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James E Tcheng

Publications and source records attributed to James E Tcheng.

At least 19 recordsLinked to original sources
PubMed2004

Double jeopardy of renal insufficiency and anemia in patients undergoing percutaneous coronary interventions.

Anemia and renal insufficiency impart an increased risk of mortality in patients with congestive heart failure. There is a paucity of data on the mortality hazard associated with anemia and renal insufficiency in patients undergoing percutaneous coronary intervention in the setting of contemporary practice. We analyzed the short- and long-term outcomes among patients enrolled in EPIC, EPILOG and EPISTENT trials according to degree of kidney dysfunction (glomerular filtration rate [GFR] <60, 60 to 75, and >75 ml/min/1.73 m2) and by hematocrit (<35, 35 to 39 and 40). GFR was calculated as GFR = 186 x (serum creatinine-1.154) x (age-0.203) x 1.212 (if black) or x 0.742 (if female). There were 20 deaths (3.2%) among 638 patients with a hematocrit of <35, 41 deaths among 2,066 patients (2.0%) with a hematocrit of 35 to 39, and 43 deaths in 3,618 patients (1.2%) with a hematocrit >40 at 6 months (p <0.001). Similarly, a significant increase in mortality was seen with lower GFR [33 of 1,168 (2.9%) at GFR <60, 33 of 1,766 (1.9%) at GFR 60 to 75 and 37 of 3,317 (1.1%) at GFR >75, p <0.001)]. Further, GFR and anemia independently and in combination predicted mortality at 3 years. Thus, renal insufficiency and anemia are significant independent and additive predictors of short- and long-term complications in patients undergoing percutaneous coronary intervention.

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PubMed2004

Impact of intravenous beta-blockade before primary angioplasty on survival in patients undergoing mechanical reperfusion therapy for acute myocardial infarction.

OBJECTIVES: We sought to examine the effect of intravenous beta-blockers administered before primary percutaneous coronary intervention (PCI) on survival and myocardial recovery after acute myocardial infarction (AMI). BACKGROUND: Studies of primary PCI but not thrombolysis have suggested that beta-blocker administration before reperfusion may enhance survival. Whether oral beta-blocker use before admission modulates this effect is unknown. METHODS: The Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial randomized 2082 AMI patients to either stenting or balloon angioplasty, each +/- abciximab. In accordance with the protocol, intravenous beta-blockers were administered before PCI in the absence of contraindications. RESULTS: A total of 1136 patients (54.5%, BB+ group) received beta-blockers before PCI, whereas 946 (45.5%, BB- group) did not. The 30-day mortality was significantly lower in the BB+ group than in the BB- group (1.5% vs. 2.8%, p = 0.03), an effect entirely limited to patients who had not been receiving beta-blockers before admission (1.2% vs. 2.9%, p = 0.007). In contrast, no survival benefit with pre-procedural beta-blockers was observed in patients receiving beta-blockers at home (3.3% vs. 1.9%, respectively, p = 0.47). By multivariate analysis, pre-procedural beta-blocker use was an independent predictor of lower 30-day mortality among patients without previous beta-blocker therapy (relative risk = 0.38 [95% confidence interval 0.17 to 0.87], p = 0.02). The improvement in left ventricular ejection fraction from baseline to seven months was also greater after intravenous beta-blockers (3.8% vs. 1.3%, p = 0.01), an effect limited to patients not receiving oral beta-blockers before admission. CONCLUSIONS: In patients with AMI undergoing primary PCI, myocardial recovery is enhanced and 30-day mortality is reduced with pre-procedural intravenous beta-blockade, effects confined to patients untreated with oral beta-blocker medication before admission.

Adrenergic beta-Antagonists↗
PubMed2004

Importance of mitral regurgitation inpatients undergoing percutaneous coronary intervention for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.

