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• Complete multivessel revascularization in STEMI. Reply to the letter by Shah et al.
  Eliano Navarese
  Published on: 10 April 2016
• Complete vs Culprit-only Revascularization for Patients with ST-Segment Elevation Myocardial Infarction
  RAHMAN SHAH
  Published on: 4 April 2016
• Misinterpretation risks with a superficial reading of a meta-analysis. Reply to the letter by Nairooz et al.
  Eliano P. Navarese
  Published on: 15 March 2016
• Complete revascularization in STEMI
  Ramez S Nairooz
  Published on: 15 March 2016

• Published on: 10 April 2016

  Complete multivessel revascularization in STEMI. Reply to the letter by Shah et al.

  • Eliano Navarese
  • Other Contributors:
    • Mariusz Kowalewski

  To the Editor:

  We read with interest the letter by dr Shah [1] regarding our recent meta-analysis: "Complete revascularisation in ST-elevation myocardial infarction and multivessel disease: meta-analysis of randomised controlled trials" [2]. The meta-analysis was designed to compare complete multivessel PCI (MV-PCI) with non-complete MV-PCI in ST-elvation myocardial infarction (STEMI) and MV disease. Complete MV...

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  To the Editor:

  We read with interest the letter by dr Shah [1] regarding our recent meta-analysis: "Complete revascularisation in ST-elevation myocardial infarction and multivessel disease: meta-analysis of randomised controlled trials" [2]. The meta-analysis was designed to compare complete multivessel PCI (MV-PCI) with non-complete MV-PCI in ST-elvation myocardial infarction (STEMI) and MV disease. Complete MV-PCI was defined as revascularisation to non-infarct-related artery lesions during index procedure, non-complete MV-PCI-encompassed culprit-only revascularization (COR) and staged approaches. First of all, we appreciate the comments by Shah and are glad that our research has become of interest to a large international readership. At the same time we believe that criticism about methodology or clinical meaningfulness of a meta- analysis should be based upon specific clinical knowledge of the topic, and, above all, careful reading of the meta-analysis design.

  Shah suggests that because the majority of staged procedures were performed within days to weeks of their index procedures, they would be considered more like complete than incomplete revascularizations over a 12 -month follow-up. This is a simply arbitrary reclassification, given the large time discrepancy between the two approaches in all included studies that were however not designed to define an optimal timing, nor it was the primary focus of our paper. As a result, Shah speculates that staged PCI should became anyhow bundled in the same group with complete revascularization. This arbitrary re-reclassification is also in contrast with the natural history of the untreated coronary lesions. These patients present a different risk profile from those allocated to staged PCI; as a reflection of this, the untreated lesions over time in the second group have led to an accrual over time of the MI rates in the IRA- only treated patients; a difference in time in this group is pivotal to demonstrate the impact of leaving a non culprit plaque untreated; same applies to staged procedures. The approach in our analysis therefore reflects true clinical practice and indeed is based on coronary- and risk profile evaluation of the patients with non culprit plaques. An arbitrary, fixed time-frame second revascularisation for all patients with non culprit lesions is not only infeasible in clinical setting but, indeed, dangerous treating in the same way patients with different coronary artery lesions; as a sensitivity analysis, a stratified meta-analysis by intervention in the control group was performed as well. Our study was not designed to compare in the same setting complete revascularization (CR) vs index hospitalization CR vs later date CR vs IRA only revascularization; neither was any study conducted to date.

  Secondly, Shah is concerned about the validity of the findings due to inconsistency driven by inclusion of the entire complete revascularization cohort from the Complete versus Culprit-Lesion Only Primary PCI Trial (CvLPRIT), while in the Supplementary Table 5 CR was performed during the index procedure for 97 patients [3]. Current meta-analysis was performed according to intention-to-treat (ITT) which is recommended as the least biased way to estimate intervention effects in randomized trials [4]: principles of ITT analyses are, first of all, to classify participants in the intervention groups to which they were randomized, regardless of the intervention they actually received, therefore inclusion of post-hoc analyses which is the case for Supplementary Table 5, is not only forbidden by design of the meta-analysis but may also lead to attrition bias with patients dropping out from the initial randomization group and consequently to results that are unequal in regard to exposure and/or outcome. In the methods section of the CvLPRIT one reads that "if randomized to complete revascularization, it was mandated that the IRA be treated first. If there were no clinical contraindications, complete revascularization was recommended at the same sitting to reduce multiple vascular punctures, avoid prolonged hospitalization, and attenuate potential patient dropout". Decision for the procedure to be staged was based on clinical reasons and left to the operator, which we cannot answer for.

