CLINICAL STUDIES
Acute and nine-month clinical outcomes after "suboptimal" coronary stenting
Results from the STent anti-thrombotic regimen study (STARS) registry
Donald E. Cutlip, MD, FACC*,
Martin B. Leon, MD, FACC ,
Kalon K. L. Ho, MD, MSc, FACC ,
Paul C. Gordon, MD, FACC ,
Alessandro Giambartolomei, MD, FACC||,
Daniel J. Diver, MD, FACC¶,
David M. Lasorda, DO, FACC#,
David O. Williams, MD, FACC**,
Michelle M. Fitzpatrick, RN,
April Desjardin, MS,
Jeffrey J. Popma, MD, FACC,
Richard E. Kuntz, MD, MSc,
Donald S. Baim, MD, FACC for the STent Anti-thrombotic Regimen Study Investigators
* University of Rochester Medical Center, Rochester, New York, USA
Washington Hospital Center, Washington, DC, USA
Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
Miriam Hospital, Providence, Rhode Island, USA
|| St. Joseph’s Hospital, Syracuse, New York, USA
¶ Georgetown Medical Center, Washington, DC, USA
# Allegheny University Hospitals, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA
** Rhode Island Hospital, Providence, Rhode Island, USA
Brigham and Women’s Hospital, Boston, Massachusetts, USA
Manuscript received December 29, 1998;
revised manuscript received April 7, 1999,
accepted May 16, 1999.
Reprint requests and correspondence: Dr. Donald S. Baim, Chief, Interventional Cardiology Section, Beth Israel-Deaconess Medical Center, 330 Brookline Avenue, Boston, Massachusetts
dbaim{at}bidmc.harvard.edu
OBJECTIVES
This registry collected the 30-day and 9-month clinical outcomes of patients whose coronary stent implantation was suboptimal, and compared them with the cohort of patients with "optimal" stenting in the randomized portion of the STent Anti-thrombotic Regimen Study (STARS) trial.
BACKGROUND
Although "optimal" stenting combined with an aspirin and ticlopidine regimen carries a low (0.5%) incidence of subacute stent thrombosis, only limited data are available for patients in whom stents are deployed suboptimally.
METHODS
In the STARS, 312 (15.9%) of 1,965 patients enrolled were excluded from participation in the randomized trial based on a perceived "suboptimal" result of coronary stenting. Of these, 265 patients met prespecified criteria for suboptimal stenting, and were followed in a parallel registry, which was compared with the randomized STARS optimal stenting cohort. The primary end point was a 30-day composite of death, emergent target lesion revascularization, angiographic thrombosis of the target vessel without revascularization and nonfatal myocardial infarction (MI)unrelated to direct procedural complications.
RESULTS
Registry patients had a similar frequency of the primary end point compared with the overall randomized cohort (3.0% vs. 2.2%), with this end point correlating to use of multiple stents, smaller final lumen diameter and absence of ticlopidine from the poststent regimen. Overall 30-day mortality (1.1% vs. 0.06%, p = 0.009) and periprocedural non-Q wave MI (8.7% vs. 4.2%, p = 0.003) were more frequent in registry patients, and appeared to be related to acute procedural complications. Clinical restenosis was significantly higher for registry patients (26.8% vs. 16.0%, p = 0.001), relating to greater prevalence of independent predictors such as smaller final lumen diameter and multiple stent use.
CONCLUSIONS
In the STARS registry, the inability to perform optimal stenting correlated with smaller final lumen diameter and longer stent length. With ticlopidine-containing regimens, the acute clinical results of "suboptimal" stent deployment are clinically acceptable, although they are not quite as good as those of optimal stenting using similar drug therapy.
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Abbreviations and Acronyms
| | MI | = myocardial infarction | | QMI | = Q wave myocardial infarction | | STARS | = STent Anti-thrombotic Regimen Study | | TIMI | = thrombolysis in myocardial infarction | | TLR | = target lesion revascularization | | TVF | = target vessel failure | | TVR | = target vessel revascularization |
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