Natalie Gevorkian

Correlates and Long-Term Outcomes of Angiographically Proven Stent Thrombosis With Sirolimus- and Paclitaxel-Eluting Stents

Background— Stent thrombosis (ST) is a serious complication of drug-eluting stent (DES) implantation regardless of the timing (acute, subacute, or late). The correlates of ST with DES are not yet completely elucidated. Methods and Results— From a total cohort of 2974 consecutive patients treated with DES since April 2003, we identified 38 patients who presented with angiographic evidence of ST (1.27%). The ST occurred acutely in 5 patients, subacutely (≤30 days) in 25 patients, and late (>30 days) in 8 patients. The clinical, angiographic, and procedural variables of these patients were compared with the remaining 2936 consecutive patients who underwent DES implantation and did not experience ST during a follow-up of 12 months. Logistic regression analysis was conducted to determine the correlates of ST. Compared with patients without ST, patients with ST had a higher frequency of diabetes, acute postprocedural renal failure, and chronic renal failure. There were more bifurcation lesions, type C lesions, and a trend for smaller-diameter stents. Discontinuation of clopidogrel was higher in these patients (36.8% versus 10.7%; P<0.0001). The mean duration to ST from the stent implantation was 8.9±8.5 days in subacute and 152.7±100.4 days in late thrombosis cases. Mortality was significantly higher in patients with ST compared with those without ST at 6 months (31% versus 3%; P<0.001). Multivariate analysis detected cessation of clopidogrel therapy, renal failure, bifurcation lesions, and in-stent restenosis as significant correlates of ST (P<0.05). Conclusions— ST continues to be a serious complication of contemporary DES use. Careful management is warranted in patients with renal failure and in those undergoing treatment for in-stent restenosis and bifurcations. Special focus on clopidogrel compliance may minimize the incidence of ST after DES implantation.

Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions

Bleeding related to percutaneous coronary intervention (PCI) occurs relatively frequently. We retrospectively investigated the incidence, predictors, and prognostic impact of periprocedural bleeding and transfusion in 10,974 patients who underwent PCI. Bleeding definitions were based on Thrombolysis In Myocardial Infarction (TIMI) criteria: (1) major bleeding (n = 588; 5.4%): if patients had a hemorrhagic stroke or if hematocrit decreased >15 points or by 10 to 15 points with clinical bleeding; (2) minor bleeding (n = 1,394; 12.7%): if hematocrit decreased <10 points with clinical bleeding or by 10 to 15 points without clinical bleeding; and (3) no bleeding (n = 8,992; 81.9%): if hematocrit decreased <10 points without clinical bleeding. Patients with major bleeding were older than patients with minor or no bleeding (67.8 +/- 11 vs 65.9 +/- 11 vs 63.6 +/- 11 years, respectively; p <0.001) and more often experienced intraprocedural complications, such as emergency use of an intra-aortic balloon pump (13.6% vs 6.5% vs 2.3%, respectively; p <0.001). Multivariate logistic regression analysis identified the use of an intra-aortic balloon pump (odds ratio [OR] 3.0, p <0.0001), procedural hypotension (OR 2.9, p <0.001), and age >80 years (OR 1.9 compared with age <50 years, p = 0.001) as the strongest predictors for major bleeding. Patients who had major bleeding had higher in-hospital and 1-year mortality compared with patients with minor or no bleeding. Bleeding was an independent predictor of in-hospital death. Thus, periprocedural major bleeding occurs relatively frequently and is associated with adverse outcomes. Patients >80 years of age who experience intraprocedural complications are at particularly high risk.

Outcomes of Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention With Drug-Eluting Stents for Patients With Multivessel Coronary Artery Disease

Background— Advances in coronary artery bypass grafting (CABG) surgery and percutaneous coronary intervention (PCI) with drug-eluting stents have dramatically improved results of these procedures. The optimal treatment for patients with multivessel coronary artery disease is uncertain given the lack of prospective, randomized data reflecting current practice. This study represents a “real-world” evaluation of current technology in the treatment of multivessel coronary artery disease. Methods and Results— A total of 1680 patients undergoing revascularization for multivessel coronary artery disease were identified. Of these, 1080 patients were treated for 2-vessel disease (196 CABG and 884 PCI) and 600 for 3-vessel disease (505 CABG and 95 PCI). One-year mortality, cerebrovascular events, Q-wave myocardial infarction, target vessel failure, and composite major adverse cardiovascular and cerebrovascular events were compared between the CABG and PCI cohorts. Outcomes were adjusted for baseline covariates and reported as hazard ratios. The unadjusted major adverse cardiovascular and cerebrovascular event rate was reduced with CABG for patients with 2-vessel disease (9.7% CABG versus 21.2% PCI; P<0.001) and 3-vessel disease (10.8% CABG versus 28.4% PCI; P<0.001). Adjusted outcomes showed increased major adverse cardiovascular and cerebrovascular event with PCI for patients with 2-vessel (hazard ratio 2.29; 95% CI 1.39 to 3.76; P=0.01) and 3-vessel disease (hazard ratio 2.90; 95% CI 1.76 to 4.78; P<0.001). Adjusted outcomes for the nondiabetic subpopulation demonstrated equivalent major adverse cardiovascular and cerebrovascular event with PCI for 2-vessel (hazard ratio 1.77; 95% CI 0.96 to 3.25; P=0.07) and 3-vessel disease (hazard ratio 1.70; 95% CI 0.77 to 3.61; P=0.19). Conclusions— Compared with PCI with drug-eluting stents, CABG resulted in improved major adverse cardiovascular and cerebrovascular event in patients with 2- and 3-vessel coronary artery disease, primarily in those with underlying diabetes. Coronary artery bypass surgery may be the preferred revascularization strategy in diabetic patients with multivessel coronary artery disease.