OBJECTIVES: We sought to determine the prognostic importance of mitral regurgitation (MR) in patients undergoing percutaneous coronary intervention for acute myocardial infarction (AMI). BACKGROUND: Mitral regurgitation has been associated with a poor prognosis in patients treated with thrombolytic therapy for AMI. The prognostic significance of MR in patients undergoing mechanical reperfusion therapy for AMI is unknown. METHODS: Left ventriculography was performed during the index procedure in 1,976 (95%) of 2,082 non-shock patients enrolled in a prospective, multicenter, randomized trial of mechanical reperfusion strategies in AMI. The severity of operator-assessed MR was divided into four strata: none (n = 1,726), mild (n = 192), and moderate/severe (n = 58). RESULTS: Patients with progressively more severe MR were older (p < 0.0001), were more often women (p < 0.0001), and had higher Killip class (p = 0.0007). More severe grades of MR correlated with triple-vessel disease (p < 0.0001) and lower left ventricular ejection fraction (LVEF) as measured during the index procedure (p = 0.0004). Increasingly severe MR was strongly associated with a higher mortality at 30 days (1.4% vs. 3.7% vs. 8.6%, respectively; p < 0.0001) and at one year (2.9%, 8.5%, 20.8%, respectively; p < 0.0001). By multivariate analysis, the presence of even mild MR was an independent predictor of long-term mortality (mild MR, relative risk [RR] = 2.40, p = 0.005; moderate/severe MR, RR = 2.82, p = 0.006). CONCLUSIONS: Mitral regurgitation of any degree present on the baseline left ventriculogram during the index procedure is a powerful, independent predictor of mortality in patients undergoing mechanical reperfusion therapy for AMI. The presence of MR identifies high-risk patients in whom close out-patient follow-up is warranted, and who may benefit from aggressive adjunctive medical or surgical therapies.

Abciximab↗
PubMed2004

Final results of the ReoPro readministration registry.

Because of its potential for antigenicity, theoretical concerns related to readministration of abciximab have been raised. We conducted the ReoPro Readministration Registry to assess the efficacy and safety of abciximab readministration. A total of 1,342 patients who underwent percutaneous coronary intervention and who received abciximab for at least a second time were recruited. Safety end points were hypersensitivity reactions, major bleeding, and thrombocytopenia (TCP). Human antichimeric antibody (HACA) titers were determined before and after readministration. Procedural success was 98% and was not influenced by the number of courses of abciximab or the presence of HACA. There were no cases of anaphylaxis. There were 5 minor allergic reactions, none of which required termination of the infusion. Clinically significant bleeding occurred in 31 patients (2.3%), including 1 (0.07%) with intracranial hemorrhage. TCP (<100 x 10(9)/L) developed in 5% of patients; profound TCP (<20 x 10(9)/L) occurred in 2%. In patients who received abciximab within 1 month of a previous treatment (n = 115), the risk of developing TCP and profound TCP was 16.5% and 12.2%, respectively. Having a positive HACA before readministration was not correlated with adverse clinical outcomes or bleeding, but was associated with TCP (14.1% vs 4.4%, p = 0.002) and profound TCP (5.6% vs 1.6%, p = 0.036). Readministration of abciximab can be accomplished without severe allergic responses and with a bleeding and efficacy profile similar to first-time administration. However, the rate of severe and profound TCP is increased relative to first-time administration, particularly when the time between treatments is <30 days or when HACA is present.

Abciximab↗
PubMed2004

Relation between late patency of the infarct-related artery, left ventricular function, and clinical outcomes after primary percutaneous intervention for acute myocardial infarction (CADILLAC trial).

The importance of sustained patency of the infarct-related artery after primary percutaneous coronary intervention for acute myocardial infarction is controversial. We examined serial measures of left ventricular function and clinical outcomes in 280 patients with an initially occluded infarct artery in whom Thrombolysis In Myocardial Infarction trial grade 3 flow was achieved and routine follow-up angiography was performed 7 months after percutaneous coronary intervention. Reocclusion of the infarct artery was associated with decreased event-free survival, and the degree of restenosis was an independent predictor of the lack in improvement in left ventricular ejection fraction over time.

