"Real World" Adhoc Percutaneous Coronary Interventions With Use of Sirolimus Eluting Stents: A Single Operator Experience and Long-term Follow-up
Keywords:coronary artery disease, coronary angioplasty, coronary stents, drug-eluting stents, sirolimus-eluting stents, stent thrombosis, restenosis
BACKGROUND: Drug eluting stents (DES) have ushered in a new era in percutaneous coronary intervention (PCI), curtailing significantly the restenosis rates compared with bare metal stents (BMS). However, their use has been plagued with the late stent thrombosis phenomenon.
OBJECTIVE: During a 5-year period, sirolimus-eluting stents (SES) were employed in 260 patients among 675 consecutive patients submitted to PCI by a single-operator with a uniform technique. The objective of this study was to assess the clinical and angiographic results and to report the incidence of stent thrombosis and the long-term outcome in these patients.
METHODS & PATIENTS: A consistent single-operator approach with 0.5 mm stent oversizing and high pressure (>12-18 bar) stent deployment was adopted, routinely combined with long-term dual antiplatelet therapy for at least a two-year period post-implantation. The study included 213 men and 47 women, aged 64+12 years, who presented with stable angina and/or positive exercise test (n=54), unstable coronary syndrome (n=125), or acute myocardial infarction (MI) (n=81). The dilated vessel was the left main stem (n=4), left anterior descending and/or its diagonal branch (n=178), the right coronary (n=103), the circumflex and/or its obtuse marginal branch (n=89), the ramus branch (n=10), a saphenous vein (n=11) or arterial (n=2) graft. Three groups were compared: 104 (40%) patients receiving SES alone (Group A), 122 patients receiving SES plus other DES (Group B), and 34 patients receiving SES plus BMS (Group C).
RESULTS: The majority (93.8%) of PCI procedures were performed adhoc during the same session of coronary angiography. All 3 groups had similar demographics, mean age (62-66 years), initial stenosis (88-89%) and mean ejection fraction (45-55%). Procedural success (99-100%) and residual stenosis (<0-10%) were also similar. Multivessel PCI and stenting was performed in 120 (46.3%) patients and multilesion PCI in the majority (89.2%) in this cohort. Overall, a mean number of 1.6+0.7 vessels and 3.1+1.6 (range, 1-9) lesions were dilated. A median of 2 stents (mean of 2.6+1.3 stents) were implanted in 260 patients; group A (patients receiving SES alone) received the least number of stents (1.7+0.7). There was one occurrence of subacute stent thrombosis in group C (0.4%). All patients received combined therapy with aspirin and clopidogrel, the latter administered for >24 months. Over 16.3+14.7 months of follow-up, survival free of events (death, MI, stroke, repeat revascularization and restenosis) was excellent at 98%, 96%, and 97% at 12 months and 95%, 90% and 97% at 24 months for groups A, B and C respectively; long-rank (Mantel-Cox) test p value= 0.27. Clinical restenosis rates were low in all 3 groups (0% vs 1.6% vs 5.9%) (p=NS). Possible very late stent thrombosis could be suspected in 1 patient (group B) who had sudden cardiac death at 32 months after the procedure.
CONCLUSION: In a consecutive series of 260 patients receiving SES and/or other stents, a uniform single-operator approach with 0.5 mm stent oversizing and high-pressure (>12-18 bar) deployment routinely combined with long-term dual antiplatelet therapy resulted in high procedural success (>99%), very low rate of subacute (0.4%) and late stent thrombosis (0.4%), very low clinical restenosis rates (0-5.9%) and overall excellent survival free of cardiovascular events at 1 and 2 years.
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