristics are given in Table 1. Proportion of patients assigned in the quinapril arm was 49.1% in the PCI group and 50.1% in the non-PCI group, P = 0.69. Patients in the PCI group had experienced significantly more MI before surgery [1.21 (0.46)] than in the non-PCI group [1.11 (0.35), P = 0.0002]. Of the 216 patients having a known date of MI in the PCI group, 133 (62%) had an MI prior to PCI, 47 (22%) had their PCI on the same day as their MI, and 34 (16%) more than 1 month after PCI.


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  		Table 1 Baseline characteristics

 
Total cholesterol, LDL-C, and HDL-C were better controlled in the PCI group (Table 1). LVEF was equivalent in both groups. The medical therapy of patients in both groups was similar.

Characteristics of the CABG
The distribution of patients with one-, two-, or three-vessel disease was unbalanced with remarkably more patients with one-vessel disease in the PCI group (12.3 vs. 6.6%) (Table 2). The number of patients with left main coronary artery (LM) stenosis is lower in the PCI group. The average number of distal anastomosis was significantly lower in the PCI group; however, completeness of coronary revascularization appeared to be equivalent between groups, with Definition 1 favouring more complete revascularization in PCI group, and Definition 2 favouring more complete revascularization in the non-PCI group. The ratio number of saphenous vein anastomosis by the total number of anastomosis was significantly lower in the PCI group [0.43 (0.31)] than in the non PCI group [0.48 (0.29), P = 0.003], suggesting that more arterial anastomosis was performed in PCI patients. The number of off-pump procedures performed was equivalent in both groups.


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  		Table 2 Results for operative characteristics

 
Comparability after adjusting for the propensity score quintile
For continuous variables, the results from the two-way analysis for the patient and CABG characteristics revealed that balance was achieved after stratification based on the propensity score. The two-way interaction of quintile and group was non-significant in all instances. For categorical variables with two-level responses, the Breslow-Day test of the homogeneity of the quintile-specific OR was non-significant in all instances except for the covariate previous MI. The {chi}2 test was significant for the second quintile (P = 0.04) although the exact test revealed non-significance at P = 0.06. The Mantel–Haenszel test of the significance of the common OR was non-significant in all cases. For three-level response variables (one-, two-, or three-vessel disease), logistic regression revealed no differences.

Events
Out of the 2489 patients, 313 experienced a primary endpoint, 73 in the PCI group (17.0%), and 240 in the non-PCI group (11.6%). There was a significant increase in the primary IMAGINE endpoint in the PCI group with an unadjusted hazard ratio of 1.53 [1.17–1.98], P = 0.0016. The individual components of the primary endpoint were also frequently significantly higher in the PCI group (Table 3): coronary revascularization HR = 1.80 [1.13–2.87], P = 0.014, unstable angina requiring hospitalization HR = 2.43 [1.52–3.89], P = 0.0002. Adjustment for baseline characteristics (age, sex, history of MI or stroke, diabetes, treatment group, or off-pump surgery) did not alter the results. There was no difference when comparing patients undergoing CABG within 6 months after PCI to those undergoing CABG >6 months after PCI. By multivariable analysis (Table 4) including baseline characteristics as well as the potential confounding factors detailed above, it was showed that the PCI group had a significantly higher risk of experiencing a primary event after CABG surgery than the non-PCI group (HR = 1.38 [1.05–1.81]). Adjusting for the propensity score quintile (HR = 1.38 [1.06–1.81]) did not alter the significance of the results. A multivariable analysis done for each individual endpoint showed similar results, with the PCI group having, after surgery, significantly more coronary revascularization (HR = 1.68 [1.04–2.71]) and unstable angina requiring hospitalization (HR = 2.34 [1.44–3.80]) than the non-PCI group (Table 3). When adjusting for the propensity score quintile, similar results were obtained.


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  		Table 3 Hazard ratio for individual endpoints

 

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  		Table 4 Multivariable analysis for primary events

 
When focusing on the MACE endpoints (death, MI, and coronary revascularization), 35 events occurred in PCI group (8.1%) and 103 in non-PCI group (5%), yielding an unadjusted hazard ratio of 1.68[1.14–2.46], P = 0.0081. Adjusting for baseline characteristics, the hazard ratio was 1.59[1.08–2.34], P = 0.0190.

Our data met the assumption of proportional hazards as the effect of the predictor variable does not change across time (P = 0.99).

Discussion
Among the 2553 patients included in the IMAGINE study, 64 had a previous CABG. Because this specific population (i) had specific needs in terms of coronary revascularization which was different from the overall population, (ii) raised specific questions in terms of PCI (native vessel or graft stenoses), and (iii) was unbalanced between the two groups [25 (5.5%) in the PCI group and 39 (1.9%) in the non-PCI group, p < 0.0001], we excluded these patients from the current analysis.