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PubMed2004

Improved clinical outcomes with abciximab therapy in acute myocardial infarction: a systematic overview of randomized clinical trials.

BACKGROUND: Investigations of glycoprotein (GP) IIb/IIIa inhibition in primary percutaneous coronary intervention (PCI) have suggested the efficacy of abciximab in improving clinical and angiographic outcomes, but sample-size limitations and variability in trial design preclude the ability to generalize these results to a broader patient population. METHODS: Meta-analytic techniques were used to evaluate clinical outcomes from randomized trials comparing GP IIb/IIIa inhibition with placebo or control therapy in primary PCI for acute myocardial infarction (MI). RESULTS: In 3266 patients, treatment with abciximab significantly reduced the 30-day composite end point of death, reinfarction, or ischemic or urgent target-vessel revascularization (TVR; odds ratio [OR], 0.54; 95% CI, 0.40-0.72), with trends toward reduced 30-day death and death or reinfarction. Abciximab resulted in an increased likelihood of major bleeding (OR, 1.74; 95% CI, 1.11-2.72). By 6 months, abciximab significantly reduced the occurrence of death, reinfarction, or any TVR (OR, 0.80; 95% CI, 0.67-0.97), and there were positive trends favoring a decrease in mortality alone and the composite of death or reinfarction. CONCLUSIONS: Treatment with abciximab significantly reduces early adverse ischemic events, a clinical benefit that is maintained at 6-month follow-up. These findings support the use of adjunctive GP IIb/IIIa inhibition in primary PCI.

Abciximab↗
PubMed2004

Impact of ST-segment resolution after primary angioplasty on outcomes after myocardial infarction in elderly patients: an analysis from the CADILLAC trial.

BACKGROUND: Age is a strong independent predictor of outcomes after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Whether lower rates of reperfusion success contribute to the poor prognosis in elderly patients is unknown. METHODS: A formal ST-segment analysis substudy was performed in 695 patients undergoing primary PCI for AMI in the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial. Reperfusion success (determined by the magnitude of ST-segment elevation resolution [STR] after PCI) was evaluated in 4 age groups: <50 years (n = 163), >or=50 to <60 years (n = 187), >or=60 to <70 years (n = 194), and >or=70 years (n = 151). RESULTS: There were no differences in the age groups for angiographic procedural success (>91% in all, P =.6), postprocedural Thrombolysis in Myocardial Infarction grade 3 flow (>94%, P =.8), and the proportions of patients with complete, partial, or absent STR (P >.8). However, rates of 30-day mortality (0.6%, 1.1%, 3.6%, 6.0%, respectively) and major adverse cardiac events (MACE; 2.5%, 4.8%, 6.2% 9.3%, respectively) increased with age. Rates of mortality and MACE were also inversely related to the magnitude of STR. Absent STR (hazard ratio, 3.00; 95% CI, 1.37-6.58; P =.006) and age (hazard ratio, 1.34; 95% CI, 1.01-1.77; P =.04) were independent predictors of 30-day MACE by using multivariable modeling. CONCLUSIONS: Lack of effective myocardial reperfusion is not a contributory mechanism responsible for the high morbidity and mortality rates observed in elderly patients. Nevertheless, advanced age and absent STR are both independent predictors of adverse outcomes after primary PCI, emphasizing the importance of successful reperfusion in the elderly population.

Abciximab↗
PubMed2004

Incidence and predictors of major vascular complications after percutaneous coronary intervention in the glycoprotein IIb/IIIa platelet inhibitor era.

