Catheterization and Cardiovascular Interventions 84:165–166 (2014)
Rebuttal Rebuttal: “Closure of Patent Foramen Ovale and Prevention of Recurrent Thromboembolic Events”
TO THE EDITOR,
We have recently published the results of a metaanalysis of transcatheter closure of a patent foramen ovale (PFO) versus medical therapy for prevention of recurrent thromboembolic events in patients with cryptogenic cerebrovascular events [1]. Percutaneous closure of a PFO in these patients resulted in a 30– 38% reduction of recurrent cerebrovascular events when compared with medical therapy alone. This difference was statistically significant for the “as-treated” population (OR: 0.62; 95% CI, 0.41–0.94, P ¼ 0.02) and showed a trend for the “intention-to-treat” population (OR: 0.70; 95% CI, 0.47–1.05, P ¼ 0.08). As Zhang et al. pointed out in their letter to the editor, meta-analyses have limitations and should be interpreted carefully [2]. We agree with the authors of this letter, in that a transient ischemic attack (TIA) may be a softer end-point compared with a cerebrovascular accident (CVA), and that in clinical practice this diagnosis may sometimes be given to nonspecific neurological symptoms. However, a TIA was strictly defined, in the CLOSURE-1 and PC trials for example, as a clear motor deficit or speech abnormality localizable to a particular vascular territory [3,4], and therefore it has significant implications in the prognosis and management of a patient. In our manuscript, we had also acknowledged other limitations, including the different devices used and the heterogeneity in the inclusion criteria, study end-points, and allowed medical therapy amongst the three randomized controlled trials (RCT) included in our meta-analysis. At least two other meta-analyses have reached a similar conclusion with slightly different numerical results due to the different statistical methods used [5,6]. They additionally demonstrated that percutaneous PFO closure is better than medical therapy to prevent recurrent cerebrovascular events in patients with a substantial shunt, and in those who received the C 2013 Wiley Periodicals, Inc. V
Amplatzer PFO occluder. None of the three available RCTs may had been sufficiently powered to demonstrate a significant difference between the two treatment groups, and therefore, we believe that the pooled data from these three RCTs is currently, the best available evidence. Andr es M. Pineda,* MD Francisco O. Nascimento, MD Solomon C. Yang, MD Columbia University Department of Cardiology Mount Sinai Heart Institute Miami Beach, Florida Ajay J. Kirtane, MD Robert J. Sommer, MD The Department of Cardiology Columbia University Medical Center New York, New York Nirat Beohar, MD Columbia University Department of Cardiology Mount Sinai Heart Institute Miami Beach, Florida REFERENCES 1. Pineda AM, Nascimento FO, Yang SC, Kirtane AJ, Sommer RJ, Beohar N. A meta-analysis of transcatheter closure of patent foramen ovale versus medical therapy for prevention of recurrent thromboembolic events in patients with cryptogenic cerebrovascular events. Catheter Cardiovasc Interv 2013;82:968–975. 2. Zhang B, Zhou J, Zhao Q. Closure of patent foramen ovale and prevention of recurrent thromboembolic events. Catheter Cardiovasc Interv 2013 July 30 [Epub ahead of print]. 3. Furlan AJ, Reisman M, Massaro J, et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012;366:991–999.
Conflict of interest: Nothing to report. *Correspondence to: Andres M. Pineda, MD, Columbia University, Division of Cardiology, Mount Sinai Heart Institute, 4300 Alton Road, Miami Beach, FL 33140. E-mail: [email protected] Received 2 December 2013; Revision accepted 4 December 2013 DOI: 10.1002/ccd.25345 Published online 11 December 2013 in Wiley Online Library (wileyonlinelibrary.com)
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Pineda et al.
4. Meier B, Kalesan B, Mattle HP, et al. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013;368:1083–1091. 5. Rengifo-Moreno P, Palacios IF, Junpaparp P, et al. Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: A systematic review and meta-
analysis of randomized controlled trials. Eur Heart J 2013;34: 3342–3352. 6. Khan AR, Bin Abdulhak AA, Sheikh MA, et al. Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke: A systematic review and meta-analysis. JACC Cardiovasc Interv 2013 October 10 [Epub ahead of print].
