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Review
. 2015 Sep 14;36(35):2381-9.
doi: 10.1093/eurheartj/ehv252. Epub 2015 Jul 3.

Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis

David M Kent  1 , Issa J Dahabreh  2 , Robin Ruthazer  3 , Anthony J Furlan  4 , Christian Weimar  5 , Joaquín Serena  6 , Bernhard Meier  7 , Heinrich P Mattle  8 , Emanuele Di Angelantonio  9 , Maurizio Paciaroni  10 , Herwig Schuchlenz  11 , Shunichi Homma  12 , Jennifer S Lutz  3 , David E Thaler  13
Affiliations
Review

Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis

David M Kent et al. Eur Heart J. .

Abstract

Aims: The preferred antithrombotic strategy for secondary prevention in patients with cryptogenic stroke (CS) and patent foramen ovale (PFO) is unknown. We pooled multiple observational studies and used propensity score-based methods to estimate the comparative effectiveness of oral anticoagulation (OAC) compared with antiplatelet therapy (APT).

Methods and results: Individual participant data from 12 databases of medically treated patients with CS and PFO were analysed with Cox regression models, to estimate database-specific hazard ratios (HRs) comparing OAC with APT, for both the primary composite outcome [recurrent stroke, transient ischaemic attack (TIA), or death] and stroke alone. Propensity scores were applied via inverse probability of treatment weighting to control for confounding. We synthesized database-specific HRs using random-effects meta-analysis models. This analysis included 2385 (OAC = 804 and APT = 1581) patients with 227 composite endpoints (stroke/TIA/death). The difference between OAC and APT was not statistically significant for the primary composite outcome [adjusted HR = 0.76, 95% confidence interval (CI) 0.52-1.12] or for the secondary outcome of stroke alone (adjusted HR = 0.75, 95% CI 0.44-1.27). Results were consistent in analyses applying alternative weighting schemes, with the exception that OAC had a statistically significant beneficial effect on the composite outcome in analyses standardized to the patient population who actually received APT (adjusted HR = 0.64, 95% CI 0.42-0.99). Subgroup analyses did not detect statistically significant heterogeneity of treatment effects across clinically important patient groups.

Conclusion: We did not find a statistically significant difference comparing OAC with APT; our results justify randomized trials comparing different antithrombotic approaches in these patients.

Keywords: Cardiogenic stroke; Cryptogenic stroke; Medical stroke treatment; Patent foramen ovale; Secondary stroke prevention.

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Figures

Figure 1
Figure 1
Flow diagram showing cases included in the TAcTiCS analysis and detailing reasons for exclusion of potentially eligible participants from the 12 component studies.
Figure 2
Figure 2
Summary results for composite outcome by study. Open circles represent crude HRs for individual studies; solid circles represent the adjusted HRs in individual studies. Pooled estimates, represented by diamonds, were computed from a random-effects model. Horizontal lines through the circles and diamonds denote the 95% CIs for individual studies and summary results, respectively.
Figure 3
Figure 3
Summary results for composite outcome by subgroup. Circles represent adjusted stratum-specific HRs pooled across studies using a random-effects model. Horizontal lines through the circles denote the 95% CIs. Inter. P value, interaction p-value comparing treatment effects between strata; RAD SUP, superficial lesion on neuroimaging; TEE, trans-esophageal echocardiography.
See this image and copyright information in PMC

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