Comparison of three diagnostic strategies for suspicion of pulmonary embolism: planar ventilation/perfusion scan, CT pulmonary angiography and single-photon emission CT ventilation/perfusion scan - a multicentre, non-inferiority randomised controlled trial.

Methods

We conducted a non-inferiority randomised trial comparing SPECT V/Q-, computed tomography pulmonary angiography (CTPA)- and planar V/Q-based diagnostic strategies using a 2:1:1 allocation.

我们进行了一项非劣效性随机试验，比较了基于SPECT V/Q、计算机断层扫描肺动脉造影（CTPA）和传统平面V/Q的诊断策略，采用2:1:1的分配比例。

The primary end-point was the 3-month risk of venous thromboembolism (VTE) in untreated patients with a negative workup, comparing SPECT V/Q to the combined CTPA and planar V/Q arms.

主要终点是未经治疗、检查结果为阴性的患者在3个月内发生静脉血栓栓塞（VTE）的风险，比较SPECT V/Q与CTPA和计划V/Q的联合使用。

A non-inferiority margin of 1% absolute difference in 3-month VTE risk was defined.

定义了3个月VTE风险的非劣效性边界为1%的绝对差异。

Secondary outcomes included PE diagnosis rates.

次要结果包括肺栓塞诊断率。

The trial ended prematurely in October 2024 due to slow recruitment and funding limitations.

由于招募缓慢和资金限制，该试验于2024年10月提前结束。

Results

From July 2017 to October 2024, 603 patients were randomised.

从2017年7月到2024年10月，共有603名患者被随机分配。

PE was diagnosed in 61/303 (20.1%) in the SPECT V/Q arm, 31/150 (20.7%) in the CTPA arm and 24/150 (16.0%) in the planar V/Q arm.

在SPECT V/Q组中，61/303（20.1%）的患者被诊断为PE，在CTPA组中，31/150（20.7%）的患者被诊断为PE，而在平面V/Q组中，24/150（16.0%）的患者被诊断为PE。

The 3-month VTE risk in patients left untreated after a negative workup was 0.5% (1/221) for SPECT V/Q, 0.0% (0/107) for CTPA and 0.8% (1/118) for planar V/Q.

在阴性检查结果后未接受治疗的患者中，3个月静脉血栓栓塞（VTE）风险对于SPECT V/Q为0.5%（1/221），CTPA为0.0%（0/107），平面V/Q为0.8%（1/118）。

The difference in outcome between SPECT V/Q and the combined arms was 0.0% (95% CI -1.2-1.3%).

SPECT V/Q与联合组之间的结果差异为0.0%（95% 置信区间 -1.2-1.3%）。

Conclusions

After being prematurely discontinued, this randomised trial did not demonstrate the non-inferiority of a SPECT V/Q-based strategy to reference standards for PE diagnosis.

在提前终止后，这项随机试验未能证明基于SPECT V/Q的策略在PE诊断上与参考标准相比具有非劣效性。

However, the results suggest a low 3-month VTE risk in patients managed using a SPECT V/Q-based diagnostic strategy.

然而，结果表明，采用基于SPECT V/Q的诊断策略管理的患者在3个月内的VTE风险较低。

Among patients with clinically suspected acute PE requiring chest imaging, a SPECT V/Q-based algorithm might be a reliable alternative in clinical practice.

在需要胸部成像的临床怀疑急性肺栓塞患者中，基于SPECT V/Q的算法可能是临床实践中一个可靠的替代方案。