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Minerva Cardiology and Angiology 2021 May 04

DOI: 10.23736/S2724-5683.21.05645-3


language: English

Impact of coronary stenting on top of medical therapy and of inclusion of periprocedural infarctions on hard composite endpoints in patients with chronic coronary syndromes: a meta-analysis of randomized controlled trials

Mattia GALLI 1, 2, Giovanni M. VESCOVO 3, Felicita ANDREOTTI 1, 2, Domenico D'AMARIO 1, Antonio M. LEONE 1, 2, Stefano BENENATI 4, Rocco VERGALLO 1, Giampaolo NICCOLI 1, 2, Carlo TRANI 1, 2, Italo PORTO 4, 5

1 Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; 2 Università Cattolica del Sacro Cuore, Rome, Italy; 3 Division of Cardiology, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy; 4 IRCCS Ospedale Policlinico San Martino, Italian IRCCS Cardiovascular Network, Genoa, Italy; 5 Dipartimento di Medicina Interna e Specialità Mediche (DIMI), Università di Genova, Genoa, Italy

BACKGROUND: Composite endpoints are pivotal when assessing rare outcomes over relatively short follow-ups. Most randomized controlled trials (RCTs) comparing percutaneous coronary intervention (PCI) with stent implantation to optimal medical therapy (OMT) in chronic coronary syndromes (CCS) patients included both hard and soft outcomes in their primary endpoint, with periprocedural myocardial infarctions (MIs) systematically allocated to the PCI arm. We metaanalysed the above RCTs for composite hard endpoints, with and without periprocedural MIs.
METHODS: This study is registered in PROSPERO CRD42020166754 and follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane Collaboration reporting. Patients had inducible ischemia, no left main disease nor severe left ventricular dysfunction.
RESULTS: Six RCTs involving 10,751 patients followed for a mean of 4.4 years were included. PCI+OMT versus OMT alone was associated with no difference in the two co-primary composite endpoints of all-cause death/MI/stroke and cardiovascular death/MI including all-MIs (IRR 0.99; 95% CI 0.90-1.08 and IRR 0.95; 95% CI 0.83-1.08 respectively). After inclusion of spontaneous rather than all-MIs (i.e., excluding periprocedural MIs), the odds showed benefit of PCI+OMT for both co-primary endpoints (IRR 0.88; 95% CI 0.80-0.97, P<0.01 and IRR 0.81; 95% CI 0.69-0.95, P=0.01 respectively) with numbers needed to treat of 42 in both cases.
CONCLUSIONS: Among CCS patients with inducible myocardial ischemia without severely reduced ejection fraction or left main disease, adding PCI to OMT reduces hard composite outcomes only after exclusion of periprocedural MIs. Continued efforts to define periprocedural MIs reproducibly, to assess their prognostic relevance and to prevent them are warranted.

KEY WORDS: Percutaneous coronary intervention; Medical therapy; Composite endpoints; Periprocedural myocardial infarction; Stable coronary artery disease

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