Percutaneous coronary intervention-associated nephropathy foreshadows increased risk of late adverse events in patients with normal baseline serum creatinine

In patients with chronic renal insufficiency, further decline in renal function (DRF) after percutaneous coronary intervention (PCI) is accompanied not only by adverse in‐hospital events but also by increased risk of mortality and myocardial infarction at 1 year. This analysis was undertaken to determine if patients with normal renal function who develop DRF after PCI have a comparable increase in risk of death and myocardial infarction at 1 year, and whether this risk is independent of in‐hospital complications (death, myocardial infarction, urgent coronary artery bypass grafting). We performed a retrospective analysis of all patients from a single center who underwent successful PCI with no major in‐hospital complications who had pre‐PCI serum creatinine (SCr) ≤ 1.2 mg/dl and no history of renal insufficiency. One‐year follow‐up was obtained by mail or telephone. There were 5,967 consecutive patients who met the inclusion criteria. Of these, 208 (3.5%) developed DRF (an increase in SCr ≥ 50% of baseline). They were more likely to be older, female, non‐Caucasian, diabetic and/or hypertensive. They reported more prior cerebral or peripheral vascular events. They had undergone more complex PCI and were exposed to more radiographic contrast than the 96.5% who did not develop DRF. After adjustment for baseline variables, DRF remained an independent predictor of 1‐year mortality, myocardial infarction, and target vessel revascularization. In patients without prior renal impairment, DRF post‐PCI is rare but is associated with an increased risk of late adverse cardiac events similar to that in chronic renal insufficiency patients. Cathet Cardiovasc Intervent 2003;59:338–343.

Treatment of drug‐eluting stent restenosis with the same versus different drug‐eluting stent

The authors aimed to compare the clinical outcomes with repeat drug‐eluting stent (DES) implantation utilizing the same type versus an alternate DES type for in‐stent restenosis (ISR) of DES.

Percutaneous coronary intervention with drug‐eluting stents in octogenarians: Characteristics, clinical presentation, and outcomes

Objectives: We aimed to compare clinical outcomes of octogenarians ≥80 years of age after coronary drug‐eluting stent (DES) implantation. Background: Although octogenarians constitute a fast‐growing portion of cardiovascular patients, they are not adequately represented in current clinical revascularization trials. Methods: We analyzed the data of 3,166 consecutive patients who underwent percutaneous coronary intervention (PCI) and DES implantation since March 2003. Periprocedural events, 1‐ and 6‐month clinical outcomes were compared between octogenarians (n = 339) and patients <80 years of age (n = 2,827). Results: Baseline characteristics revealed a higher prevalence of females (P < 0.001), Caucasians (P = 0.004), chronic renal failure (P < 0.001), heart failure (P < 0.001), number of diseased vessels (P = 0.009), and lower ejection fraction (P = 0.03) in octogenarians. Patients <80 years showed more positive family history (P < 0.001), hyperlipidemia (P = 0.006), smoking (P < 0.001), and obesity (P < 0.001). Clinical presentation and procedural success were similar in both groups as were death, myocardial infarction (MI), and repeat revascularization in‐hospital. At 6 months, restenosis rates were low and comparable. In the subgroup of octogenarians who presented with acute coronary syndrome, mortality (15% vs. 3%, P < 0.001) and Q‐wave MI occurred more often. Multivariate analysis revealed age >80 (P = 0.008), cardiogenic shock (P < 0.001), Q‐wave MI at presentation (P = 0.003), and length of hospital stay (P = 0.003) to be independent predictors of mortality. Conclusions: PCI with DES in octogenarians results in a similar reduction of restenosis rates when compared to patients <80 years. Yet in octogenarians who presented with acute coronary syndrome, incidence of mortality and Q‐wave MI at 6 months was higher as compared to younger patients.

