Successful linkage of French large-scale national registry populations to national reimbursement data: Improved data completeness and minimized loss to follow-up.

BACKGROUND: Registries, a cornerstone of contemporary medicine, frequently suffer from incomplete documentation and losses to follow-up. By linking data to a single-payer national claims database, national registries may be enriched and the quality enhanced. AIMS: To explore the value of data from the French Système National des Données de Santé (SNDS) as a resource to enhance the quality of registries when combined with data from electronic case report forms, and to assess the power to minimize data gaps and losses to follow-up. METHODS: A probabilistic algorithm was developed to link and match records in the SNDS with patient data from the electronic case report forms of two registries on transcatheter aortic valve implantation: FRANCE-2 and FRANCE-TAVI. The algorithm created patient profiles from transcatheter aortic valve implantation procedures in the SNDS, matching them as closely as possible to the profiles in the registry databases. The objective was to achieve 90% linkage of the populations. The linked database was analysed for completeness and loss to follow-up. For validation, mortality curves for the linked registry cohorts were compared with those for the original populations. RESULTS: A total of 34,397 unique registries entries were identified, and 89.9% of patients in the SNDS could be linked. Rates of losses to follow-up over 2 years were 1.0% in the linked FRANCE-TAVI population compared with 40.3% based on electronic case report form documentation. For FRANCE-2, 3-year rates of losses to follow-up were 1.7% and 6.1%, respectively. Mortality curves for populations based on SNDS and electronic case report form data were practically superimposable. CONCLUSIONS: Linking data from a single-payer national claims database to national registries using a probabilistic approach is feasible and can close data gaps and practically abolish losses to follow-up in the registry population.

X-sizer for thrombectomy in acute myocardial infarction improves ST-segment resolution: results of the X-sizer in AMI for negligible embolization and optimal ST resolution (X AMINE ST) trial.

OBJECTIVES: We sought to compare, in a prospective randomized multicenter study, the effect of adjunctive thrombectomy using X-Sizer (eV3, White Bear Lake, Minnesota) before percutaneous coronary intervention (PCI) versus conventional PCI in patients with acute myocardial infarction (AMI) for <12 h and Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1. The primary end point was the magnitude of ST-segment resolution after PCI. BACKGROUND: Despite a high rate of TIMI flow grade 3 achieved by PCI in patients with AMI, myocardial reperfusion remains relatively low. Distal embolization of thrombotic materials may play a major role in this setting. METHODS: We conducted a prospective, randomized, multicenter study in patients with AMI <12 h and initial TIMI flow grade 0 to 1 who were treated with primary PCI. The magnitude of ST-segment resolution 1 h after PCI was the primary end point. RESULTS: A total of 201 patients were included. Treatment groups were comparable by age (61 +/- 13 years), diabetes (22%), previous MI (8%), anterior MI (52%), onset-to-angiogram (258 +/- 173 min), and glycoprotein IIb/IIIa inhibitor use (59%). The magnitude of ST-segment resolution was greater in the X-Sizer group compared with the conventional group (7.5 vs. 4.9 mm, respectively; p = 0.033) as ST-segment resolution >50% (68% vs. 53%; p = 0.037). The occurrence of distal embolization was reduced (2% vs. 10%; p = 0.033) and TIMI flow grade 3 was obtained in 96% vs. 89%, respectively (p = 0.105). Myocardial blush grade 3 was similar (30% vs. 31%; p = NS). Six-month clinical outcome was comparable (death, 6% vs. 4% and major adverse cardiac and cerebral events, 13% vs. 13%, respectively). By multivariate analysis, independent predictors of ST-segment resolution >50% were: younger age, non-anterior MI, use of the X-Sizer, and a short time interval from symptom onset. CONCLUSIONS: Reducing thrombus burden with X-Sizer before stenting leads to better myocardial reperfusion, as illustrated by a reduced risk of distal embolization and better ST-segment resolution.

Twelve month clinical and angiographic outcome after stenting of unprotected left main coronary artery stenosis with paclitaxel-eluting stents--results of the multicentre FRIEND registry.

