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Stone GW, Webb J, Cox DA, et al. Distal Microcirculatory Protection During Percutaneous Coronary Intervention in Acute ST-Segment Elevation Myocardial Infarction: A Randomized Controlled Trial. JAMA. 2005;293(9):1063–1072. doi:10.1001/jama.293.9.1063
Author Affiliations: Columbia University Medical
Center and Cardiovascular Research Foundation, New York, NY (Drs Stone, Lansky,
and Mehran); St Paul’s Hospital, Vancouver, British Columbia (Dr Webb);
Mid Carolina Cardiology, Charlotte, NC (Dr Cox); Moses Cone Hospital, Greensboro,
NC (Dr Brodie); St Joseph Mercy Hospital, Ypsilanti, Mich (Dr Qureshi); Crawford
Long Hospital, Atlanta, Ga (Dr Kalynych); Washington Adventist Hospital, Tacoma
Park, Md (Dr Turco); University Hospital Benjamin Franklin, Berlin, Germany
(Dr Schultheiss); Mercy Hospital, Coon Rapids, Minn (Dr Dulas); St Luke’s
Hospital, Kansas City, Mo (Dr Rutherford); Policlinico Careggi, Florence,
Italy (Dr Antoniucci); Duke University Medical Center, Durham, NC (Dr Krucoff);
Mayo Clinic Foundation, Rochester, Minn (Dr Gibbons); Medtronic Corp, Santa
Rosa, Calif (Ms Jones).
Context Atheromatous and thrombotic embolization during percutaneous coronary
intervention (PCI) in acute myocardial infarction is common and may result
in microcirculatory dysfunction, the prevention of which may improve reperfusion
success, reduce infarct size, and enhance event-free survival.
Objective To determine whether protection of the distal microcirculation from
thromboembolic debris liberated during primary PCI results in improved reperfusion
and decreased infarct size.
Design, Setting, and Patients Prospective randomized controlled trial at 38 academic and community-based
institutions in 7 countries enrolling 501 patients aged 18 years or older
with ST-segment elevation myocardial infarction (STEMI) presenting within
6 hours of symptom onset and undergoing primary PCI or rescue intervention
after failed thrombolysis.
Interventions Patients were randomized between May 20, 2002, and November 21, 2003,
to receive PCI with a balloon occlusion and aspiration distal microcirculatory
protection system vs angioplasty without distal protection.
Main Outcome Measures Coprimary end points were ST-segment resolution (STR) measured 30 minutes
after PCI by continuous Holter monitoring and infarct size measured by technetium
Tc 99m sestamibi imaging between days 5 and 14. Secondary end points included
major adverse cardiac events.
Results Among 252 patients assigned to distal protection, aspiration was performed
in 97% (242/251), all angioplasty balloon inflations were fully protected
in 79% (193/245), and visible debris was retrieved from 73% (182/250). Complete
STR was achieved in a similar proportion reperfused with vs without distal
protection (63.3% [152/240] vs 61.9% [148/239], respectively; absolute difference,
1.4% [95% confidence interval, –7.7% to 10.5%; P = .78]),
and left ventricular infarct size was similar in both groups (median, 12.0%
[n = 229] vs 9.5% [n = 208], respectively; P = .15). Major adverse cardiac events at 6 months occurred
with similar frequency in the distal protection and control groups (10.0%
vs 11.0%, respectively; P = .66).
Conclusions A distal balloon occlusion and aspiration system effectively retrieves
embolic debris in most patients with acute STEMI undergoing emergent PCI.
Nonetheless, distal embolic protection did not result in improved microvascular
flow, greater reperfusion success, reduced infarct size, or enhanced event-free
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