This analysis of the IMAGINE study database indicates that patients with preserved systolic function having had a previous PCI had a worse outcome post-CABG (unadjusted HR for IMAGINE primary endpoint = 1.53 [1.17–1.98]), even after adjusting for baseline cardiovascular risk factors and propensity score quintile. This increased risk was particularly marked for unstable angina requiring hospitalization (HR = 2.43 [1.52–3.89]) and coronary revascularization (HR = 1.80 [1.13–2.87]).

Previous studies showed diabetes,8 number of diseased vessels,8 type of lesion,9 topography of the lesions,9 and incomplete PCI revascularization9,10 as risk factors for requiring a subsequent CABG after PCI.

Other studies showed the increased risk of PCI patients when undergoing CABG.

  • Using multivariate and propensity score matching techniques in 6032 patients presenting for CABG, Hassan et al.11 found that patients with prior PCI had greater in-hospital mortality (OR = 1.93, P = 0.003) despite less co-morbidity and, as found in IMAGINE, less coronary artery disease. Patients with prior PCI did, however, have more advanced symptoms and greater urgency for CABG. As in the IMAGINE study, randomization was done after CABG, intra-operative mortality was not available.
  • Kalaycioglu et al.12 compared, with a 36 month follow-up, 40 patients who had undergone CABG with a prior PCI with a case-matched control group of 40 patients who underwent CABG without prior PCI. As in our study, patients with a prior PCI had less extensive coronary artery disease, and requiring fewer bypass grafts had a greater risk of angina and need for repeat revascularization.
  • Thielmann et al.13 compared the surgical outcome of 621 non-PCI patients with 128 PCI patients. All patients presented with diabetes mellitus and triple-vessel disease. PCI patients had a greater risk of in-hospital mortality (OR = 2.84 [1.19–6.68]) and a greater risk of MACE (OR = 2.51[1.32–4.73]). Our data confirm a greater risk of MACE, 1.68[1.14–2.46].

The worse surgical results in PCI patients could be explained by a more serious disease in PCI patients. This hypothesis is not supported by our data:

  • PCI patients have, not at the time of operation, a more advanced coronary artery disease.
    • In the PCI group, there were more patients with one- or two-vessel disease and less patients with three-vessel disease or LM disease than in the non-PCI.
    • If patients with a previous PCI had more often a history of MI than non-PCI patients, their ejection fraction remains equivalent to that of non-PCI patients.

  • PCI patients were better treated than non-PCI patients.
    • Although patients in the PCI group had more statin and acetylsalicyclic acid (ASA) use pre-CABG, there was no difference in the therapy between groups during the post-operative study period (Table 5).
    • The ratio number of saphenous vein anastomosis to the total number of anastomoses was significantly lower in the PCI group than in the non-PCI group, showing that more arterial anastomosis (with a better theoretical patency) were performed in PCI patients.
    • The discrepancy between the results of the two definitions for completeness of revascularization between groups suggests that there were more patients with poor vessel runoff in the non-PCI group.
    • There were less coronary artery grafts per patient in the PCI group, but with a more complete surgical revascularization.


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  		Table 5 Medications taken before CABG and at discharge

 
  • PCI patients have not a more progressive disease.
    • If so, PCI patients should be more likely to experience their first endpoint before non-PCI patients. This is not confirmed by our data, where the pattern of time to first event did not differ significantly between groups (median PCI, 8 months; non-PCI, 10 months; P = 0.37).
    • Of 392 patients with multivessel disease randomized to an initial strategy of PTCA or CABG in the Emory Angioplasty vs. Surgery Trial (EAST), 298 patients (152 PTCA and 146 CABG) completed 3 year angiographic follow-up. The authors showed that more patients developed at least one significant new native coronary artery lesion in the CABG group (21%) than in the PTCA group (15%). In multivariate analysis, native coronary disease progression was not correlated to PTCA or CABG14

Limitations
Limitations of the study include the fact that this is an analysis of the IMAGINE trial and, hence, was not designed specifically to determine the impact of PCI on outcome of CABG. Owing to the inclusion period of the IMAGINE study and of most of the referenced studies, our conclusions are not relevant for drug-eluting stents.


   Conclusions
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 Methods
 Results
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Funding
 References
 
Our study shows that patients with an LVEF of ≥40% having a history of PCI have a worse prognosis post-CABG. Although this association may simply be a reflection of more aggressive coronary artery disease in these patients, the hypothesis that PCI has a negative effect per se cannot be excluded. Therefore, the current practice favouring PCI to CABG when a patient is eligible for both procedures and has a high likehood of requiring a subsequent CABG has to be revisited, because previous PCI may alter the outcomes post-CABG. 'If PCI does not work, the patient will be referred safely to surgery' is no longer a valid assumption and warrants confirmation by a randomized, controlled trial.

Conflict of interest: S.C. has been reimbursed by Pfizer and speaker's bureau $<10K; R.B. none; J.L.R. consulting for Novartis $>10K; W.J.W. Speaker's bureau Pfizer and Novartis $<10K; P.B. Research grant $<10K; D.J. Honoraria and advisory board—Pfizer $<10K; M.G.M. Speaker's Bureau—Pfizer $>10K, advisory board—Pfizer $<10K, C.D.C.—PM: employees of Pfizer Canada, A.N. former employee of Pfizer, Canada, W.H.vG. none.


