ORAL CILOSTAZOL TREATMENT PREVENTS RESTENOSIS AND MAJOR ADVERSE CLINICAL EVENTS AFTER DRUG-ELUTING STENT IMPLANTATION: EVIDENCE FROM A META-ANALYSIS G.

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ORAL CILOSTAZOL TREATMENT PREVENTS RESTENOSIS AND MAJOR ADVERSE CLINICAL EVENTS AFTER DRUG-ELUTING STENT IMPLANTATION: EVIDENCE FROM A META-ANALYSIS G. Biondi-Zoccai,1 C. Moretti,1 F. Sciuto,1 P. Omedé,1 C. La Spina,1 V. Infantino,1 E. Cavallero,1 E. Giraudi,1 E. Menditto,1 C. Iacovino,1 F. Colombo,1 P. Agostoni,2 A. Abbate,3 M. Bollati,1 I. Sheiban1 1University of Turin, Turin, Italy (gbiondizoccai@gmail.com); 2AZ Middelheim, Antwerp, Belgium; 3Virginia Commonwealth University, Virginia, USA

BACKGROUND Drug-eluting stents (DES) reduce in-stent neointimal hyperplasia, but restenosis, repeat revascularization and stent thrombosis still remain a concern in several high-risk patients. Cilostazol, an oral antiplatelet agent with pleiotropic effects including inhibition of neointimal hyperplasia which is already FDA approved for the treatment of claudication, could hold the promise of further inhibiting restenosis and prevent thrombosis.

OBJECTIVES We systematically reviewed randomized clinical trials (RCT) on the impact of cilostazol after PCI with DES implantation. Our goal was specifically to pool major outcomes from included studies with meta-analytic techniques.

METHODS We searched Bio-MedCentral, CENTRAL, clinicaltrials.gov, EMBASE, and PubMed for randomized trials comparing cilostazol vs control after PCI (keywords: cilostazol, coronary, and restenosis; updated March 2008). Inclusion criteria were: (a) randomized allocation, (b) comparison of cilostazol vs control, (c) after PCI with DES, and (d) follow-up ≥1 month. Exclusion criteria were: (a) duplicate reports, (b) lack of outcome data beyond hospitalization, and (c) equivocal or nonrandom treatment allocation.

METHODS The primary angiographic end-point was binary restenosis at 6 months of follow-up. The primary clinical end-point was the rate of major adverse cardiac events (MACE), ie the composite of death, myocardial infarction (MI) or repeat target vessel/lesion revascularization (TVR/TLR) at 6-9 months.

INCLUDED STUDIES Study Year Pts on cilostazol Pts on control Rx CIDES 2008 113 124 DECLARE-Diabetes 200 DECLARE-Long 2007 250 OPTIMUS-2 13 12

RESULTS A total of 4 RCTs were included (1,205 patients), with median follow-up of 6 months. Pooled analysis showed that cilostazol was associated with statistically significant reductions in binary angiographic restenosis (RR=0.53 [0.36-0.79], p=0.001), as well as target lesion revascularization (RR=0.41 [0.24-0.69], p=0.0008).

RESULTS These benefits on restenosis and lead to significant benefits of cilostazol on the occurrence of MACE (RR=0.43 [0.26-0.70], p=0.0008). Cilostazol appeared also safe, with no significant increase in the risk of death (RR=0.67 [0.11-4.0], p=0.66), stent thrombosis (RR=0.74 [0.15-3.7], p=0.71), or bleeding (RR=0.71 [0.23-2.2], p=0.56).

RISK OF BINARY RESTENOSIS RISK OF TLR

RISK OF TVR RISK OF MACE

RISK OF DEATH RISK OF MI

RISK OF STENT THROMBOSIS RISK OF BLEEDING

FUNNEL PLOT FOR MACE

CONCLUSIONS Cilostazol appears effective and safe in reducing the risk of restenosis, repeat revascularization and major adverse cardiac events after PCI with DES. Awaiting larger RCTs, this inexpensive treatment can be envisaged in selected patients deemed at high-risk of restenosis despite being treated with DES, such as diabetics, those with chronic renal failure, small vessel disease or bifurcation lesions.

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