AIMS: To evaluate the angiographic and clinical outcome of patients undergoing paclitaxel-eluting stent (PES) implantation for unprotected left main coronary artery (ULMCA) stenosis in a multicentre, prospective registry. The overall event rate for PCI of ULMCA disease remains higher than in on-label use making additional outcome data and risk-stratification tools for the ULMCA population desirable. METHODS AND RESULTS: A prospective registry included all patients with a significant (> 50%) stenosis in ULMCA disease. In 151 of these patients the target lesion involved the distal bifurcation in 100 patients (66%), which was treated by predominantly using a "provisional T stenting" strategy. In distal ULMCA disease group, 72% had only one stent implantation while 28% had multiple (either 2 or 3) stents implanted. At a median follow-up of 472 +/- 75 days, cardiac death occurred in 3 patients (2%) and major adverse cardiac and cerebrovascular events (MACCE) in 16 patients (10.6%). CONCLUSIONS: In the drug-eluting stent era, paclitaxel eluting stent implantation of ULMCA stenosis provided excellent immediate and mid-term results in this selected population, suggesting that it may be considered as a safe and effective alternative to CABG for selected patients with ULMCA who are treated in institutions performing large numbers of PCI procedures.

First-in-human feasibility and safety study of a true bifurcated stent for the treatment of bifurcation coronary artery lesions (DBS stent): six month angiographic results and five year clinical follow-up.

AIMS: To evaluate the safety and long-term efficacy of a true dedicated bifurcation bare metal stent (DBS) for the treatment of bifurcation coronary artery lesions. METHODS AND RESULTS: Thirty-four patients were enrolled in this prospective multicentre study. The majority of culprit lesions were located on the left anterior descending artery/diagonal bifurcation (n=19) followed by the distal protected left main (n=7), the left circumflex artery/obtuse marginal (n=4) and the distal right coronary artery/posterior descending artery (n=4). Successful delivery of the DBS stent at the bifurcation site was achieved in 32 patients (94%). Angiographic follow-up at six months was complete in 29 patients (91%). Clinical follow-up was achieved at five years in all DBS patients. There were no cardiac deaths or stent thrombosis. At six months, the MACE rate was 6/32 (19%) and the total binary restenosis rate was 10/29 (34%). MACE at 5 years consisted only in target vessel revascularisation and occurred in eight patients (25%). CONCLUSIONS: The DBS bare metal true bifurcated stent can be delivered successfully and safely in selected bifurcated lesions and has demonstrated long-term efficacy in most patients.

Stenting of bifurcation lesions using the Bestent: a prospective dual-center study.

Treatment of bifurcation lesions remains a technical challenge. Among 13 stents previously tested in a bench study, the Bestent seemed of particular interest in this indication as it provided good access to the side branch after stent implantation in the main branch associated with a satisfactory coverage of the lesion after kissing balloon inflation. The use of Bestent implanted in the main branch or both branches for treatment of bifurcation lesions involving a side branch > or = 2.2 mm in diameter was prospectively evaluated in a dual-center prospective study with a prospective 6-month clinical follow-up. All angiographic documents were analyzed by an independent corelab (CORISIS). Between 11 September 1997 and 21 February 1998, 96 patients were consecutively included (mean age, 63.7 +/- 11.4 years; 81.3% male; 58.3% with unstable angina and 6.3% acute myocardial infarction). The lesion involved the left anterior descending-diagonal coronary bifurcation in 55% of cases, left circumflex-marginal 23%, posterior descending-postero-lateral 12%, distal left main 6%, and others 4%. The main branch (proximal reference diameter: 3.43 +/- 0.45 mm) was stented in 98% of cases and the side branch (2.72 +/- 0.38 mm) in 38% (both branches in 34% of cases). T-stenting or provisional T-stenting was used in 88% of cases and final kissing balloon inflation was performed in 78% of cases. Procedural success was obtained in 100% of cases in the main branch and 98% in both branches. Major cardiac and cerebral events (MACCE) during hospitalization occurred in 4.2% of cases, non-Q-wave myocardial infarction (MI) in 3.1%, Q-wave MI in 1.0%, repeat PTCA in 2.1%; there were no major access site complication, no emergency coronary artery bypass grafting operation, no death. At 6-month follow-up, total MACCE rate was 14.6% (Q-wave MI, 3.1%; non-Q-wave MI, 3.1%; target vessel revascularization, 9.4%; death, 2.1%). Patients with target vessel revascularization (TVR) had restenosis of both branches in 22.2% of cases, main branch in 22.2%, and side branch in 55.6%. This study shows that using a simple strategy of provisional T-stenting of the side branch in the majority of cases, the Bestent can be used for treating bifurcation lesions with a high rate of success and an acceptable rate of TVR at 6-month follow-up.