Since the introduction of platelet glycoprotein (GP) IIb/IIIa inhibitors, reports of vascular complications after percutaneous coronary intervention (PCI) have focused on bleeding and the need for surgical repair, whereas specific major vascular complications have been less consistently identified. Moreover, data from clinical trials may lack applicability to the general population. The purpose of this study was to determine the incidence of major vascular complications after PCI and to identify associated risk factors in patients routinely receiving GP IIb/IIIa inhibitors. During a 12-month period, 1,634 consecutive patients underwent PCI at a single institution. Clinical characteristics and procedural data were collected prospectively; data regarding vascular sheath removal were obtained retrospectively. Univariate and multivariable regression methods were used to identify independent predictors of major vascular complications. Major vascular complications occurred in 2.9% of patients. Multivariable analysis revealed advanced age (odds ratio [OR] 1.05, P = 0.0025) and female sex (OR 2.9, P = 0.0002) as clinical characteristics associated with major vascular complications, whereas hypertension had an inverse relationship (OR 0.46, P = 0.013). Procedural factors included use of the following: stents (OR 5.59, P < 0.0001), vascular sheaths >6F (OR 3.25, P = 0.016), and mechanical clamp (OR 2.71, P = 0.0012). The presence of a hematoma >4 cm(2) had a positive predictive value of 12% for major vascular complications. The incidence of major vascular complications in this large, single-center study from the GP IIb/IIIa inhibitor era is consistent with data from the pre-GP IIb/IIIa inhibitor era and recent randomized trials.

Abciximab↗
PubMed2003

Impact of renal insufficiency in patients undergoing primary angioplasty for acute myocardial infarction.

BACKGROUND: The prognostic importance of renal insufficiency (RI) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) has not been well characterized. METHODS AND RESULTS: PCI was performed in 2082 AMI patients without shock presenting within 12 hours of symptom onset in a prospective, multicenter randomized trial. RI was defined as a calculated (Cockroft-Gault) creatinine clearance (CrCl) < or =60 mL/min. RI at baseline was present in 18% of patients. Compared with patients without RI, patients with RI were older and were more likely to be female; to have hypertension, peripheral vascular disease, or cerebrovascular disease; and to present in heart failure. Mortality was markedly increased in patients with versus without baseline RI both at 30 days (7.5% versus 0.8%, P<0.0001) and at 1 year (12.7% versus 2.4%, P<0.0001). Mortality rates increased incrementally for every 10-mL/min decrease in baseline CrCl. By multivariate analysis, reduced baseline CrCl was a powerful independent predictor of 30-day mortality (hazard ratio, 5.77; P<0.0001) and remained associated with reduced survival at 1 year (hazard ratio, 1.98; P=0.08). Hemorrhagic complications and transfusion requirements were also increased more than 2-fold in patients with RI, as were severe restenosis (diameter stenosis > or =70%; 20.6% versus 11.8%, P=0.024) and infarct artery reocclusion (14.7% versus 7.3%, P=0.02). CONCLUSIONS: Baseline RI in patients with AMI undergoing primary PCI is associated with a markedly increased risk of mortality, as well as bleeding and restenosis. Novel approaches are needed to improve the otherwise poor prognosis of patients with RI and AMI.

Abciximab↗
PubMed2003

Cost-effectiveness of coronary stenting and abciximab for patients with acute myocardial infarction: results from the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) trial.

