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Advises caution adopting unproven PCI technologies; leaves open optimal trial designs integrating economic and ethical endpoints.
New devices for catheter‐based coronary revascularization provide substantial economic and ethical challenges. It is important for new technologies to undergo rigorous evaluation, and for the outcome assessment to include long‐term follow‐up. The outcome should include medical resource use and economic end points, as well as the traditional clinical measures, so that the cost‐effectiveness of new technology can be assessed. Society must strike a balance between uncontrolled proliferation of new technology and the stifling of innovation by restrictive regulatory and reimbursement policies. The clinical investigator and interventional cardiologist must be aware of the potential of new technology to pose ethical dilemmas, and establish checks and balances to protect against abuses .
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Mark A. Hlatky (1996) studied this question.
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