One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial.

OBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study. DESIGN: Multicentre, double blind, randomised trial. SETTING: Percutaneous coronary intervention for single de novo coronary lesions. PATIENTS: 238 patients with stable or unstable angina. INTERVENTIONS: Randomisation to sirolimus eluting stent or bare stent implantation. MAIN OUTCOME MEASURES: Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs. RESULTS: At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of 1286. At one year, however, the estimated additional cost difference had decreased to 54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at 166. CONCLUSIONS: The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined.

Elevated troponin T and C-reactive protein predict impaired outcome for 4 years in patients with refractory unstable angina, and troponin T predicts benefit of treatment with abciximab in combination with PTCA.

AIMS: Treatment with the glycoprotein IIb/IIIa receptor antagonist abciximab before and during coronary intervention in refractory unstable angina improves early outcome. We collected 4-year follow-up data to assess whether this benefit is sustained. Additionally, we investigated the predictive value of baseline troponin T and CRP for long-term cardiovascular events. METHODS AND RESULTS: Of 1265 patients enrolled in the CAPTURE trial follow-up was available in 94% of the patients alive after 6 months (median 48 months). Survival was similar in both groups. Both elevated troponin T and CRP were associated with impaired outcome, independently of other established risk factors, but with a different time course. Elevated troponin was associated with increased procedure related risk, and elevated CRP with increased risk for subsequent events. Lower rates of the composite end-point of death or myocardial infarction with abciximab vs. placebo were sustained during long-term follow up: 15.7% vs 17.2% at 4 years (P=ns), particularly in patients with elevated troponin T: 16.9% with abciximab vs 28.4% with placebo: P=0.015. Elevated CRP was not associated with specific benefit of abciximab. CONCLUSION: Troponin T as a marker of thrombosis and CRP as a marker of inflammation are independent predictors of impaired outcome at 4 years follow-up. The initial benefit from abciximab with regard to death and myocardial infarction was preserved at 4 years. No specific benefit with abciximab was observed for patients with elevated CRP, suggesting that a chronic inflammatory process is not affected by abciximab. In contrast the benefit of treatment in patients with elevated troponin T implies that the acute thrombotic process in refractory unstable angina is treated effectively.

Platelet GP IIb/IIIa receptor blockers for failed thrombolysis in acute myocardial infarction, alone or as adjunct to other rescue therapies; single centre retrospective analysis of 548 consecutive patients with acute myocardial infarction.

In order to study the safety of 'rescue' strategies in the treatment of patients with failed thrombolysis, all 548 patients admitted with evolving myocardial infarction to the Thoraxcenter, Rotterdam, from January 1997 until April 1999 were reviewed. Of these patients, 49% had received thrombolysis. Of patients treated with thrombolysis and not referred from other hospitals (n = 154) 36% received rescue therapy for failed thrombolysis. Three rescue therapies were used after failed thrombolysis: percutaneous coronary intervention (74%), retreatment with thrombolysis (39%) and platelet glycoprotein (GP) IIb/IIIa receptor blockers (53%), often in combination. Platelet GP IIb/IIIa receptor blockers were administered in 64% of patients treated with rescue percutaneous coronary intervention. Major bleeding occurred in 14% of all thrombolysis treated patients, and in 30% of patients who received multiple rescue therapies. Bleeding was related to heparin usage and platelet GP IIb/IIIa receptor blockers, as was the insertion of catheters for percutaneous coronary intervention or intra-aortic balloon pumps. Major bleeding resulted in one death due to a ruptured ventricle, one haemorrhagic stroke, and three cases of tamponade for which surgery was needed. Four of these patients had received combination rescue therapy. Rescue therapy is a widely used strategy for failed thrombolysis, but is associated with a high bleeding rate. Alternative reperfusion strategies to avoid failed thrombolysis should be considered in high risk patients.