BACKGROUND: Both stenting and the glycoprotein IIb/IIIa inhibitor abciximab improve outcomes for patients undergoing primary angioplasty for acute myocardial infarction (AMI). However, the cost-effectiveness of these strategies is unknown. METHODS AND RESULTS: We performed a prospective cost-utility analysis among US participants in the CADILLAC trial. Patients with AMI (n=1703) were randomized to stenting versus balloon angioplasty (PTCA) and abciximab versus no abciximab according to a 2-by-2 factorial design. Total 1-year costs and lifetime incremental cost-effectiveness ratios, measured as cost per quality-adjusted year of life (QALY) gained, were calculated. Compared with PTCA, stenting increased procedural costs by 1148 dollars and initial hospital costs by 1384 dollars (both P<0.001). By 1-year, stenting led to fewer repeat revascularization procedures and reduced follow-up medical care costs by 1215 dollars, such that aggregate costs were similar for the PTCA and stent groups (18 690 dollars versus 18 859 dollars, P=0.75). The cost-effectiveness ratio for stenting versus PTCA was favorable at 11 237 dollars/QALY gained and remained <20 000 dollars/QALY in sensitivity analyses. Compared with standard anticoagulation, abciximab increased initial procedural costs by 1122 dollars (P<0.001). By facilitating accelerated hospital discharge, abciximab reduced length of stay by approximately 0.6 days, offsetting most of the drug costs. These cost offsets were not maintained, however; aggregate 1-year costs for the abciximab group were 1244 dollars greater than for standard therapy (19 389 dollars versus 18 145 dollars , P=0.02). Abciximab was reasonably cost-effective (cost-effectiveness ratio 21 305 dollars/QALY) only if nonsignificant differences in 1-year mortality (3.7% versus 4.3%, P=0.62) were incorporated in the analysis. CONCLUSIONS: Primary stenting is a highly cost-effective treatment for AMI. The cost-effectiveness of abciximab in this setting is uncertain and depends primarily on whether long-term survival is enhanced.

Abciximab↗
PubMed2003

Outcomes following bail-out abciximab administration during primary intervention in acute myocardial infarction (The CADILLAC Trial).

The utility of glycoprotein IIb/IIIa receptor inhibitors as a "bail-out" modality after unsuccessful primary percutaneous coronary intervention for acute myocardial infarction is unknown. In the CADILLAC trial, of 1,030 control patients, 62 patients (6.0%) crossed over and received abciximab for procedural complications or suboptimal angioplasty results. Compared with patients who received routine upfront abciximab, those treated with bail-out abciximab had markedly lower rates of Thrombolysis In Myocardial Infarction grade 3 flow and increased rates of hemorrhagic and ischemic complications at 30 days and 1 year.

Abciximab↗
PubMed2003

Outcomes of bail-out stenting for suboptimal balloon angioplasty during primary intervention in acute myocardial infarction (The CADILLAC trial).

The results of bail-out stenting after unsuccessful primary balloon angioplasty compared with routine stenting or successful balloon angioplasty in acute myocardial infarction are unknown. In the CADILLAC trial, 168 of 1,044 patients (16.1%) randomized to balloon angioplasty crossed over to stenting after unsuccessful dilatation. Event-free survival was similar after bail-out and routine stenting, and was greater than after successful balloon angioplasty.

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PubMed2003

Feasibility and implications of an early discharge strategy after percutaneous intervention with abciximab in acute myocardial infarction (the CADILLAC Trial).

Early complications may hamper efforts to hasten discharge after primary percutaneous coronary intervention (PCI) for myocardial infarction (MI). Glycoprotein IIb/IIIa inhibitors, by reducing early recurrent ischemia, may aid in these efforts. We examined whether adjunctive abciximab could accelerate discharge and reduce costs within a trial of primary PCI after acute MI. The CADILLAC trial randomized 2,082 patients with MI to 1 of 4 reperfusion strategies in a 2 x 2 factorial design: angioplasty, angioplasty with abciximab, stent implantation, or stenting with abciximab. Patients randomized to abciximab had postprocedural heparin withheld, and discharge scheduled for days 1.5 to 2 (low-risk patients) or days 2 to 3 (high-risk patients) after MI if they were stable. Other patients were discharged at the physician's discretion. Abciximab treatment was associated with significant reductions in the primary end points of in-hospital death, reinfarction, ischemic target vessel revascularization (TVR), or disabling stroke (5.6% vs 2.7%, p = 0.003)--largely reflecting reduced ischemic TVR (3.8% vs 1.4%, p = 0.002)--and in early subacute thrombosis (1.3% vs 0.2%, p = 0.01). Hospitalization was significantly shorter in abciximab-treated patients (median 3.1 vs 3.5 days, p <0.001), but total in-hospital costs did not differ significantly (13,413 +/- 5,309 US dollars vs 13,000 +/- 6,006 US dollars, p = 0.13). Rates of the composite end point did not differ significantly during the week after discharge (0.8% vs 0.2%, p = 0.10), nor did component event rates. Abciximab during primary PCI is associated with fewer early adverse outcomes, likely contributing to offset its cost. Hospitalizations after primary PCI are so short, however, that efforts to accelerate discharge with abciximab appear unfeasible, and overall costs remain unchanged.

