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CLINICAL RESEARCH: CLINICAL TRIAL

Increased Rate of Stent Thrombosis and Target Lesion Revascularization After Filter Protection in Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction

15-Month Follow-Up of the DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction) Trial

Anne Kaltoft, MD, PhD^_*,_*, Henning Kelbæk, MD, DMSci, Lene Kløvgaard, RN, Christian Juhl Terkelsen, MD, PhD^_*, Peter Clemmensen, MD, DMSci, Steffen Helqvist, MD, DMSci, Jens Flensted Lassen, MD, PhD^_* and Leif Thuesen, MD, DMSci^_*

^_* Department of Cardiology, Aarhus University Hospital, Skejby, Denmark
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

Manuscript received July 13, 2009; revised manuscript received September 4, 2009, accepted September 14, 2009.

^_* Reprint requests and correspondence: Dr. Anne Kaltoft, Department of Cardiology B, Aarhus University Hospital, Brendstrupgaardsvej 100, Skejby, 8200 Aarhus N, Denmark (Email: annekaltoft{at}stofanet.dk).

Objectives: The purpose of this study was to evaluate the long-term effects of distal protection during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).

Background: The use of distal filter protection during primary PCI increases procedure complexity and may influence lesion treatment and stent implantation.

Methods: The STEMI patients were assigned to distal protection (DP) (n = 312) or conventional treatment (CT) (n = 314). Clinical follow-up was performed after 1, 6, and 15 months, and angiographic follow-up after 8 months. All target lesion revascularizations (TLRs) were clinically driven. We report the pre-specified end points of stent thrombosis according to the criteria of the Academic Research Consortium, TLR, and reinfarction after 15 months.

Results: The total number of stent thrombosis was 11 in the DP group and 4 in the CT group (p = 0.06). The rate of definite stent thrombosis was significantly increased in the DP group as compared with the CT group, with 9 cases versus 1 (p = 0.01). Clinically driven TLRs (31 patients vs. 18 patients, p = 0.05) and clinically driven target vessel revascularizations (37 patients vs. 22 patients, p = 0.04) were more frequent in the DP group.

Conclusions: In primary PCI for STEMI, the routine use of DP increased the incidence of stent thrombosis and clinically driven target lesion/vessel revascularization during 15 months of follow-up. (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction Trial [DEDICATION]; NCT00192868)

Key Words: primary PCI • distal protection • stent thrombosis

Abbreviations and Acronyms   BMS = bare metal stent(s)   CT = conventional treatment   DES = drug-eluting stent(s)   DP = distal protection   MACCE = major adverse cardiac and cerebral events   MACE = major adverse cardiac events   PCI = percutaneous coronary intervention   STEMI = ST-segment elevation myocardial infarction   TLR = target lesion revascularization   TVR = target vessel revascularization

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