The proposed scope of work complements and expands our ongoing grant (5U01 HL33292-17) of the NHLBI """"""""Dynamic Registry,"""""""" which for years has provided objective, """"""""real world"""""""" assessment of the changing practice of percutaneous coronary intervention (PCI). In just 25 years, the practice of PCI has evolved from balloon angioplasty-to directional and rotational coronary atherectomy-to bare-metal stents-to new interventional devices including lasers and therapeutic ultrasound-to intracoronary radiation-to distal protection devices-and most recently to the widely anticipated introduction of drug-eluting stents. These evolutions, which have been accompanied by a 150% increase in PCI procedures in the U.S. in the past 8 years alone, necessitate ongoing evaluation in diverse clinical practices across all patient subgroups, as many promising results observed initially in clinical trials are not realized, or are only marginally realized, in clinical practice. The multi-center Dynamic Registry fulfills this mission, and is the only formal registry of consecutive PCI-treated cases that captures both in-hospital and long-term patient outcomes, while characterizing initial procedural strategy and outcome in great detail on the patient and lesion level. Collectively, more than 7,000 citations have emanated from publications of the NHLBI PCI registries. The present application proposes to: a) continue annual patient follow-up from 3 to 5 years for the 2020 Wave 2 Registry patients who underwent PCI in 1999 (characterized by frequent stent use of varying types); b) perform one-year follow-up on the 2124 Wave 3 Registry patients, and annual follow-up to 5 years on the approximately 150 Wave 3 patients who underwent PCI in 2001/2002 and received the then novel intracoronary radiation therapy; c) enroll and follow annually for 4 years a Wave 4 of 2000 Registry patients who will undergo PCI following the introduction of the much awaited drug-eluting stents into clinical practice; d) enroll and follow for at least one year a Wave 5 of 2000 Registry patients who will undergo PCI at a time when subsequent generations of drug-eluting stents have penetrated clinical practice. As successfully accomplished with all previous waves of patient enrollment, women and minorities will continue to be oversampled in the Registry, as an important study aim is to investigate potential health disparities in clinical practice and outcome by gender, and race/ethnicity, while controlling for socioeconomic status. Finally, we also propose to coordinate a cost effectiveness analysis on the use of drug-eluting stents in a same of Wave 4 registry patients supported through a separate source of funding, and pilot test new data collection forms in the setting of peripheral arterial disease catheter-based interventions. In summary, continued support of the Dynamic Registry Study, which includes an experienced clinical investigative team of leaders in interventional cardiology and collaboration with Coordinating Center investigators to carry out proven, established methods of data collection, management, statistical analysis, manuscript preparation, and information dissemination, will continue to serve the NHLBI and cardiology community at large in objectively evaluating the evolving practice of PCI in diverse real-world clinical settings. We welcome this opportunity.
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