Abciximab↗
PubMed2003

Outcomes of optimal or "stent-like"balloon angioplasty in acutemyocardial infarction: the CADILLAC trial.

OBJECTIVES: We sought to compare outcomes between patients with acute myocardial infarction (AMI) undergoing percutaneous transluminal coronary angioplasty (PTCA) with an optimal or "stent-like" result versus patients who underwent routine stent placement. BACKGROUND: Recent studies in patients with AMI undergoing stent implantation have suggested that PTCA may no longer be a relevant treatment modality for stent eligible lesions. However, whether routine stent placement is superior or necessary when an optimal PTCA or "stent-like" result is achieved is unknown. METHODS: In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial, 2,082 patients with AMI were randomly assigned to undergo PTCA alone, PTCA + abciximab, stenting alone, or stenting + abciximab. Outcomes were compared in patients achieving an optimal acute PTCA result (residual core laboratory diameter stenosis <30% without significant dissection) versus those assigned to routine stenting. RESULTS: Optimal PTCA was achieved in 40.7% of patients randomized to balloon angioplasty, including 38.5% and 42.7% assigned to PTCA alone and PTCA + abciximab, respectively. Ischemic target vessel revascularization (TVR) at 30 days occurred more frequently after optimal PTCA than routine stenting (5.1% vs. 2.3%, p = 0.007). The one-year composite adverse event rate (death, reinfarction, disabling stroke, or TVR) was greater after optimal PTCA than routine stenting (21.9% vs. 13.8%, p < 0.001), driven largely by increased rates of ischemic TVR (19.1% vs. 9.1%, p < 0.001); no significant differences were present in the rates of death, reinfarction, or disabling stroke between the two groups. Angiographic restenosis also was more common with optimal PTCA than routine stenting (36.2% vs. 22.2%, p = 0.003). Even a post-PTCA diameter stenosis of <20% (realized in 12% of patients) did not result in outcomes equivalent to stenting. CONCLUSIONS: Even if an optimal result is achieved after primary PTCA in AMI, early and late outcomes can be further improved with routine stent implantation.

Abciximab↗
PubMed2003

A novel point-of-care enoxaparin monitor for use during percutaneous coronary intervention. Results of the Evaluating Enoxaparin Clotting Times (ELECT) Study.

OBJECTIVES: The aim of this study was to discern a target range of anticoagulation for enoxaparin during percutaneous coronary intervention (PCI) as measured by the Rapidpoint ENOX (Pharmanetics Inc., Morrisville, North Carolina), a new point-of-care test. BACKGROUND: In the U.S., enoxaparin has been used in only a small proportion of PCI procedures, partly because a rapid enoxaparin-specific assay was unavailable. METHODS: We analyzed data from 445 enrolled patients receiving subcutaneous or intravenous enoxaparin in a prospective, multicenter study. Serial anticoagulation measurements and clinical outcomes were recorded. RESULTS: The in-hospital composite occurrence of death, myocardial infarction, and urgent target vessel revascularization was 5.4%, and Thrombolysis In Myocardial Infarction (TIMI) major bleeding, minor bleeding, and any reported bleeding occurred in 0.2%, 1.3%, and 7.9% of patients, respectively. No significant association between procedural ENOX times and ischemic events was observed (p = 0.222), although the event rate was 4.0% among those with ENOX times between 250 to 450 s versus 7.2% for those outside this range (p = 0.134). Increasing ENOX time at sheath removal was correlated with any bleeding (p = 0.010) with a 1% increase for every approximately 30-s rise. CONCLUSIONS: Ischemic events were infrequent, and the rate appeared lowest in the mid-range of ENOX times. Bleeding events increased with increasing ENOX times. These observations, combined with a suggested procedural anti-Xa level of 0.8 to 1.8 IU/ml, translate into a recommended ENOX time range of 250 to 450 s for PCI and <200 to 250 s for sheath removal.