  Thirdly, Shah cited part of the methods from the study by Maamoun et al. [5] and concluded this study was an observational cohort; this remark is however incorrect because what is reported also in the abstract is: "A total of 78 patients (72 males and 6 females) with ST-elevation MI presented within 12 h from the onset of symptom who had at least two angiographically-documented diseased coronary arteries (luminal diameter narrowing ?70%) and received primary PCI were included. They were randomly assigned to receive either PCI for culprit vessel only in the initial procedure (SR group) followed by another session of angioplasty to other diseased vessels (within 7 days), or (CR group) consisted of 42 patients who had received complete revascularization during the initial procedure after intracoronary administration of nitroglycerin to avoid stenting of functionally nonsignificant lesions". We have no reasons to believe it was otherwise.

  Finally, Shah advises that the trial by Ghani et al. [6] should have had as well been included in the meta-analysis. While report by Ghani et al. comprises a follow-up study, the main results derive from the article by Dambrink et al. [7]. This study was intentionally excluded as not pertinent to the design of the meta-analysis. Dambrink et al. randomized STEMI patients to invasive and conservative treatment after primary angioplasty. In the invasive- group, "ischaemia-guided additional revascularisation was performed during the in-hospital phase after primary PCI or in an out-patient setting but no later than three weeks after STEMI", therefore nowhere close to complete MV-PCI during index procedure. The last claim of other studies intentionally omitted, undermining the validity of this meta-analysis, we leave to the discretion of the Heart Editor and the Readership.

  References

  1. Rahman Shah. Letter to the Editor regarding heartjnl-2014- 307293.R2 - Complete Revascularization in ST-Elevation Myocardial Infarction and Multivessel Disease. Meta-Analysis of Randomized Controlled Trials. 17.03.2016

  2. Kowalewski M, Schulze V, Berti S, Waksman R, Kubica J, Kolodziejczak M, Buffon A, Suryapranata H, Gurbel PA, Kelm M, Pawliszak W, Anisimowicz L, Navarese EP. Complete revascularisation in ST-elevation myocardial infarction and multivessel disease: meta-analysis of randomised controlled trials. Heart 2015;101:1309-1317.

  3. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015;65:963-72.

  4. Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol 1992;21:837-841.

  5. Maamoun W, Elkhaeat N, Elarasy R. Safety and feasibility of complete simultaneous revascularization during primary PCI in patients with STEMI and multivessel disease. Egyptian Heart J 2011;63:39-43.

  6. Ghani A1, Dambrink JH, van 't Hof AW, et al. Treatment of non- culprit lesions detected during primary PCI: long-term follow-up of a randomised clinical trial. Neth Heart J. 2012 Sep; 20(9): 347-353

  7. Dambrink JH, Debrauwere JP, van 't Hof AW, Ottervanger JP, Gosselink AT, Hoorntje JC, de Boer MJ, Suryapranata H. Non-culprit lesions detected during primary PCI: treat invasively or follow the guidelines? EuroIntervention 2010;5:968-975.

  Conflict of Interest:

  None declared

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  Conflict of Interest:
  None declared.

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• Published on: 4 April 2016

  Complete vs Culprit-only Revascularization for Patients with ST-Segment Elevation Myocardial Infarction

  • RAHMAN SHAH, Physician
  • Other Contributors:
    • Melissa A Mooney MD

  To the Editor: We read with great interest the recent meta-analysis by Kowalewski et al.[1] The authors should be congratulated for their work. However, we would like to make few comments about some issues with the meta-analysis. First, complete revascularizations (CRs) done as staged procedures (SPs) were analyzed with the incomplete revascularization group, but endpoints were measured at a median follow-up of 12 months. Becaus...