Clinical outcomes following stent implantation in internal mammary artery grafts

We evaluated our experience with percutaneous coronary intervention (PCI) of internal mammary artery (IMA) grafts. From the institutions database we identified 288 patients with 311 IMA lesions. Of these, 82 (26.4%) had stents placed during PCI. Angiographic success was 92%. Mortality at 1 month was 1.7%, myocardial infarction (MI) 15.7%, and target lesion revascularization (TLR) 0.4%. Cumulative 1‐year event rates were mortality 6.4%, MI 20.4%, and TLR 8.0%. TLR rates were significantly higher in the stented lesions than lesions treated with angioplasty alone (19.2% vs. 4.9%; P = 0.004). The higher TLR rate in stented lesions was most apparent at the anastomotic site (25.0% vs. 4.2%; P = 0.006). Percutaneous revascularization of IMA grafts can be performed safely with high procedural success and excellent short‐ and long‐term results. Stenting, particularly at the anastomotic site, was associated with significantly greater rates of TLR than angioplasty alone. Cathet Cardiovasc Intervent 2003;59:436–441.

Does creatine kinase-MB (CK-MB) isoenzyme elevation following percutaneous coronary intervention with drug-eluting stents impact late clinical outcome?

The incidence of postprocedural creatine kinase (CK)‐MB elevation to >3× the upper limit of normal after percutaneous coronary intervention (PCI) has been reported at rates of up to 18% in the bare metal stent era and is correlated with higher adverse cardiovascular outcomes. This study examined the incidence and prognostic significance of CK‐MB elevations after drug‐eluting stent (DES) implantation.

Comparison between sirolimus- and paclitaxel-eluting stents in complex patient and lesions subsets.

Background: Sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) both significantly reduce the need for repeat intervention compared to bare metal stents. Studies comparing the clinical outcomes of these stents in noncomplex subsets of patients and lesions demonstrate a similar safety and efficacy profile. The data for more complex subsets of patients and lesions remains conflicting. This study aimed to compare SES with PES in a selected population with a broad range of complex features. Methods and Results: The patient population consisted of 1,591 consecutive patients with complex features undergoing drug‐eluting stent (DES) implantation. In the SES group there were 1,095 patients (1,653 lesions) and in the PES group 496 patients (802 lesions). In‐hospital, 30‐day, and 12‐month clinical outcomes were compared between groups. No discernable difference in major adverse cardiac events (MACE) between SES and PES was detected at intermediate and longer‐term follow‐up (SES 22.4% vs. PES 20.5% at 12 months; P = 0.407). A trend toward increased angiographically documented stent thrombosis was observed in the SES group at both 3 and 12 months (SES 2.2% vs. PES 0.8% at 12 months; P = 0.051). When adopting the more inclusive definition of probable stent thrombosis, this trend was no longer seen. After adjusting for baseline differences between the two groups, there still remained no difference in MACE between SES and PES (HR 1.051 [CI 0.826–1.339] P = 0.685). The trend toward increased angiographically documented stent thrombosis in the SES group remained after adjustment for baseline differences (HR 2.836 [CI 0.968–8.311] P = 0.057). Conclusions: In a selected population with complex disease the rate of MACE was comparable between SES and PES, with higher overall rates of thrombosis and MACE compared to a noncomplex population. Thus, the focus should be directed to prevent late complications in this complex subset regardless of stent type selection.

Response to Letter Regarding Article, “Correlates and Long-Term Outcomes of Angiographically Proven Stent Thrombosis with Sirolimus- and Paclitaxel-Eluting Stents”

BACKGROUND Stent thrombosis (ST) is a serious complication of drug-eluting stent (DES) implantation regardless of the timing (acute, subacute, or late). The correlates of ST with DES are not yet completely elucidated. METHODS AND RESULTS From a total cohort of 2974 consecutive patients treated with DES since April 2003, we identified 38 patients who presented with angiographic evidence of ST (1.27%). The ST occurred acutely in 5 patients, subacutely (< or =30 days) in 25 patients, and late (>30 days) in 8 patients. The clinical, angiographic, and procedural variables of these patients were compared with the remaining 2936 consecutive patients who underwent DES implantation and did not experience ST during a follow-up of 12 months. Logistic regression analysis was conducted to determine the correlates of ST. Compared with patients without ST, patients with ST had a higher frequency of diabetes, acute postprocedural renal failure, and chronic renal failure. There were more bifurcation lesions, type C lesions, and a trend for smaller-diameter stents. Discontinuation of clopidogrel was higher in these patients (36.8% versus 10.7%; P<0.0001). The mean duration to ST from the stent implantation was 8.9+/-8.5 days in subacute and 152.7+/-100.4 days in late thrombosis cases. Mortality was significantly higher in patients with ST compared with those without ST at 6 months (31% versus 3%; P<0.001). Multivariate analysis detected cessation of clopidogrel therapy, renal failure, bifurcation lesions, and in-stent restenosis as significant correlates of ST (P<0.05). CONCLUSIONS ST continues to be a serious complication of contemporary DES use. Careful management is warranted in patients with renal failure and in those undergoing treatment for in-stent restenosis and bifurcations. Special focus on clopidogrel compliance may minimize the incidence of ST after DES implantation.