Angioplasty, Balloon, Coronary↗
PubMed2003

Meta-analysis of survival with platelet glycoprotein IIb/IIIa antagonists for percutaneous coronary interventions.

We performed a cumulative meta-analysis of available studies to evaluate the effect of intravenous platelet glycoprotein (GP) IIb/IIIa antagonists on survival at 30 days and 6 months after percutaneous coronary intervention (PCI). Compounds that block the GP IIb/IIIa receptor substantially reduce myocardial infarctions (MIs) and repeat revascularization. We included 12 trials, which enrolled 20,186 patients in all, in the analysis. Overall, 30-day mortality was significantly reduced with GP IIb/IIIa inhibition (odds ratio 0.73, 95% confidence interval 0.55 to 0.96, p = 0.024). Although 10 of the 12 trials showed a beneficial effect of GP IIb/IIIa inhibitor treatment on mortality, no individual trial detected a statistically significant mortality benefit. The 30-day mortality benefit became significant at the p <0.05 level with addition of the ADMIRAL trial and was further enhanced by the CADILLAC trial. No significant heterogeneity was detected in the collection of trials. At 6 months, the odds ratio was 0.84 (95% confidence interval 0.69 to 1.03, p = 0.087). This survival benefit amounts to preventing approximately 1 of every 3 deaths that occur within 30 days after PCI, saving 2.8 lives/1,000 patients treated (number needed to treat, 357). Thus, patients who undergo PCI can expect significantly lower 30-day mortality, in addition to known reductions in nonfatal MI and repeat procedures, with GP IIb/IIa inhibition. There also is increasing evidence that mortality reductions are preserved at 6 months.

Angioplasty, Balloon, Coronary↗
PubMed2003

Reduction of myocardial ischemic injury following coronary intervention (the MC-1 to Eliminate Necrosis and Damage trial).

Myocardial ischemic injury complicating acute myocardial infarction (AMI) and coronary revascularization procedures remains an unresolved clinical dilemma. In preclinical studies, treatment with pyridoxal-5'-phosphate monohydrate (MC-1), a vitamin B6 metabolite, has demonstrated cardioprotective effects. Sixty patients scheduled for elective percutaneous coronary intervention (PCI) who had clinically high-risk characteristics for ischemic complications were randomized to treatment with MC-1 or placebo in a 2:1 double-blinded fashion. The primary end point was defined as infarct size as measured by area under the curve creatine kinase MB (CK-MB) enzymes. Secondary end points included periprocedural ischemia as assessed by continuous electrocardiographic monitoring, 30-day major adverse cardiac events, and net clinical safety, which included liver function testing. The primary end point, median periprocedural CK-MB area under the curve, was reduced from 32.9 ng/ml in the placebo group to 18.6 ng/ml with MC-1 treatment (p = 0.038), reflecting a shift in the distribution of CK-MB. By categorical classification, the occurrence of 30-day nonfatal AMI did not differ between groups. There were no deaths, and 30-day composite adverse event rates were similar (17.9% MC-1 vs 15.0% placebo, p = 1.0). There were no significant differences in ischemia parameters per continuous electrocardiographic monitoring, and no safety issues were identified. In this phase II pilot study, treatment of high-risk patients who underwent PCI with MC-1 was associated with a decrease in the total amount of CK-MB released after PCI. These results support the evaluation of MC-1 in pivotal trials of patients at risk for developing myocardial ischemia, infarction, or reperfusion injury.

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