   Funding
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The study was supported by Pfizer Canada, Netherlands, Belgium, and France.


   References
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  1. Mercado N, Wijns W, Serruys PW, Sigwart U, Flather MD, Stables RH, O'Neill WW, Rodriguez A, Lemos PA, Hueb WA, Gersh BJ, Booth J, Boersma E. One-year outcomes of coronary artery bypass graft surgery versus percutaneous coronary intervention with multiple stenting for multisystem disease: a meta-analysis of individual patient data from randomized clinical trials. J Thorac Cardiovasc Surg (2005) 130:512–519.[Abstract/Free Full Text]
  2. Hoffman SN, TenBrook JA Jr, Wolf MP, Pauker SG, Salem DN, Wong JB. A meta-analysis of randomized controlled trials comparing coronary artery bypass graft with percutaneous transluminal coronary angioplasty: one- to eight-year outcomes. J Am Coll Cardiol (2003) 41:1293–1304.[Abstract/Free Full Text]
  3. van Domburg RT, Foley DP, de Jaegere PT, de Feyter P, van den Brand m, van der Giessen W, Hamburger J, Serruys PW. Long term outcome after coronary stent implantation: a 10 year single centre experience of 1000 patients. Heart (1999) 82:27–34.[Abstract/Free Full Text]
  4. Kettelkamp R, House J, Garg M, Stuart RS, Grantham A, Spertus J. Using the risk of restenosis as a guide to triaging patients between surgical and percutaneous coronary revascularization. Circulation (2004) 110(Suppl. 1):II50–II54.[Web of Science][Medline]
  5. Warnica WJ, Van Gilst WH, Baillot R, Johnstone D, Block P, Myers MG, Chocron S, Ave SD, Martineau P, Rouleau JL. Ischemia management with accupril post bypass graft via inhibition of angiotensin converting enzyme (IMAGINE): a multi-center randomized trial-design and rationale. Can J Cardiol (2002) 18:1191–2000.[Web of Science][Medline]
  6. Rouleau JL, Warnica WJ, Baillot R, Block P, Chocron S, Johnstone D, Myers MG, Calciu CD, Dalle-Ave S, Martineau P, Mormont C, Patni R, Van Gilst WH. Effects of angiotensin-converting enzyme inhibition in low-risk patients early after coronary artery bypass surgery. Circulation (2008) 117:24–31.[Abstract/Free Full Text]
  7. D'Agostino Ralph B Jr. Tutorial in Biostatistics propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Statist Med (1998) 17:2265–2281.[CrossRef]
  8. Haase J, Jung T, Störger H, Hofmann M, Reinemer H, Schwarz CE, Schöpf J, Schwarz F. Long-term outcome after implantation of bare metal stents for the treatment of coronary artery disease: rationale for the clinical use of antiproliferative stent coatings. J Interv Cardiol (2003) 16:469–473.[CrossRef][Medline]
  9. Johnson RG, Sirois C, Thurer RL, Sellke FW, Cohn WE, Kuntz RE, Weintraub RM. Predictors of CABG within one year of successful PTCA: a retrospective, case-control study. Ann Thorac Surg (1997) 64:3–7.[Abstract/Free Full Text]
  10. Bourassa MG, Yeh W, Holubkov R, Sopko G, Detre KM. Long-term outcome of patients with incomplete vs complete revascularization after multivessel PTCA. A report from the NHLBI PTCA Registry. Eur Heart J (1998) 19:103–111.[Abstract/Free Full Text]
  11. Hassan A, Buth KJ, Baskett RJF, Ali IS, Maitland A, Sullivan JAP, Ghali WA, Hirsch GM. The association between prior percutaneous coronary intervention and short-term outcomes after coronary artery bypass grafting. Am Heart J (2005) 150:1026–1031.[CrossRef][Medline]
  12. Kalaycioglu S, Sinci V, Oktar L. Coronary artery bypass grafting (CABG) after successful percutaneous transluminal coronary angioplasty (PCI): is PCI a risk for CABG? Int Surg (1998) 83:190–193.[Medline]
  13. Thielmann M, Neuhäuser N, Knipp S, Kottenberg-Assenmacher E, Marr A, Pizanis N, Hartmann M, Kamler M, Massoudy P, Jakob H. Prognostic impact of previous percutaneous coronary intervention in patients with diabetes mellitus and triple-vessel disease undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg (2007) 134:470–476.[Abstract/Free Full Text]
  14. Zhao XQ, Kosinski AS, Barnhar HXt, Superko HR, King SB. Prediction of native coronary artery disease progression following PTCA or CABG in the emory angioplasty versus surgery trial. Med Sci Monit (2003) 9:CR48–54.[Medline]

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