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Rebuttal Rebuttal: “Closure of Patent Foramen Ovale and Prevention of Recurrent Thromboembolic Events”
TO THE EDITOR,
We have recently published the results of a metaanalysis of transcatheter closure of a patent foramen ovale (PFO) versus medical therapy for prevention of recurrent thromboembolic events in patients with cryptogenic cerebrovascular events [1]. Percutaneous closure of a PFO in these patients resulted in a 30– 38% reduction of recurrent cerebrovascular events when compared with medical therapy alone. This difference was statistically significant for the “as-treated” population (OR: 0.62; 95% CI, 0.41–0.94, P ¼ 0.02) and showed a trend for the “intention-to-treat” population (OR: 0.70; 95% CI, 0.47–1.05, P ¼ 0.08). As Zhang et al. pointed out in their letter to the editor, meta-analyses have limitations and should be interpreted carefully [2]. We agree with the authors of this letter, in that a transient ischemic attack (TIA) may be a softer end-point compared with a cerebrovascular accident (CVA), and that in clinical practice this diagnosis may sometimes be given to nonspecific neurological symptoms. However, a TIA was strictly defined, in the CLOSURE-1 and PC trials for example, as a clear motor deficit or speech abnormality localizable to a particular vascular territory [3,4], and therefore it has significant implications in the prognosis and management of a patient. In our manuscript, we had also acknowledged other limitations, including the different devices used and the heterogeneity in the inclusion criteria, study end-points, and allowed medical therapy amongst the three randomized controlled trials (RCT) included in our meta-analysis. At least two other meta-analyses have reached a similar conclusion with slightly different numerical results due to the different statistical methods used [5,6]. They additionally demonstrated that percutaneous PFO closure is better than medical therapy to prevent recurrent cerebrovascular events in patients with a substantial shunt, and in those who received the C 2013 Wiley Periodicals, Inc. V
Amplatzer PFO occluder. None of the three available RCTs may had been sufficiently powered to demonstrate a significant difference between the two treatment groups, and therefore, we believe that the pooled data from these three RCTs is currently, the best available evidence. Andr es M. Pineda,* MD Francisco O. Nascimento, MD Solomon C. Yang, MD Columbia University Department of Cardiology Mount Sinai Heart Institute Miami Beach, Florida Ajay J. Kirtane, MD Robert J. Sommer, MD The Department of Cardiology Columbia University Medical Center New York, New York Nirat Beohar, MD Columbia University Department of Cardiology Mount Sinai Heart Institute Miami Beach, Florida REFERENCES 1. Pineda AM, Nascimento FO, Yang SC, Kirtane AJ, Sommer RJ, Beohar N. A meta-analysis of transcatheter closure of patent foramen ovale versus medical therapy for prevention of recurrent thromboembolic events in patients with cryptogenic cerebrovascular events. Catheter Cardiovasc Interv 2013;82:968–975. 2. Zhang B, Zhou J, Zhao Q. Closure of patent foramen ovale and prevention of recurrent thromboembolic events. Catheter Cardiovasc Interv 2013 July 30 [Epub ahead of print]. 3. Furlan AJ, Reisman M, Massaro J, et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012;366:991–999.
Conflict of interest: Nothing to report. *Correspondence to: Andres M. Pineda, MD, Columbia University, Division of Cardiology, Mount Sinai Heart Institute, 4300 Alton Road, Miami Beach, FL 33140. E-mail: [email protected] Received 2 December 2013; Revision accepted 4 December 2013 DOI: 10.1002/ccd.25345 Published online 11 December 2013 in Wiley Online Library (wileyonlinelibrary.com)
166
Pineda et al.
4. Meier B, Kalesan B, Mattle HP, et al. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013;368:1083–1091. 5. Rengifo-Moreno P, Palacios IF, Junpaparp P, et al. Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: A systematic review and meta-
analysis of randomized controlled trials. Eur Heart J 2013;34: 3342–3352. 6. Khan AR, Bin Abdulhak AA, Sheikh MA, et al. Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke: A systematic review and meta-analysis. JACC Cardiovasc Interv 2013 October 10 [Epub ahead of print].
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