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  To the Editor: We read with great interest the recent meta-analysis by Kowalewski et al.[1] The authors should be congratulated for their work. However, we would like to make few comments about some issues with the meta-analysis. First, complete revascularizations (CRs) done as staged procedures (SPs) were analyzed with the incomplete revascularization group, but endpoints were measured at a median follow-up of 12 months. Because the majority of SPs were performed within days to weeks of their index procedures, clinical wisdom suggests they would behave more like CRs than incomplete revascularizations over a 12-month follow-up. Therefore, we believe that from statistical and clinical points of view, CRs performed as SPs should have been included in the complete revascularization group, as was done in other meta-analyses and randomized trials.[2] Furthermore, the authors did not consistently analyzed CRs performed as SPs with the incomplete arm. In the Complete versus Culprit-Lesion Only Primary PCI Trial (CvLPRIT), CR was performed during the index procedure for 97 patients (Supplementary Table 5 in the CvLPRIT trial),[2] but this group (for this meta-analysis)was combined with patients receiving CRs as SPs, bringing the total to 150. This inconsistency significantly impacts the validity of the meta-analysis. In addition, the title indicates the study was a meta-analysis of randomized trials, yet it included the study by Maamoun et al, an observational cohort study,[3] as evidenced by a statement in the Methods section. Maamoun et al state, "Group 1 consisted of 36 patients presented in the 1st year of the study and had undergone primary PCI for culprit vessel only in the initial procedure followed by another session of angioplasty to other diseased vessels and group 2 consisted of 42 patients presented in the 2nd year of the study and had received complete revascularization during the initial procedure." Finally, the authors did not include a trial by Ghani et al.[4] No reason for this omission was mentioned in the Methods or Discussion. Therefore, we wonder if other studies were also omitted, undermining the validity of this meta-analysis. References: 1. Kowalewski M, Schulze V, Berti S, et al. Complete revascularisation in ST-elevation myocardial infarction and multivessel disease: meta-analysis of randomised controlled trials. Heart. 2015;101(16):1309-17. 2. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015;65:963-72. 3. Maamoun W, Elkhaeat N, Elarasy R. Safety and feasibility of complete simultaneous revascularization during primary PCI in patients with STEMI and multivessel disease. Egyptian Heart J 2011;63:39-43. 4. Ghani A1, Dambrink JH, van 't Hof AW, et al. Treatment of non-culprit lesions detected during primary PCI: long-term follow-up of a randomised clinical trial. Neth Heart J. 2012 Sep; 20(9): 347-353.

  Conflict of Interest:

  None declared

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• Published on: 15 March 2016

  Misinterpretation risks with a superficial reading of a meta-analysis. Reply to the letter by Nairooz et al.

  • Eliano P. Navarese, Director of Trial and Translational Unit
  • Other Contributors:
    • Mariusz Kowalewski, Michalina Kolodziejczak

  Nairooz and Naidu [1] claim that definitions of complete and non- complete MV-PCI in our meta-analysis[2] (multivessel percutaneous coronary intervention) might have been missed or misinterpreted in one included study. As a matter of fact, CvLPRIT trial randomized STEMI (ST-elevation myocardial infarction) patients to either complete revascularization (including all N-IRAs [non-infarct related artery]) or IRA-only treatmen...

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  Nairooz and Naidu [1] claim that definitions of complete and non- complete MV-PCI in our meta-analysis[2] (multivessel percutaneous coronary intervention) might have been missed or misinterpreted in one included study. As a matter of fact, CvLPRIT trial randomized STEMI (ST-elevation myocardial infarction) patients to either complete revascularization (including all N-IRAs [non-infarct related artery]) or IRA-only treatment. Indeed, by study design, complete revascularization was recommended during index procedure, truly reflecting the inclusion criteria of our meta- analysis. Nairooz and Naidu are once more wrong when they argue that different time frames between index PCI and second procedure across the studies might have influenced the outcomes. While small number of studies conducted so far precludes detailed analyses, to assess the optimal timing of the second procedure, was not indeed the objective of the current meta- analysis. Nairooz and Naidu claim that staged PCI became anyhow bundled in the same group with IRA-only revascularization. These patients are similarly different to complete MV-PCI; indeed, the risk of MI in the IRA- only treated patients accrues over time; a difference in time in this group is pivotal also to demonstrate the impact of leaving a non culprit plaque untreated; the approach in our analysis therefore reflects the true clinical practice and indeed is based on coronary- and risk profile evaluation of the patients with non culprit plaques. An arbitrary,fixed time-frame second revascularisation for all patients with non culprit lesions is not only infeasible in clinical setting but ,indeed, dangerous treating in the same way patients with different coronary artery lesions; as a sensitivity analysis, a stratified meta-analysis by intervention in the control group was performed as well and results reported, showing consistency of results. Our study was not designed to compare same setting complete revascularization (CR) vs index hospitalization CR vs later date CR vs IRA only revascularization; neither was any study conducted to date. The criticism about methodology or clinical meaningfulness of a meta- analysis should be based upon specific clinical knowledge of the topic, and, above all, careful reading of the meta-analysis design.

  References:

  1. Nairooz R, Naidu SS. Complete revascularization in STEMI. Heart 2015 [Epub ahead of print] 2. Kowalewski M, Schulze V, Berti S, et al. Complete revascularisation in ST-elevation myocardial infarction and multivessel disease: meta-analysis of randomised controlled trials. Heart. 2015 Jun 2.

  Conflict of Interest:

  None declared

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  Conflict of Interest:
  None declared.

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• Published on: 15 March 2016

  Complete revascularization in STEMI

  • Ramez S Nairooz, Cardiology Fellow
  • Other Contributors:
    • Srihari S Naidu

  Cover Letter

  Complete revascularization in STEMI

  a Ramez Nairooz, MD, b Srihari S Naidu, MD.

  a Division of Cardiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas; b Division of Cardiology, Winthrop University Hospital, Mineola, New York.

  Funding: None Conflicts of interest: none Word Count: 325 Corresponding author & (address for reprints) Ramez Nairooz, MD...

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  Cover Letter

  Complete revascularization in STEMI

  a Ramez Nairooz, MD, b Srihari S Naidu, MD.

  a Division of Cardiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas; b Division of Cardiology, Winthrop University Hospital, Mineola, New York.

  Funding: None Conflicts of interest: none Word Count: 325 Corresponding author & (address for reprints) Ramez Nairooz, MD Division of Cardiology University of Arkansas for Medical Sciences 4301 West Markham, Slot 532, Little Rock, AR 72205-7199 Tel: (714)-606-5550; Fax: (501)-686-6439 Email: ramez.nairooz@gmail.com

  Letter to editor

  We read with interest the recently published meta-analysis by Kowalewski and colleagues (1) titled "Complete revascularization in ST- elevation myocardial infarction and multivessel disease: meta-analysis of randomized controlled trials". However, we feel there are a few questions that need addressing: 1. The authors define complete revascularization as "revascularization to non-infarct-related artery lesions during index procedure" and non- complete MV-PCI "encompassed culprit only revascularization and staged approaches". Hence we ask the authors why they used the CvLPRIT (2) event numbers for the total population in whom complete revascularization was done both same setting and staged during index hospitalization? Shouldn't they have used the clinical outcomes of immediate vs staged PCI (published as supplementary material) to stay true to their definition?

  2. Is staged PCI during index hospitalization same as after discharge at later date revascularization? Can they be all added in one group "non- complete MV-PCI"? Maamoun et al scheduled the second procedure at 7 days, Ochala had the second procedure at average of 27 days while Politi et al staged it at an average of 56 days. How did staged PCI become bundled in the same group with infarct related artery only revascularization as seen in PRAMI, CvLPRIT and HELP-AMI? Thus we ask the authors were there any differences in outcomes of those who were staged in hospital vs staged at a later time?

  3. Finally we ask, what conclusion should clinicians draw from this analysis based on the heterogeneous trials which constitute it? Can clinicians conclude meaningful deductions regarding same setting complete revascularization (CR) vs index hospitalization CR vs later date CR vs infarct related artery only revascularization? These questions face the interventional community on daily basis and have no conclusive answer, with guidelines remaining equivocal on the topic. The COMPLETE trial (NCT01740479), currently ongoing, may shed some light on index hospitalization CR vs. infarct related artery only revascularization as the initial strategy, but cannot entirely answer the question as to optimal strategy.

  References: 1. Kowalewski M, Schulze V, Berti S, et al. Complete revascularisation in ST-elevation myocardial infarction and multivessel disease: meta-analysis of randomised controlled trials. Heart. 2015 Jun 2. pii:heartjnl-2014- 307293. doi: 10.1136/heartjnl-2014-307293. [Epub ahead of print] 2. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015;65:963-72.

  Conflict of Interest:

  None declared

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  Conflict of Interest:
  None declared.

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